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
Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at firstname.lastname@example.org.