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Merck Enters in Third Clinical Trial Collaboration with Adagene to Advance ADG106 + Keytruda (pembrolizumab) for Solid Tumors and Hematological Malignancies

Shots: The companies collaborated to evaluate ADG106 + Keytruda in dose-escalation and expansion clinical study to treat advanced or metastatic solid tumors & hematological malignancies In preclinical studies, ADG106 showed antitumor activity and was well tolerated as a monothx. and in combination with other immuno-oncology therapies ADG106 is a fully human, ligand-blocking, agonistic anti-CD137 IgG4 …

Merck Enters in Third Clinical Trial Collaboration with Adagene to Advance ADG106 + Keytruda (pembrolizumab) for Solid Tumors and Hematological Malignancies 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 »

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 »

GSK’s Jemperli (dostarlimab) Receives the EC’s Approval for Recurrent or Advanced dMMR/MSI-H Endometrial Cancer

Shots: The EC has granted conditional approval for Jemperli in women with dMMR/ MSI-H endometrial cancer that has progressed on or following prior treatment with a Pt.- containing regimen AnaptysBio has received $10M as milestones upon the EC’s approval and will receive $35M as regulatory milestones in the US & EU, $165M as sales milestones …

GSK’s Jemperli (dostarlimab) Receives the EC’s Approval for Recurrent or Advanced dMMR/MSI-H Endometrial Cancer Read More »

Astellas and Seagen Report the US FDA’s Acceptance of Two sBLA for Padcev (enfortumab vedotin) in Locally Advanced or Metastatic Urothelial Cancer

Shots: The first sBLA is based on the P-III EV-301 trial assessing Padcev vs CT in ~ 600 patients with LA or mUC prior treated with PD-1/L1 inhibitor and platinum-based therapy. The first sBLA seeks to convert PADCEV’s accelerated approval to regular approval The second sBLA is based on cohort 2 of the P-II EV-201 …

Astellas and Seagen Report the US FDA’s Acceptance of Two sBLA for Padcev (enfortumab vedotin) in Locally Advanced or Metastatic Urothelial Cancer Read More »

Innovent and Lilly Present Results of Tyvyt (sintilimab) in P-III ORIENT-3 Trial as 2L Treatment for Advanced or Metastatic Squamous NSCLC at AACR 2021

Shots: The P-III ORIENT-3 trial involves assessing the efficacy and safety of Tyvyt (sintilimab) vs docetaxel (q3w) in 290 patients in a ratio (1:1) as a 2L treatment for advanced or m-sqNSCLC The trial met its 1EP i.e improvement in OS, mOS (11.79 vs 8.25 mos.), mPFS (4.30 vs 2.79 mos.), ORR (25.5% vs 2.2%), …

Innovent and Lilly Present Results of Tyvyt (sintilimab) in P-III ORIENT-3 Trial as 2L Treatment for Advanced or Metastatic Squamous NSCLC at AACR 2021 Read More »

Taiho Oncology’s Futibatinib (TAS-120) Receives the US FDA’s Breakthrough Therapy Designation for Advanced Cholangiocarcinoma

Shots: The designation is based on efficacy & safety results from the P-II FOENIX-CCA2 study involves assessing futibatinib (TAS-120) in patients with advanced cholangiocarcinoma. The findings will be presented at AACR 2021 The preliminary clinical evidence showed improvement on at least one clinical EPs over available therapy Futibatinib (TAS-120, PO) is a covalently-binding FGFR inhibitor …

Taiho Oncology’s Futibatinib (TAS-120) Receives the US FDA’s Breakthrough Therapy Designation for Advanced Cholangiocarcinoma Read More »

Astellas and Seagen Report EMA’s Acceptance of MAA for Enfortumab Vedotin to Treat Locally Advanced or Metastatic Urothelial Cancer

