FDA Approves Imfinzi® Combination to Treat Extensive-Stage Lung Cancer

The U.S. Food and Drug Administration approved Imfinzi® (durvalumab) in combination with etoposide plus either carboplatin or cisplatin as first-line treatment for adults with extensive-stage small cell lung cancer (ES-SCLC).

The approval was based on results from the randomized, open-label, multicenter, global, phase III CASPIAN trial, which included 805 patients with ES-SCLC. Patients were randomized to receive one of three regimens: durvalumab in combination with etoposide and either carboplatin or cisplatin, durvalumab and chemotherapy plus tremelimumab, or chemotherapy alone (standard of care group). Durvalumab was given at 1,500 mg every three weeks for four cycles plus chemotherapy then every four weeks until disease progression.

Reduced risk of death with the addition of durvalumab to chemotherapy

Patients who received durvalumab plus chemotherapy had a 27% reduced risk of death (hazard ratio, 0.73; 95% CI, 0.59-0.92; P=0.0047) compared with standard of care alone: median overall survival was 13.0 months versus 10.3 months, respectively.

Patients receiving durvalumab plus chemotherapy also had an increased confirmed objective response rate (68%) compared with standard of care alone (58%).

The safety and tolerability of durvalumab plus chemotherapy was consistent with the known safety profiles of these medicines, according to the researchers.