Arvinas, Inc. ARVN and Pfizer Inc. PFE launched topline outcomes from the Part 3 VERITAC-2 trial evaluating vepdegestrant monotherapy versus fulvestrant in grownup sufferers with superior or metastatic breast most cancers.
The outcomes of the trial, launched Monday, included estrogen receptor-positive, human epidermal progress issue receptor 2-negative (ER+/HER2-) superior or metastatic breast most cancers sufferers whose illness progressed following prior therapy with cyclin-dependent kinase (CDK) 4/6 inhibitors and endocrine remedy.
These are the primary pivotal knowledge for vepdegestrant.
The trial met its main endpoint within the estrogen receptor 1-mutant (ESR1m) inhabitants, demonstrating a statistically important and clinically significant enchancment in progression-free survival (PFS) in comparison with fulvestrant.
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The outcomes exceeded the pre-specified goal hazard ratio of 0.60 within the ESR1m inhabitants.
The trial didn’t attain statistical significance in enchancment in PFS within the intent-to-treat (ITT) inhabitants.
General survival was not mature on the time of the evaluation, with lower than 1 / 4 of the required variety of occasions having occurred.
The trial will proceed to evaluate general survival as a key secondary endpoint.
Within the trial, vepdegestrant was typically properly tolerated.
Detailed outcomes from VERITAC-2 can be submitted for presentation at a medical assembly later this yr.
In February 2024, the U.S. Meals and Drug Administration (FDA) granted Quick Observe designation for vepdegestrant for monotherapy for adults with ER+/HER2- superior or metastatic breast most cancers beforehand handled with endocrine-based remedy.
Worth Motion: ARVN inventory is down 52.4% at $8.35 on the final test Tuesday.
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