Dive Brief:
- Revolution Medicines said Monday its experimental pancreatic cancer drug hit every goal at an early checkpoint in a Phase 3 trial, helping people who got it live nearly twice as long as those who got standard chemotherapy.
- Enrollees who got daraxonrasib lived a median of 13.2 months after treatment, compared with 6.7 months for those who got chemo, a finding that equates to a 60% reduction in the risk of death among those who got the experimental drug. Daraxonrasib achieved its other objectives at an interim look at the results, findings so striking that the company ended the trial early. Revolution enrolled people whose metastatic pancreatic cancer had returned after an earlier treatment.
- The Food and Drug Administration has already awarded daraxonrasib a “national priority” voucher that could help Revolution gain an approval within weeks of an official submission. Revolution shares rose nearly 40% in early trading, adding $7 billion to the company’s already hefty valuation.
Dive Insight:
Daraxonrasib is one of many drugs in development targeting cancer-driving mutations in the “RAS” family. These proteins were once seen as “undruggable,” but that view has been shifting. Multiple drugs targeting a specific KRAS mutation are now available for certain lung and colorectal cancers, and Revolution’s results suggest pancreatic tumors — which are particularly dependent on RAS mutations — could follow.
While Revolution’s RASolute 302 trial enrolled a broad population of previously treated people with pancreatic cancer, its main goals were to delay tumor progression and extend survival in people whose cancers had a mutation called RAS G12. Trial investigators measured similar endpoints in people with and without the mutation - the “intent-to-treat” population - as secondary goals.
Revolution didn’t release specific data on the primary goal, so it’s unclear how much the apparent benefits were driven by results in the RAS G12-mutated population. Those details could influence regulators’ and investors’ views of daraxonrasib. In a Monday note to clients, Leerink Research analyst Jonathan Chang wrote that Revolution’s findings were consistent with the 13.1 month survival data observed in the RAS-mutated population in the company’s Phase 1 trial.
Revolution plans to submit the data for presentation at the American Society of Clinical Oncology’s upcoming annual meeting.
Daraxonrasib has been spotlighted in mainstream media outlets of late, as it’s been used to treat former U.S. lawmaker Ben Sasse. In an interview with the New York Times, Sasse described the treatment as a “nasty” drug that does “crazy stuff,” including causing certain types of bleeding. In its statement, however, Revolution said, without specifics, that daraxonrasib was “generally well tolerated, with a manageable safety profile and with no new safety signals.”
In a client note, RBC Capital Markets analyst Leonid Timashev wrote that a physician his firm has consulted with who have used daraxonrasib describe the side effects as “more of a ‘nuisance’” that can be “well managed with prophylactic strategies and temporary dose reductions.”
Timashev described the data as a “game-changer” and “among the most important advancements in the broader field of treating pancreatic cancer.”
The data could re-ignite speculation about a possible acquisition of Revolution. Merck & Co had been rumored to be in the hunt for Revolution earlier this year, but has since made a bid for Terns Pharmaceuticals. The price the two companies had been considering would have been well higher than the biggest acquisition of 2026 so far, Gilead Sciences’ $7.8 billion takeout of Arcellx.
