Revolution Medicines Inc. saw its stock rise in early U.S. premarket trading on Monday following the release of late-stage trial results indicating that its experimental oral therapy for pancreatic cancer significantly improved survival compared to standard chemotherapy. The company's shares were last trading at $157.48, up $2.93, or 1.9%, ahead of the regular Nasdaq session. The company's market capitalization stood at approximately $31.2 billion.
The data, presented on Sunday at the American Society of Clinical Oncology (ASCO) annual meeting and simultaneously published in the New England Journal of Medicine, provided investors with a comprehensive look at the efficacy and safety of daraxonrasib. The Phase 3 RASolute 302 trial enrolled 500 patients with pancreatic cancer and evaluated daraxonrasib against chemotherapy. The results showed a median overall survival of 13.2 months for patients receiving daraxonrasib, compared to 6.7 months for those on chemotherapy, representing a hazard ratio of 0.40, which translates to a 60% reduction in the risk of death during the study period.
In addition to the survival benefit, daraxonrasib also demonstrated a significant improvement in progression-free survival. The median progression-free survival was 7.2 months for the daraxonrasib group versus 3.6 months for the chemotherapy group, as reported by Dana-Farber Cancer Institute. Dr. Brian Wolpin, the trial's lead investigator from Dana-Farber, stated, "If approved, this would be a dramatic shift in pancreatic cancer treatment."
Daraxonrasib targets the RAS family of genes, which are mutated in over 90% of pancreatic cancers. RAS proteins have historically been considered a difficult target for drug development due to their smooth surface and lack of deep binding pockets. However, Revolution Medicines has developed a compound that inhibits the active "on" state of RAS, potentially offering a broader therapeutic approach compared to existing KRAS G12C inhibitors such as Amgen's Lumakras and Bristol Myers Squibb's Krazati.
Revolution Medicines' chief executive, Mark Goldsmith, has already begun to shift focus from clinical data to drug access. In an interview with STAT on May 30, Goldsmith confirmed that the company has started shipping daraxonrasib under an expanded access program, which allows seriously ill patients to receive an investigational therapy outside of a clinical trial. "We are now shipping the drug," he said.
The company plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) using a Commissioner's National Priority Voucher, which could expedite the review process. This move is crucial for Revolution Medicines, which currently has no approved products or product revenue. The company has reported that it expects to continue incurring losses for the foreseeable future as it invests in research and development.
The safety profile of daraxonrasib appears favorable compared to chemotherapy. The incidence of Grade 3 or higher treatment-related adverse events was 43.6% in the daraxonrasib group, compared to 57.5% in the chemotherapy group. The most common severe side effects with daraxonrasib were rash and stomatitis. One treatment-related death due to pneumonitis was reported in the daraxonrasib arm.
Despite the positive data, the competitive landscape remains uncertain. Gilead Sciences is also monitoring the RAS space, with its chief medical officer, Dietmar Berger, noting at ASCO that "there is an opportunity to innovate even further." Revolution's stock had already surged 40% following the initial top-line data in April, suggesting that some optimism was already priced in ahead of Monday's premarket move.
Investors will be watching closely for any signs of regulatory delays, label limitations, manufacturing issues, or new safety concerns that could impact the stock. As a late-stage biotech company with no approved products, Revolution Medicines faces significant risks, but the latest data provides a strong foundation for its first potential commercial medicine.
