Announcement • Sep 04

Revolution Medicines Publishes Phase 1/2 Clinical Data on Rasonque (Daraxonrasib) in Metastatic Non-Small Cell Lung Cancer

Revolution Medicines announced that The New England Journal of Medicine has published a report describing data from the Phase 1/2 clinical trial evaluating RASONQUE (daraxonrasib), an oral, RAS (ON) multi-selective inhibitor, in patients with previously treated advanced RAS mutant non-small cell lung cancer (NSCLC). The rates of objective response, disease control and survival observed in patients treated with RASONQUE in this Phase 1/2 study support the ongoing global, randomized pivotal RASolve 301 trial evaluating RASONQUE in previously treated RAS mutant non-small lung cancer. The results published in NEJM are based on the Phase 1/2 RMC-6236-001 trial (NCT05379985), with a July 21, 2025 data cut off. The trial evaluated the safety and efficacy of once-daily doses of RASONQUE 300 mg or less in 136 patients with second-line or later NSCLC with tumors carrying diverse RAS mutations other than RAS G12C, and whose disease had progressed following, or who were intolerant to, platinum-based chemotherapy and anti-PD-(L)1 therapy. RASONQUE demonstrated dose-dependent antitumor activity and exhibited a manageable safety profile in the Phase 1/2 trial. Within the 160 mg to 220 mg dose group, a subgroup of 38 docetaxel-naïve patients had previously received first- or second-line platinum-based chemotherapy and anti-PD-(L)1 therapy. In this subgroup, the confirmed objective response rate was 42% (95% confidence interval [CI], 26%-59%) and a disease control rate of 89% (95% CI, 75%-97%). The median progression-free survival was 8.3 months (95% CI: 4.0-12.5) and median overall survival was 16.0 months (95% CI, 9.5-not estimable). At these dose levels, Grade 3 treatment-related adverse events (TRAEs) occurred in 25% of patients, most commonly rash (8%) and diarrhea (3%). No Grade 4 or Grade 5 TRAEs were reported within this dose range. The results from this Phase 1/2 trial informed the design and initiation of RASolve 301 (NCT06881784), the company’s ongoing global, randomized, open-label Phase 3 trial evaluating RASONQUE compared with docetaxel in patients with previously treated, locally advanced or metastatic RAS mutant NSCLC. RASONQUE is an investigational agent for the treatment of RAS mutant NSCLC. RASONQUE is an oral, RAS(ON) multi-selective, noncovalent, tri-complex inhibitor, approved by the U.S. FDA for the treatment of adult patients with metastatic pancreatic adenocarcinoma (PDAC) who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy. RASONQUE is designed to target cancers driven by a broad range of common RAS genotypes, including PDAC, non-small cell lung cancer (NSCLC), and colorectal cancer. It works by suppressing RAS signaling through inhibition of the interaction between both wild-type and mutant RAS(ON) proteins and their downstream effectors. RASONQUE is being advanced through a global Phase 3 registrational program in patients with PDAC and metastatic RAS mutant NSCLC. Outside the U.S., RASONQUE is an investigational agent that has not been approved by any regulatory authority. RASONQUE is indicated for the treatment of adult patients with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy. RASONQUE is associated with the following Warnings and Precautions: Dermatologic and Soft Tissue Toxicity, Stomatitis and Oral Disorders, Diarrhea, Gastrointestinal Perforation, Interstitial Lung Disease (ILD)/Pneumonitis, and Embryo-Fetal Toxicity. RASONQUE can cause dermatologic toxicity, which may be severe. Clinical manifestations included, but were not limited to, rash, pruritus, paronychia, dry skin, and skin fissures. In clinical trials of patients with pancreatic adenocarcinoma, dermatologic toxicity occurred in 86% of patients treated with RASONQUE, of which 10% were Grade 3. Monitor patients who develop dermatologic or soft tissue toxicities while receiving RASONQUE. Initiate prophylactic measures (e.g., topical corticosteroids, emollient creams, sunscreen, oral antibiotics) prior to the first dose of RASONQUE to reduce the risk of moderate to severe dermatologic reactions. Advise patients to limit sun exposure while taking RASONQUE. Initiate supportive measures (e.g., oral corticosteroids) as clinically indicated, and consider dermatologic consultation. Withhold, reduce the dose, or permanently discontinue RASONQUE based on severity. RASONQUE can cause stomatitis, including mouth ulcers and oral mucositis. In clinical trials of patients with pancreatic adenocarcinoma, stomatitis occurred in 57% of patients, of which 9% were Grade 3. Monitor patients for signs and symptoms of stomatitis while receiving RASONQUE. Initiate a steroid-containing mouthwash for treatment of stomatitis and administer other topical treatments (e.g., chlorhexidine mouthwash, 2% lidocaine viscous) as clinically indicated. Withhold, reduce the dose, or permanently discontinue RASONQUE based on severity. RASONQUE can cause diarrhea. In clinical trials of patients with pancreatic adenocarcinoma, diarrhea occurred in 63% of patients, of which 6% were Grade 3. If diarrhea occurs, administer antidiarrheal treatment as clinically indicated. Withhold, reduce the dose, or permanently discontinue RASONQUE based on severity. RASONQUE can cause gastrointestinal perforation. In clinical trials of patients with pancreatic adenocarcinoma, gastrointestinal perforation occurred in 0.9% of patients treated with RASONQUE, of which 0.5% were Grade 3, one event was Grade 4, and one event was fatal. Monitor patients for gastrointestinal perforation.

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