P-III

Coherus and Junshi Present Interim Results of Toripalimab in P-III JUPITER-06 Trial as 1L Treatment for Advanced Esophageal Squamous Cell Carcinoma at ESMO 2021

Shots: The P-III JUPITER-06 trial evaluates toripalimab + CT vs PBO + CT in a ratio (1:1) in 514 treatment-naive patients with advanced or metastatic ESCC The study met its co-primary 1EPs i.e., improvements in PFS & OS compared to CT alone. At a prespecified interim analysis on Mar 22, 2021 @median follow-up of 7.4 …

Coherus and Junshi Present Interim Results of Toripalimab in P-III JUPITER-06 Trial as 1L Treatment for Advanced Esophageal Squamous Cell Carcinoma at ESMO 2021 Read More »

BMS Reports Five-Year Data of Opdivo (nivolumab) + Yervoy (ipilimumab) in P-III CheckMate -214 for the Treatment of Advanced or Metastatic Renal Cell Carcinoma

Shots: The P-III CheckMate -214 trial evaluates Opdivo (3mg/kg) + Yervoy (1mg/kg, q3w for 4 doses) vs sunitinib in 1096 patients with previously untreated advanced/mRCC Results: @median follow-up of 67.7mos., combination showed superior OS in intermediate, poor risk patients & randomized or ITT population; m-OS (47.0 vs 26.6mos.) & (55.7 vs 38.4mos.); ORR (42% vs …

BMS Reports Five-Year Data of Opdivo (nivolumab) + Yervoy (ipilimumab) in P-III CheckMate -214 for the Treatment of Advanced or Metastatic Renal Cell Carcinoma Read More »

Coherus and Junshi Present Interim Results of Toripalimab in P-III CHOICE-01 Trial as 1L Treatment for Non-Small Cell Lung Cancer at WCLC 2021

Shots: The P-III CHOICE-01 trial evaluates toripalimab + CT vs CT alone in 465 patients in a ratio (2:1) with advanced sq./nonsq. NSCLC without driver mutations The interim analysis met its 1EPs i.e., improvement in PFS, superior ORR & DoR, OS data are still maturing. The safety profile was consistent with PD-1 inhibitor while final …

Coherus and Junshi Present Interim Results of Toripalimab in P-III CHOICE-01 Trial as 1L Treatment for Non-Small Cell Lung Cancer at WCLC 2021 Read More »

BMS Reports Three-Year Data of Opdivo (nivolumab) + Yervoy (ipilimumab) in P-III CheckMate -743 Trial for 1L Treatment of Unresectable Malignant Pleural Mesothelioma

Shots: The P-III CheckMate -743 trial evaluates Opdivo (3mg/kg, q2w) + Yervoy (1mg/kg, q6w) vs CT in 605 patients with previously untreated unresectable MPM. The results will be presented at ESMO 2021 The result showed an improvement in OS with a reduction in risk of death, patients were alive (23% vs 15%) @3yrs., improvement in …

BMS Reports Three-Year Data of Opdivo (nivolumab) + Yervoy (ipilimumab) in P-III CheckMate -743 Trial for 1L Treatment of Unresectable Malignant Pleural Mesothelioma Read More »

AstraZeneca Presents Results of Imfinzi (durvalumab) + Tremelimumab in P-III POSEIDON Study as 1L Treatment for Stage IV NSCLC at WCLC 2021

Shots: The P-III POSEIDON trial evaluates Imfinzi (1500mg, q3w, FD, for 4 cycles) + Pt-based CT or Imfinzi + Tremelimumab + CT vs CT alone in 1013 patients with mNSCLC The results showed an improvement in OS & PFS, 28% reduction in risk of cancer progressing or death with an m-PFS (6.2 vs 4.8mos.), 23% …

AstraZeneca Presents Results of Imfinzi (durvalumab) + Tremelimumab in P-III POSEIDON Study as 1L Treatment for Stage IV NSCLC at WCLC 2021 Read More »

Samsung Bioepis Reports Results of Post-Hoc Analysis from P-III Study of Byooviz (biosimilar, ranibizumab) for the Treatment of nAMD

Shots: The P-III study evaluates Byooviz (0.5 mg, IVT) vs ranibizumab in 634 patients with nAMD. The results will be presented at EURETINA 2021 The 1EPs are changed from baseline in BCVA @8wks. and change in CST @4wks. with both EPs, followed by 52wks. The post-hoc analysis showed that the baseline age, BCVA, CST, and …

Samsung Bioepis Reports Results of Post-Hoc Analysis from P-III Study of Byooviz (biosimilar, ranibizumab) for the Treatment of nAMD Read More »

Dermavant Reports the First Patient Dosing in P-III ADORING Program of Tapinarof for the Treatment of Atopic Dermatitis

Shots: The first patient has been dosed in a P-III program that consists of P-III ADORING 1/2 and long-term extension ADORING 3 study evaluates the safety and efficacy of tapinarof (1% dosed, qd) vs vehicle-controlled cream in patients aged ≥2yrs. with AD The 1EPs of ADORING 1/2 studies will be the proportion of patients achieving …

Dermavant Reports the First Patient Dosing in P-III ADORING Program of Tapinarof for the Treatment of Atopic Dermatitis Read More »

AstraZeneca Reports Results of PT027 (albuterol and budesonide) in P-III MANDALA and DENALI Trials for the Treatment of Asthma

Shots: The P-III MANDALA & DENALI trial evaluates the efficacy & safety of PT027 (180/160mcg & 180/80mcg doses) vs albuterol & albuterol and budesonide aged ≥4yrs. in 3132 & 1001 patients with asthma Both trials met its 1EPs i.e., reductions in risk of severe exacerbations in the MANDALA trial, improvement in lung function as measured …

AstraZeneca Reports Results of PT027 (albuterol and budesonide) in P-III MANDALA and DENALI Trials for the Treatment of Asthma Read More »

Sanofi Provides Update on P-III PEGASUS Trial of Rilzabrutinib for the Treatment of Pemphigus

Shots: The P-III PEGASUS trial evaluates pemphigus (BTK inhibitor) vs PBO in 131 patients with newly diagnosed or relapsing mod. to sev. pemphigus in 19 countries globally The trial did not meet its 1EPs or 2EPs i.e., complete remission from 29 to 37wks. with minimal doses of CS (≤10/mg day). The safety profile remained consistent …

Sanofi Provides Update on P-III PEGASUS Trial of Rilzabrutinib for the Treatment of Pemphigus Read More »

AstraZeneca and Hutchmed Initiate P-III SANOVO Trial for Orpathys (savolitinib) + Tagrisso (osimertinib) as a 1L Therapy for Non-small Cell Lung Cancer in China

Shots: The companies initiate P-III SANOVO study to evaluates the efficacy & safety of Orpathys in combination with AstraZeneca’s Tagrisso (irreversible EGFR TKI) vs Tagrisso alone in patients with NSCLC whose tumors harbor EGFR mutation and overexpress MET. The first patient was dosed on Sept 7, 2021 The 1EPs of the study is m-PFS as …

AstraZeneca and Hutchmed Initiate P-III SANOVO Trial for Orpathys (savolitinib) + Tagrisso (osimertinib) as a 1L Therapy for Non-small Cell Lung Cancer in China Read More »

Takeda’s Pevonedistat Fails to Meet Primary Endpoints in P-III PANTHER Trial as 1L Treatment for Patients with Rare Bone Marrow Cancer

Shots: The P-III PANTHER trial evaluates pevonedistat + azacitidine vs azacitidine alone in patients with higher-risk MDS, CMML and AML The study did not achieve its pre-defined 1EPs of EFS, the safety profile was consistent with previously reported data of the combination regimen Pevonedistat is an NAE inhibitor that leads to cancer cell death by …

Takeda’s Pevonedistat Fails to Meet Primary Endpoints in P-III PANTHER Trial as 1L Treatment for Patients with Rare Bone Marrow Cancer Read More »

Bayer Initiates P-III OASIS Program of Elinzanetant for the Treatment of Vasomotor Symptoms During Menopause

Shots: The company initiates P-III OASIS program to evaluate the efficacy and safety of elinzanetant (120mg, qd) in 1300 patients with vasomotor symptoms during menopause at 200+ centers across 20+ countries The design and dosing of the P-III clinical development program is based on the results from two P-II studies i.e., P-Ib/IIa RELENT-1 & P-IIb …

Bayer Initiates P-III OASIS Program of Elinzanetant for the Treatment of Vasomotor Symptoms During Menopause Read More »

Boehringer Ingelheim and Eli Lilly Present Results of Jardiance (empagliflozin) in P-III EMPEROR-Preserved Trial for the Treatment of HFpEF at ESC 2021

Shots: The P-III EMPEROR-Preserved trial evaluates the safety & efficacy of empagliflozin (10mg, qd) vs PBO in 5988 patients with chronic HFpEF The results demonstrated a 21% reduction in risk for composite 1EPs of CV death or hospitalization for HF. The 2EPs showed a 27% reduction in risk of first & recurrent hospitalizations for HF …

Boehringer Ingelheim and Eli Lilly Present Results of Jardiance (empagliflozin) in P-III EMPEROR-Preserved Trial for the Treatment of HFpEF at ESC 2021 Read More »

Janssen Reports Post-Hoc Analysis of P-III GRIPHON and P-IIIb TRITON Studies of Uptravi (selexipag) for the Treatment of Pulmonary Arterial Hypertension #ESC2021

Shots: The P-III GRIPHON & P-IIIb TRITON trials evaluate Uptravi vs control group in 404 & 245 patients with PAH, respectively The results from a post-hoc pooled analysis showed a 52% reduction in the risk of disease progression @6mos., Additionally, 48% reduction in the risk of disease progression among patients who received triple therapy group, …

Janssen Reports Post-Hoc Analysis of P-III GRIPHON and P-IIIb TRITON Studies of Uptravi (selexipag) for the Treatment of Pulmonary Arterial Hypertension #ESC2021 Read More »

Bone Therapeutics’s JTA-004 Fails to Meet its All Endpoints in P-III Study for Knee Osteoarthritis

Shots: The P-III study involves assessing JTA-004 (enhanced viscosupplement) vs PBO and the active comparator to reduce pain measured by the WOMAC pain subscale in patients with osteoarthritic pain in the knee The study showed that all treatment arms have similar efficacy, no significant difference in knee pain reduction b/w JTA-004, PBO, and active comparator …

Bone Therapeutics’s JTA-004 Fails to Meet its All Endpoints in P-III Study for Knee Osteoarthritis Read More »

Pfizer Reports Results of Abrocitinib in P-III JADE DARE Study to Treat Atopic Dermatitis

Shots: The head-to-head P-III JADE DARE study involves assessing the efficacy of Abrocitinib (200mg, qd, PO) vs dupilumab (300mg, SC, q2w followed by 600mg induction dose) in adult patients on background topical therapy with moderate to severe AD The study met its co-1EPs of at least a 4-point improvement in the severity of PP-NRS4 @2wks. …

Pfizer Reports Results of Abrocitinib in P-III JADE DARE Study to Treat Atopic Dermatitis Read More »

Amgen Presents Results of Repatha (evolocumab) in P-III HUYGENS Study for the Treatment of Acute Coronary Syndrome at ESC 2021

