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Durvalumab Approved for Extensive-Stage SCLC

Small-cell lung cancer cells.

The FDA has approved durvalumab (Imfinzi®, AstraZeneca) in combination with either carboplatin/etoposide or cisplatin/etoposide for patients with previously untreated extensive-stage small-cell lung cancer (ES-SCLC).

The approval was based on CASPIAN (NCT03043872), a phase 3 trial that enrolled 537 patients with untreated ES-SCLC. Patients were randomized in a 1:1:1 ratio to receive durvalumab/platinum/etoposide, durvalumab/tremelimumab/platinum/etoposide, or platinum/etoposide alone. Platinum-based chemotherapy consisted of investigator's choice of either carboplatin or cisplatin. The primary end point was overall survival, with secondary end points of progression-free survival and objective response rate.

Compared with platinum/etoposide alone, durvalumab/platinum/etoposide significantly increased median overall survival (13.0 months vs 10.3 months) and produced a higher overall response rate (68% vs 58%). At 18 months, 34% of patients in the durvalumab/platinum/etoposide group were alive, compared with 25% of patients receiving platinum/etoposide alone.

Grade 3/4 adverse events occurred at an equal rate in patients in both groups (62%), with adverse events leading to death occurring in 5% of patients receiving durvalumab/platinum/etoposide and 6% of patients receiving platinum/etoposide alone. The most common adverse events were nausea, fatigue, and alopecia. Serious adverse events included immune-mediated pneumonitis, hepatitis, colitis or diarrhea, endocrinopathies, nephritis, infection, and rash or dermatitis.

"First-line durvalumab plus platinum/etoposide significantly improved overall survival in patients with ES-SCLC versus a clinically relevant control group," conclude the study authors, led by first author Luis Paz-Ares, MD, Professor of Medicine and Chair of the Department of Medical Oncology at the Hospital Universitario Doce de Octubre in Madrid, Spain. "Safety findings were consistent with the known safety profiles of all drugs received."

The recommended dose is 1,500 mg of durvalumab followed by 80-100 mg/m2 of etoposide and either 5-6 mg/mL of carboplatin or 75-80 mg/m2 of cisplatin. Durvalumab should be administered in combination with platinum/etoposide once every three weeks, followed by once every four weeks as a single agent.

For More Information

Paz-Ares L, Dvorkin M, Chen Y, et al (2019). Durvalumab plus platinum-etoposide versus platinum-etoposide in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): a randomised, controlled, open-label, phase 3 trial. Lancet, 394(10212): 1929-1939. DOI:10.1016/S0140-6736(19)32222-6

Clinicaltrials.gov. Durvalumab ± tremelimumab in combination with platinum based chemotherapy in untreated extensive-stage small cell lung cancer (CASPIAN). NLM identifier: NCT03043872

Image credit: Yale Rosen. Licensed under CC BY-SA 2.0


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