Shots: The MAA is based on the P-III EV-301 trial which involves assessing Enfortumab Vedotin vs CT in ~ 600 patients with LA/m-UC, prior treated with Pt.-based CT and a PD-1/L1 inhibitor The 1EPs of the trial is OS and 2EPs include PFS, ORR, DoR, DCR as well as the assessment of safety/tolerability and QoL …

Astellas and Seagen Report EMA’s Acceptance of MAA for Enfortumab Vedotin to Treat Locally Advanced or Metastatic Urothelial Cancer Read More »

Astellas Reports NDA Submission of Enfortumab Vedotin to the MHLW for Locally Advanced or Metastatic Urothelial Cancer in Japan

Shots: The submission is based on EV-301 and EV-201 trials in Japan. The P-III EV-301 trial assessing Enfortumab Vedotin vs CT in ~ 600 patients with LA/m-UC, prior treated with platinum-based CT and PD-1/L1 inhibitor The P-II EV-201 trial assessing Enfortumab Vedotin in ~128 patients with LA/m-UC, prior treated with PD-1/L1 inhibitor, including those who …

Astellas Reports NDA Submission of Enfortumab Vedotin to the MHLW for Locally Advanced or Metastatic Urothelial Cancer in Japan Read More »

BMS’ Opdivo (nivolumab) + Cabometyx (cabozantinib) Receive CHMP’s Positive Opinion as 1L Treatment for Advanced Renal Cell Carcinoma

Shots: The CHMP recommendation is based on P-III CheckMate -9ER trial involves assessing Opdivo + Cabometyx vs sunitinib in 651 patients with previously untreated advanced or metastatic RCC The P-III result showed improvements in PFS, OS and ORR with consistent efficacy benefits observed across key subgroups of patients and was well tolerated, with a low …

BMS’ Opdivo (nivolumab) + Cabometyx (cabozantinib) Receive CHMP’s Positive Opinion as 1L Treatment for Advanced Renal Cell Carcinoma Read More »

AstraZeneca to Withdraw Imfinzi Indication in Advanced Bladder Cancer in the US

Shots: The company reported the voluntary withdrawal of the Imfinzi (durvalumab) indication in the US for prior treated adult patients with LA or metastatic bladder cancer. The withdrawal was made in consultation with the US FDA The withdrawal is aligned with FDA guidance for evaluating indications with accelerated approvals that did not meet post-marketing requirements …

AstraZeneca to Withdraw Imfinzi Indication in Advanced Bladder Cancer in the US Read More »

Regeneron and Sanofi’s Libtayo (cemiplimab-rwlc) Receives US FDA’s Approval for Patients with Advanced Basal Cell Carcinoma

Shots: The FDA approval is based on P-II trial involves assessing Libtayo (350mg, q3w) in patients with locally advanced BCC & metastatic BCC (nodal or distant) Results: median follow-up (9.5 & 15.1mos.); ORR (21% & 29%); PR (21% & 23%); D0R @≥6mos. (100% & 79%); with longer follow up, 0RR with LA BCC (31%) as …

Regeneron and Sanofi’s Libtayo (cemiplimab-rwlc) Receives US FDA’s Approval for Patients with Advanced Basal Cell Carcinoma Read More »

Amgen’s Sotorasib Receives NMPA’s Breakthrough Therapy Designation in China for the Treatment of Advanced NSCLC With KRAS G12C Mutation

Shots: The BT designation is based on P-II CodeBreaK 100 study assessing Sotorasib in 126 patients with KRAS G12C-mutated locally advanced or metastatic NSCLC who have received at least one prior systemic therapy. The findings will be presented at the IASLC 2020 WCLC Presidential Symposium The company is currently recruiting in a P-III study (CodeBreaK …

Amgen’s Sotorasib Receives NMPA’s Breakthrough Therapy Designation in China for the Treatment of Advanced NSCLC With KRAS G12C Mutation Read More »

Amgen Report Results of Sotorasib in P-II Study for KRAS G12C-Mutated Advanced NSCLC