Shots: The P-III HUYGENS study evaluates Repatha + optimized statin therapy vs optimized statin therapy alone in patients with ACS for 52wks. The study met its 1EPs i.e., improvement in the features of plaque morphology by increasing the fibrous cap thickness (75% vs 39%) as measured by OCT. The therapy also improved all 2EPs includes …

Amgen Presents Results of Repatha (evolocumab) in P-III HUYGENS Study for the Treatment of Acute Coronary Syndrome at ESC 2021 Read More »

AstraZeneca’s ALXN1840 Meets its Primary Endpoint in P-III FoCus Trial for the Treatment of Wilson Disease

Shots: The P-III FoCus trial evaluates the efficacy and safety of ALXN1840 vs SoC in 214 patients aged ≥12yrs. in a ratio (3:1) with Wilson disease The trial met its 1EPs i.e., improvement in daily mean copper mobilization from tissues defined as daily mean AUEC for directly measured dNCC @48wks. The therapy was generally well-tolerated …

AstraZeneca’s ALXN1840 Meets its Primary Endpoint in P-III FoCus Trial for the Treatment of Wilson Disease Read More »

Merck Reports Results of Vaxneuvance (pneumococcal 15-valent conjugate vaccine) in P-III PNEU-PED Study for the Prevention of Invasive Pneumococcal Disease

Shots: The P-III PNEU-PED study evaluates immunogenicity, safety & tolerability of Vaxneuvance (4-dose regimen) vs PCV13 in 1720 infants aged b/w 42-90 days with IPD Vaxneuvance showed a non-inferior immune response to PCV13 for 12 & 13 shared serotypes @ 30days, following PD3 & for all 13 based on serotype-specific IgG GMCs, following PD4. The …

Merck Reports Results of Vaxneuvance (pneumococcal 15-valent conjugate vaccine) in P-III PNEU-PED Study for the Prevention of Invasive Pneumococcal Disease Read More »

Novartis’ Kymriah (tisagenlecleucel) Fails to Meet its Primary Endpoint in P-III BELINDA Study as 2L Treatment in Aggressive B-Cell Non-Hodgkin Lymphoma

Shots: The P-III BELINDA study evaluates the efficacy, safety, & tolerability of Kymriah vs SOC in patients with aggressive B-cell NHL who had primary refractory disease or relapsed within 12mos. of 1L treatment in 73 sites across 18 countries globally The study did not meet its 1EPs of EFS while the safety profile was consistent …

Novartis’ Kymriah (tisagenlecleucel) Fails to Meet its Primary Endpoint in P-III BELINDA Study as 2L Treatment in Aggressive B-Cell Non-Hodgkin Lymphoma Read More »

PharmaShots Interview: Rain Therapeutic’s Avanish Vellanki Shares Insight on the Initiation of P-III MANTRA Trial of Milademetan for Dedifferentiated Liposarcoma

In an interview with PharmaShots, Avanish Vellanki, CEO and Cofounder at Rain Therapeutics shared his views on the initiation of the P-III MANTRA trial to evaluate the safety & efficacy of Milademetan for dedifferentiated liposarcoma and provide updates about the company’s lead candidate, RAIN-32. Shots: The company initiates P-III MANTRA trial to evaluate safety & …

PharmaShots Interview: Rain Therapeutic’s Avanish Vellanki Shares Insight on the Initiation of P-III MANTRA Trial of Milademetan for Dedifferentiated Liposarcoma Read More »

Alexion to Discontinue its P-III CHAMPION-ALS Trial of Ultomiris (ravulizumab) for Amyotrophic Lateral Sclerosis

Shots: The IDMC has recommended the discontinuation of the P-III CHAMPION-ALS trial for Ultomiris (IV, q8w) in adults with ALS. Additionally, enrolled patients will discontinue the study medication and complete any required follow-up assessment The discontinuation is due to lack of efficacy based on the pre-specified interim analysis. No new safety was identified while the …

Alexion to Discontinue its P-III CHAMPION-ALS Trial of Ultomiris (ravulizumab) for Amyotrophic Lateral Sclerosis Read More »

Coherus and Junshi Report Interim Results of Toripalimab + CT in P-III CHOICE-01 Trial as 1L Treatment for Non-Small Cell Lung Cancer

Shots: The P-III CHOICE-01 trial evaluates toripalimab + CT vs PBO + CT in 465 patients in a ratio (2:1) with advanced sq./nonsq. NSCLC. The results of the study will be presented at WCLC 2021 Results: improvement in PFS with m-PFS (8.3 vs 5.6mos.), m-OS (21.0 vs 16.0mos.). In sq. & nonsq. NSCLC patients – …

Coherus and Junshi Report Interim Results of Toripalimab + CT in P-III CHOICE-01 Trial as 1L Treatment for Non-Small Cell Lung Cancer Read More »

AbbVie Publishes 12-week Results of Atogepant in P-III ADVANCE Trial for the Preventive of Migraine in NEJM

Shots: The P-III ADVANCE trial evaluates efficacy, safety & tolerability of atogepant (PO, 10/30/60 mg, qd) vs PBO in 910 patients with EM who experienced 4-14 migraine days/mos. Results: patients achieving a ≥50% reduction in monthly migraine days (55.6%/58.7%/60.8% vs 29.0%) @12wks. & all doses were well tolerated. Additionally, 30/60 mg doses showed improvements in …

AbbVie Publishes 12-week Results of Atogepant in P-III ADVANCE Trial for the Preventive of Migraine in NEJM Read More »

Novartis Reports Results of Beovu (brolucizumab) in P-III KITE & KINGFISHER Trials for the Treatment of Diabetic Macular Edema

Shots: The company reported 2yrs. & 1 yrs. results from P-III KITE & KINGFISHER studies evaluating Beovu (6mg, q4w) vs aflibercept (2mg) in 926 patients with DME across 36 countries The results showed non-inferiority to aflibercept in a change in BCVA from baseline @100wks. in KITE & 52wks. in KINGFISHER studies. The therapy also demonstrated …

Novartis Reports Results of Beovu (brolucizumab) in P-III KITE & KINGFISHER Trials for the Treatment of Diabetic Macular Edema Read More »

Lilly Reports Results of Lebrikizumab in P-III ADvocate 1 and 2 Studies for the Treatment of Moderate to Severe Atopic Dermatitis

Shots: The ongoing P-III ADvocate 1 & 2 studies evaluate lebrikizumab as monothx. vs PBO in adult & adolescent patients aged 12 to less than 18 yrs. with mod. to sev. AD for 52wks. The 1EPs & 2EPs of study i.e >75% change from baseline in EASI score @16wks., improvement in skin clearance & itch …

Lilly Reports Results of Lebrikizumab in P-III ADvocate 1 and 2 Studies for the Treatment of Moderate to Severe Atopic Dermatitis Read More »

Alnylam Reports Completion of Patient Enrollment in P-III HELIOS-B Study for Vutrisiran to Treat ATTR Amyloidosis with Cardiomyopathy

Shots: The company has completed the enrolment in the P-III HELIOS-B study evaluates the efficacy and safety of vutrisiran (25 mg, SC, q3M, for ~ 36 mos.) vs PBO in 600 patients in a ratio (1:1) with ATTR amyloidosis with cardiomyopathy across 123 activated sites in 32 countries The 1EP of the study is to …

Alnylam Reports Completion of Patient Enrollment in P-III HELIOS-B Study for Vutrisiran to Treat ATTR Amyloidosis with Cardiomyopathy Read More »

Genentech Reports Results of Polivy (polatuzumab vedotin-piiq) + R-CHP in P-III POLARIX Trial for the Treatment of Diffuse Large B-Cell Lymphoma

Shots: The P-III POLARIX trial evaluates the efficacy, safety, and PK of Polivy + R-CHP vs R-CHOP in 879 patients in a ratio (1:1) with previously untreated DLBCL for 6 cycles, followed by Rituxan for 2cycles; or R-CHOP + Polivy PBO for 6 cycles, followed by 2 cycles of Rituxan. The trial is being conducted …

Genentech Reports Results of Polivy (polatuzumab vedotin-piiq) + R-CHP in P-III POLARIX Trial for the Treatment of Diffuse Large B-Cell Lymphoma Read More »

Eli Lilly and Innovent Report Results of Sintilimab + CT in P-III ORIENT-11 Study as 1L Treatment of NSCLC

Shots: The P-III ORIENT-11 study evaluates the efficacy & safety of sintilimab (200mg) + pemetrexed and platinum CT vs PBO + CT in 397 patients in a ratio (2:1) as 1L treatment for advanced or metastatic nonsq. NSCLC without sensitizing EGFR mutations or ALK rearrangements The results demonstrated an OS benefit with a median follow-up …

Eli Lilly and Innovent Report Results of Sintilimab + CT in P-III ORIENT-11 Study as 1L Treatment of NSCLC Read More »

Takeda Publishes the Results of Takhzyro (lanadelumab) in P-III HELP Study for the Prevention of Hereditary Angioedema Attacks in the Journal Allergy

Shots: The P-III HELP OLE study evaluates the safety & efficacy of Takhzyro (300mg, q2w) in 212 patients aged ≥12yrs. with HAE attacks for ~2.5yrs. Results: 87.4% mean reduction in attack rate compared to baseline; attacks requiring acute treatment (93.4%); mod. or sev. attacks (84.3%); HAE attack-free (97.7%) with a duration of the attack-free period …

Takeda Publishes the Results of Takhzyro (lanadelumab) in P-III HELP Study for the Prevention of Hereditary Angioedema Attacks in the Journal Allergy Read More »

Merck’s Keytruda (pembrolizumab) Receives the US FDA’s Priority Review for the Adjuvant Treatment of Stage II Resected High-Risk Melanoma

Shots: The priority review is based on P-III KEYNOTE-716 trial assessing Keytruda (anti-PD-1 therapy) vs PBO in 954 patients aged ≥12yrs. with stage II resected high-risk melanoma. The anticipated PDUFA date for the therapy is Dec 04, 2021 The trial met its 1EPs of RFS with no new safety signals observed. Based on this data, …

Merck’s Keytruda (pembrolizumab) Receives the US FDA’s Priority Review for the Adjuvant Treatment of Stage II Resected High-Risk Melanoma Read More »

BeyondSpring Reports Results of Plinabulin + Docetaxel in P-III DUBLIN-3 Trial for 2L and 3L Treatment of NSCLC with EGFR Wild Type

Shots: The P-III DUBLIN-3 trial evaluates plinabulin + docetaxel vs docetaxel alone in 599 patients with 2L & 3L NSCLC EGFR wild type, with measurable lung lesion The trial met its 1EPs & 2EPs i.e improvement in OS, ORR, PFS, and OS rate @24 & 36mos. (22.1% vs 12.5% & 11.7% vs 5.3%); @48mos. OS …

BeyondSpring Reports Results of Plinabulin + Docetaxel in P-III DUBLIN-3 Trial for 2L and 3L Treatment of NSCLC with EGFR Wild Type Read More »

Regeneron and Sanofi Report Results of Dupixent (dupilumab) in P-III LIBERTY CUPID Clinical Program for Chronic Spontaneous Urticaria

Shots: The study A of P-III LIBERTY CUPID trial evaluates Dupixent vs SoC in 138 patients aged ≥6 yrs. with CSU who remained symptomatic despite antihistamine use and who were not previously treated with anti-IgE therapeutics The trial met its 1EPs & 2EPs @24wks. i.e. showed a reduction in itch severity (63% vs 35%), reduction …

