Overview
- Median overall survival reached 47.5 months with osimertinib plus platinum–pemetrexed versus 37.6 months with osimertinib alone in newly diagnosed advanced EGFR-mutated NSCLC.
- The final analysis was presented at the ESMO 2025 Congress in Berlin and published simultaneously in the New England Journal of Medicine.
- Patients with central nervous system metastases saw a notable benefit, with median overall survival of 40.9 months on the combination versus 29.7 months on monotherapy.
- Added chemotherapy increased early adverse events such as nausea, vomiting, fatigue, and bone marrow toxicities, which typically lessen during maintenance therapy.
- The regimen received FDA approval in February 2024 based on progression-free survival, and investigators say the new overall survival data support its use as a first-line standard option and a platform for future combinations.