NEW HAVEN, Conn. - Arvinas, Inc. (NASDAQ: ARVN) and Pfizer Inc. (NYSE: NYSE:PFE) today announced continued positive results from a Phase 1b trial of vepdegestrant in combination with palbociclib for treating advanced ER+/HER2- breast cancer.
The latest data, consistent with previous reports, was presented at the European Society for Medical Oncology (ESMO) Breast Cancer Annual Congress.
The clinical trial evaluated the combination therapy in patients who had undergone a median of four prior therapies. The updated results showed a clinical benefit rate of 63% and an objective response rate of 41.9%.
Moreover, the median progression-free survival was reported at 11.2 months across all dose levels, with a notable 13.9 months at the recommended Phase 3 dose of 200 mg vepdegestrant.
Circulating tumor DNA analyses indicated a significant reduction in tumor fraction after one treatment cycle, which was sustained through multiple cycles at the 200 mg dose. The safety profile remained consistent with previous findings, with the most common severe adverse events being neutropenia and decreased white blood cell count.
Vepdegestrant is an investigational oral PROTAC estrogen receptor degrader, being co-developed by Arvinas and Pfizer. It aims to leverage the body's natural protein disposal system to degrade the estrogen receptor, a key target in ER+/HER2- breast cancer. This trial's promising results suggest potential for vepdegestrant as a new treatment option for this patient population.
The drug is also being evaluated in the Phase 3 VERITAC-2 trial as a monotherapy and in the Phase 3 VERITAC-3 trial in combination with palbociclib. Pfizer's Chief Development Officer, Oncology, expressed hope for establishing a new standard-of-care endocrine therapy backbone for patients with ER+/HER2- breast cancer.
The U.S. Food and Drug Administration has granted vepdegestrant Fast Track designation for the treatment of advanced or metastatic breast cancer previously treated with endocrine-based therapy. The collaboration between Arvinas and Pfizer includes shared development costs, commercialization expenses, and profits worldwide.
This article is based on a press release statement from Arvinas, Inc.
InvestingPro Insights
As Arvinas, Inc. (NASDAQ: ARVN) continues to show promise in the oncology space with its latest clinical trial results, investors and industry observers are closely monitoring its financial health and market performance. The company's commitment to innovation in breast cancer treatment is reflected in its strategic partnership with Pfizer and the potential of vepdegestrant as a game-changing therapy.
Arvinas holds a strong financial position, with more cash than debt on its balance sheet, which is reassuring for stakeholders considering the company's future investment in research and development. InvestingPro Tips indicate that analysts have revised their earnings upwards for the upcoming period, signaling confidence in the company's trajectory. However, it is noted that Arvinas is quickly burning through cash, which is not uncommon for biotech firms in the growth phase of drug development.
From a market perspective, Arvinas has a market capitalization of $2.21 billion, reflecting its significant potential in the biopharmaceutical industry. Despite a revenue decline over the last twelve months as of Q1 2024, the company maintains a gross profit margin of 100%, indicating strong pricing power and cost management for its existing revenue streams. The stock price has experienced considerable volatility, with a 55.43% uptick over the last six months, followed by a 38.2% drop in the past three months, highlighting the high-risk, high-reward nature of investing in the biotech sector.
For those considering an investment in Arvinas, it's worth noting that the company does not currently pay a dividend, which is typical for growth-oriented biotech companies reinvesting earnings into development. Investors seeking additional insights can find more InvestingPro Tips for Arvinas, including detailed financial metrics and analyst forecasts, to help inform their decisions. Remember to use coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription at InvestingPro, where 9 additional tips are available to subscribers.
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