Regeneron and Sanofi Report Results of Dupixent (dupilumab) in P-III LIBERTY CUPID Clinical Program for Chronic Spontaneous Urticaria Read More »

AbbVie Presents Results of AGN-190584 in P-III GEMINI 1 Study for Presbyopia at 2021 ASCRS

Shots: The P-III GEMINI 1 study involves assessing AGN-190584 (pilocarpine 1.25%, qd) ophthalmic solution in 323 patients in a ratio (1:1) with presbyopia for 30days. The study demonstrated that AGN-190584 met both its 1EPs & 2EPs with patients achieving near & intermediate vision gains. In addition, AGN-190584 showed no loss of distance vision, rapid onset …

AbbVie Presents Results of AGN-190584 in P-III GEMINI 1 Study for Presbyopia at 2021 ASCRS Read More »

Samsung Bioepis Initiates P-III Clinical Trial of SB17 Proposed Biosimilar to Stelara (ustekinumab)

Shots: The company initiates P-III clinical trial to evaluate the efficacy, safety, tolerability, PK, and immunogenicity of SB17 vs Stelara in a ratio (1:1) in patients with moderate to severe plaque psoriasis Additionally, patients either continue on Stelara or transition to SB17 @28wks. The IPs (SB17 or Stelara, q12w) will be administered @0, 4 and …

Samsung Bioepis Initiates P-III Clinical Trial of SB17 Proposed Biosimilar to Stelara (ustekinumab) Read More »

GSK Reports Results of Daprodustat in P-III ASCEND Program for the Treatment of Anemia due to Chronic Kidney Disease

Shots: The P-III ASCEND program includes 5 studies i.e ASCEND-ND, D, ID, NHQ & TD studies evaluating efficacy & safety of daprodustat vs ESA in ~8,000 patients with anemia due to CKD for ~ 3.75yrs. The program met its 1EPs in 5 studies i.e improvement in Hgb levels in untreated patients and maintaining Hgb levels …

GSK Reports Results of Daprodustat in P-III ASCEND Program for the Treatment of Anemia due to Chronic Kidney Disease Read More »

Bio-Thera Reports First Patient Dosing in P-III Study for BAT2206 Proposed Biosimilar of Stelara (ustekinumab)

Shots: The first patient has been dosed in a P-III clinical study evaluating the efficacy and safety of BAT2206 vs reference Stelara in ~ 472 patients with moderately to severely PsO BAT2206 represents the 4th biosimilar of Bio-Thera’s portfolio to enter P-III study. The advancement of BAT2206 in P-III study demonstrates company’s commitment to develop …

Bio-Thera Reports First Patient Dosing in P-III Study for BAT2206 Proposed Biosimilar of Stelara (ustekinumab) Read More »

Galapagos Reports New Post-Hoc Analyses from P-III SELECTION Program of Filgotinib to Treat Ulcerative Colitis

Shots: The P-III SELECTION trial comprises 2 induction trials & a maintenance trial evaluating filgotinib (200/100 mg) vs PBO in adult patients with active UC Induction studies results: improvements in PROs of SF & RB in biologic-naïve & biologic-experienced patients (200mg dose). In induction study A & B (18.8% vs 9.5% & 10.7% vs 4.2%) …

Galapagos Reports New Post-Hoc Analyses from P-III SELECTION Program of Filgotinib to Treat Ulcerative Colitis Read More »

Takeda Presents Results of Takhzyro (lanadelumab) in P-III HELP Study Open-Label Extension to Treat Hereditary Angioedema Attacks at EAACI 2021

Shots: The P-III HELP OLE study evaluating the safety & efficacy of Takhzyro (300mg, q2w) in 212 patients aged ≥12yrs. with HAE attacks for ~2.5 yrs. Results: 87.4% mean reduction in attack rate compared to baseline & median reduction was 97.7%. Additionally, @70 day steady-state, attack rates were further reduced to a mean of 92.4% …

Takeda Presents Results of Takhzyro (lanadelumab) in P-III HELP Study Open-Label Extension to Treat Hereditary Angioedema Attacks at EAACI 2021 Read More »

Merck Collaborates with OncoSec to Evaluate TAVO (tavokinogene telseplasmid) + Keytruda (pembrolizumab) in P-III KEYNOTE-C87 Trial for Late-Stage Metastatic Melanoma

Shots: The companies collaborated to evaluate OncoSec’s TAVO + Merck’s Keytruda vs SoC in a P-III KEYNOTE-C87 trial in ~400 patients with metastatic melanoma who are refractory to immune checkpoint therapy across the US, Canada, EU & Australia The companies will responsible for internal costs with OncoSec covering the third-party costs. The trial is intended …

Merck Collaborates with OncoSec to Evaluate TAVO (tavokinogene telseplasmid) + Keytruda (pembrolizumab) in P-III KEYNOTE-C87 Trial for Late-Stage Metastatic Melanoma Read More »

STADA and Xbrane’s Xlucane (biosimilar, ranibizumab) Meet its Primary Endpoint in P-III Xplore Study

Shots: The P-III Xplore study involves assessing ranibizumab biosimilar vs Lucentis in 583 patients. The study met its 1EPs demonstrating the equivalent efficacy in BCVA @ 8wks. treatment Additionally, the interim analysis of 6mos. data demonstrated that the biosimilar has a similar PK, safety, and immunogenicity profile compared to Lucentis. The companies plan to submit …

STADA and Xbrane’s Xlucane (biosimilar, ranibizumab) Meet its Primary Endpoint in P-III Xplore Study Read More »

BeiGene Reports First Patient Dosing in P-III AdvanTIG-302 Trial of Ociperlimab (BGB-A1217) + Tislelizumab (BGB-A317) to Treat Non-Small Cell Lung Cancer

Shots: The first patient has been dosed in global P-III AdvanTIG-302 trial evaluating ociperlimab + tislelizumab in 605 naïve patients with locally advanced, unresectable, or metastatic NSCLC whose tumors exhibit high PD-L1 expression and do not harbor EGFR-sensitizing mutations or ALK translocations across the US, Australia & other countries globally The 1EPs of the trial …

BeiGene Reports First Patient Dosing in P-III AdvanTIG-302 Trial of Ociperlimab (BGB-A1217) + Tislelizumab (BGB-A317) to Treat Non-Small Cell Lung Cancer Read More »

Biogen Reports First Patient Dosing in P-III TOPAZ-1 Study of BIIB059 to Treat Systemic Lupus Erythematosus

Shots: The first patient has been dosed in the P-III TOPAZ-1 study evaluating efficacy & safety of BIIB059 vs PBO in 540 adults with active SLE for 52 wks. The trial is expected to conduct at ~135 sites globally The 1EPs of study are to demonstrate a reduction in disease activity, proportion of patients achieve …

Biogen Reports First Patient Dosing in P-III TOPAZ-1 Study of BIIB059 to Treat Systemic Lupus Erythematosus Read More »

Regeneron Reports Results of REGEN-COV (casirivimab and imdevimab) in P-III RECOVERY Trial for COVID-19 Patients

Shots: The P-III RECOVERY trial evaluating REGEN-COV (8,000 mg) vs usual care alone in seronegative patients with COVID-19 demonstrates 20% reduction in risk of death in patients failing to exhibit a natural antibody response The 1EPs showed 20% reduction in all-cause mortality, no longer significant effect on 28-day mortality on combining larger seropositive group (also …

Regeneron Reports Results of REGEN-COV (casirivimab and imdevimab) in P-III RECOVERY Trial for COVID-19 Patients Read More »

Sage and Biogen Report Results of Zuranolone in P-III WATERFALL Study for Major Depressive Disorder

Shots: The P-III WATERFALL study involves assessing the efficacy and safety of zuranolone (50mg, once-nightly for 2wks.) in 543 adults aged 18-64yrs. with MDD with a HAMD-17 total score ≥24 at screening and day 1 prior to dosing The study met its 1EPs demonstrating improvement in depressive symptoms @day15 as assessed by the HAMD-17 total …

Sage and Biogen Report Results of Zuranolone in P-III WATERFALL Study for Major Depressive Disorder Read More »

AbbVie Presents Results of Imbruvica (ibrutinib) + Venclexta/Venclyxto in P-III GLOW Study as 1L Treatment for CLL or SLL at EHA 2021

Shots: The P-III GLOW study evaluates Imbruvica + Venclexta/Venclyxto (I+V) vs chlorambucil + obinutuzumab (C+O) in 211 patients in a ratio (1:1) aged ≥65yrs. with CLL/SLL The study met its 1EPs of PFS as assessed by IRC & showed a 78% reduction in risk of disease progression or death, mPFS (not reached vs 21mos.) & …

AbbVie Presents Results of Imbruvica (ibrutinib) + Venclexta/Venclyxto in P-III GLOW Study as 1L Treatment for CLL or SLL at EHA 2021 Read More »

Janssen Presents Results of Darzalex (daratumumab) in P-III MAIA Study for Transplant Ineligible Patients with Multiple Myeloma at EHA 2021

Shots: The P-III MAIA study assessing Darzalex + lenalidomide & dexamethasone (DRd) vs Rd in 737 newly diagnosed patients aged 45-90yrs. with MM ineligible for high-dose CT & ASCT MAIA longer-term follow-up analysis showed i.e @5yrs., OS rate (66% vs 53%), PFS rate (53% vs 29%), ORR (93% vs 82%) & median time to next …

Janssen Presents Results of Darzalex (daratumumab) in P-III MAIA Study for Transplant Ineligible Patients with Multiple Myeloma at EHA 2021 Read More »

Sanofi Presents Results of Sutimlimab in P-III CADENZA Trial to Treat Hemolysis Patients with Cold Agglutinin Disease at EHA 2021

Shots: Part A of the P-III CADENZA trial involves assessing the efficacy & safety of sutimlimab (6.5g/ 7.5g) vs PBO in a ratio (1:1) in 42 patients with CAD without blood transfusion. The study met its 1EPs i.e. improvement in Hgb ≥1.5 g/dL from baseline @23, 25, & 26wks., avoidance of transfusions & other CAD-related …

Sanofi Presents Results of Sutimlimab in P-III CADENZA Trial to Treat Hemolysis Patients with Cold Agglutinin Disease at EHA 2021 Read More »

BeyondSpring Presents Results of Plinabulin in P-III PROTECTIVE-1 Study for Prevention of Chemotherapy-Induced Neutropenia at ASCO 2021

Shots: The P-III PROTECTIVE-1 study assessing plinabulin as monothx vs Pegfilgrastimfor in patients with CIN. The US FDA accepted the NDA & PR and the anticipated PDUFA date is Nov 30, 2021 The trial met its 1EP i.e plinabulin (day 1 dose as CT) demonstrates non-inferiority against Pegfilgrastim, improvement in bone pain, and platelet count. …

BeyondSpring Presents Results of Plinabulin in P-III PROTECTIVE-1 Study for Prevention of Chemotherapy-Induced Neutropenia at ASCO 2021 Read More »

Bio-Thera Reports the Initiation of P-III Clinical Trial for BAT2506 (biosimilar, golimumab)

