The FDA accepted a supplemental biologics license application and granted a priority review to durvalumab for the treatment of patients with previously untreated extensive-stage small cell lung cancer.
The FDA accepted a supplemental biologics license application (sBLA) and granted a priority review to durvalumab (Imfinzi) for the treatment of patients with previously untreated extensive-stage small cell lung cancer (SCLC), according to AstraZeneca, the drug’s manufacturer.1
The sBLA was based on positive results from the phase III CASPIAN trial, designed to evaluate durvalumab with or without the CTLA-4 inhibitor tremelimumab plus chemotherapy, of which both arms were compared with platinum/etoposide chemotherapy alone. The interim analysis -- which were recently published in The Lancet and presented at the IASLC 20th World Conference on Lung Cancer2,3 -- included 268 patients randomized to the durvalumab/chemotherapy regimen and 269 treated with chemotherapy alone.
Results from the study showed that durvalumab in combination with standard-of-care chemotherapy demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS). The risk for death was reduced by 27% (HR, 0.73; 95% CI, 0.591-0.909; P = .0047), with median OS of 13.0 months for the combination versus 10.3 months for chemotherapy alone.
Results also showed an estimated 33.9% of patients were alive at 18 months following treatment with the combination compared with 24.7% of patients receiving standard of care.
The CASPIAN trial, which is being conducted in over 200 location across 23 countries, is continuing until the final OS analysis for the cohort of patients receiving durvalumab plus tremelimumab and chemotherapy.
A Prescription Drug User Fee Act date is set for the first quarter of 2020.
1. Imfinzi granted FDA Priority Review for the treatment of patients with extensive-stage small cell lung cancer. Published November 29, 2019. https://bit.ly/2ODJCWt. Accessed December 2, 2019.
2. Paz-Ares L, Dvorkin M, Chen Y, et al. 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. 2019;394:10212(P1929-1939). doi:10.1016/S0140-6736(19)32222-6.
3. L. Paz-Ares, Y. Chen, N. Reinmuth, et al. Overall survival with durvalumab plus etoposide-platinum in first-line extensive-stage SCLC: results from the CASPIAN study. Presented at: IASLC 20th World Conference on Lung Cancer; September 7-10, 2019; Barcelona, Spain. Abstract OA02.02.