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October 28, 2021

Immunotherapy for Patients With Small-Cell Lung Cancer—2 Gains, 2 Losses

Author Affiliations
  • 1Oncology Center of Excellence, US Food and Drug Administration, Silver Spring, Maryland
JAMA Oncol. 2022;8(1):37-38. doi:10.1001/jamaoncol.2021.4956

Although the treatment of non–small-cell lung cancer (NSCLC) has rapidly benefited from the approvals of antibodies against programmed cell death 1 (PD-1) and PD-1 ligand 1 (PD-L1), as well as targeted drugs aimed at specific variants, progress in small-cell lung cancer (SCLC) therapy has been much slower. Recently, the introduction of PD-L1 antibodies in combination with chemotherapy for initial treatment of advanced SCLC represented the first advance since the introduction of etoposide chemotherapy regimens decades ago. Trials and the regulatory history of these antibodies have had mixed results. When combined with chemotherapy in the first-line treatment of SCLC, atezolizumab and durvalumab received regular approval after demonstrating improvements in overall survival (OS). However, 2 other antibodies, nivolumab and pembrolizumab, which were initially approved by the US Food and Drug Administration (FDA) in a later-line SCLC setting, had their indications withdrawn after confirmatory trials did not demonstrate the clinical benefit required as a condition for their accelerated approvals.

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