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04 Apr 2023: Keytruda / Padcev (enfortumab vedotin-ejfv) / 1L Urothelial cancer / Merck / Astellas Pharma / Seagen: US FDA granted accelerated approval for KEYNOTE-869 trial
- FDA granted accelerated approval for Keytruda and Padcev combination based on the KEYNOTE-869 trial, this marks the first time an anti-PD-1 therapy has been approved in combination with an antibody-drug conjugate for Urothelial cancer in the U.S
- This approval was based on dose escalation cohort, Cohort A and Cohort K, which was conducted in collaboration with Seagen and Astellas
- Results from the dose escalation cohort, Cohort A and Cohort K (n=121), KEYTRUDA + Enfortumab vedotin were:
- ORR: 68% (12% achieved a complete response and 55% partial response)
- mDOR: Cohort A (22.1 months), Cohort K (Not reached)
- The most common adverse reactions reported were increased glucose, increased aspartate aminotransferase etc
“This approval is a major milestone in the treatment of patients with locally advanced or metastatic urothelial carcinoma because it is the first approved combination of an immunotherapy and an antibody-drug conjugate for these patients,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories
