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Home / News / Research / Daraxonrasib, a game changer for pancreatic cancer patients

Daraxonrasib, a game changer for pancreatic cancer patients

Final clinical trial results will redefine standard of care for metastatic pancreatic cancer

June 2, 2026

The wait is over. On Sunday May 31st 2026, Brian M Wolpin MD, MPH, the Director of the Hale Family Center for Pancreatic Cancer Research at Dana Farber Cancer Institute, presented the highly anticipated results for Revolution Medicine’s phase 3 clinical trial, RASolute 302, evaluating daraxonrasib in metastatic pancreatic cancer at the 2026 American Society for Clinical Oncology Annual Meeting in Chicago.

Mutations in KRAS (one of three forms of RAS) are present in >90% of pancreatic ductal adenocarcinoma (PDAC), the most common type of pancreatic cancer, resulting in uncontrolled tumor cell growth and survival. Daraxonrasib, a RAS(ON) inhibitor, binds the active form of the RAS protein to block growth and survival signaling to cancer cells. Remarkably, daraxonrasib treatment was associated with a 60% reduction in the risk of death for the patients enrolled in this study. These findings resulted in a standing ovation and a round of applause from clinicians in the audience who know what a game changer these results are for patients with pancreatic cancer.

Most treatments come with side effects and that is particularly true for cancer treatments. For patients in this trial, almost 100% reported at least one adverse event. However, the types of adverse events differed between the patients on daraxonrasib and those on chemotherapy. Rashes and mouth inflammation were the most common high grade adverse events for the daraxonrasib group while low white blood cells (neutropenia), low platelets, and anemia were the most common high grade adverse events for the chemotherapy group. Most importantly, while adverse events caused a reduction in the amount of drug given to patients in both groups, the discontinuation rate was only 1.2% for daraxonrasib group compared to 11.2% in the chemotherapy, suggesting the of side effects for daraxonrasib were more manageable than chemotherapy causing less patients to stop treatment early.

Simultaneous to Sunday’s ASCO presentation, the New England Journal of Medicine published an article “Daraxonrasib or Chemotherapy in Previously Treated Metastatic Pancreatic Cancer” detailing the trial results. These results are especially meaningful for UCLA as it was one of the RASolute 302 participating locations with Dr. Zev Wainberg, the Co-Director of the UCLA GI Oncology Program and member of the Agi Hirshberg UCLA Center for Pancreatic Diseases, as a lead author of the study. Remarking on the powerful results, Dr. Wainberg said “Now, for the first time, we have demonstrated that targeted inhibition of RAS using an oral inhibitor is changing the landscape of this terrible disease. Seeing this magnitude of benefit in a randomized phase 3 study is very encouraging for all patients with advanced pancreatic cancer and is a paradigm shift in this deadly disease”.

After the presentation Dr. Jennifer J. Knox, MD, MSc a clinical investigator at the Princess Margaret Cancer Center in Toronto, Canada noted “My key takeaway point is that we have a new standard of care in the second line setting with daraxonrasib” highlighting how these results will transform that care for many patients with metastatic pancreatic cancer. The FDA already has daraxonrasib on track for an accelerated approval and on May 1st, 2026, granted Revolution Medicines permission for an expanded access program (see our What Patients Need To Know article) allowing patients trials to access daraxonrasib outside of the clinical trial setting.

Revolution Medicines has two additional ongoing phase 3 trials evaluating daraxonrasib in metastatic patients without any prior chemotherapy (called the first line setting) as well as in patients with localized disease who have undergone surgical resection underscoring the promise of RAS inhibition to all patients with pancreatic cancer. Similarly, as other solid tumors such as non-small cell lung cancer (NSCLC) and colorectal cancer (CRC) harbor RAS mutations, there are clinical trials underway to assess daraxonrasib for indications outside of PDAC.

For patients, this is a huge step towards bringing new treatments and new hope to a pancreatic cancer diagnosis. It’s important to remember that this breakthrough occurred due to years of hard work and dedication from an entire field with the goal to bring better options and outcomes to pancreatic cancer patients that desperately need them. With clinical validation for RAS inhibition now accomplished, we must now continue the hard work and capitalize on momentum to increase the length and quality of life for all pancreatic cancer patients.


RASolute 302 Clinical Trial Details

Who: Patients with metastatic PDAC who had undergone at least one round of chemotherapy with either gemcitabine or fluorouracil were eligible for enrollment.

What: 500 enrolled patients were treated with either 300 mg of daraxonrasib once daily, or with one of the following chemotherapy protocols: gemcitabine plus nab-paclitaxel, modified FOLFIRINOX, FOLFOX, or liposomal irinotecan plus fluorouracil.

Where: The trial was run at more than 60 locations across the United States, France, Germany, Italy, Japan, Puerto Rico, and Spain.

Results

While a majority of PDAC patients have KRAS G12 mutations, daraxonrasib does not target a specific form of RAS (KRAS, NRAS, or HRAS), nor does it target specific mutations. The trial was therefore open to all patients regardless of RAS gene status.

Across all patients, the following results were observed:

Outcome Daraxonrasib (n=248) Chemotherapy (n=252)
Median Overall Survival (mOS) 13.2 months 6.7 months
Median Progression-Free Survival (mPFS) 7.2 months 3.6 months
Confirmed Overall Response Rate (ORR) 31.6% 11.2%

Tolerability

Most common adverse events (any grade) — daraxonrasib group:

  • Rashes — 85.5%
  • Diarrhea — 58.1%
  • Stomatitis (mouth inflammation) — 53%
  • Nausea — 46.5%
  • Vomiting — 36.9%

High-grade (Grade ≥3) adverse events: rashes (13.7%) and stomatitis (12%)

Most common adverse events (any grade) — chemotherapy group:

  • Fatigue — 44.4%
  • Anemia — 39.7%
  • Nausea — 39.3%
  • Neutropenia (reduction in white blood cells) — 38.3%
  • Diarrhea — 37.9%
  • Thrombocytopenia (reduction in platelets) — 33.2%
  • Peripheral neuropathy — 25.2%

High-grade (Grade ≥3) adverse events: neutropenia (27.6%) and anemia (16.4%)

 

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Filed Under: News, Research

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