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.

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May 20, 2019

Impact Level: Moderate

  • Merck has announced that its Phase 3 KEYNOTE-119 trial assessing Keytruda (pembrolizumab) monotherapy compared to chemotherapy (capecitabine, eribulin, gemcitabine, or vinorelbine) in 2L and 3L metastatic triple-negative breast cancer (TNBC) patients did not meet the primary endpoint of OS.
  • In accordance with the study protocol, other endpoints (PFS, ORR, disease control rate, and duration of response) were not formally tested since OS was not met.
  • Merck plans to present these results at an upcoming medical conference.

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