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FDA approval of tremelimumab in combination with durvalumab in metastatic NSCLC

Oncologyme  /  Mar 26, 2023


On November 10, 2022, the FDA approved #tremelimumab in combination with #durvalumab and platinum-based chemotherapy as first line therapy for adult patients with metastatic non-small cell lung cancer (#NSCLC) with no EGFR or ALK genomic tumor aberrations.

The approval was based on phase III POSEIDON trial, in which tremelimumab plus durvalumab and platinum-based chemotherapy demonstrated a statistically significant and clinically meaningful improvement in OS compared to platinum-based chemotherapy, median OS was 14 months and 11.7 months respectively (HR = 0.77, p= 0.00304). Additionally, median PFS was 6.2 months and 4.8 months in the treatment arms respectively (HR 0.72, p= 0.00031).