Revolution Medicines shares up 6% after presenting initial RMC-9805 study data

Revolution Medicines (RVMD) on Sunday announced new clinical data for zoldonrasib, or RMC-9805, a RAS(ON) G12D-selective inhibitor, as monotherapy in patients with KRAS G12D mutant non-small cell lung cancer. Results were highlighted in the official press program at the American Association for Cancer Research Annual Meeting in Chicago, Illinois. “We are pleased to share new clinical data for zoldonrasib, our innovative, oral RAS(ON) G12D-selective inhibitor, which demonstrates acceptable safety and tolerability and encouraging initial antitumor activity in patients with non-small cell lung cancer. These data reinforce the clinical potential of zoldonrasib following the initial tolerability and antitumor activity reported late last year in patients with pancreatic ductal adenocarcinoma,” said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. “Together these results support further evaluation of zoldonrasib as monotherapy and in combination as we continue efforts to advance innovative targeted medicines for patients living with these hard-to-treat cancers.” RMC-9805-001 is a multicenter, open-label, dose escalation and dose-expansion Phase 1 study designed to evaluate zoldonrasib in patients with advanced solid tumors harboring a KRAS G12D mutation. As of a December 2, 2024 data cutoff date, 90 solid tumor patients were treated with 1200 mg once daily, the candidate recommended Phase 2 dose. In these patients, zoldonrasib demonstrated an acceptable safety profile, that was generally consistent with previously reported data for this compound in pancreatic cancer, and was generally well tolerated. The most common treatment-related adverse events occurring in at least 10% of patients were nausea, diarrhea, vomiting, and rash. TRAEs were primarily Grade 1 or 2 in severity, with two patients experiencing Grade 3 events that resolved following dose interruption. Zoldonrasib had a favorable mean dose intensity of 98% and no dose limiting toxicities were observed. Preliminary antitumor activity was assessed in 18 efficacy-evaluable patients with NSCLC at the 1200 mg QD dose. The objective response rate was 61% and the disease control rate was 89%. Shares of Revolution Medicines are up 6% to $41.10 in afternoon trading.