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Merck’s Keytruda + Padcev Received the US FDA Approval for the Treatment of Urothelial Cancer

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Merck’s Keytruda + Padcev Received the US FDA Approval for the Treatment of Urothelial Cancer

Shots:

  • The approval was based on the P-III (KEYNOTE-A39) trial evaluating Keytruda + Padcev vs CT (gemcitabine + cisplatin/carboplatin) in patients (n=886) with locally advanced or metastatic urothelial cancer. The result of the study demonstrated statistically significant improvement in OS & PFS
  • Additionally, the result also demonstrated a median OS of 31.5 vs 16.1mos. along with a reduced risk of death by 53% & disease progression by 55%. Median PFS was 12.5 vs 6.3mos. & ORR was 68% vs 44%. Furthermore, CR was found to be 29% vs 12%, & PR was 39% vs 32%
  • Keytruda, humanized mAb activates T lymphocytes, which may have an impact on both tumor cells and healthy cells, by interfering with the interaction between PD-1 and its ligands, PD-L1 and PD-L2

Ref: Merck | Image: Merck

Related News:- Moderna and Merck Report Results from the P-IIb (KEYNOTE-942) Study of mRNA-4157 (V940) + Keytruda (pembrolizumab) for Resected High-Risk Melanoma

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Kritika Jha

Kritika is a content writer at PharmaShots. She is interested in covering recent innovations from the pharma & MedTech industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.

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