Shots: The company has initiated a P-III clinical study to evaluate the efficacy and safety of BAT2506 vs Simponi in ~ 480 volunteers with PsA. Simponi is approved for moderately to severely active RA, active PsA, active AS & UC BAT2506 is the 3rd proposed biosimilar of the company to enter a global P-III study …

Bio-Thera Reports the Initiation of P-III Clinical Trial for BAT2506 (biosimilar, golimumab) Read More »

AstraZeneca Reports Updated Results of Imfinzi (durvalumab) in P-III PACIFIC Trial for Non-Small Cell Lung Cancer

Shots: The P-III PACIFIC trial involves assessing Imfinzi vs PBO in 713 patients with unresectable, stage III NSCLC whose disease had not progressed following concurrent platinum-based CRT in 235 centers across 26 countries The updated post-hoc analyses demonstrated OS @5yrs. (42.9% vs 33.4%), m-OS (47.5 vs 29.1mos); at the treatment course of one year patients …

AstraZeneca Reports Updated Results of Imfinzi (durvalumab) in P-III PACIFIC Trial for Non-Small Cell Lung Cancer Read More »

Tonix Pharmaceuticals Presents Results of TNX-102 SL in P-III RELIEF study for the Management of Fibromyalgia at ASCP 2021

Shots: The P-III RELIEF study evaluating the efficacy and safety of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) vs PBO in patients for the management of fibromyalgia. The first 2 wks treatment start on TNX-102 SL (2.8 mg) or PBO and after that the dose increased to TNX-102 SL (5.6 mg) or 2 PBO for 12 …

Tonix Pharmaceuticals Presents Results of TNX-102 SL in P-III RELIEF study for the Management of Fibromyalgia at ASCP 2021 Read More »

BMS Presents Results of Opdivo (nivolumab) + CT or Yervoy (ipilimumab) in P-III CheckMate -648 Trial for Unresectable Advanced or Metastatic ESCC at ASCO 2021

Shots: The P-III CheckMate -648 trial evaluating Opdivo + CT or Opdivo (3 mg/kg, q2w) + Yervoy (1 mg/kg, q6w up to 24mos.) in patients with unresectable advanced or metastatic ESCC Results: Both combinations showed OS benefits over CT in PD-L1 positive & all-randomized populations, m-OS for Opdivo + CT (13.7 vs 9.1 mos. & …

BMS Presents Results of Opdivo (nivolumab) + CT or Yervoy (ipilimumab) in P-III CheckMate -648 Trial for Unresectable Advanced or Metastatic ESCC at ASCO 2021 Read More »

United Therapeutics Reports the First Patient Enrollment in P-III TETON Study of Tyvaso for Idiopathic Pulmonary Fibrosis

Shots: The first patient has enrolled in P-III TETON study to evaluate the safety and efficacy of treprostinil (Inhalation Solution) or PBO in a ratio (1:1) in 396 adult patients with IPF The 1EPs of the study is the change in FVC from baseline@ 52 wks. and 2EPs include time to clinical worsening, time to …

United Therapeutics Reports the First Patient Enrollment in P-III TETON Study of Tyvaso for Idiopathic Pulmonary Fibrosis Read More »

Merck Presents Results of Keytruda (pembrolizumab) in P-III KEYNOTE-564 as Adjuvant Therapy for Renal Cell Carcinoma at ASC0 2021

Shots: The P-III KEYNOTE-564 evaluating Keytruda monothx (200 mg, IV, on day1 of each 3wks. cycle for up to 17 cycles) vs PBO in 950 patients with RCC, following nephrectomy & resection of metastatic lesions Results: @ median follow-up of 24.1 mos., 32% reduction in the risk of disease recurrence or death, a favorable trend …

Merck Presents Results of Keytruda (pembrolizumab) in P-III KEYNOTE-564 as Adjuvant Therapy for Renal Cell Carcinoma at ASC0 2021 Read More »

Celltrion Presents One Year Results of Yuflyma (biosimilar, adalimumab) in P-III CT-P17 3.1 Trial for Rheumatoid Arthritis at EULAR 2021

Shots: The P-III CT-P17 3.1 trial involves assessing Yuflyma (adalimumab, 40mg, high-concentration formulation, low-volume and citrate-free, q2w, up to 24 wks.) vs reference adalimumab in a ratio (1:1) in 648 patients with active RA The one year data demonstrated comparable efficacy of Yuflyma to reference adalimumab in terms of ACR20/50/70 response rates in patients receiving …

Celltrion Presents One Year Results of Yuflyma (biosimilar, adalimumab) in P-III CT-P17 3.1 Trial for Rheumatoid Arthritis at EULAR 2021 Read More »

AbbVie Presents Results of Long-Term Efficacy and Safety Analyses for Rinvoq (upadacitinib) in P-III SELECT-COMPARE Study for Rheumatoid Arthritis at EULAR 2021

Shots: The P-III SELECT-COMPARE study evaluates the safety and efficacy of Rinvoq (15 mg, qd) vs PBO and Humira (SC, 40mg, every other week) in a ratio (2:2:1) in adult patients with a mod. to sev. active RA who had an inadequate response to MTX and continued a stable background of MTX The new analysis …

AbbVie Presents Results of Long-Term Efficacy and Safety Analyses for Rinvoq (upadacitinib) in P-III SELECT-COMPARE Study for Rheumatoid Arthritis at EULAR 2021 Read More »

Alnylam Reports Completion of Patient Enrollment in P-III APOLLO-B Study for Patisiran to Treat Transthyretin-Mediated (ATTR) Amyloidosis with Cardiomyopathy

Shots: The company has completed the enrolment in the P-III APOLLO-B study to evaluate the efficacy & safety of patisiran vs PBO in a ratio (2:1) in 300 patients with ATTR amyloidosis with cardiomyopathy across 90 sites in 20+ countries. The results are expected in mid-2022 The 1EPs of the trial is the change from …

Alnylam Reports Completion of Patient Enrollment in P-III APOLLO-B Study for Patisiran to Treat Transthyretin-Mediated (ATTR) Amyloidosis with Cardiomyopathy Read More »

Novartis Reports One Year Results of Beovu (brolucizumabin) in P- III MERLIN Study to Treat Wet Age-Related Macular Degeneration

Shots: The P- III MERLIN study involves assessing the efficacy & safety of Beovu (6 mg, q4w) vs aflibercept (2 mg, q4w) following the loading phase in patients with wet AMD who have persistent retinal fluid despite anti-VEGF therapy Results: met its 1EPs i.e. non-inferiority in mean change in BCVA from baseline and superiority on …

Novartis Reports One Year Results of Beovu (brolucizumabin) in P- III MERLIN Study to Treat Wet Age-Related Macular Degeneration Read More »

Sanofi and GSK Initiate P-III Clinical Study of their COVID-19 Vaccine

Shots: The companies have started enrollment of patients in a P-III clinical study to assess the safety, efficacy & immunogenicity of COVID-19 vaccine candidate vs PBO in 35,000+ volunteers aged ≥ 18yrs. from multiple countries including the US The 1EP& 2EP of the study is to prevent symptomatic & asymptomatic infection respectively. A two-stage study …

Sanofi and GSK Initiate P-III Clinical Study of their COVID-19 Vaccine Read More »

Reistone Reports First Patient Dosing in P-III RSJ10333 Trial of SHR0302 for the Treatment of Atopic Dermatitis

Shots: The 1st patient has been dosed in the P-III RSJ10333 trial to evaluate the safety and efficacy of SHR0302 (4mg/8mg, after the completion of 16 wks treatment) vs. PBO in 330 adolescent & adult aged ≥12 yrs with a mod. to sev. AD for 52 wks. The trial is being conducted in Canada & …

Reistone Reports First Patient Dosing in P-III RSJ10333 Trial of SHR0302 for the Treatment of Atopic Dermatitis Read More »

AstraZeneca and Amgen Present Results of Tezepelumab in P-III NAVIGATOR Study for Severe Asthma at ATS2021

Shots: The P-III NAVIGATOR study involves assessing Tezepelumab + SOC vs PBO + SOC in adults (18–80 yrs.) & adolescents (12–17 yrs.) with severe uncontrolled asthma The results demonstrate superiority in 1EP & 2EP in a broad population i.e., 77% reduction in AAER with blood eosinophil counts (≥300 cells/ microlitre) and FeNO levels (≥25 parts/ …

AstraZeneca and Amgen Present Results of Tezepelumab in P-III NAVIGATOR Study for Severe Asthma at ATS2021 Read More »

Antengene Receives IND Approval for P-III SIENDO Trial of XPOVIO (Selinexor) to Treat Advanced or Recurrent Endometrial Cancer in China

Shots: The NMPA has approved the IND application for the P- III SIENDO trial to evaluate the safety and efficacy of selinexor for advanced or recurrent endometrial cancer. The trial is being conducted over 80 centers across North America, Europe, and Asia and the results are expected in H2’2021 Antengene holds the exclusive development and …

Antengene Receives IND Approval for P-III SIENDO Trial of XPOVIO (Selinexor) to Treat Advanced or Recurrent Endometrial Cancer in China Read More »

Regeneron and Sanofi Present Positive Results of Libtayo (cemiplimab) from P-III Trial for Cervical Cancer at ESMO2021

Shots: The P-III trial involves assessing libtayo (300mg, IV, q3w) as monothx. vs CT in patients with recurrent or metastatic cervical cancer that has progressed on platinum-based CT. The companies expect the regulatory submission in 2021 The results demonstrated a 31% reduction in the risk of death in the total population, improvement in OS, PFS, …

Regeneron and Sanofi Present Positive Results of Libtayo (cemiplimab) from P-III Trial for Cervical Cancer at ESMO2021 Read More »

Incyte and MorphoSys Report First Patient Dosing in P-III frontMIND Study of Tafasitamab + Lenalidomide as a 1L Treatment for DLBCL

Shots: The first patient has been dosed in the P-III frontMIND study evaluating tafasitamab + lenalidomide + R-CHOP vs R-CHOP alone as a 1L treatment for high-intermediate and high-risk ~880 patients with DLBCL The 1EP of the study is PFS and 2EP include event-free survival, OS, metabolic CRR, and ORR The preliminary data from the …

Incyte and MorphoSys Report First Patient Dosing in P-III frontMIND Study of Tafasitamab + Lenalidomide as a 1L Treatment for DLBCL Read More »

Bayer Reports Results of Finerenone in P- III FIGARO-DKD CV Outcomes Study for Chronic Kidney Disease and Type 2 Diabetes

Shots: The P-III FIGARO-DKD study involves assessing the efficacy and safety of finerenone (10/20mg, PO, qd) + SoC vs PBO + SoC in ~7400 patients with CKD and T2D at 1,000+ sites across 47 countries globally The study resulted in meeting its 1EPs i.e reduction in the composite risk of time to the first occurrence …

Bayer Reports Results of Finerenone in P- III FIGARO-DKD CV Outcomes Study for Chronic Kidney Disease and Type 2 Diabetes Read More »

Aurinia Publishes the Results of Lupkynis (voclosporin) in P-III AURORA 1 Study for Patients with Active Lupus Nephritis in The Lancet

Shots: The P-III AURORA 1 study involves assessing the efficacy and safety of Lupkynis (23.7mg, bid) + MMF and low-dose corticosteroids vs MMF and low-dose corticosteroids alone in 357 adults with SLE and LN The trial met its 1EP and 2EPs i.e. complete renal response rates (41% vs 23%) @52wks. and 50% reduction from baseline …

