Clinical-stage biotechnology company Arvinas Inc (Nasdaq:ARVN) and biopharmaceutical company Pfizer Inc (NYSE:PFE) on Tuesday announced positive topline results from the Phase 3 VERITAC-2 trial evaluating vepdegestrant in estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced or metastatic breast cancer.
The trial met its primary endpoint in the estrogen receptor 1-mutant population, showing a statistically significant and clinically meaningful improvement in progression-free survival compared to fulvestrant.
Vepdegestrant is the first PROTAC degrader to demonstrate clinical benefit in a Phase 3 trial. However, the trial did not achieve statistical significance in progression-free survival improvement in the intent-to-treat population.
Overall survival data remain immature, with the trial continuing to assess this secondary endpoint. Vepdegestrant was generally well tolerated, with a safety profile consistent with previous studies.
The companies plan to present detailed results at a medical meeting later this year and share data with regulatory authorities to support potential filings.
Innovent's limertinib receives Chinese regulatory approval for first-line treatment of lung cancer
Johnson & Johnson reports TAR-200 monotherapy study data in bladder cancer
InnoCare receives NMPA approval for orelabrutinib as first-line treatment for CLL/SLL in China
RaySearch Laboratories announces order from Odense University Hospital for RayStation
Guardant Health and Pfizer enter global collaboration to advance cancer therapy development
Adcendo to present clinical stage ADC data at 2025 AACR Annual Meeting
Tagworks Pharmaceuticals' TGW101 IND application granted FDA clearance for Phase 1 clinical trial
1Cell.Ai launches OncoIncytes multi-modal cancer diagnostic panel
Atossa Therapeutics secures new US patent for (Z)-endoxifen formulations