Can Zoldenrasib Redefine the Treatment Landscape for KRAS G12D-Mutant NSCLC? AACR 2026

Standard second-line treatment for KRAS G12D-mutant NSCLC offers a median progression-free survival (PFS) of only 3 to 4.5 months. However, new data from the RMC-9805-001 Phase 1 study shows that zoldenrasib (RMC-9805), a mutant-selective covalent inhibitor targeting the active "ON" state of KRAS G12D, may offer a significant breakthrough.12

Clinical Efficacy Highlights

In a population previously treated with platinum chemotherapy and immunotherapy, zoldenrasib (1,200 mg daily) demonstrated:
Confirmed Overall Response Rate (ORR): 52%.3
Median PFS: 11.1 months.4
Disease Control Rate (DCR): 93%.5
Molecular Response: 73% of patients achieved complete clearance of KRAS G12D ctDNA.6
Safety and Tolerability

Zoldenrasib was well tolerated, with most treatment-related adverse events being Grade 1 gastrointestinal issues. No Grade 4 or 5 toxicities were reported, supporting its potential for use in earlier treatment lines and rational combinations.78

Video Chapters
00:00 - KRAS G12D Mechanism and Unmet Need
03:26 - RMC-9805-001 Study Design
04:24 - Patient Demographics
05:35 - Safety and Tolerability Profile
07:11 - Efficacy: Response Rates and PFS
08:01 - ctDNA Molecular Response
09:29 - Q&A: Clinical Perspectives

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