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In mid-November, the US Food and Drug Administration announced the approval of two new combinations for the treatment of non-small cell lung cancer (NSCLC).
First, the agency approved cemiplimab-rwlc in combination with platinum-based chemotherapy for adult patients with advanced NSCLC with no EGFR, ALK, or ROS1 mutations. The approval was based on efficacy data from the EMPOWER-Lung 3 study.
The data showed cemiplimab-rwlc plus platinum-based chemotherapy demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) compared to placebo plus chemotherapy. Median OS was 21.9 months (95% CI: 15.5, not evaluable) in the cemiplimab-rwlc plus chemotherapy arm compared to 13.0 months (95% CI: 11.9, 16.1) in the placebo plus chemotherapy arm. Additionally, median progression free survival (PFS) was 8.2 months (95% CI: 6.4, 9.3) in the cemiplimab-rwlc plus chemotherapy arm and 5.0 months (95% CI: 4.3, 6.2) in the placebo plus chemotherapy arm. Confirmed overall response rate was 43% (95% CI: 38, 49) and 23% (95% CI: 16, 30) in the respective treatments.
The FDA also approved tremelimumab in combination with durvalumab and platinum-based chemotherapy for adult patients with metastatic NSCLC without EGFR or ALK mutations.
The approval was based on data from the POSEIDON trial, a randomized, multicenter, active-controlled, open-label study in patients with metastatic NSCLC who had not received prior systemic treatment. In its decision, the FDA cited POSEIDON data that showed tremelimumab plus durvalumab and platinum-based chemotherapy demonstrated a statistically significant and clinically meaningful improvement in OS and progression-free survival compared to platinum-based chemotherapy alone.
Median OS was 14 months (95% CI: 11.7, 16.1) for tremelimumab plus durvalumab and platinum-based chemotherapy compared to 11.7 months (95% CI: 10.5, 13.1) for platinum-based chemotherapy alone. Median PFS was 6.2 months (95% CI: 5.0, 6.5) and 4.8 months (95% CI 4.6, 5.8) in the treatment arms, respectively. The overall response rate was 39% (95% CI: 34,44) for tremelimumab plus durvalumab and platinum-based chemotherapy compared to 24% (95% CI: 20, 29) for platinum-based chemotherapy alone.
