Revolution Medicines, Inc. (NASDAQ:RVMD) on Sunday announced new clinical data for zoldonrasib (RMC-9805), a RAS$(ON)$ G12D-selective inhibitor, as monotherapy in patients with KRAS G12D mutant non-small cell lung cancer (NSCLC). Results were highlighted at the American Association for Cancer Research Annual Meeting.

"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, CEO 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," Goldsmith commented.

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 December 2, 2024, the data cutoff date, 90 solid tumor patients were treated with 1200 mg once daily $(QD)$, the candidate's 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 were primarily Grade 1 or 2 in severity, with two patients (2%) 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 (confirmed or pending confirmation) was 61% (n=11), and the disease control rate was 89% (n=16).

In October 2024, Revolution Medicines announced preliminary safety and antitumor data for RMC-9805 in patients with previously treated pancreatic ductal adenocarcinoma.

At a candidate-recommended Phase 2 dose of 1200 mg daily (20 patients at 1200 mg QD and 20 patients at 600 mg BID), patients who received a first dose of RMC-9805 at least 14 weeks before the data cutoff date achieved a 30% (n = 12) objective response rate (confirmed or pending) and an 80% (n = 32) disease control rate.

Price Action: RVMD stock is up 6.76% at $41.39 at the last check Monday.

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