Key Takeaways
- Revolution Medicines (RVMD) shares skyrocketed 20% after daraxonrasib achieved a historic milestone as the first treatment to extend median survival beyond 12 months in a Phase 3 pancreatic cancer study.
- The experimental drug reduced mortality risk by 60%, with patients achieving median survival of 13.2 months compared to 6.7 months with standard chemotherapy.
- The company has initiated a rolling NDA submission to the FDA and is preparing for worldwide regulatory applications.
- Summit Therapeutics (SMMT) climbed 3.6% following positive results showing ivonescimab extended survival by 15% versus Tevimbra in lung cancer patients.
- The data from both biotechnology companies was unveiled at the American Society of Clinical Oncology (ASCO) conference in Chicago over the weekend.
Shares of Revolution Medicines (RVMD) jumped 20% during overnight trading Sunday and climbed 7.3% to $169 in Monday’s premarket session following the release of Phase 3 trial data for daraxonrasib, its investigational pancreatic cancer treatment, which industry experts are characterizing as groundbreaking.
Revolution Medicines, Inc., RVMD
The clinical results emerged from the RASolute 302 Phase 3 trial, which was showcased during the ASCO Plenary Session and simultaneously published in The New England Journal of Medicine.
Patients treated with daraxonrasib achieved a median overall survival of 13.2 months — essentially doubling the 6.7-month median observed with conventional chemotherapy. This marks a historic achievement, representing the first time any Phase 3 clinical trial has demonstrated median survival exceeding 12 months in previously treated metastatic pancreatic cancer.
The international trial enrolled 500 participants and evaluated the once-daily oral medication against standard chemotherapy in individuals who had previously undergone one line of systemic treatment.
Beyond extending life, daraxonrasib demonstrated a 60% reduction in mortality risk and significantly delayed disease progression. The median progression-free survival reached 7.2 months for daraxonrasib patients, more than doubling the 3.6-month median seen with chemotherapy.
Tumor response rates also favored the experimental treatment, with approximately 32% of daraxonrasib patients experiencing tumor shrinkage versus just 11% in the chemotherapy arm. Notably, the therapeutic benefit was observed regardless of whether patients had detectable RAS mutations.
Additional Clinical Benefits and Safety Profile
Beyond extending survival, daraxonrasib helped patients maintain control over cancer-associated pain for a median duration of 9.2 months, substantially longer than the 3.8 months observed with chemotherapy. Quality of life metrics remained stable for 5.7 months on daraxonrasib, compared to just 2.6 months in the control group.
The safety profile proved equally impressive. Only 1.2% of participants discontinued daraxonrasib due to adverse events, a stark contrast to the 11.2% discontinuation rate among chemotherapy patients.
Raymond James analyst Sean McCutcheon characterized the survival outcomes as a “home run” and anticipates swift and widespread adoption. Multiple brokerage firms have labeled the clinical data as “compelling.”
CEO Mark Goldsmith stated that the medication “redefined treatment expectations” for this patient group.
Revolution Medicines has commenced a rolling New Drug Application (NDA) submission and intends to pursue regulatory approvals internationally, including with the FDA, utilizing a Commissioner’s National Priority Voucher. The FDA has already granted authorization for an expanded access program, enabling qualified patients to access the drug ahead of potential approval.
RVMD stock has approximately doubled in value year-to-date and advanced more than 9% during May.
Summit Therapeutics Posts Gains on Lung Cancer Data
Summit Therapeutics (SMMT) rose 3.6% to $18.17 in premarket activity following the announcement that ivonescimab — co-developed with Chinese partner Akeso — delivered a 15% survival benefit compared to Tevimbra in a direct comparison trial.
Patients diagnosed with advanced squamous non-small cell lung cancer who were administered ivonescimab plus chemotherapy survived for an average of 27.9 months, outperforming the 23.7-month average seen with Tevimbra and chemotherapy.
The clinical study was performed in China. Summit maintains commercialization rights for ivonescimab across the United States, Canada, Europe, and Japan through a licensing agreement valued at up to $5 billion.
Some market observers expressed reservations. Jefferies analyst Faisal Khurshid noted that investors will likely scrutinize whether these findings can be reproduced in international studies, especially within U.S. and European patient populations.
SMMT shares have remained relatively unchanged year-to-date.
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