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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

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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

Click here to­ read the full press release 

Senior Editor

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 connect@pharmashots.com.

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