Revolution Medicines begins phase 3 trial for lung cancer drug

Published 14/05/2025, 13:14
Revolution Medicines begins phase 3 trial for lung cancer drug

REDWOOD CITY, Calif. - Revolution Medicines, Inc. (NASDAQ:RVMD), a clinical-stage oncology company with a market capitalization of $7.44 billion, announced today the initiation of a Phase 3 clinical trial for its investigational drug daraxonrasib, aimed at treating non-small cell lung cancer (NSCLC) with specific RAS mutations. According to InvestingPro data, the company maintains a strong financial position with more cash than debt and a healthy current ratio of 13.46, providing substantial runway for its clinical programs.

The trial, named RASolve 301, is an open-label study comparing the efficacy and safety of daraxonrasib to docetaxel chemotherapy in patients with advanced or metastatic RAS mutant NSCLC who have undergone prior treatments. Approximately 420 patients globally are expected to enroll, having previously received therapy that includes an anti-PD-1 or anti-PD(L)-1 agent and platinum-based chemotherapy. Wall Street analysts maintain a strong bullish stance on RVMD, with price targets ranging from $57 to $88 per share, as revealed by InvestingPro’s comprehensive analysis.

Daraxonrasib, identified as RMC-6236, is a RAS(ON) multi-selective inhibitor targeting mutations at positions G12, G13, and Q61, which are known to drive tumor growth in a significant portion of lung cancer cases. The primary endpoints of the trial are progression-free survival (PFS) and overall survival (OS) in a core group of patients with G12 mutations, with key secondary endpoints including PFS, OS, and objective response rate (ORR) in a broader patient population.

Mark A. Goldsmith, M.D., Ph.D., CEO and chairman of Revolution Medicines, expressed optimism about the potential of daraxonrasib to provide a new treatment option for people living with RAS mutant lung cancer, emphasizing the lack of approved targeted drugs for the majority of these cases.

The decision to progress daraxonrasib to a Phase 3 trial was supported by early evidence from a single-arm trial indicating an acceptable safety profile and promising antitumor activity. In addition to NSCLC, daraxonrasib is being assessed in the RASolute 302 clinical trial for metastatic pancreatic ductal adenocarcinoma (PDAC).

NSCLC remains a leading cause of cancer-related mortality, with an estimated 197,000 new cases annually in the U.S. alone. Approximately 30% of NSCLC cases involve RAS mutations, underscoring the need for targeted therapies in this area.

Revolution Medicines’ pipeline includes other RAS(ON) inhibitors targeting different oncogenic RAS mutations, with plans to introduce additional compounds into clinical development. While the company’s Financial Health score is rated as ’FAIR’ by InvestingPro, with particularly strong momentum metrics, investors should note that analysts expect continued investment in R&D to impact near-term profitability. For a deeper understanding of RVMD’s financial position and growth prospects, investors can access the detailed Pro Research Report, available exclusively to InvestingPro subscribers.

The information in this article is based on a press release statement from Revolution Medicines, Inc.

In other recent news, Revolution Medicines Inc. reported its first-quarter 2025 financial results, highlighting a strong cash position of $2.1 billion, which is projected to fund operations into the second half of 2027. Despite a net loss of $213.4 million, the company emphasized its focus on advancing its cancer treatment pipeline, particularly its RAS inhibitor portfolio. Research and development expenses increased to $205.7 million, reflecting the company’s commitment to developing cancer therapies. The company has not yet specified its revenue for the quarter. Revolution Medicines is preparing for Phase III trials in pancreatic and lung cancer, with pivotal trial data expected in 2026.

Additionally, Revolution Medicines is expanding its commercial capabilities in the United States and exploring opportunities for commercialization outside the U.S. Analyst firms have not provided recent upgrades or downgrades for the company’s stock. The company continues to face challenges, such as the absence of full regulatory approvals for its RAS inhibitors, which could delay market entry. The oncology sector remains highly competitive, posing further challenges to the company’s strategic initiatives.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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