Amgen’s LUMAKRAS (sotorasib) and Vectibix (panitumumab) combination has received approval from the US Food and Drug Administration (FDA) to treat adults with Kirsten rat sarcoma virus gene (KRAS) glycine 12 to cysteine (G12C)-mutated metastatic colorectal cancer (mCRC).
The combination is intended for patients who have previously undergone chemotherapy based on fluoropyrimidine, oxaliplatin and irinotecan.
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The approval is anchored in the outcomes of the Phase III CodeBreaK 300 trial which showed the therapy combination as the first targeted treatment duo for chemorefractory KRAS G12C-mutated mCRC to outperform the investigated standard-of-care (SOC) in terms of progression-free survival (PFS).
Amgen research and development executive vice-president Jay Bradner stated: “LUMAKRAS plus Vectibix offers a targeted, biomarker-driven combination therapy that helps delay disease progression more effectively than the investigated standard of care.
“This new option validates our combination approach to improve outcomes for patients living with advanced KRAS G12C-mutated metastatic colorectal cancer.”
The trial, which enrolled 160 subjects, compared two different doses of LUMAKRAS plus Vectibix against the investigator’s choice of SOC, which included trifluridine/tipiracil or regorafenib.
The study met its primary endpoint by demonstrating a significant improvement in PFS. The change in overall survival was not statistically significant.
Results indicated that the combination of LUMAKRAS at a dose of 960 mg daily with Vectibix led to a median PFS of 5.6 months versus just two months for the investigator’s choice of care-recipients.
The ORR for the combination therapy was 26%. Safety profiles were consistent with the known effects of LUMAKRAS and Vectibix.
Between 3% and 5% of colorectal cancers exhibit the KRAS G12C mutation, and require identification through an FDA-approved biomarker test.
In May 2021, the company gained FDA approval for LUMAKRAS for treating adults with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer.
Update: The seventh paragraph was updated to reflect the correct data on overall survival.
