Glecirasib Hits 48% ORR and 8.2-Month PFS in KRAS G12C NSCLC Phase 2b

Glecirasib (JAB-21822), a covalent oral KRAS G12C inhibitor, was evaluated in the single-arm Phase 2b NCT05009329. 119 previously treated Chinese patients with locally advanced/metastatic KRAS G12C NSCLC received 800 mg once daily, yielding a 47.9% ORR (56/117) and 86% disease control; median PFS was 8.2 months and median OS 13.6 months. Grade 3/4 treatment-related AEs occurred in 38.7% with 5% discontinuations due to TRAEs, matching the class. Of note, 13% of all NSCLC cases have the KRAS 12C mutation. By comparison, sotorasib and adagrasib (two approved KRAS G12C inhibitors) showed ORRs 37% and 43%, median PFS 6.8 and 6.9 months, and grade ≥3 TRAEs 42% and 45% in prior studies of KRAS G12C-mutated, advanced NSCLC.