Revolution Medicines announced on June 25 that its second RAS inhibitor, zoldonrasib, showed encouraging response rates in a Phase 1/2 study for pancreatic cancer. The company said the data further strengthen its position in the treatment of this disease.
The lead asset from Revolution, daraxonrasib, previously doubled overall survival compared to chemotherapy in a Phase 3 trial involving patients with pancreatic cancer. Zoldonrasib is designed to target the G12D mutation in RAS, which Revolution describes as “the most common driver of RAS-addicted cancers.”
Data from the Phase 1/2 trial will be presented at the ESMO Gastrointestinal Cancers Congress in Munich. According to Revolution, zoldonrasib used as a frontline treatment alongside standard chemotherapy (mFOLFIRINOX) produced an overall response rate of 82% among patients with metastatic pancreatic ductal adenocarcinoma carrying the RAS-G12D mutation. Truist Securities analysts told investors that this outcome “compares favorably with chemo alone,” which typically results in an overall response rate of about 30% to 40% for this patient group and treatment setting.
Earlier this week, Revolution launched the Phase 3 RASolute 305 study to test zoldonrasib plus mFOLFIRINOX as a frontline therapy for PDAC. The primary completion date is set for December 2028, according to a federal clinical trials database. Truist said if successful, this combination “could provide an additional treatment option – and potentially a more active regimen” for patients who cannot tolerate more intensive treatments. The safety profile reported was described as manageable and consistent with known chemotherapy toxicities.
At ESMO GI, Revolution will also present data on a combination regimen of zoldonrasib and daraxonrasib used as second-line therapy; this combination achieved a 50% overall response rate among metastatic PDAC patients. Truist said these regimens “reinforce the path to leadership in PDAC” for Revolution.
Following positive results earlier this year from daraxonrasib studies, Truist has projected that Revolution could become “the next oncology titan,” saying it is evolving into a major revenue-generating oncology company with potential drug approvals expected soon.