Merck’s Keytruda (pembrolizumab) Receives the US FDA’s Approval for the Treatment of Non-Small Cell Lung Cancer
- The approval was based on the P-III trial (KEYNOTE-091) results evaluating Keytruda (200mg, IV, q3w) vs PBO in a ratio (1:1) in 1177 patients with completely resected stage IB (T2a ≥4 cm), II, or IIIA NSCLC
- The results showed an improvement in DFS who received adjuvant Pt-based CT following surgical resection, a 27% reduction in risk of disease recurrence or death, m-DFS (58.7mos. vs 34.9mos.) in patients regardless of PD-L1 expression
- In an exploratory subgroup analysis, the DFS HR was 1.25 among 167 patients who did not receive adjuvant CT while the AEs reported in the trial (KEYNOTE-091) were similar to that observed in other trials of pembrolizumab
Ref: Merck | Image: Merck
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