TLDR
- RVMD surged 20% overnight after its pancreatic cancer drug daraxonrasib became the first to push median survival beyond one year in a Phase 3 trial.
- Daraxonrasib cut the risk of death by 60%, with patients living a median of 13.2 months versus 6.7 months on chemotherapy.
- Revolution Medicines is moving forward with a rolling NDA submission to the FDA and plans global regulatory filings.
- Summit Therapeutics (SMMT) rose 3.6% after its lung cancer drug ivonescimab helped patients live 15% longer than a competing therapy in a head-to-head trial.
- Both companies presented data at the American Society of Clinical Oncology (ASCO) meeting in Chicago on Sunday.
Revolution Medicines (RVMD) stock surged 20% in overnight trading on Sunday and was up 7.3% at $169 in premarket Monday after its experimental pancreatic cancer pill, daraxonrasib, delivered results that analysts are calling “unprecedented.”
Revolution Medicines, Inc., RVMD
The data came out of the Phase 3 RASolute 302 study, presented at the ASCO Plenary Session and published in The New England Journal of Medicine.
Patients on daraxonrasib lived a median of 13.2 months — nearly double the 6.7 months seen with standard chemotherapy. That makes it the first drug in any Phase 3 trial to push median survival past one year for previously treated metastatic pancreatic cancer.
The 500-patient global study tested the once-daily oral pill against chemotherapy in patients who had already gone through one round of treatment.
Daraxonrasib also cut the risk of death by 60% and reduced the risk of disease progression. Patients went a median of 7.2 months before their cancer got worse, compared to 3.6 months on chemotherapy.
About 32% of patients saw their tumors shrink on daraxonrasib, versus 11% on chemotherapy. The benefit appeared across both patients with and without identified RAS mutations.
What the Data Showed Beyond Survival
Patients on daraxonrasib maintained control of cancer-related pain for a median of 9.2 months, versus 3.8 months on chemotherapy. Quality of life was preserved for 5.7 months, compared to 2.6 months.
Side effects were also notably lower. Just 1.2% of patients stopped taking daraxonrasib due to side effects, compared to 11.2% for those on chemotherapy.
Raymond James analyst Sean McCutcheon called the overall survival data a “home run” and expects rapid and broad uptake. At least two brokerages described the trial data as “compelling.”
CEO Mark Goldsmith said the drug “redefined treatment expectations” in this patient population.
Revolution Medicines is now moving forward with a rolling NDA submission and plans to file with global regulators, including the FDA, under a Commissioner’s National Priority Voucher. The FDA has already authorized an expanded access protocol, letting eligible patients receive the drug before potential approval.
RVMD stock has nearly doubled so far this year and jumped over 9% in May alone.
Summit Therapeutics Also Moves Higher
Summit Therapeutics (SMMT) gained 3.6% to $18.17 in premarket trading after its lung cancer drug ivonescimab — developed with China-based partner Akeso — showed a 15% survival advantage over Tevimbra in a head-to-head study.
Patients with advanced squamous non-small cell lung cancer who received ivonescimab and chemotherapy lived an average of 27.9 months, versus 23.7 months for Tevimbra and chemotherapy.
The study was conducted in China. Summit holds rights to ivonescimab in the U.S., Canada, Europe, and Japan through a deal worth up to $5 billion.
Some analysts flagged caution. Jefferies analyst Faisal Khurshid said investors will likely focus on whether the results can be replicated in global trials, particularly in the U.S. and Europe.
SMMT stock has been mostly flat year-to-date.
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