LUMAKRAS® (SOTORASIB) CODEBREAK 100 STUDY SHOWS TWO-YEAR OVERALL SURVIVAL OF 32…. – Press Release

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Long-Term Clinical Benefit and Prolonged Tumor Response Seen With 40.7% Objective Response Rate

No New Safety Signals Observed

Longest Follow-Up of Patients Treated With a KRASG12C Inhibitor

THOUSAND OAKS, Calif., April 10, 2022 /PRNewswire/ — Amgen AMGN today announced the presentation of long-term efficacy and safety data from the CodeBreaK 100 Phase 1/2 trial in patients with KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC) who received LUMAKRAS® (sotorasib)*. The two-year follow-up data will be 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.

“With regulatory approvals in nearly 40 countries and thousands of patients treated, LUMAKRAS, the only approved KRASG12C inhibitor, is a transformative targeted therapy for the treatment of patients living with KRAS G12C-mutated NSCLC,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “We are pleased with these latest results from the CodeBreaK 100 study, which represent the longest follow-up of patients treated with a KRASG12C inhibitor and confirm rapid, deep and durable responses in patients receiving LUMAKRAS.”

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…

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