- Merck & Co Inc (NYSE: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.
Kratos Defense & Security Solutions Sees Q2 Revenue $265M-$280M Vs $270.76M Est.; FY24 Revenue $1.125B-$1.150B Vs $1.14B Est.
Financial GuidanceWe are providing our initial 2024 second quarter financial guidance and affirming our full year 2024 guidance today, which includes our current forecasted business mix assumptions, including as related
