POSEIDON — Durvalumab (± Tremelimumab) Plus Chemotherapy Versus Chemotherapy in First-Line Metastatic NSCLC

Phase 3 · 2023 · Non-Small Cell Lung Cancer

Design

Randomized open-label 3-arm trial: tremelimumab + durvalumab + chemotherapy vs durvalumab + chemotherapy vs chemotherapy alone in first-line metastatic NSCLC.

Population

Treatment-naive metastatic NSCLC without EGFR/ALK alterations, any PD-L1 level, ECOG 0-1.

Primary Endpoint

progression-free survival and overall survival for durvalumab + chemotherapy vs chemotherapy

Key Result

Tremelimumab + durvalumab + chemo mOS 14.0 vs 11.7 mo (HR 0.77) and PFS 6.2 vs 4.8 mo (HR 0.72); 4-yr OS 25.0% vs 13.6%.

Guideline Impact

FDA-approved 2022; NCCN-listed first-line option for metastatic NSCLC without EGFR/ALK alterations