Olomorasib+Pembrolizumab in KRAS G12C-Mutant NSCLC: Results from LOXO-RAS-20001 and SUNRAY-01

Background: Olomorasib has demonstrated promising antitumor activity and a manageable safety profile in KRAS G12C-mutant NSCLC with pembrolizumab (pembro) for patients (pts) with NSCLC. Here we report results of an integrated analysis in 1L pts who received olomorasib+pembro from LOXO-RAS-20001 (Phase 1) and the dose optimization for SUNRAY-01 (Phase 3). Methods: Eligible pts with advanced NSCLC were randomized to olomorasib (50/100 mg, orally BID)+pembro (200 mg Q3W) and stratified based on PD-L1 expression (0-49% vs≥50%). One prior cycle of pembro was allowed. Results: As of 15 January 2025, 85 pts received olomorasib+pembro including 14 pts (17%) who received 1 cycle of pembro prior to enrollment; 63% were PD-L1≥50%. 21% were PD-L1 1-49%, and 16% were PD-L1