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Merck Reports the CHMP’s Positive Opinion of Keytruda Plus Padcev to Treat Unresectable or Metastatic Urothelial Carcinoma

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Merck Reports the CHMP’s Positive Opinion of Keytruda Plus Padcev to Treat Unresectable or Metastatic Urothelial Carcinoma

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  • The CHMP has granted positive opinion to Keytruda + Padcev as a 1L treatment of unresectable or metastatic urothelial carcinoma adults, based on first interim data from P-III (KEYNOTE-A39/ EV-302) trial, carried out with Pfizer & Astellas. Final decision is anticipated Q3’24
  • The P-III (EV-302/KEYNOTE-A39) trial evaluated Keytruda + Padcev vs Pt-containing CT (SoC) in patients (n=886) with previously untreated la/mUC. The 1EPs were OS & PFS and 2EPs were ORR, DoR & safety
  • Study demonstrated reduction in the death risk by 53% & reduction in risk of disease progression or death by 55% with the combination

Ref: Merck | Image: Merck

Related News:- Astellas Receives the MHLW’s Priority Review for the sNDA Submitted for Padcev and Keytruda as Combination Therapy to Treat Bladder Cancer

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Disha Nankani

Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.

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