Quick Facts

• Daraxonrasib tripled survival time to 13.2 months compared to 6.7 months with chemotherapy in Phase 3 trials
• Personalized mRNA vaccines kept nearly 90% of immune responders alive for up to six years after treatment
• FDA granted breakthrough therapy designation for daraxonrasib, with expanded access available before approval

Two breakthrough treatments are changing the outlook for pancreatic cancer patients, offering the first meaningful survival gains in decades for a disease that kills more than 52,000 Americans annually.

The drug daraxonrasib demonstrated unprecedented results in Phase 3 trials, extending median survival to 13.2 months versus 6.7 months for standard chemotherapy. The hazard ratio of 0.40 represents a 60% reduction in death risk.

“I do think it’s a revolution,” said Dr. Paul Oberstein of NYU Langone’s Perlmutter Cancer Center. “No drug has shown an overall survival benefit greater than one year in a Phase 3 trial for pancreatic cancer.”

Daraxonrasib targets mutated RAS proteins found in 95% of pancreatic cancers. At the 300 mg daily dose, 30% of patients with one prior treatment experienced tumor shrinkage, while 90% achieved disease control.

Revolution Medicines CEO Mark Goldsmith called the results “unprecedented.” The company plans to submit for FDA approval under a priority program, with expanded access already available for eligible patients.

A second breakthrough involves personalized mRNA vaccines developed by BioNTech and Genentech. These vaccines are custom-designed for each patient based on their tumor’s genetic profile and manufactured within nine weeks.

Long-term follow-up data shows remarkable durability. Among 16 patients in the original trial, eight developed immune responses to the vaccine. Seven of those eight responders remained alive at six years, compared to just two of the eight non-responders.

“At an extended 3.2-year median follow-up, responders with vaccine-induced T cells had prolonged recurrence-free survival,” researchers reported. The median survival time for responders has not yet been reached.

The advances come at a critical time. Pancreatic cancer remains the third-leading cause of cancer deaths in the United States, with a five-year survival rate of just 13%. About 80% of the 67,530 new cases expected in 2026 will be diagnosed at late stages.

Revolution Medicines stock jumped 30% following the trial results. The company has been preparing for commercialization by building a specialized sales force with expertise in gastrointestinal cancers.

Dr. Eileen O’Reilly of Memorial Sloan Kettering described daraxonrasib as “potentially going to be a landmark shift in how we treat pancreatic cancer.”

More than 70 companies are developing RAS inhibitors for pancreatic cancer, creating a competitive landscape. Revolution Medicines is also developing RM-055, described as a “novel class of catalytic inhibitors” that could turn cancer proteins off entirely.

Researchers envision combining these approaches. RAS inhibitors could serve as a backbone therapy used alongside mRNA vaccines and other treatments, potentially leading to longer survival or even cures.

Access remains a concern. While expanded access programs are available, Hispanic patients account for less than 8% of pancreatic cancer study participants despite representing a growing share of those at risk.

Read more: She’s trying to outrun pancreatic cancer. Breakthrough treatments give her hope