sBLA Submitted for Additional Keytruda Indication
Merck announced that it has submitted a supplemental Biologics License Application (sBLA) to the Food and Drug Administration (FDA) for Keytruda (pembrolizumab) for the treatment of advanced non-small cell lung cancer (NSCLC).
The sBLA submission is based on data from KEYNOTE-001 in patients with ≥50% of tumor cells positive for PD-L1 expression. KEYNOTE-001 investigated the use of Keytruda in naïve and previously-treated patients with advanced NSCLC. In an analysis of 313 patients from a validation data set for tumor PD-L1 expression, overall-response rate (ORR) was 45.4% (95% CI, 33.5–57.3) in patients ≥50% of tumor cells positive for PD-L1 expression (n=73). In the other PD-L1 subgroups, ORR was 16.5% (95% CI, 9.9–25.1) in patients with 1–49% tumor cells positive (n=103) and 10.7% (95% CI, 2.3–28.2) in patients with <1% tumor cells positive (n=28) for PD-L1 expression. In the total study population, ORR was 19.4% (95% CI, 16.0–23.2) (n=495), which was consistent with data previously presented from this study.
Keytruda, a humanized monoclonal antibody is already indicated for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and if BRAF V600 mutation positive, a BRAF inhibitor.
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