Aurinia Publishes the Results of Lupkynis (voclosporin) in P-III AURORA 1 Study for Patients with Active Lupus Nephritis in The Lancet Read More »

Novavax Reports the Pediatric Expansion for P-III Clinical Trial of NVX-CoV2373 Against COVID-19

Shots: The company has reported the expansion of P-III PREVENT-19 pivotal trial to evaluate the efficacy, safety, and immunogenicity of NVX-CoV2373 vs PBO in ~3,000 adolescents aged 12-17yrs. against COVID 19 across 75 sites in the US Patients will receive two doses of either NVX-CoV2373 or PBO given 21 days apart and participants will be …

Novavax Reports the Pediatric Expansion for P-III Clinical Trial of NVX-CoV2373 Against COVID-19 Read More »

BMS Presents Clinical and RWE Data of Mavacamten for Obstructive Hypertrophic Cardiomyopathy at ACC 2021

Shots: The company presented new analysis data from the P-III EXPLORER-HCM trial assessing mavacamten in patients with oHCM that tested the impact of the therapy on patients’ health status i.e symptoms, function, and QoL The company unveils the interim results from MAVA-LTE, 5yrs. extension study of the EXPLORER-HCM. The study demonstrated improvement in LVOT gradients, …

BMS Presents Clinical and RWE Data of Mavacamten for Obstructive Hypertrophic Cardiomyopathy at ACC 2021 Read More »

Sandoz Initiates Patient Enrolment of Proposed Biosimilar Aflibercept in P-III MYLIGHT Study for Neovascular Age-Related Macular Degeneration

Shots: The company starts enrolling patients in the P-III MYLIGHT study to evaluate the safety and efficacy of biosimilar aflibercept vs Eylea in patients with nAMD for 48wks. The study is expected to enroll 460 patients across 20 countries The study is a part of a biosimilar development program that includes analytical, pre/ clinical data. …

Sandoz Initiates Patient Enrolment of Proposed Biosimilar Aflibercept in P-III MYLIGHT Study for Neovascular Age-Related Macular Degeneration Read More »

Eli Lilly and Incyte Present New Data of Olumiant (baricitinib) in P-III BREEZE-AD5 Trial Moderate to Severe Atopic Dermatitis at AAD2021

Shots: The new analyses of the P-III BREEZE-AD5 trial and an extended safety analysis across multiple trials for Olumiant (2mg, qd) vs PBO in patients with AD showed improvements in the severity and extent of AD and patient outcomes, other key symptoms, and QoL as early as 1wks. Olumiant has also evaluated in patients with …

Eli Lilly and Incyte Present New Data of Olumiant (baricitinib) in P-III BREEZE-AD5 Trial Moderate to Severe Atopic Dermatitis at AAD2021 Read More »

Sobi and Hellenic Institute Report Results of Anakinra in P-III SAVE-MORE Study for Hospitalized Patients with COVID-19 Pneumonia

Shots: The P-III SAVE-MORE study involves assessing the efficacy and safety of anakinra (100mg/day, SC for up to 10 days) + SoC guided by suPAR vs PB0 + SOC in 600 hospitalized patients in mod. to sev. COVID-19 pneumonia over 28days across 40 sites in Greece and Italy The study demonstrated improvement in the overall …

Sobi and Hellenic Institute Report Results of Anakinra in P-III SAVE-MORE Study for Hospitalized Patients with COVID-19 Pneumonia Read More »

Novartis Presents Results of Beovu (brolucizumab -dbll) in P-III KESTREL and KITE Studies for Diabetic Macular Edema at ARVO2021

Shots: The company reported the 1yrs. results from the P-III KESTREL & KITE studies assessing Beovu (6mg) vs aflibercept (2mg) in 926 patients with DME across 36 countries Results: met its 1EPs i.e. non-inferiority in mean change BCVA from baseline @48wks., patients treated with Beovu (6mg) experienced fluid (IRF/SRF) resolution and achieved CSFT levels below …

Novartis Presents Results of Beovu (brolucizumab -dbll) in P-III KESTREL and KITE Studies for Diabetic Macular Edema at ARVO2021 Read More »

Regeneron and Sanofi Report Results of Libtayo (cemiplimab) in P-III Trial for Cervical Cancer

Shots: The P-III trial involves assessing Libtayo (300mg, IV, q3w) as monothx. vs CT in patients with recurrent or metastatic cervical cancer that has progressed on platinum-based CT. The trial enrolled patients regardless of their PD-L1 status The results demonstrated a 31% reduction in the risk of death in the total population, improvement in OS, …

Regeneron and Sanofi Report Results of Libtayo (cemiplimab) in P-III Trial for Cervical Cancer Read More »

Vir and GSK Report Results of VIR-7831 in P-III COMET-ICE Trial for COVID-19

Shots: The IDMC has recommended stopping the enrollment in the P-III COMET-ICE trial due to evidence of profound efficacy. The study involves assessing VIR-7831 (GSK4182136) vs PBO in 583 patients for the early treatment of COVID-19 in adults at high risk of hospitalization The results demonstrated an 85% reduction in hospitalization or death and were …

Vir and GSK Report Results of VIR-7831 in P-III COMET-ICE Trial for COVID-19 Read More »

Lee’s Pharma to Initiate P-III Trial of Socazolimab as 1L Treatment of Extensive-stage Small-Cell Lung Cancer

Shots: The NMPA has approved Lee pharma to initiate P-III clinical trials to evaluate Socazolimab + CT as a 1L treatment of ES-SCLC. The study is expected to initiate patient recruitment in Q2’21 The clearance is based on the results from P- Ib trial in which Socazolimab + carboplatin and etoposide demonstrated a promising efficacy …

Lee’s Pharma to Initiate P-III Trial of Socazolimab as 1L Treatment of Extensive-stage Small-Cell Lung Cancer Read More »

Eli Lilly and Incyte Report Results of Olumiant (baricitinib) in P-III BRAVE-AA2 Study for Severe Alopecia Areata

Shots: The P-III BRAVE-AA2 study involves assessing Baricitinib (2mg & 4mg, qd) vs PBO in 546 adults with a SALT score ≥ 50 (i.e., who had ≥50% scalp hair loss) and a current episode of severe AA lasting at least 6mos. but no >8yrs. The P-III study met its 1EPs @36wks. and demonstrated significant improvement …

Eli Lilly and Incyte Report Results of Olumiant (baricitinib) in P-III BRAVE-AA2 Study for Severe Alopecia Areata Read More »

Amgen Reports Results of Blincyto (blinatumomab) in P-III Study for Relapsed Acute Lymphoblastic Leukemia in Pediatric Patients

Shots: The P-III 20120215 study involves assessing of Blincyto vs SoC consolidation CT before alloHSCT in pediatric patients with high-risk first relapsed B-cell ALL. The findings were published in JAMA Results: @median follow-up 22.4mos., patients that are alive and event-free (69% vs 43%); patients achieved MRD negative remission (93% vs 24%); @36mos. OS was (81.1% …

Amgen Reports Results of Blincyto (blinatumomab) in P-III Study for Relapsed Acute Lymphoblastic Leukemia in Pediatric Patients Read More »

Veru to Advance VERU-111 in P-III Study for COVID-19 Patients at High Risk for Acute Respiratory Distress Syndrome

Shots: The US FDA agreed to advance VERU-111 into a P-III study which will evaluate VERU-111 vs PBO in ~400 hospitalized patients in a ratio (2:1) with COVID-19 and are at high risk for ARDS. The study is anticipated to begin in Apr’2021 with clinical results expected in Q4’21 The P-II trial has demonstrated clinically …

Veru to Advance VERU-111 in P-III Study for COVID-19 Patients at High Risk for Acute Respiratory Distress Syndrome Read More »

AstraZeneca and Amgen Report Results of Tezepelumab in P-III NAVIGATOR Trial for Severe Asthma

Shots: The P-III NAVIGATOR study involves assessing Tezepelumab + SOC vs PBO + SOC in 1061 adults (18–80yrs.) & adolescents (12–17yrs.) with severe, uncontrolled asthma, who were receiving treatment with medium/high dose ICS + at least 1 additional controller medication with/ out OCS The trial met its 1EPs i.e. 56% reduction in AAER @52wks. in …

AstraZeneca and Amgen Report Results of Tezepelumab in P-III NAVIGATOR Trial for Severe Asthma Read More »

Regeneron Reports IDMC Clearance of Efficacy for REGEN-COV (Casirivimab + Imdevimab) in P-III COVID-19 Outpatient Outcomes Trial

Shots: Regeneron reported changes to the P-III study assessing REGEN-COV in non-hospitalized patients with COVID-19, following recommendations from the IDMC The IDMC found clear clinical efficacy in reducing the rate of hospitalization and death with both doses (1,200 & 2,400 mg) of REGEN-COV vs PBO. The company will immediately stop enrolling patients in the PBO …

Regeneron Reports IDMC Clearance of Efficacy for REGEN-COV (Casirivimab + Imdevimab) in P-III COVID-19 Outpatient Outcomes Trial Read More »

AbbVie Report Results of Rinvoq (upadacitinib) in Second P-III Induction Study for Ulcerative Colitis

Shots: The P-III U-ACCOMPLISH induction study involves assessing upadacitinib (45 mg, qd) vs PBO in patients with mod. to sev. UC The study met its 1EPs @8wks. i.e, patients achieved clinical remission (per Adapted Mayo Score) (31% vs 4%); met its 2EPs i.e clinical response @8wks. & @2wks. (74% vs 25% & 63% vs 26%); …

AbbVie Report Results of Rinvoq (upadacitinib) in Second P-III Induction Study for Ulcerative Colitis Read More »

Dermavant Report Results of Tapinarof Cream in P-III PSOARING 3 Study with Durable and Remittive Benefits for Plaque Psoriasis

Shots: The P-III PSOARING 3 is an OLE study assessing Tapinarof (1%) in patients with plaque psoriasis for ~40wks. and a 4wks. safety follow-up period The interim analyses showed 57.3% of study participants who entered the study with a PGA of ≥ 2 achieved a PGA of 0 or 1 while 39.2% achieved PGA 0 …

Dermavant Report Results of Tapinarof Cream in P-III PSOARING 3 Study with Durable and Remittive Benefits for Plaque Psoriasis Read More »

GSK Initiates P-III study for RSV Candidate Vaccine Programme for Older Adults

Shots: The first P-III AReSVi 004 study evaluates the immunogenicity, safety, reactogenicity and persistence of RSV candidate vaccine in 1650 adults ≥ aged 60 years. The study is expected to end in early 2024, with interim results expected to be available in the H1’ 2022 The second P-III AReSVi 006 study assessing the efficacy of …

GSK Initiates P-III study for RSV Candidate Vaccine Programme for Older Adults Read More »

Takeda Report Results of TAK-620 (maribavir) in P-III SOLCTICE Trial for the Treatment of Post-Transplant Patients with Cytomegalovirus Infection

Shots: The P-III TAK-620-303 (SOLSTICE) trial involves assessing TAK-620 (400mg) vs conventional antiviral therapies (IAT) in HCT and SOT recipients in a ratio (2:1) with R/R CMV infection refractory with/ out resistance, to one or a combination of the conventional antiviral therapies The 1EPs study shows confirmed CMV viremia clearance @ 8wk; (55% vs 26.1% …

