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Investing.com -- Shares of Arvinas, Inc. (NASDAQ:ARVN) plummeted 41% today following the announcement of positive topline results from its Phase 3 VERITAC-2 clinical trial. Despite meeting its primary endpoint for a subset of patients with a specific estrogen receptor mutation, the trial did not achieve statistical significance in the broader intent-to-treat population, causing investor concern.
The New Haven-based biopharmaceutical company, in partnership with Pfizer Inc. (NYSE:PFE), revealed that the trial achieved its primary endpoint in the estrogen receptor 1-mutant (ESR1m) population. The study, which evaluated the efficacy of vepdegestrant monotherapy in comparison to fulvestrant, showed a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for patients with this particular mutation. However, the lack of statistical significance in the overall patient population appears to have overshadowed the positive results, leading to the sharp decline in stock value.
Arvinas CEO John Houston expressed that the trial represents a significant achievement, as vepdegestrant is the first PROTAC degrader to demonstrate clinical benefit in a Phase 3 trial. The company plans to share detailed results at a medical conference later in 2025 and engage with global regulatory authorities for potential filings.
Despite the positive outcomes for the ESR1m population, the overall survival data is not yet mature, with less than a quarter of the required events having occurred. The trial will continue to monitor overall survival as a key secondary endpoint. The safety profile of vepdegestrant was generally well-tolerated, aligning with previous studies.
The collaboration between Arvinas and Pfizer aims to address the challenges faced by patients with ER+/HER2- metastatic breast cancer, particularly after disease progression and the development of resistance to endocrine therapies. Vepdegestrant, an investigational oral PROTAC ER degrader, is designed to target and degrade the estrogen receptor, offering a new approach to treatment.
Arvinas and Pfizer will share the costs and profits of the development and commercialization of vepdegestrant, which has received Fast Track designation from the FDA for the treatment of adults with advanced or metastatic breast cancer previously treated with endocrine-based therapy.
While the news of the trial’s success in a specific patient group is promising, investors seem to have focused on the broader implications of the failure to meet the primary endpoint in the overall population, leading to a significant drop in Arvinas stock.
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