- Merck & Co Inc MRK is discontinuing the Phase 3 KEYNOTE-641 trial evaluating Keytruda (pembrolizumab) in combination with enzalutamide and androgen deprivation therapy (ADT) for metastatic castration-resistant prostate cancer (mCRPC).
- At an interim analysis, Keytruda plus enzalutamide and ADT did not demonstrate an improvement in radiographic progression-free survival (rPFS) or overall survival (OS), the trial's dual primary endpoints to placebo plus enzalutamide and ADT.
- The study crossed a pre-specified futility boundary for OS.
- Related: Merck Says Keytruda/Chemo Combo Improved Overall Survival Compared To Chemo Alone In Gastric Cancer Settings.
- Merck also announced that the Phase 3 KEYNOTE-789 trial evaluating Keytruda plus pemetrexed plus platinum-based chemotherapy did not meet its dual primary endpoint of OS for metastatic nonsquamous non-small cell lung cancer (NSCLC), with epidermal growth factor receptor (EGFR)-genomic tumor mutations, who have previously progressed on a tyrosine kinase inhibitor (TKI).
- At the study's final analysis, there was an improvement in OS for patients who received the Keytruda combo compared to pemetrexed with platinum-based chemotherapy; however, these results did not meet statistical significance.
- At an earlier interim analysis, the trial's other dual primary endpoint, progression-free survival (PFS), was tested and showed an improvement in the Keytruda arm compared to chemotherapy alone but did not reach statistical significance.
- Price Action: MRK shares are down 2.19% at $106.96 on the last check Tuesday.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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