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The FDA has approved Lumakras with Vectibix for adults with KRAS G12C-mutated metastatic colorectal cancer who received chemotherapy.
The FDA approved Lumakras with Vectibix for KRAS G12C-mutated metastatic colorectal cancer.
The Food and Drug Administration (FDA) has approved Lumakras (sotorasib) with Vectibix (panitumumab) for adults with KRAS G12C-mutated metastatic colorectal cancer (mCRC), as determined by an FDA-approved test, who have received previous fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.
Progression-free survival: the time a patient lives without their cancer spreading or worsening.
Objective response rate: patients who responded partially or completely to treatment.
Overall survival: the time a patient lives, regardless of disease status.
Duration of response: the time a patient responds to treatment.
Stomatitis: swelling and sores inside the mouth.
The efficacy of the combination was determined in the CodeBreaK 300 trial which evaluated 160 patients with KRAS G12C-mutated mCRC who had previously received fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. Patients were randomized to receive 960 milligrams (mg) of Lumakras orally once daily and Vectibix at 6 mg per kilogram (kg) intravenously (IV) every two weeks; Lumakras at 240 mg orally once daily and Vectibix at 6 mg/kg IV every two weeks; or investigator’s choice of standard of care (SOC) trifluridine/tipiracil or regorafenib.
The median progression-free survival (PFS) was 5.6 months in the 960 mg Lumakras /Vectibix arm and 2 months in the standard of care arm. The final analysis of overall survival was not statistically significant. The objective response rate was 26% in the 960 mg Lumakras/Vectibix arm and 0 in the standard of care arm. The median duration of response was 4.4 months in the 960 mg Lumakras/Vectibix arm, the agency reported.
The final analysis of PFS for patients in the 240 mg Lumakras Vectibix arm compared with standard of care was not statistically significant, the FDA advised.
The most common side effects in the 960 mg Lumakras/Vectibix arm, occurring in at least 20% of patients, included rash, dry skin, diarrhea, stomatitis, fatigue and musculoskeletal pain. The most common Grade 3 (severe) to 4 (life-threatening) laboratory abnormalities, which occurred in at least two patients, were decreased magnesium, decreased potassium, decreased corrected calcium and increased potassium.
The recommended Lumakras dose is 960 mg orally once daily. The recommended Vectibix dose is 6 mg/kg administered as an IV infusion every 14 days until disease progression, unacceptable toxicity, or until Lumakras is withheld or discontinued.
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