Press release
LUMAKRAS®/LUMYKRAS® (SOTORASIB) DEMONSTRATES SUPERIOR PROGRESSION-FREE SURVIVAL OVER DOCETAXEL IN FIRST POSITIVE PHASE 3 TRIAL OF A KRAS G12C INHIBITOR IN NON-SMALL CELL LUNG CANCER
At 1-Year, Progression-Free Survival was 25% for LUMAKRAS Versus 10% for Docetaxel LUMAKRAS Met Key Secondary Endpoint of Objective Response Rate THOUSAND
About this update from Amgen Inc.
[{"type":"text","content":"At 1-Year, Progression-Free Survival was 25% for LUMAKRAS Versus 10% for Docetaxel\nLUMAKRAS Met Key Secondary Endpoint of Objective Response Rate\nTHOUSAND OAKS, Calif., Sept. 11, 2022 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced detailed results from the global Phase 3 CodeBreaK 200 trial, which showed once-daily oral LUMAKRAS®/LUMYKRAS® (sotorasib) led to significantly superior progression-free survival (PFS; primary endpoint) and a significantly higher objective response rate (ORR; a key secondary endpoint) in patients with KRAS G12C-mutated non small cell lung cancer (NSCLC), compared with intravenous chemotherapy, docetaxel. These data will be presented today, Monday, Sept. 12 at 5:20 p.m. CEST at the Presidential Symposium III session as a late-breaker oral presentation (#LBA5812) during the European Society for Medical Oncology (ESMO) Congress 2022 in Paris.\n\"The totality of evidence from this study supports LUMAKRAS as an important targeted treatment option for patients with non-small cell lung cancer who harbor the KRAS G12C mutation, and reinforces the critical need for comprehensive biomarker testing for all patients with advanced disease,\" said David M. Reese, M.D., executive vice president of Research and Development at Amgen. \"We plan to submit this data to health authorities around the world where LUMAKRAS/LUMYKRAS is conditionally approved, and we look forward to our discussions with regulators.\"\nLUMAKRAS significantly improved PFS as determined by Blinded Independent Central Review (BICR) compared to docetaxel in heavily pre-treated patients (HR, 0.66 [95% CI: 0.51, 0.86]; P = 0.002), and PFS favored LUMAKRAS across all clinically relevant subgroups. The proportion of patients with PFS at one year was 25% for LUMAKRAS versus 10% for docetaxel. LUMAKRAS demonstrated a significantly higher ORR than docetaxel with double the response rates in the LUMAKRAS arm (28% versus 13%, respectively; P \nThere were fewer treatment-related adverse events (TRAEs) for LUMAKRAS versus docetaxel. Grade ≥ 3 TRAEs (33% LUMAKRAS; 40% docetaxel) and serious TRAEs (11% LUMAKRAS; 23% docetaxel) were lower with LUMAKRAS compared to docetaxel. The most common TRAEs reported by at least 15% of patients in either treatment group were diarrhea (34% LUMKRAS; 19% docetaxel), fatigue (7% LUMAKRAS; 25% docetaxel), alopecia (1% LUM...