Bristol Myers Squibb receives EMA validation for Opdivo plus Yervoy for first-line treatment of advanced hepatocellular carcinoma
- The European Medicines Agency (EMA) validated Bristol Myers Squibb's application for Opdivo (nivolumab) plus Yervoy (ipilimumab) as a first-line treatment for unresectable or advanced hepatocellular carcinoma (HCC).
- The application is based on the Phase 3 CheckMate -9DW trial, which showed significant improvement in overall survival compared to lenvatinib or sorafenib.
- The safety profile of the combination treatment was consistent with previous data and manageable with established protocols.
- Next steps include the EMA's centralized procedure review.
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AVEO Oncology announces phase 3 renal cell carcinoma clinical trial (TiNivo-2) results
- The TiNivo-2 Phase 3 trial did not meet its primary endpoint of increasing progression-free survival (PFS) with the addition of nivolumab to low dose tivozanib.
- Tivozanib monotherapy at the standard dose demonstrated clinically meaningful efficacy and safety in the second-line setting following prior immune checkpoint inhibitor (ICI) therapy.
- The trial's control arm results support the use of tivozanib as a well-tolerated treatment option for relapsed or refractory advanced RCC.
- Detailed findings are expected to be presented at an upcoming scientific meeting.
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European Medicines Agency accepts Deciphera’s marketing authorization application for vimseltinib for treatment of patients with tenosynovial giant cell tumor (TGCT)
- The European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) for vimseltinib, developed by Deciphera Pharmaceuticals, for the treatment of tenosynovial giant cell tumor (TGCT).
- The application is supported by data from the pivotal Phase 3 MOTION study, which showed a statistically significant and clinically meaningful objective response rate (ORR) at Week 25.
- Vimseltinib demonstrated significant improvements in all key secondary endpoints and had a manageable safety profile consistent with previous trials.
- The review process will cover all 27 EU member states, as well as Iceland, Liechtenstein, and Norway.
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FDA accepts and prioritizes review of tabelecleucel for EBV+ PTLD treatment
- Pierre Fabre Pharmaceuticals Inc. announces FDA acceptance and priority review of the Biologics License Application (BLA) for Tabelecleucel (Tab-cel).
- Tab-cel is indicated for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) in patients who have received at least one prior therapy.
- The BLA is supported by data from the pivotal Phase 3 ALLELE study, which investigated Tab-cel in relapsed or refractory EBV+ PTLD following solid organ transplant (SOT) or hematopoietic cell transplant (HCT).
- The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of January 15, 2025.
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BriaCell quadruples progression free survival in patient with metastatic breast cancer
- Progression free survival (PFS) extended to 9.1 months in an ADC-resistant patient.
- Significant reduction of 'eye-bulging' metastatic breast cancer tumor reported.
- Patient had failed 8 prior regimens and continues to receive BriaCell treatment.
- Ongoing Phase 3 study aims to replicate these positive results.
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Haystack Oncology and Lisata Therapeutics initiate research collaboration to evaluate pancreatic cancer therapy
- Haystack Oncology and Lisata Therapeutics have announced a research collaboration.
- Lisata will use Haystack's MRD technology to detect ctDNA in a study evaluating certepetide plus chemotherapy for metastatic pancreatic cancer.
- The FORTIFIDE study will assess the safety, tolerability, and efficacy of certepetide in combination with standard-of-care treatment for mPDAC patients.
- Haystack's MRD technology will measure serum ctDNA levels at multiple timepoints to analyze the early therapeutic effect of certepetide.
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