P-III

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

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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… 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

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

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

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

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

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

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

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

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

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

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

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

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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… 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

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

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

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

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

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

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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… 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

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

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

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

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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… 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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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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… 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

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

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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 [email protected] 5/10 mg of DAYVIGO: headache… Read More »Eisai Reports Results of DAYVIGO (lemborexant) in P-III SUNRISE 1 Study in Patients with Insomnia Disorder

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

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