On March 27, the U.S. Food and Drug Administration (FDA) approved durvalumab (Imfinzi) in combination with etoposide and either carboplatin or cisplatin as first-line treatment of patients with extensive-stage small cell lung cancer (SCLC).
Efficacy of this combination in patients with previously untreated extensive-stage SCLC was investigated in CASPIAN, a randomized, multicenter, active-controlled, open-label phase III trial. The evaluation was based on the comparison of patients randomly assigned to durvalumab plus chemotherapy vs chemotherapy alone. The major efficacy outcome measure was overall survival; additional efficacy outcome measures were investigator-assessed progression-free survival and objective response rate per Response Evaluation Criteria in Solid Tumors, version 1.1.
Median overall survival was 13.0 months (95% confidence interval [CI] = 11.5–14.8) in the durvalumab-plus-chemotherapy arm vs 10.3 months (95% CI = 9.3–11.2) in the chemotherapy-alone arm (hazard ratio = 0.73, 95% CI = 0.59–0.91, P = .0047).
Investigator-assessed progression-free survival (96% of total planned events) showed a hazard ratio of 0.78 (95% CI = 0.65–0.94), with median progression-free survival of 5.1 months (95% CI = 4.7–6.2) in the durvalumab-plus-chemotherapy arm and 5.4 months (95% CI = 4.8–6.2) in the chemotherapy-alone arm. The investigator-assessed confirmed objective response rate was 68% (95% CI = 62%–73%) in the durvalumab-plus-chemotherapy arm and 58% (95% CI = 52%–63%) in the chemotherapy-alone arm.
The most common adverse reactions seen with durvalumab in patients (≥ 20%) were nausea, fatigue/asthenia, and alopecia.
For patients with extensive-stage SCLC, durvalumab is to be administered prior to chemotherapy on the same day. The recommended durvalumab dose when administered with etoposide and either carboplatin or cisplatin is 1,500 mg every 3 weeks prior to chemotherapy and then every 4 weeks as a single agent.