Shots: The P-II cohort of the CodeBreaK 100 clinical study involves assessing Sotorasib (AMG 510, 960mg, qd) in 126 patients with KRAS G12C-mutated advanced NSCLC. The findings will be presented at the IASLC 2020 WCLC Results: @median follow up of 12.2 mos., ORR (37.1%); DCR (80.6%); mDoR (10 mos.), PFS (6.8 mos.). Median tumor shrinkage …

Amgen Report Results of Sotorasib in P-II Study for KRAS G12C-Mutated Advanced NSCLC Read More »

BeiGene’s Tislelizumab (BGB-A317) + CT Receive NMPA’s Approval as 1L Therapy for Advanced Squamous NSCLC

Shots: The approval is based on Tislelizumab + CT regimen vs CT as monothx. in 360 patients with a ratio (1:1:1) as a 1L for patients with advanced squamous NSCLC The trial met the 1EP, i.e. improvement in PFS, as assessed by IRC in the pre-planned interim analysis. The safety profile of tislelizumab in both …

BeiGene’s Tislelizumab (BGB-A317) + CT Receive NMPA’s Approval as 1L Therapy for Advanced Squamous NSCLC Read More »

Chi-Med Initiates Rolling Submission of NDA to the US FDA of Surufatinib to Treat Advanced Neuroendocrine Tumors

Shots: Chi-Med initiated the filing of NDA to the US FDA for surufatinib to treat pancreatic & non-pancreatic NET & plans to complete the NDA submission in the H1’21 The NDA is based on two P-III studies that demonstrated a reduction in risk of progression or death by 67% & 51%, extending PFS of non-pancreatic …

Chi-Med Initiates Rolling Submission of NDA to the US FDA of Surufatinib to Treat Advanced Neuroendocrine Tumors Read More »

Amgen Reports NDA Submission of Sotorasib to the US FDA for Advanced/Metastatic NSCLC With KRAS G12C Mutation

Shots: The NDA submission is based P-II CodeBreaK 100 study assessing Sotorasib in patients with KRAS G12C-mutated NSCLC prior treated with CT and immunotherapy The study provided durable anticancer activity with a positive benefit-risk profile The US FDA has reviewed the NDA under RTOR pilot program, which aims to explore efficient review process that ensures …

Amgen Reports NDA Submission of Sotorasib to the US FDA for Advanced/Metastatic NSCLC With KRAS G12C Mutation Read More »

Roche Launches Cobas PIK3CA Mutation Test for Patients with Advanced or Metastatic Breast Cancer

Shots: Roche launches the cobas PIK3CA mutation test for patients with advanced/ m-BC in countries accepting the CE mark The IVT test is a real-time PCR test for the qualitative detection & identification of 17 mutations in exons 2, 5, 8, 10 & 21 in the gene encoding the catalytic subunit of PIK3CA in DNA …

Roche Launches Cobas PIK3CA Mutation Test for Patients with Advanced or Metastatic Breast Cancer Read More »

Zymeworks and ALX Oncology Collaborate to Evaluate Zanidatamab + ALX148 for Advanced HER2‑Expressing Breast Cancer

Shots: Zymeworks will conduct a P-Ib study to assess the safety and efficacy of the combination of zanidatamab and ALX148 in a two-part study The 1st part will evaluate the safety of the combination regimen while the 2nd part will assess the safety, tolerability, and anti-tumor activity in separate cohorts of subjects with HER2+ BC, …

Zymeworks and ALX Oncology Collaborate to Evaluate Zanidatamab + ALX148 for Advanced HER2‑Expressing Breast Cancer Read More »

AstraZeneca and MSD’s Lynparza (olaparib) Receive EU’s Approval as 1L Maintenance Treatment for HRD-Positive Advanced Ovarian Cancer

