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FDA Approves Durvalumab–Chemo Combo for Extensive-Stage SCLC
On March 27, 2020, the FDA approved durvalumab (Imfinzi; AstraZeneca) combined with etoposide and carboplatin or cisplatin for the first-line treatment of patients with extensive-stage small-cell lung cancer (ES-SCLC). The application for this indication was granted priority review and orphan drug designation by the FDA.
This approval was based on efficacy findings from the multi-center, open-label, CASPIAN trial, which evaluated this combination regimen in treatment-naïve patients with ES-SCLC. These patients were randomized to receive durvalumab plus chemotherapy or chemotherapy alone and assessed for overall survival (OS). Investigator-assessed progression-free survival (PFS) and objective response rate (ORR) were also evaluated.
The median OS was 13.0 months (95% CI, 11.5-14.8) versus with 10.3 months (95% CI, 9.3-11.2) in the durvalumab plus chemotherapy and chemotherapy alone arms, respectively (hazard ratio [HR], 0.73; 95% CI, 0.59-0.91; P = .0047).
Findings also yielded a median PFS of 5.1 months (95% CI, 4.7-6.2) with durvalumab plus chemotherapy versus 5.4 months (95% CI, 4.8-6.2) with chemotherapy alone (HR, 0.78; 95% CI, 0.65-0.94). The investigator-assessed ORR was 68% (95% CI, 62%-73%) versus 58% (95% CI, 52%-63%), respectively.
The most frequently reported (≥20%) adverse events associated with this regimen were nausea, fatigue/asthenia, and alopecia.—Hina Porcelli
Source: US Food and Drug Administration. FDA approves durvalumab for extensive-stage small cell lung cancer. Updated March 30, 2020. www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-extensive-stage-small-cell-lung-cancer. Accessed March 30, 2020
