The European Commission (EC) granted conditional authorization for LUMYKRAS® (sotorasib), a first-in-class KRASG12C inhibitor, for the treatment of adults with advanced non-small cell lung cancer (NSCLC) who have progressed after at least one prior line of systemic therapy, according to Amgen. Continued approval for this indication could be conditional on a confirmatory trial demonstrating and documenting clinical benefit (s).
This will be the first targeted therapy approved in the European Union for patients with the KRAS G12C mutation. The approval is based on Pivotal CodeBreaK 100 data that shows long-term responses and a favorable benefit-risk profile for LUMYKRAS. Through the most advanced KRAS G12C clinical development program, LUMYKRAS is now approved in 35 countries around the world.
“The approval of LUMYKRAS, the first and only targeted therapy for KRAS G12C-mutated NSCLC with proven efficacy, has the potential to transform treatment outcomes for people in the European Union living with this notoriously difficult-to-treat cancer. Amgen’s landmark scientific discovery allowed investigators to advance the first KRASG12C inhibitor into the clinic, and we look forward to bringing this critical innovation to more patients across the globe,”said David M. Reese, M.D., executive vice president of Research and Development at Amgen.
The EC decision comes after the Committee for Medicinal Products for Human Use (CHMP) recommended approval and is based on positive results from the Phase 2 CodeBreaK 100 clinical study in NSCLC, which is the largest trial to date for patients with the KRAS G12C mutation. LUMYKRAS 960 mg had an objective response rate of 37.1 percent (95 percent CI: 28.6-46.2) and a median duration of response (DoR) of 11.1 months when given orally once daily. The most prevalent side effects were diarrhea (34%), nausea (25%), and exhaustion (25%). (21 percent ). Elevated alanine aminotransferase level (ALT; 5%), increased aspartate aminotransferase (AST; 4%), and diarrhea was the most prevalent severe (grade 3) adverse events (4 percent ).
NSCLC is responsible for over 84 percent of the 2.2 million new lung cancer diagnoses worldwide each year, with about 400,000 new cases in Europe. 1,2 KRAS G12C is one of the most common driver mutations in NSCLC, with the KRAS G12C variant found in 13-15 percent of European patients with non-squamous NSCLC. 3,4 Clinicians in all European Union member countries, as well as Norway, Iceland, and Liechtenstein, will be able to offer LUMYKRAS to suitable patients with NSCLC, pending EC clearance and local reimbursement applications.