Vepdegestrant shows promise in Phase 3 breast cancer trial

NEW HAVEN, Conn. - Arvinas, Inc. (NASDAQ: ARVN), a $1.2 billion market cap biotechnology company, and Pfizer Inc. (NYSE: PFE) announced today that their Phase 3 clinical trial, VERITAC-2, has met its primary endpoint, showing a statistically significant improvement in progression-free survival (PFS) for patients with a specific type of advanced breast cancer. According to InvestingPro data, Arvinas maintains a strong financial position with more cash than debt on its balance sheet, providing stability for its clinical development programs. The trial evaluated the efficacy of vepdegestrant, an investigational oral PROTAC ER degrader, against fulvestrant in adults with estrogen receptor-positive, HER2-negative advanced or metastatic breast cancer.

The trial specifically found that vepdegestrant significantly improved PFS in patients whose tumors have estrogen receptor 1 mutations (ESR1m), after their disease had progressed following treatment with CDK 4/6 inhibitors and endocrine therapy. However, it did not reach statistical significance for PFS improvement in the overall intent-to-treat population.

This marks the first Phase 3 data for a PROTAC degrader, a new class of drugs designed to target and degrade disease-causing proteins. The trial included 624 patients across 26 countries, comparing vepdegestrant’s oral administration to the intramuscular administration of fulvestrant.

While overall survival data are not yet mature, with less than a quarter of the required number of events having occurred, the trial will continue to assess this as a key secondary endpoint. The safety profile of vepdegestrant was consistent with previous studies, and the drug was generally well tolerated.

The companies plan to present detailed results at a medical conference later in 2025 and will share the data with global regulatory authorities, potentially supporting regulatory filings. The U.S. Food and Drug Administration (FDA) granted Fast Track designation to vepdegestrant in February 2024 for the treatment of this patient population.

Estrogen receptor-positive, HER2-negative breast cancer constitutes about 70% of all breast cancer cases, with a significant number of patients developing resistance to current treatments. ESR1 mutations, which are found in approximately 40% of patients in the second-line setting, are a common cause of this resistance.

The collaboration between Arvinas and Pfizer aims to provide a new treatment option for patients with limited choices after disease progression. The VERITAC-2 clinical trial results suggest that vepdegestrant could offer these patients additional time without disease progression. Wall Street appears optimistic about the company’s prospects, with InvestingPro showing that 4 analysts have recently revised their earnings expectations upward. The stock is currently trading below its Fair Value, according to InvestingPro’s proprietary analysis.

The information in this article is based on a press release statement. While Arvinas showed impressive revenue growth of 235% in the last twelve months, InvestingPro analysis indicates analysts anticipate a sales decline in the current year. Discover more insights about Arvinas and other biotech companies with InvestingPro’s comprehensive research reports, covering over 1,400 US stocks with detailed financial analysis and expert insights.

In other recent news, Arvinas Inc. reported its earnings for the fourth quarter of 2024, showcasing a smaller-than-expected loss per share of -$0.63, beating the forecasted -$0.96. However, the company’s revenue fell short of projections, reaching $59.2 million against an expected $62.67 million. Analysts have made adjustments to their price targets for Arvinas, with Stifel reducing its target to $51 while maintaining a Buy rating, and H.C. Wainwright adjusting its target to $81, also maintaining a Buy rating. BMO Capital Markets lowered its target to $82 but kept an Outperform rating, citing confidence in Arvinas’ strong financial position and upcoming clinical data. UBS continues to rate Arvinas as a Buy with a target of $74, emphasizing the potential of the ongoing VERITAC-2 Phase 3 study in partnership with Pfizer. The study, focusing on the efficacy of vepdegestrant for breast cancer treatment, is expected to yield results in the first quarter of 2025. These developments are being closely watched by investors, particularly the anticipated data release from the VERITAC-2 study, which could significantly impact Arvinas’ future trajectory in the cancer therapeutics market.

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