Lumakras CODEBREAK 100 study shows two year overall survival of 32.5% in KRAS G12C mutated NSCLC.
Amgen has announced the presentation of long-term efficacy and safety data from the CodeBreaK 100 Phase 1/II trial in patients with KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC) who received Lumakras (sotorasib).
The two-year follow-up data was presented orally as part of a clinical trials plenary session at the American Association for Cancer Research (AACR) annual meeting on April 10, 2022.
Lumakras is the first and only KRASG12C inhibitor to-date to show long-term clinical benefit and overall survival in patients with NSCLC harboring the KRAS G12C mutation.
In this long-term, two-year analysis of 174 heavily pre-treated patients (172 with baseline measurable lesion(s)), Lumakras demonstrated a centrally confirmed objective response rate (ORR) of 40.7%, disease control rate (DCR) of 83.7% and median duration of response (DOR) of 12.3 months. Five patients achieved complete responses and 65 patients achieved partial responses. The results also showed median progression-free survival (PFS) of 6.3 months and overall survival (OS) of 12.5 months with 32.5% of patients still alive at two years. No new safety signals for Lumakras were identified with the long-term follow-up.