ASCO Expert Perspective
“With this presentation, we now have data on several different KRAS^G12C inhibitors with similar efficacy outcomes. To change practice outside of China, this drug will have to differentiate itself from other approved compounds in a meaningful way—by way of characteristics such as tolerability, dosing, adverse events, or intracranial penetration. The key takeaway here is that we now have another agent with activity demonstrated in the pretreated space. The drug demonstrates an encouraging safety profile, with low rates of GI-related adverse events, which could set it apart from other KRAS^G12C inhibitors.”
– Charu Aggarwal, MD, ASCO Expert in Lung Cancer

Patients with KRAS^G12C mutated-non-small cell lung cancer (NSCLC) who were treated with glecirasib, a KRAS^G12C-inhibitor, experienced promising outcomes according to new findings that will be presented in the upcoming April 2024 session of the American Society of Clinical Oncology (ASCO) Plenary Series.

The KRAS^G12C mutation occurs in approximately 4.3% of NSCLC cases in China, and there are currently no approved targeted therapies for this type of mutation in China. This phase II single-arm study conducted across 43 sites in China provides new data on the effectiveness of glecirasib in patients who have progressed after standard treatment with chemotherapy and immunotherapy treatment.

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).

Key Findings

• 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, figures that are favorably comparable with international standards.
• The treatment was well-tolerated, with only 5% of patients stopping treatment due to treatment-related adverse events (TRAEs). The most common TRAES 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. 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,” said lead author Yuankai Shi, MD, Chinese Academy of Medical Sciences, Beijing.

Abstract and presentation will be available here on April 30, 2024 at 3:00 pm ET

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