Takeda Report Results of TAK-620 (maribavir) in P-III SOLCTICE Trial for the Treatment of Post-Transplant Patients with Cytomegalovirus Infection Read More »

BMS Report Results of Opdivo (nivolumab) + Cabometyx (cabozantinib) in P-III CheckMate -9ER Trial for 1L Treatment of Advanced Renal Cell Carcinoma

Shots: The P-III CheckMate -9ER trial involves assessing Opdivo + Cabometyx vs sunitinib in 651 patients with previously untreated advanced or metastatic RCC Results: @median follow-up of two years (23.5 mos.); median PFS (17.0 vs 8.3mos.), ORR (54.8% vs. 28.4%); Disease control rate (88.2% vs. 69.9%); CR (9.3% vs 4.3%); OS (34% reduction in risk …

BMS Report Results of Opdivo (nivolumab) + Cabometyx (cabozantinib) in P-III CheckMate -9ER Trial for 1L Treatment of Advanced Renal Cell Carcinoma Read More »

BMS’ Deucravacitinib Demonstrate Superiority Over Otezla (apremilast) in P-III POETYK PSO-2 Study for Plaque Psoriasis

Shots: The P-III POETYK PSO-2 study involves assessing deucravacitinib (6mg, qd) vs PBO & Otezla (30mg, bid) in 1,020 patients with moderate to severe plaque psoriasis The trial met its co-1EPs & 2EPs demonstrating deucravacitinib was superior to Otezla (apremilast) in the patients reaching a PASI 75 and sPGA 0/1 @16wks. The overall safety profile …

BMS’ Deucravacitinib Demonstrate Superiority Over Otezla (apremilast) in P-III POETYK PSO-2 Study for Plaque Psoriasis Read More »

Johnson & Johnson Report Results from P-III ENSEMBLE Trial for COVID-19 Vaccine

Shots: The P-III ENSEMBLE trial to evaluate the efficacy and safety of Janssen’s COVID-19 vaccine candidate in protecting mod-to-severe COVID-19 in 43,783 participants accruing 468 symptomatic cases with assessment of efficacy as of day 14 and as of day 28 as co-primary endpoints Results: The level of protection against mod-to-severe COVID-19 infection was 72% in …

Johnson & Johnson Report Results from P-III ENSEMBLE Trial for COVID-19 Vaccine Read More »

Merck’s Report Results of Keytruda (pembrolizumab) in Combination With Ipilimumab vs Keytruda Monotherapy in P-III KEYNOTE-598 for Metastatic Non-Small Cell Lung Cancer Patients

Shots: The P- III trial involves assessing of Keytruda in combination with ipilimumab vs Keytruda monothx in 568 patients in a ratio (1:1) as 1L treatment for metastatic NSCLC patients without EGFR or ALK genomic tumor aberrations and whose tumors express PD-L1 Results: @ median follow-up (20.6 mos.); mOS (21.4 vs 21.9 mos.); mPFS (8.2 …

Merck’s Report Results of Keytruda (pembrolizumab) in Combination With Ipilimumab vs Keytruda Monotherapy in P-III KEYNOTE-598 for Metastatic Non-Small Cell Lung Cancer Patients Read More »

Roche Reports Updated OS Data of Tecentriq + Avastin in P-III IMbrave150 Study for Unresectable HCC

Shots: The approval is based on P-III IMbrave150 study involves assessing of Tecentriq (1200mg) + Avastin (15 mg/kg) on day 1 of each 21-day cycle vs sorafenib (400mg, bid) on days 1-21 of each 21-day cycle in 501 patients in a ratio (2:1) with unresectable HCC, prior not treated with systemic therapies Results: @median follow-up …

Roche Reports Updated OS Data of Tecentriq + Avastin in P-III IMbrave150 Study for Unresectable HCC Read More »

BioMarin Reports Results of Valoctocogene Roxaparvovec in P-III GENEr8-1 Study for Hemophilia A

Shots: The ongoing P-III GENEr8-1 study involves assessing of valoctocogene roxaparvovec (6e13 vg/kg dose) in 134 patients with with severe hemophilia A. The patients received a single dose of valoctocogene roxaparvovec and completed a year or more of follow-up The study met 1EPs & 2EPs i.e. reduction in ABR by 84% demonstrating superiority to factor …

BioMarin Reports Results of Valoctocogene Roxaparvovec in P-III GENEr8-1 Study for Hemophilia A Read More »

Pfizer Reports the First Patients Dosing of PF-06939926 in P-III CIFFREO Study for DMD

Shots: The first patient has been dosed in P-III CIFFREO study assessing PF-06939926 vs PBO in 99 ambulatory male patients aged 4-7yrs. with DMD across 55 sites in 15 countries. The first patient was dosed at a site in Barcelona, Spain on Dec 29, 2020. The 1EPs of the study is the change in NSAA …

Pfizer Reports the First Patients Dosing of PF-06939926 in P-III CIFFREO Study for DMD Read More »

Alnylam Reports Results of Vutrisiran in P-III HELIOS-A Study for Patients with hATTR Amyloidosis with Polyneuropathy

Shots: The P-III HELIOS-A study assessing vutrisiran (25mg, SC, once every 3mos.) vs patisiran (0.3 mg/kg, IV, q3w) in 164 patients in a ratio (3:1) with hATTR amyloidosis with polyneuropathy The study met its 1EPs & 2EPs i.e. change from baseline in the mNIS+7 @9mos. & changes in QoL assessed by Norfolk QoL-DN and gait …

Alnylam Reports Results of Vutrisiran in P-III HELIOS-A Study for Patients with hATTR Amyloidosis with Polyneuropathy Read More »

AbbVie Reports Results of Skyrizi (Risankizumab) in P-III Studies for Active Psoriatic Arthritis

Shots: The two P-III studies KEEPsAKE-1 & -2 involves assessing Skyrizi (150mg) vs PBO followed by risankizumab (150mg, @24wks.) in patients with active PsA who had an inadequate response or intolerant to at least one biologic therapy and/or non-biologic DMARDs respectively Results: ACR20 (57% & 51% vs 34% & 27%); ACR50 (33% & 26% vs …

AbbVie Reports Results of Skyrizi (Risankizumab) in P-III Studies for Active Psoriatic Arthritis Read More »

Zydus Cadila Seeks Approval to Commence P-III Clinical Study of ZyCoV-D

Shots: The company reported that the COVID-19 vaccine is safe, well-tolerated & immunogenic in the P-I/II study & plans to initiate P-III clinical trial in ~30000 volunteers upon receiving necessary approvals The P-II study of ZyCoV-D had been conducted in ~1000 healthy adult volunteers as part of the adaptive P-I/II dose-escalation study The trial has …

Zydus Cadila Seeks Approval to Commence P-III Clinical Study of ZyCoV-D Read More »

AstraZeneca’s Tezepelumab Fails to Meet its Primary Endpoint in P-III SOURCE Study for Asthma

Shots: The P-III SOURCE study involves assessing Tezepelumab (210mg, q4w) vs PBO in 150 adult patients as add-on therapy with patients maintained on their currently prescribed ICS + LABA, with/ out other asthma controller therapy for 48wks. The trial did not meet its 1EPs i.e., reduction in the daily OCS dose, without loss of asthma …

AstraZeneca’s Tezepelumab Fails to Meet its Primary Endpoint in P-III SOURCE Study for Asthma Read More »

Roche Reports Results of Faricimab in Two Global P-III Studies for Diabetic Macular Edema

Shots: The P-III YOSEMITE & RHINE studies assessing faricimab vs aflibercept in 1891 people living with DME. The studies include 3 treatment arms: faricimab (6mg) administered at personalized dosing intervals of ~16wks and at fixed 8wks. intervals & aflibercept (2mg) at fixed 8wks. intervals The studies met its 1EPs i.e faricimab in both the doses …

Roche Reports Results of Faricimab in Two Global P-III Studies for Diabetic Macular Edema Read More »

Roche Presents Results of Tecentriq (atezolizumab) in P-III IMvigor010 Study for MIUC at ESMO 2020

Shots: Roche reports an exploratory analysis of P-III IMvigor010 study assessing efficacy and safety of adjuvant treatment with Tecentriq vs observation in 809 people with MIUC, who are at high risk of recurrence following resection Results: in people with ctDNA, DFS Median (5.9 vs 4.4 mos.); median OS (25.8 vs 15.8 mos.). As presented in …

Roche Presents Results of Tecentriq (atezolizumab) in P-III IMvigor010 Study for MIUC at ESMO 2020 Read More »

Novartis Reports Results of Kisqali in P-III MONALEESA-7 Trial to Treat HR+/HER2- Metastatic Breast Cancer

Shots: The P-III MONALEESA-7 trial involves assessing Kisqali + endocrine therapy (goserelin + either an aromatase inhibitor or tamoxifen) as initial treatment vs endocrine therapy alone in patients with HR+/HER2- m-BC Result: @53.5 mos. follow-up, m-OS (58.7 vs 48.0 mos.); similar m-OS (58.7 vs 47.7 mos.) observed in IIT population; @ 42 mos. follow-up, estimated …

Novartis Reports Results of Kisqali in P-III MONALEESA-7 Trial to Treat HR+/HER2- Metastatic Breast Cancer Read More »

Roche Presents Results of Hemlibra Reinforcing the Long-Term Benefits for Hemophilia A at ASH 2020

Shots: The 4 pivotal HAVEN studies (HAVEN-1, 2, 3, 4) included pooled data from 401 people with hemophilia A with/ out factor VIII inhibitors, with a median duration efficacy period of 120.4wks. Hemlibra maintained low treated bleed rates with ABR remaining low throughout the evaluation period at 1.4. The proportion of participants who experienced 0 …

Roche Presents Results of Hemlibra Reinforcing the Long-Term Benefits for Hemophilia A at ASH 2020 Read More »

Roche Reports Long-Term Benefits of Venclexta/Venclyxto Based Combination for R/R Chronic Lymphocytic Leukemia

Shots: Five-year data from P-III MURANO trial shows sustained PFS with Venclexta/Venclyxto + MabThera/Rituxan vs BR in patients with r/r CLL The data showed a reduction in the risk of disease progression or death by 81%, m-OS (82.1% vs 62.2%), patients who completed 2yrs. of treatment without the progressive disease, 63.8% had uMRD The P-III …

Roche Reports Long-Term Benefits of Venclexta/Venclyxto Based Combination for R/R Chronic Lymphocytic Leukemia Read More »

Jazz Pharma and PharmaMar’s Zepzelca Fail to Meet its Primary Endpoint in P-III ATLANTIS Study for SCLC

Shots: The P-III ATLANTIS study involves assessing Zepzelca (lurbinectedin, 2.0mg/m2) + doxorubicin vs topotecan/ CAV in 613 adult patients in a ratio (1:1) aged ≥18yrs. with SCLC whose disease progressed following one prior Pt.-containing line The study did not meet its 1EP of OS in the ITT population while there were no adverse effects on …

Jazz Pharma and PharmaMar’s Zepzelca Fail to Meet its Primary Endpoint in P-III ATLANTIS Study for SCLC Read More »

Bausch Health Initiates Second P-III Study for NOV03 (perfluorohexyloctane) to Treat DED Associated With MGD

