At the 2026 American Society of Clinical Oncology (ASCO) annual congress, topline data from the Phase III RASolute 302 was presented at the plenary session.
At an 8.5-month follow-up all primary and secondary endpoints were met. Previously treated metastatic pancreatic cancer patients who received Revolution Medicine’s oral RAS(ON) inhibitor daraxonrasib achieved a median overall survival (OS) of 13.2 months, almost double that of chemotherapy(6.7 months) in the control arm with a hazard ratio of 0.40. The survival benefit was matched by a meaningful improvement in progression-free survival (PFS) of 7.2 months vs 3.6 months. Response rates nearly tripled with an objective response rate (ORR) of 31.6% compared to 11.2% in the chemotherapy arm. The field is ecstatic about the prospect of a targeted therapy meaningfully extending OS at a rate that is higher than many frontline chemotherapy regimens achieve.
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First generation KRAS inhibitors isotorasib and adagarasib are limited by the fact that they only bind to RAS in its rare off-state, while daraxonrasib inhibits it during its active “on” signaling state. Additionally, due to its ability to sterically block RAS, the drug can target up to 90% of pancreatic tumors that are KRAS driven, including those with G12D, G12V, G12R, G12C mutations, unlike the RAS inhibitors that specifically target G12C. Results from RASolute 302 were consistent among those who were not identified with a RAS mutation.
Daraxonrasib holds Breakthrough Therapy and Orphan Drug designations. Revolution Medicines will submit a New Drug Application utilizing the Commissioner’s National Priority Voucher, a mechanism that compresses the FDA review timeline to around two months, which was granted in October 2025. In late April, the company applied for an expanded access program that was approved within 48 hours. In terms of adverse events, the drug comes with a toxicity burden that requires management. Grade >3 AEs occurred in 44% of patients compared to 58% in the chemo arm. The most common AE was rash (14%) followed by stomatitis (12%), although discontinuation due to AEs was rare (1.2%) compared to (11.2%) for chemotherapy.
For Revolution Medicines, the opportunity does not stop at second-line: the Phase III RASolute 303 trial enrolls first-line patients, with early data showing response rates of 47% as a monotherapy and 58% ORR in combination with chemotherapy, as well as disease control in approximately 90% of patients. If those results translate into a similar survival advantage, daraxonrasib could dominate the metastatic pancreatic cancer landscape. GlobalData anticipates sales for daraxonrasib to surpass $1bn by 2029 , reaching $4.3bn by 2032.
