FDA has approved Lumakras, the first and only targeted treatment for patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer
The U.S. Food and Drug Administration ( FDA ) has approved Lumakras ( Sotorasib ) for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer ( NSCLC ), as determined by an FDA-approved test, who have received at least one prior systemic therapy.
Lumakras has received accelerated approval based on overall response rate ( ORR ) and duration of response ( DoR ). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
The FDA approval of Lumakras is based on results from a subset of patients in CodeBreaK 100, the largest clinical trial conducted to date exclusively for patients with the KRAS G12C mutation.
The trial has demonstrated favorable efficacy and tolerability in 124 patients with KRAS G12C mutation-positive NSCLC who had disease progression after receiving an immunotherapy and/or chemotherapy.
In the trial, 960 mg of Sotorasib administered orally once-daily demonstrated an ORR ( a proportion of patients with 30% or more decrease in tumor ) of 36% ( 95% CI: 28-45 ) with 81% ( 95% CI: 73-87 ) of patients achieving disease control ( percentage of patients who have achieved complete response, partial response and stable disease for more than three months ). The median DoR was 10 months.
The most common adverse reactions ( 20% or more ) were diarrhea, musculoskeletal pain, nausea, fatigue, hepatotoxicity and cough.
Adverse reactions resulting in permanent discontinuation of Lumakras occurred in 9% of patients.
NSCLC accounts for approximately 84% of the 2.2 million new lung cancer diagnoses each year worldwide, including approximately 236,000 new cases in the U.S.
KRAS G12C is one of the most prevalent driver mutations in NSCLC, with about 13% of patients with non-squamous NSCLC in the U.S. having the KRAS G12C mutation. ( Xagena )
Source: Amgen, 2021