The European Commission ( EC ) has granted conditional marketing authorization for Lumykras ( Sotorasib ), a first-in-class KRASG12C inhibitor, for the treatment of adults with advanced non-small cell lung cancer ( NSCLC ) with KRAS G12C mutation and who have progressed after at least one prior line of systemic therapy.
Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
The EC decision follows the recommendation for approval by the Committee for Medicinal Products for Human Use ( CHMP ) and is based on the results from the phase 2 CodeBreaK 100 clinical trial in NSCLC, the largest trial conducted to date for patients with the KRAS G12C mutation.
Lumykras 960 mg, administered orally once-daily, has demonstrated an objective response rate ( ORR ) of 37.1% ( 95% CI: 28.6-46.2 ) and a median duration of response ( DoR ) of 11.1 months.
The most common adverse reactions were diarrhea ( 34% ), nausea ( 25% ), and fatigue ( 21% ). The most common severe ( grade 3 or more ) adverse reactions were increased alanine aminotransferase level ( ALT; 5% ), increased aspartate aminotransferase ( AST; 4% ), and diarrhea ( 4% ).
NSCLC accounts for approximately 84% of the 2.2 million new lung cancer diagnoses globally each year, including approximately 400,000 new cases in Europe.
KRAS G12C is one of the most prevalent driver mutations in NSCLC, with about 13-15% of European patients with non-squamous NSCLC having the KRAS G12C mutation. ( Xagena )
Source: Amgen, 2022