Full Breakdown
Daraxonrasib Shows Near-Doubling of Survival for Advanced Pancreatic Cancer
5/7/2026, 11:46:41 AM
Breakthrough Trial Results
In May 2024 the FDA granted fast-track status to Revolution Medicines’ oral RAS inhibitor daraxonrasib and opened an expanded-access program for metastatic pancreatic cancer. A Phase 3 trial showed median overall survival of 13.2 months with daraxonrasib plus chemotherapy versus 6.7 months with chemotherapy alone.
Context
Pancreatic cancer accounts for about 67,000 U.S. diagnoses and 52,000 deaths annually. Five-year survival for metastatic disease is roughly 3 %, and median survival after second-line chemotherapy is 5–7 months. Over 90 % of tumors have KRAS mutations, long deemed “undruggable.” There is no effective screening test, and vague early symptoms cause 80 % of cases to be diagnosed at advanced stages.
Key Figures & Groups
Revolution Medicines created daraxonrasib. Clinical leads include Dr. Brian Wolpin (Dana-Farber), Dr. David Hong (MD Anderson) and Dr. Dae Won Kim (Moffitt). Independent oncologists Dr. Reza Nazemzadeh (Atrium Health) and Dr. Sekhar Padmanabhan (Vanderbilt) provided commentary. The FDA authorized expanded access in May 2024.
Data & Statistics
The Phase 1/2 trial enrolled 168 patients; 96 % had at least one adverse event and 30 % experienced severe events, most commonly rash, oral mucositis, nausea and diarrhea. Eight participants stopped treatment because of toxicity. In the highest-dose group, progression-free survival was 8.1 months and overall survival 15.6 months.
Clinical and Therapeutic Implications
The survival gain points to a shift from chemotherapy-only to targeted combination therapy. Inclusion of non-KRAS patients suggests broader use. Ongoing trials are testing daraxonrasib as first-line and in KRAS-mutated colorectal and lung cancers. Researchers anticipate the regimen could become a new standard of care for second-line therapy.
Official Statements & Responses
Study leaders called the results a “new day” for pancreatic cancer treatment and said benefits outweigh manageable side effects. The FDA’s expanded-access decision cited a favorable risk-benefit profile, reflecting confidence pending full approval.
Skepticism & Opposition
Some oncologists warned that media hype can outpace evidence. Dr. Nazemzadeh noted cynicism about new data but recognized the trial’s significance. Severe adverse events occurred in roughly one-third of patients, reinforcing the need for vigilant monitoring.
Conflicting Reports & Gaps
Survival estimates differ modestly between Phase 1/2 (15.6 months) and Phase 3 (13.2 months). Long-term outcomes, quality-of-life data, and efficacy in non-KRAS tumors remain unreported.
Verbatim Quotes
- “We have been desperately working very hard trying to find other ways to treat the cancer,” — Dr. Brian Wolpin, Dana-Farber Cancer Institute
- “This really feels like a watershed moment.” — Dr. Brian Wolpin, Dana-Farber Cancer Institute
- “But this is a big deal. This drug is the most exciting thing in pancreas cancer in over a decade.” — Dr. Reza Nazemzadeh, Atrium Health
- “But those effects are manageable in most patients, and the benefits significantly outweigh those adverse effects.” — Dr. David Hong, MD Anderson Cancer Center
What’s Next
Revolution Medicines is completing a 500-patient late-stage trial to be presented at the American Society of Clinical Oncology meeting. The FDA is expected to issue a decision later this year, and other KRAS-mutated cancers are under study.
