Garsorasib shows therapeutic potential in KRASG12C-mutated NSCLC

The investigational garsorasib, a potent KRAS^G12C inhibitor, appears to induce high response rate while having a manageable safety profile in patients with previously treated KRAS^G12C-mutated non–small cell lung cancer (NSCLC), according to the results of a phase II study.

The open-label, multicentre, single-arm trial included 123 adult patients (median age 64 years, 88 percent male) with KRAS^G12C-mutated NSCLC who previously received platinum-based chemotherapy and immune checkpoint inhibitors across 43 hospitals in China. These patients were treated with 600 mg garsorasib, administered orally twice per day.

Researchers performed tumour assessments at baseline, at the end of every two cycles (of 21 days) for the first eight cycles, and at the end of every three cycles thereafter. Objective response rate (ORR), the primary endpoint, was evaluated by an independent review committee (IRC) following the guidelines in Response Evaluation Criteria in Solid Tumours, version 1.1. All patients who received at least one dose of garsorasib were included in the efficacy and safety assessments.

Treatment was discontinued in 82 patients (67 percent). Over a median follow-up of 7.9 months, the IRC-confirmed ORR was 50 percent (95 percent confidence interval [CI], 41–59).

A total of 117 (95 percent) patients had treatment-related adverse events (AEs), with 61 (50 percent) experiencing grade 3 or higher AEs. Hepatic and gastrointestinal events were the most common grade 3 or higher AEs associated with garsorasib. These AEs included liver enzyme elevation (aspartate aminotransferase 17 percent, alanine aminotransferase 15 percent, and gamma-glutamyltransferase 23 percent), nausea (2 percent), and vomiting (2 percent). No new safety signals emerged, and most of the AE were well managed.