FDA Approval Summary: Sotorasib for KRAS G12C Mutated Metastatic NSCLC
Cette étude analyse les données de l'essai ayant conduit la "Food and Drug Administration" à autoriser l'utilisation du sotorasib pour traiter les patients atteints d'un cancer du poumon non à petites cellules de stade avancé et présentant la mutation G12C du gène KRAS
On May 28, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to sotorasib (Lumakras, Amgen) for the treatment of adults with advanced non-small cell lung cancer (NSCLC) with a Kirsten rat sarcoma proto-oncogene (KRAS) G12C mutation who have received at least one prior systemic therapy. The approval was based on CodeBreaK 100 (Study 20170543), a dose escalation and dose expansion trial in patients with an advanced, KRAS G12C-mutated, solid tumor. The overall response rate (ORR) observed in patients with KRAS G12C-mutated NSCLC treated with sotorasib (n = 124) was 36% (95% CI 28, 45). The median duration of response (DOR) was 10.0 months (95% CI 6.9, not estimable). The most common adverse reactions (greater than or equal to 20%) were diarrhea, musculoskeletal pain, nausea, fatigue, hepatotoxicity, and cough. This is the first approval of a targeted therapy for KRAS G12C-mutated NSCLC. Due to pharmacokinetic data and ORRs of patient cohorts who took sotorasib at lower doses in the dose escalation portion of CodeBreaK 100, a dose comparison study is being conducted as a post-marketing requirement (PMR).