Shots: The enrollment of the first P-III study is currently underway & has reached 85% of its enrollment goal. In a P-II study of 336 patients, NOV03 met its 1EP of efficacy i.e. improvement of total corneal fluorescein staining over control @8wks. Additionally, NOV03 showed improvement of certain symptoms, such as severity & frequency of …

Bausch Health Initiates Second P-III Study for NOV03 (perfluorohexyloctane) to Treat DED Associated With MGD Read More »

AstraZeneca’s AZD1222 Meets its Primary Endpoint in Preventing COVID-19

Shots: Interim analysis results of COV002 & COV003 study of AZD1222 in the UK & Brazil showed the vaccine is effective in preventing COVID-19 and no hospitalizations/ severe cases of the disease were reported One dosing regimen showed an efficacy of 90% when AZD1222 was given as a half dose, followed by a full dose …

AstraZeneca’s AZD1222 Meets its Primary Endpoint in Preventing COVID-19 Read More »

Bharat Biotech Initiates P-III Study for Covaxin Against COVID-19

Shots: Following the successful completion of the interim analysis from the P-I & P-II clinical trials of Covaxin, the company has received the DCGI approval to conduct a P-III study of its COVID-19 vaccine The study will assess Covaxin (6mcg, IM at an interval of 28days) vs PBO in ~26,000 volunteers in a ratio (1:1) …

Bharat Biotech Initiates P-III Study for Covaxin Against COVID-19 Read More »

AstraZeneca and Amgen Report Results of Tezepelumab in P-III NAVIGATOR for Asthma

Shots: The P-III NAVIGATOR study involves assessing Tezepelumab + SOC vs pbo + SOC in adults (18–80yrs.) & adolescents (12–17yrs.) with severe, uncontrolled asthma, who were receiving treatment with medium/high dose ICS + at least 1 additional controller medication with or without OCS Trial met its 1EPs i.e. reduction in AAER @52wks. in the overall …

AstraZeneca and Amgen Report Results of Tezepelumab in P-III NAVIGATOR for Asthma Read More »

The US FDA’s Advisory Panel Slams Biogen’s Aducanumab for Alzheimer’s Disease

Shots: The advisory committee voted 1-8, with 2 members voting uncertain that EMERGE study (without regard for ENGAGE study) provides strong evidence, supporting the effectiveness of aducanumab as a treatment for AD. The committee also voted 0-7 with 4 members voting uncertain that PRIME study provides supporting evidence for aducanumab The committee voted 5-0 and …

The US FDA’s Advisory Panel Slams Biogen’s Aducanumab for Alzheimer’s Disease Read More »

BMS’ Deucravacitinib (BMS-986165) Demonstrate Superiority Over Amgen’ Otezla (apremilast) in P-III POETYK PSO-1 Study for Plaque Psoriasis

Shots: The P-III POETYK PSO-1 study involves assessing deucravacitinib (6mg, qd) vs PBO & Otezla (apremilast) in 666 patients with moderate to severe plaque psoriasis The trial met its co-1EPs & 2EPs demonstrating deucravacitinib was superior to Otezla (apremilast) in the patients reaching a PASI 75 and sPGA 0/1 @16wks. The overall safety profile of …

BMS’ Deucravacitinib (BMS-986165) Demonstrate Superiority Over Amgen’ Otezla (apremilast) in P-III POETYK PSO-1 Study for Plaque Psoriasis Read More »

Novartis Reports Results of Kisqali (ribociclib) in P-III MONALEESA-7 Study in Women with HR+/HER2- Advanced Breast Cancer

Shots: The pivotal P-III MONALEESA-7 study assessing Kisqali + endocrine therapy vs PBO + endocrine therapy, in pre- & perimenopausal women with HR+/HER2- advanced or metastatic-BC The study met its 2EPs of OS, demonstrating a significant improvement in OS, and is consistent for the NSAI population & across exploratory subgroups, m-OS was not reached while …

Novartis Reports Results of Kisqali (ribociclib) in P-III MONALEESA-7 Study in Women with HR+/HER2- Advanced Breast Cancer Read More »

Celltrion Presents Results of CT-P17 (biosimilar, adalimumab) in P-III Study for RA at ACR 2020

Shots: The P-III study involves assessing CT-P17 (40mg, q2w) vs reference adalimumab for up to 24wks. in 648 patients with active moderate-to-severe RA despite MTX treatment Results demonstrated that CT-P17 has equivalent efficacy to reference adalimumab i.e. ACR20 is 82.7% for both, 2EPs include ACR20/50/70 response rates, mean DAS28, CDAI & SDAI & EULAR (CRP) …

Celltrion Presents Results of CT-P17 (biosimilar, adalimumab) in P-III Study for RA at ACR 2020 Read More »

UCB Reports Results of Bimekizumab in P-III BE SURE Study for Moderate-to-Severe Psoriasis

Shots: The P-III BE SURE study involves assessing bimekizumab vs Humira (adalimumab) for 24wks. is followed until 56wks. in 478 adult patients with chronic PsO for at least 6 mos. before screening & with an affected body surface area of at least 10%, PASI of at least 12 & IGA score equal to or > …

UCB Reports Results of Bimekizumab in P-III BE SURE Study for Moderate-to-Severe Psoriasis Read More »

AbbVie Reports Results of SKYRIZI (risankizumab) in P-III LIMMitless Study in Patients with Moderate to Severe Plaque Psoriasis

Shots: The P-III LIMMitless study is designed to evaluate the long-term safety & efficacy assessing risankizumab (150 mg q12wks.) continuous risankizumab with a loading dose in adults with moderate to severe plaque psoriasis. The analysis includes integrated data from five P-II & III studies (ultIMMa-1, ultIMMa-2, SustaIMM, IMMvent and NCT03255382) and the LIMMitless study Results: …

AbbVie Reports Results of SKYRIZI (risankizumab) in P-III LIMMitless Study in Patients with Moderate to Severe Plaque Psoriasis Read More »

Dermavant Presents Results of Tapinarof in Pivotal P-III PSOARING Program at the 29th EADV Virtual Congress

Shots: The pivotal P-III clinical program for tapinarof in adult with PsO consists of PSOARING 1 (NCT03956355) and PSOARING 2 (NCT03983980) PSOARING 3 (NCT04053387), an ongoing long-term safety study. Positive results of P-III studies were reported in Aug’2020 Tapinarof previously met the 1EP in separate P-IIb trials for PsO & AD, both studies were published …

Dermavant Presents Results of Tapinarof in Pivotal P-III PSOARING Program at the 29th EADV Virtual Congress Read More »

AstraZeneca’s Forxiga (dapagliflozin) Receive NMPA’s Approval for Label Update to Include Data of P-III DECLARE-TIMI 58 Study

Shots: The updated label includes P-III DECLARE-TIMI 58 study that assesses the effect of Forxiga vs PBO on CV outcomes in 17000+ patients with T2D at risk of CV events also assessed key renal 2EPs, across 882 sites in 33 countries The study demonstrated that Forxiga achieved a significant reduction in the composite EP of …

AstraZeneca’s Forxiga (dapagliflozin) Receive NMPA’s Approval for Label Update to Include Data of P-III DECLARE-TIMI 58 Study Read More »

AstraZeneca Resumes P-III Study of AZD1222 Against COVID-19 in the US

Shots: The US FDA authorizes the restart of the P-III clinical study in the US following the resumption of trials in other countries in recent weeks. The FDA reviewed all safety data from studies globally and concluded it was safe to resume the trial A voluntary pause across all global studies was triggered on Sept …

AstraZeneca Resumes P-III Study of AZD1222 Against COVID-19 in the US Read More »

Jazz Reports Results of Xywav (calcium, magnesium, potassium, and sodium oxybates) in P-III Study for Cataplexy or EDS in Patients with Narcolepsy

Shots: The P-III study involves assessing Xywav vs PBO in patients aged ≥ 7yrs. with cataplexy or EDS with narcolepsy Results: study met its 1EPs & 2EPs i.e. differences in median change in a weekly number of cataplexy attacks and ESS scores. Results were published at World Sleep 2019 Xywav is an oxybate product with …

Jazz Reports Results of Xywav (calcium, magnesium, potassium, and sodium oxybates) in P-III Study for Cataplexy or EDS in Patients with Narcolepsy Read More »

BMS Report Results of Opdivo (nivolumab) + CT in P-III CheckMate-816 Trial for Resectable Non-Small Cell Lung Cancer

Shots: The P-III CheckMate-816 study involves assessing of Opdivo (360mg) + CT (q3w for 3 doses) vs CT (q3w for 3 doses), followed by surgery as a neoadjuvant treatment in 358 patients with resectable NSCLC The study met its 1EPs of improved pathologic complete response. The positive results marks the first time an immune checkpoint …

BMS Report Results of Opdivo (nivolumab) + CT in P-III CheckMate-816 Trial for Resectable Non-Small Cell Lung Cancer Read More »

Novartis Reports Results of Beovu (brolucizumab) in Two New Post-Hoc Analyses of P-III HAWK and HARRIER Studies for Wet AMD

Shots: The P-III HAWK (6/3mg) & HARRIER (6mg) study assessing Beovu [q12w/q8w with the majority on q12w following the loading phase) vs aflibercept (2mg) in 1,800 patients with wet AMD across 400 centers Results: first analysis ewer patients had early persistent fluid (12.5% vs 20.4%), defined as the presence of intra-retinal fluid or subretinal fluid …

Novartis Reports Results of Beovu (brolucizumab) in Two New Post-Hoc Analyses of P-III HAWK and HARRIER Studies for Wet AMD Read More »

Novartis Reports Results of Asciminib (ABL001) in P-III ASCEMBL Study for Chronic Myeloid Leukemia

Shots: The P-III ASCEMBL study involves assessing of Asciminib (ABL001) vs bosutinib in patients with Ph+ CML-CP, prior treated with two or more TKIs The study met its 1EPs of superiority in major molecular response (MMR) rate @24wks. Asciminib (ABL001) is an investigational treatment specifically targeting the ABL myristoyl pocket (STAMP), being evaluated in multiple …

Novartis Reports Results of Asciminib (ABL001) in P-III ASCEMBL Study for Chronic Myeloid Leukemia Read More »

Novartis’ Triple Regimen Fails to Meet the Primary Endpoint in P-III COMBI-i Study for Advanced Melanoma

Shots: The P-III study involves assessing of spartalizumab (PDR001) + Tafinlar (dabrafenib) and Mekinist (trametinib) vs PBO + Tafinlar and Mekinist in previously untreated patients with unresectable or metastatic BRAF V600 mutation-positive melanoma The study was conducted in three parts while today’s results are from part 3 of the trial. The study did not meet …

Novartis’ Triple Regimen Fails to Meet the Primary Endpoint in P-III COMBI-i Study for Advanced Melanoma Read More »

Novo Nordisk Resumes P-III Study of Concizumab for Patients with Hemophilia A and B

Shots: The company resumes the P-III program (explorer6, 7, and 8) of concizumab. The clinical trials are evaluating concizumab (SC) prophylaxis treatment in hemophilia A and B patients regardless of their inhibitor status The trials will be resumed as soon as local procedures allow. This follows pausing of the trials in Mar’20 due to the …

