RE:Keytruda hit and a miss with chemotherapy & hormone therapyJanuary 25, 2023 - Merck (MSD) announced that it will stop the Phase 3 KEYNOTE-991 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with enzalutamide and androgen deprivation therapy (ADT) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC). Merck is discontinuing the study [due to futility] based on the recommendation of an independent Data Monitoring Committee which reviewed data from a planned interim analysis. https://www.biospace.com/article/releases/merck-announces-keynote-991-trial-evaluating-keytruda-pembrolizumab-plus-enzalutamide-and-androgen-deprivation-therapy-in-patients-with-metastatic-hormone-sensitive-prostate-cancer-to-stop-for-futility/
The phase 3 KEYNOTE-991 trial tested Keytruda against placebo in their respective combinations with Astellas and Pfizer’s antiandrogen drug Xtandi and androgen deprivation therapy. At the interim analysis, the Keytruda regimen failed to improve patients’ life expectancy and didn’t show a benefit in slowing tumor progression.
KEYNOTE-991 marks the third phase 3 flop for Keytruda in prostate cancer in less than a year.
Alternatively, the addition of Keytruda to standard chemotherapy showed a “statistically significant and clinically meaningful” improvement in patient survival versus chemo alone for patients with newly diagnosed biliary tract cancer.
https://www.fiercepharma.com/pharma/mercks-keytruda-takes-another-hit-prostate-cancer-rains-astrazenecas-parade