Arvinas, Inc. ARVN and Pfizer Inc. PFE released topline results from the Phase 3 VERITAC-2 trial evaluating vepdegestrant monotherapy versus fulvestrant in adult patients with advanced or metastatic breast cancer.

The results of the trial, released Monday, included estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced or metastatic breast cancer patients whose disease progressed following prior treatment with cyclin-dependent kinase (CDK) 4/6 inhibitors and endocrine therapy.

These are the first pivotal data for vepdegestrant.

The trial met its primary endpoint in the estrogen receptor 1-mutant (ESR1m) population, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to fulvestrant.

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The results exceeded the pre-specified target hazard ratio of 0.60 in the ESR1m population.

The trial did not reach statistical significance in improvement in PFS in the intent-to-treat (ITT) population.

Overall survival was not mature at the time of the analysis, with less than a quarter of the required number of events having occurred.

The trial will continue to assess overall survival as a key secondary endpoint.

In the trial, vepdegestrant was generally well tolerated.

Detailed results from VERITAC-2 will be submitted for presentation at a medical meeting later this year.

In February 2024, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for vepdegestrant for monotherapy for adults with ER+/HER2- advanced or metastatic breast cancer previously treated with endocrine-based therapy.

Price Action: ARVN stock is down 52.4% at $8.35 at the last check Tuesday.

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