Dr. Fakih on the Safety Profile of AMG 510 in KRAS G12C-Mutated CRC

Marwan Fakih, MD, professor, Department of Medical Oncology and Therapeutics Research, medical director, Judy and Bernard Briskin Center for Clinical Research, co-director, Gastrointestinal Cancer Program, and section head, Gastrointestinal Medical Oncology, City of Hope, discusses the safety profile of AMG 510 in KRAS G12C-mutated colorectal cancer (CRC).

At the 2020 ASCO Virtual Scientific Program, findings from the phase 1/2 CodeBreak 100 trial demonstrated meaningful clinical activity with AMG 510 in patients with advanced KRAS G12C-mutant CRC.

As AMG 510 is a highly selective KRAS G12C inhibitor that does not substantially bind to wild-type KRAS, limited off-target activity was observed, says Fakih.

Regarding safety, 47.6% of 42 evaluable patients experienced any-grade treatment-related adverse events (TRAEs). The most common TRAEs were diarrhea, fatigue, nausea, blood creatine phosphokinase increase, anemia, and vomiting. Grade 3 TRAEs occurred in 4.8% of patients and no grade 4 TRAEs were observed.

The favorable safety profile noted with AMG 510 suggests the agent may have utility in combination regimens going forward, concludes Fakih.