The Lynx Group

FDA Approves Imfinzi as First-Line Treatment, with Chemotherapy, for Extensive-Stage Small-Cell Lung Cancer

April 2020, Vol 11, No 2

On March 27, 2020, the FDA approved a new indication for the PD-L1 inhibitor durvalumab (Imfinzi; Astra- Zeneca), in combination with etoposide and either carboplatin or cisplatin, as first-line treatment of patients with extensive-stage small-cell lung cancer (ES-SCLC). Imfinzi was previously approved by the FDA for the treatment of patients with metastatic urothelial cancer and for patients with unresectable, stage III non–small-cell lung cancer. The FDA granted durvalumab an orphan drug designation for this new indication.

The approval of this new combination was based on the CASPIAN study, a randomized, multicenter, active-controlled, open-label, clinical trial. The study included patients with treatment- naïve ES-SCLC who were randomized to durvalumab plus chemotherapy or to chemotherapy alone.

The major efficacy outcome measure was overall survival (OS). The secondary outcome measures were investigator- assessed progression-free survival (PFS) and objective response rate (ORR), per RECIST v1.1.

At a median follow-up of 14 months, the median OS was 13 months (95% confidence interval [CI], 11.5-14.8) in the durvalumab plus chemotherapy arm versus 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).

The median PFS (by investigator assessment) was 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 ORR was 68% (95% CI, 62%-73%) in the durvalumab-based combination arm and 58% (95% CI, 52%-63%) in the chemotherapy-alone arm. The most common (≥20%) adverse events in patients with ES-SCLC in this study were nausea, fatigue/asthenia, and alopecia.

For patients with ES-SCLC, durvalumab treatment should be administered before chemotherapy, on the same day.

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