Novo Nordisk Resumes P-III Study of Concizumab for Patients with Hemophilia A and B Read More »

Roche Report Mixed Results of Etrolizumab in P-III Studies for Patients with Moderately to Severely Active Ulcerative Colitis

Shots: In the HIBISCUS I induction study, in patients without prior anti-TNF treatment, etrolizumab met its 1EPs while in HIBISCUS II study in the same kind of people, it did not meet its 1EPs. In the HICKORY study, in patients with prior anti-TNF treatment, therapy met its 1EPs at induction but not at maintenance In …

Roche Report Mixed Results of Etrolizumab in P-III Studies for Patients with Moderately to Severely Active Ulcerative Colitis Read More »

Roche’s Tecentriq (atezolizumab) + Paclitaxel Fail to Meet the Primary Endpoint in P-III IMpassion131 Study for Patients with Metastatic Triple-Negative Breast Cancer

Shots: The P-III IMpassion131 study involves assessing of Tecentriq + paclitaxel vs PBO + paclitaxel, in 651 people in a ratio (2:1) with previously untreated, inoperable, LA/ m-TNBC The study did not meet its 1EPs of PFS for 1L treatment of people with m-TNBC) in the PD-L1+ population.  The data for 2EPs of OS showed …

Roche’s Tecentriq (atezolizumab) + Paclitaxel Fail to Meet the Primary Endpoint in P-III IMpassion131 Study for Patients with Metastatic Triple-Negative Breast Cancer Read More »

Novartis Reports Results of Ofatumumab (OMB157) in P-III ASCLEPIOS Trials for Relapsing Multiple Sclerosis

Shots: The two P-III studies, ASCLEPIOS I & II involves assessing of ofatumumab (20mg, monthly SC) vs teriflunomide (14mg) in 1882 patients aged 18-55yrs with MS and EDDS score b/w 0 and 5.5.  The studies were conducted across 37 countries in 350+ sites  Results of ASCLEPIOS I & II: 51% & 58% reduction in ARR …

Novartis Reports Results of Ofatumumab (OMB157) in P-III ASCLEPIOS Trials for Relapsing Multiple Sclerosis Read More »

Eli Lilly in Collaboration with NIAID Initiate P-III Study of LY-CoV555 to Prevent COVID-19

Shots: Eli Lilly initiates P-III BLAZE-2 study assessing LY-CoV555 to prevent SARS-CoV-2 infection and COVID-19 in residents and staff at long-term care facilities in the US (skilled nursing facilities, commonly referred to as nursing homes, and assisted living facilities) The company will enroll up to ~2400 patients and test whether a single dose of LY-CoV555 …

Eli Lilly in Collaboration with NIAID Initiate P-III Study of LY-CoV555 to Prevent COVID-19 Read More »

Eli Lilly Reports Results of Jardiance (empagliflozin) in P-III EMPEROR Trial for Heart Failure Patients with Reduced Ejection Fraction with and without Diabetes

Shots: The P-III EMPEROR Trial involves assessing of Jardiance (10 mg) vs PBO in two studies EMPEROR-Reduced [NCT03057977, N=3,730] & EMPEROR-Preserved [NCT03057951, N=5,990] in patients with HFrEF & HFpEF respectively The EMPEROR-Reduced study meets its 1EPs in reducing the risk for the composite of cardiovascular death or hospitalization due to heart failure while the overall …

Eli Lilly Reports Results of Jardiance (empagliflozin) in P-III EMPEROR Trial for Heart Failure Patients with Reduced Ejection Fraction with and without Diabetes Read More »

AbbVie Report Results of Rinvoq (upadacitinib) in a P-III AD Up Study for Patients with Atopic Dermatitis

Shots: The P-III AD Up study involves assessing Rinvoq (15/30mg) + TCS vs PBO + TCS in patients (aged≥12) with the mod. to sev. AD who are candidates for systemic treatment. Patients receiving PBO + TCS were switched to either upadacitinib (15/30mg) + TCS @16wks. Results: @16wks. EASI 75 (65%/77% vs 26%); vIGA-AD 0/1 (40%/59% …

AbbVie Report Results of Rinvoq (upadacitinib) in a P-III AD Up Study for Patients with Atopic Dermatitis Read More »

Roche’s Actemra/RoActemra (tocilizumab) Fails to Meet the Primary Endpoint in P-III COVACTA Study for Patients with COVID-19 Associated Pneumonia

Shots: The P-III COVACTA study involves assessing of Actemra/RoActemra (IV) + SOC vs PBO + SOC in adult patients hospitalized with severe COVID-19 associated pneumonia. Patients will be followed for 60 days post-randomization The study did not meet its 1EPs i.e. improvement in clinical status and 2EPs i.e. difference in patient mortality @4wks. (19.7% vs …

Roche’s Actemra/RoActemra (tocilizumab) Fails to Meet the Primary Endpoint in P-III COVACTA Study for Patients with COVID-19 Associated Pneumonia Read More »

AstraZeneca Report Results of Farxiga in P-III DAPA-CKD Study for Patients with Chronic Kidney Disease

Shots: The P-III DAPA-CKD involve assessing of Farxiga ((dapagliflozin, 10mg, qd) + SOC vs PBO in 4,304 patients with CKD Stages 2–4 and elevated urinary albumin excretion, with and without T2D The study met its 1EPs i.e. worsening of renal function or risk of death (defined as a composite of an eGFR decline ≥50%, the …

AstraZeneca Report Results of Farxiga in P-III DAPA-CKD Study for Patients with Chronic Kidney Disease Read More »

Genentech Reports Results of Port Delivery System with Ranibizumab in P-III Archway Study for Neovascular Age-Related Macular Degeneration

Shots: The P-III Archway study involves assessing of PDS with ranibizumab, refilled @6mos. at fixed intervals, vs ranibizumab (0.5mg, monthly IVT) in 418 patients with nAMD, prior treated with VEGF therapy Results: 98.4% of PDS patients were able to go 6mos. without needing additional treatment and achieved vision outcomes equivalent to patients receiving ranibizumab (0.5mg, …

Genentech Reports Results of Port Delivery System with Ranibizumab in P-III Archway Study for Neovascular Age-Related Macular Degeneration Read More »

Glenmark Report Results of FabiFlu (favipiravir) in P-III Clinical Study for Patients with Mild to Moderate COVID-19

Shots: The P-III study assessing the efficacy and safety of Favipiravir + SSC vs SCC in 150 mild to moderate patients, randomized within a 48hour window of testing RT-PCR positive for COVID-19 Results: P-III study the improvement in 1EPs with 28.6% faster viral clearance in the overall population as measured by the median time until …

Glenmark Report Results of FabiFlu (favipiravir) in P-III Clinical Study for Patients with Mild to Moderate COVID-19 Read More »

AbbVie Reports Results of Rinvoq (upadacitinib) as Monotherapy in a P-III Measure Up 2 Study for Atopic Dermatitis

Shots: The P-III Measure Up 2 study involves assessing of Rinvoq (15/30mg) vs PBO in adults and adolescents aged 12-18yrs. or older with mod. to sev. AD who are candidates for systemic treatment. Placebo patients were switched to either upadacitinib (15/30mg) @16wks. The study met its co-1EPs @16wks. i.e. improvement in EASI 75 (60%/73% vs …

AbbVie Reports Results of Rinvoq (upadacitinib) as Monotherapy in a P-III Measure Up 2 Study for Atopic Dermatitis Read More »

Eli Lilly Reports Results of Mirikizumab in P-III OASIS-2 Study to Treat Moderate to Severe Plaque Psoriasis

Shots: The P-III OASIS-2 study involves assessing mirikizumab vs PBO & Cosentyx (secukinumab) in 1,465 patients with mod. to sev. PsO. The patients were randomized in a (4:4:4:1) ratio to one of the following induction and maintenance period treatments: mirikizumab (250mg) @ 0, 4, 8, 12wks. followed by 250 & 125mg, q8w starting @16wks; 300mg …

Eli Lilly Reports Results of Mirikizumab in P-III OASIS-2 Study to Treat Moderate to Severe Plaque Psoriasis Read More »

AstraZeneca Report Results of Brilinta (ticagrelor) in P-III THALES Study for Patients with Acute Ischemic Stroke or Transient Ischemic Attack

Shots: The P-III THALES study involves assessing of Brilinta (180mg as a loading dose followed by 90mg, bid) + aspirin vs aspirin as monothx. in 11,000 patients with non-cardioembolic acute ischaemic stroke or high-risk TIA for 30days Results: 17% reduction in 1EPs of stroke and death, 21% reduction in 2EPs of ischaemic stroke, the risk …

AstraZeneca Report Results of Brilinta (ticagrelor) in P-III THALES Study for Patients with Acute Ischemic Stroke or Transient Ischemic Attack Read More »

Clover Reports First Patient Dosing in P-III Trial with SCB-808 (biosimilar, etanercept) in China

Shots: The P-III study involves assessing of SCB-808 (SC) vs Enbrel (SC) in patients with ankylosing spondylitis (radiographic axial spondyloarthritis) to evaluate its safety, efficacy and PK The company utilizes its Trimer-Tag technology platform to develop novel therapies targeting trimerization-dependent pathways and is also leveraging its cGMP biomanufacturing capabilities to develop biosimilars SCB-808 is mAb …

Clover Reports First Patient Dosing in P-III Trial with SCB-808 (biosimilar, etanercept) in China Read More »

Eli Lilly Opens its P-III LIBRETTO-531 Clinical Trial for LOXO-292 (selpercatinib) to Treat RET-Mutant Medullary Thyroid Cancer (MTC) Patients

Shots: The second P-III LIBRETTO-531 involves assessing of selpercatinib vs physician’s choice of cabozantinib or vandetanib in 400 patients in ratio (2:1) with advanced or metastatic RET-mutant MTC who have received no prior systemic therapy for metastatic disease The study will have efficacy endpoints as progression-free survival (PFS), treatment failure-free survival (TFFS), overall survival (OS), …

Eli Lilly Opens its P-III LIBRETTO-531 Clinical Trial for LOXO-292 (selpercatinib) to Treat RET-Mutant Medullary Thyroid Cancer (MTC) Patients Read More »

Eisai Reports Results of DAYVIGO (lemborexant) in P-III SUNRISE 1 Study in Patients with Insomnia Disorder

Shots: The P-III SUNRISE 1 (Study 304) study involves assessing of DAYVIGO (lemborexant, 5 or 10 mg) vs an active comparator or PBO in 1,006 patients with insomnia disorder aged 55 years of age or older Results of P-III study@ 5/10 mg of DAYVIGO: headache (6.4%, 4.9 % vs 6.2%, 5.3%), somnolence (4.1%, 7.1% vs …

Eisai Reports Results of DAYVIGO (lemborexant) in P-III SUNRISE 1 Study in Patients with Insomnia Disorder Read More »

Clover Reports Dosing of SCB-808 (biosimilar, etanercept) in P-III Trial in China

Shots: The P-III study involves assessing of SCB-808 vs Enbrel in patients with AS (axSpA) via SC administration SCB-808 is being developed in the prefilled syringe formulation which is ready for injection and can be self-administered by the patients, thus overwhelming the current Enbrel biosimilar which are available in lyophilized powder formulation in China Clover …

Clover Reports Dosing of SCB-808 (biosimilar, etanercept) in P-III Trial in China Read More »