Shots: The approval is based on a biomarker subgroup analysis of P-III PAOLA-1 study assessing Lynparza + bevacizumab vs bevacizumab alone as 1L maintenance treatment in patients with newly diagnosed advanced FIGO Stage III-IV high-grade serous/ endometrioid ovarian, fallopian tube, peritoneal cancer who had CR/PR to 1L treatment with Pt. based CT and bevacizumab Results: reduction …

AstraZeneca and MSD’s Lynparza (olaparib) Receive EU’s Approval as 1L Maintenance Treatment for HRD-Positive Advanced Ovarian Cancer 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 »

GSK’s Zejula (niraparib) Receives EC’s Approval as a Treatment in Advanced Ovarian Cancer

Shots: The approval is based on PRIMA study assessing Zejula (300mg qd), later amended to incorporate an individualised starting dose of Zejula (200 mg or 300 mg, qd) based on the patient’s baseline weight and/or platelet count Results: The PRIMA study improved PFS for patients treated with Zejula, regardless of biomarker status. In the HRd …

GSK’s Zejula (niraparib) Receives EC’s Approval as a Treatment in Advanced Ovarian Cancer Read More »

STADA Expands its Specialty Footprint with the Acquisition of Lobsor Pharmaceuticals

Shots:   STADA acquires Lobsar and its innovative therapy to foster its footprints in specialty pharmaceuticals. The acquisition complements STADA’s portfolio and expertise in the treatment of late-stage Parkinson’s disease With the acquisition, STADA gain rights to a triple fixed combination (levodopa/carbidopa/ entacapone) delivered via modern pump technology, already launched in Nordic countries Levodopa, carbidopa and …

STADA Expands its Specialty Footprint with the Acquisition of Lobsor Pharmaceuticals Read More »

Roche’s Rozlytrek Receives EC’s Conditional Marketing Authorization for NTRK Fusion-Positive Solid Tumors and ROS1-Positive Advanced NSCLC

Shots: The approval is based on integrated analysis including data from 74 people with LA/ m-NTRK fusion-positive solid tumors (14 tumor types) & 161 people with ROS1+ NSCLC of the pivotal P-II STARTRK-2, P-I STARTRK-1 and P-I ALKA-372-001 trials, and data from the P-I/II STARTRK-NG study in pediatric patients Result: in NTRK fusion+ solid tumors, …

Roche’s Rozlytrek Receives EC’s Conditional Marketing Authorization for NTRK Fusion-Positive Solid Tumors and ROS1-Positive Advanced NSCLC Read More »

Roche’s Tecentriq + Cotellic and Zelboraf Receives the US FDA’s Approval for Patients with Advanced Melanoma

Shots: The approval is based on P-III IMspire150 study assessing Tecentriq (atezolizumab) + Cotellic  (cobimetinib) + Zelboraf (vemurafenib) vs  PBO + Cotellic +   Zelboraf in patients with BRAF V600 mutation-positive advanced melanoma Results: mPFS (15.1 vs 10.6mos.); the safety profile of the Tecentriq combination was consistent with the known safety profiles of the individual medicines. …

Roche’s Tecentriq + Cotellic and Zelboraf Receives the US FDA’s Approval for Patients with Advanced Melanoma Read More »

Oncorus Initiates P-I Study of ONCR-177 in Patients with Advanced/ Refractory Cutaneous Subcutaneous or Metastatic Nodal Solid Tumors

Shots: Oncorus has initiated a P-I study assessing ONCR-177 as monothx. and in combination with Merck’s Keytruda in patients with advanced and/or refractory cutaneous, subcutaneous or metastatic nodal solid tumors The P-I study enrolls ~21 cancer patients while P-II study enrolls patients to histology- specific expansion cohorts. The P-I study will evaluate the safety and …

Oncorus Initiates P-I Study of ONCR-177 in Patients with Advanced/ Refractory Cutaneous Subcutaneous or Metastatic Nodal Solid Tumors Read More »