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.
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.