Phase 2b Study Evaluates Glecirasib in Certain Patients With KRAS-Positive NSCLC

Glecirasib has shown “promising clinical efficacy” in patients with locally advanced or metastatic KRAS^G12C-mutated non-small cell lung cancer (NSCLC), according to results of a phase 2b study.

The study, published in Nature Medicine, was led by Yuankai Shi, MD, PhD, of the Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, the National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, and the Chinese Academy of Medical Sciences & Peking Union Medical College, in Beijing, China.

Glecirasib, also known as JAB-21822, is an oral, covalent KRAS^G12C inhibitor. Dr. Shi and colleagues conducted the multicenter, single-arm study to assess the safety and efficacy of oral glecirasib 800 mg in 119 patients with locally advanced or metastatic KRAS^G12C-mutated NSCLC.  The median patient age was 62 years. The primary endpoint of the phase 2b study was the objective response rate (ORR), as assessed by an independent review committee (IRC).

As of the data cut-off date of March 28, 2024, the IRC-assessed ORR was 47.9% (95% CI, 38.5–57.3). Treatment-related adverse events (TRAEs) of any grade occurred in 97.5% of patients, with grades 3 and 4 TRAEs occurring in 38.7% of patients. Treatment was discontinued in 5% of patients due to TRAEs and no treatment-related deaths occurred.

Based on these results, Dr. Shi and colleagues concluded that “glecirasib exhibited promising clinical efficacy and manageable safety profiles in these patient populations.”

Source: Nature Medicine