Merck (NYSE:MRK) said it will stop a phase 3 trial of a Keytruda combo therapy to treat a type of prostate cancer after the treatment failed to improve survival.

The study, dubbed KEYNOTE-991, was evaluating Merck's blockbuster Keytruda, in combination with enzalutamide — sold as Xtandi by Pfizer (PFE) and Astellas Pharma (OTCPK:ALPMF) (OTCPK:ALPMY) — and androgen deprivation therapy (ADT) versus placebo in combination with Xtandi plus ADT to treat patients with metastatic hormone-sensitive prostate cancer (mHSPC).

Merck said it is discontinuing the study based on the recommendation of an independent data monitoring committee which reviewed data.

At an interim analysis, the Keytruda combo did not show an improvement in overall survival (OS) or radiographic progression-free survival (rPFS), the trial's dual main goals, compared to the placebo combo.

Merck noted that the safety profile of Keytruda in the trial was consistent with that seen in previous studies. However, the combination was associated with a higher incidence of Grade 3-5 adverse events and serious adverse events compared to the control arm.

Merck added that it is informing study investigators of the decision and advises patients in the trial to speak to their physician regarding treatment.

The trial had enrolled 1,251 patients.

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 Clipped from SA:

 

Jan. 25, 2023 7:27 AM ETMerck & Co., Inc. (MRK)PFE, ALPMF, ALPMYBy: Ravikash, SA News Editor2 Comments 

 

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Moderna's 44% is looking bigger than ever. Maybe it's so big is why there is such an expensive hurry to start trials on other cancers before the P3 trial is even started, never mind product approval. MRK and MRNA must have high level of confidence that the time and money will not be for  nothing.