Patients with KRAS G12C-mutated non-small cell lung cancer (NSCLC) benefited from treated with glecirasib, a KRAS G12C inhibitor, according to new findings presented in April during an American Society of Clinical Oncology (ASCO) Plenary Series.
The findings, from a phase II single-arm study conducted across 43 sites in China, provided new data on the effectiveness of glecirasib in patients who have progressed after standard treatment with chemotherapy and immunotherapy treatment. The KRAS G12C mutation occurs in approximately 4.3% of NSCLC cases in China, and there are currently no approved targeted therapies for this mutation in China.
The study enrolled 119 participants with advanced stages of NSCLC who previously received platinum-based and immune checkpoint inhibitor therapies. The primary objective was overall response rate (ORR), with secondary objectives including duration of response (DOR), progression-free survival (PFS), and overall survival (OS).
The study showed glecirasib achieved a confirmed ORR of 47.9% and a disease control rate of 86.3%. The median PFS was 8.2 months, and the median OS was 13.6 months.
The treatment was well-tolerated, with only 5% of patients stopping treatment due to treatment-related adverse events. The most common adverse events were anemia and elevated bilirubin levels. Most notably, according to the authors, was that gastrointestinal toxicity was low, especially when compared to other FDA-approved KRAS G12C inhibitors.
“Targeted drugs for patients bearing KRAS G12C mutations are lacking in China.” said lead author Yuankai Shi, MD, of the Chinese Academy of Medical Sciences, Beijing. “Glecirasib is among the most advanced KRAS G12C inhibitors currently in clinical development for NSCLC in China. The topline results of this pivotal trial demonstrated a favorable efficacy compared with both FDA-approved KRAS G12C inhibitors sotorasib and adagrasib, and the low GI toxicity profile observed may help improve patient compliance with oral therapy.”
