Merck Reports the US FDA Acceptance of sBLA for Review of Keytruda (pembrolizumab) as Adjuvant Therapy for Stage IB-IIIA Non-Small Cell Lung Cancer
Shots:
- The sBLA was based on the P-III (KEYNOTE-091) trial evaluating Keytruda (200mg, IV, q3w) vs PBO in a ratio (1:1) in 1177 patients with stage IB to IIIA NSCLC. The US FDA’s decision is expected in Jan 29, 2023
- At the interim analysis, the therapy showed an improvement in DFS regardless of PD-L1 expression. In patients whose tumors express PD-L1 (TPS ≥50%), DFS did not attain statistical significance based on the pre-specified statistical strategy & the safety profile was consistent with prior studies
- The trial will continue to look at DFS & other 2EPs in patients whose tumors showed high levels of PD-L1 (TPS ≥50%). The company has an extensive clinical program in lung cancer & the therapy is being evaluated in multiple registration-enabling studies
Ref: Business wire | Image: Merck
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