California-based company involved in discovery and development of innovative medicines Amgen (NASDAQ:AMGN) announced on Friday FDA approval of LUMAKRAS (sotorasib) combined with Vectibix (panitumumab) for adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC) who previously received chemotherapy.

Approval is supported by the Phase 3 CodeBreaK 300 study, which demonstrated superior progression-free survival (PFS) for LUMAKRAS plus Vectibix compared to standard-of-care (SOC).

The trial showed median PFS of 5.6 months for LUMAKRAS 960 mg daily plus Vectibix versus 2 months for SOC, with a hazard ratio (HR) of 0.48 and a p-value of 0.005. An overall response rate (ORR) of 26% was observed with the combination, compared to 0% for SOC. While the study was not powered for overall survival (OS), median OS was not reached for the combination, compared to 10.3 months for SOC, with an HR of 0.7 and no statistical significance.

Safety profiles aligned with historical data, with common adverse reactions including rash (87%), dry skin (28%) and diarrhea (28%). The KRAS G12C mutation is found in 3-5% of colorectal cancers, highlighting the importance of biomarker testing to guide treatment. Eligible patients can now access targeted therapy potentially improving clinical outcomes.