The data, which come from a subgroup in an earlier trial that Truist Securities called “the most relevant” to Revolution Medicines’ ongoing Phase 3 test in RAS mutant NSCLC, showed a 42% overall response rate and overall survival of 16 months.
The picture got even brighter Wednesday for Revolution Medicines, the potential “next oncology titan,” after updated data from a mid-stage study of Rasonque—newly approved in pancreatic cancer—seemed to support the RAS inhibitor’s potential to succeed in an ongoing Phase 3 lung cancer study.
The results, from a Phase 1/2 trial of Rasonque (daraxonrasib) in patients with previously treated advanced RAS mutant non-small cell lung cancer (NSCLC) and published in The New England Journal of Medicine, “hold up in non-small cell lung cancer,” Truist Securities wrote in a Wednesday evening note. “This NEJM publication provides incremental but constructive support for RVMD’s NSCLC strategy.”
Within the dose group treated with 160 mg to 220 mg of Rasonque, 38 docetaxel-naive patients who had previously received first- or second-line platinum-based chemotherapy and anti-PD-(L)1 therapy saw a 42% overall response rate (ORR), median progression-free survival (PFS) of 8.3 months and median overall survival (OS) of 16 months. As for safety, there were no Grade 4 or 5 treatment-related adverse events (TRAEs) reported at this dose range, RevMed said, while Grade 3 TRAEs—which are medically significant but not life-threatening—occurred in 25% of patients. The most common side effects were rash and diarrhea.
In its note, Truist called this cohort “the most ph.III-relevant subgroup.”
Results from this study informed the design of RevMed’s Phase 3 RASolve 301 trial, which is evaluating Rasonque vs. chemotherapy in patients with previously treated, locally advanced or metastatic RAS mutant NSCLC, according to the company’s release. The open label study, which kicked off in May 2025, is expected to yield results in December 2027, according to ClinicalTrials.gov.
RevMed got the FDA’s greenlight for Rasonque last week—6.5 months ahead of schedule—in metastatic pancreatic cancer after the RAS inhibitor stunned the cancer space in April, delivering OS of 13.2 months compared to 6.7 months for chemotherapy in a Phase 3 trial.
In an Aug. 26 statement, Angelo de Claro, director of the FDA’s Oncology Center of Excellence, called these results “unprecedented” in an area of high unmet need. Pancreatic cancer carries just a 13% survival rate five years after diagnosis.
RAS-mutant NSCLC also carries a considerable unmet need, Truist analysts noted Wednesday, adding that they view the updated Phase 1/2 results as “underscoring daraxon’s core value proposition—broad efficacy across RAS-mutant NSCLC, and specifically beyond KRAS G12C, where no targeted therapy is approved and unmet need is highest.”
RevMed Chief Development Officer Alan Sandler also emphasized the medical need.
“RAS mutations are among the most common oncogenic drivers in lung cancer, occurring in approximately 30% of cases,” he said in a statement alongside the company’s announcement. “Targeted RAS inhibition has demonstrated clinical benefit in patients with RAS G12C non-small cell lung cancer following initial treatment with chemotherapy and immunotherapy, but there are no targeted therapies for patients with other RAS tumor mutations.”
