The FDA approved the combination of tremelimumab + durvalumab and platinum-based chemotherapy for adult patients with metastatic non-small cell lung cancer with no sensitizing epidermal growth factor receptor mutation or anaplastic lymphoma kinase genomic tumor aberrations. For patients weighing 30 kg or more, the recommended tremelimumab dose is 75 mg every 3 weeks with durvalumab 1,500 mg and platinum-based chemotherapy for four cycles, then durvalumab 1,500 mg with maintenance chemotherapy every 4 weeks. A fifth tremelimumab dose (75 mg) should be given at week 16. The approval was based on the randomized POSEIDON trial (N=675). Statistically significant and clinically meaningful improvement in overall survival was seen with tremelimumab + durvalumab and platinum-based chemotherapy versus platinum-based chemotherapy alone (HR,0.77). Median overall survival was 14 months with tremelimumab + durvalumab and 11.7 months for platinum-based chemotherapy alone. Median progression-free survival times were 6.2
months and 4.8 months, respectively (HR, 0.72). The overall response rate was 39% with the drug combination versus 24% with chemotherapy alone, with median duration of responses of 9.5 and 5.1 months, respectively.