Daraxonrasib Pancreatic Cancer Trial

Medically reviewed | Published: | Evidence level: 1A
A global phase 3 trial reported that daraxonrasib, an investigational oral RAS(ON) inhibitor, improved median overall survival in previously treated metastatic pancreatic cancer compared with chemotherapy. The findings, presented at ASCO and published in the New England Journal of Medicine, mark a major step for targeting RAS biology in a disease long dominated by cytotoxic chemotherapy.
📅 Published:
Reviewed by iMedic Medical Editorial Team
📄 Oncology

Quick Facts

Trial Size
500 patients
Median Survival
13.2 vs 6.7 months
KRAS Mutations
>90% of patients

What Is Daraxonrasib for Pancreatic Cancer?

Quick answer: Daraxonrasib is an investigational once-daily oral drug designed to block active RAS signaling, a major growth pathway in pancreatic cancer.

Daraxonrasib is a multi-selective RAS(ON) inhibitor being studied for metastatic pancreatic ductal adenocarcinoma. RAS genes, especially KRAS, are among the most important molecular drivers in pancreatic cancer, and Dana-Farber Cancer Institute notes that more than 90 percent of patients with pancreatic cancer have cancer-driving KRAS mutations.

The drug is designed to inhibit active RAS proteins rather than attacking cancer cells through traditional chemotherapy mechanisms. That matters because metastatic pancreatic cancer has historically had limited second-line treatment options, and many patients receive additional chemotherapy after first-line treatment stops working.

How Much Did Daraxonrasib Improve Survival?

Quick answer: In the phase 3 RASolute 302 trial, median overall survival was 13.2 months with daraxonrasib versus 6.7 months with chemotherapy.

The RASolute 302 trial enrolled 500 patients with metastatic pancreatic cancer across North America, Europe and Asia. Participants had already received one line of chemotherapy for metastatic disease and were randomized to receive either daraxonrasib or investigator-selected second-line chemotherapy.

According to results reported at the American Society of Clinical Oncology annual meeting and published in the New England Journal of Medicine, daraxonrasib improved both overall survival and progression-free survival. Median progression-free survival was 7.2 months with daraxonrasib versus 3.6 months with chemotherapy, while objective response rates were also higher in the daraxonrasib group.

Who Might Benefit if Daraxonrasib Is Approved?

Quick answer: The most immediate potential use is second-line treatment for metastatic pancreatic cancer after prior chemotherapy, but the drug remains investigational.

The trial population reflects a common and difficult clinical scenario: metastatic pancreatic cancer that has progressed after an initial chemotherapy regimen. If regulators approve daraxonrasib, oncologists would need to integrate it alongside molecular testing, performance status assessment, prior treatment history and patient goals.

Daraxonrasib is not yet an FDA-approved pancreatic cancer treatment. Dana-Farber reported that the FDA allowed an expanded access program to begin, and further studies are evaluating whether the drug could be used earlier in treatment, including with or without chemotherapy in the first-line setting.

Frequently Asked Questions

No. Daraxonrasib is investigational. The FDA has allowed an expanded access program, but approval would require regulatory review of safety and efficacy data.

No. The trial showed a meaningful survival improvement, but metastatic pancreatic cancer remains a serious advanced cancer. Patients should discuss trials, expanded access and approved therapies with an oncology specialist.

Reported side effects included rash, mouth inflammation, nausea and diarrhea. Investigators described the safety profile as manageable, but treatment still requires close oncology monitoring.

References

  1. Wolpin BM et al. Daraxonrasib or Chemotherapy in Previously Treated Metastatic Pancreatic Cancer. New England Journal of Medicine. 2026.
  2. Dana-Farber Cancer Institute. RAS(ON) Inhibitor Doubles Median Overall Survival in Results of Phase 3 Trial for Patients with Metastatic Pancreatic Cancer. May 31, 2026.
  3. The ASCO Post. Daraxonrasib Nearly Doubles Survival in Previously Treated Metastatic Pancreatic Cancer. June 2026.