June 18, 2019

Impact Level: High

  • FDA has granted accelerated approval to Keytruda (pembrolizumab) monotherapy for 3L treatment of metastatic SCLC. According to Keytruda’s revised label, it is indicated for use after platinum-based chemotherapy and one other line of therapy.
  • This approval is based on pooled data from the KEYNOTE-158 (Phase 2) and KEYNOTE-028 (Phase 1b) trials.

inThought Analysis

This accelerated approval adds to Keytruda’s growing momentum and comes in line with the June 17 PDFUA date. This marks Keytruda’s first entry into SCLC, where it will compete directly with Opdivo (nivolumab). Both PD-1 inhibitors are conditionally approved for 3L use, contingent on future confirmatory trial results. Pooled response data from 83 subjects showed an ORR of 19% (CR rate: 2%). In KEYNOTE-158, the ORR was 18.7% for the overall population and 35.7% for PD-L1+ individuals treated with Keytruda. For Opdivo, the ORR was 12% (CR rate: 1%) for the overall population in CheckMate-032.

Keytruda/chemotherapy is also being studied in the 1L setting for extensive-stage SCLC (KEYNOTE-604; NCT03066778). In March 2019, Tecentriq/chemotherapy became the first PD-1 axis inhibitor approved for this patient population.

SCLC accounts for 10-15% of all cases of lung cancer, occurring almost exclusively in smokers. It is an aggressive form of lung cancer, characterized by rapid doubling time and the early appearance of widespread metastases. Most patients with SCLC present with extensive stage disease.

Source: Merck press release

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