Merck Ends Phase 3 KEYNOTE-867 and KEYNOTE-630 Trials

 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today provided updates on two Phase 3 trials, KEYNOTE-867 and KEYNOTE-630. Merck is discontinuing the Phase 3 KEYNOTE-867 trial evaluating KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with stereotactic body radiotherapy (SBRT) for the treatment of patients with stage I or II (stage IIB N0, M0) non-small cell lung cancer (NSCLC), including those who are medically inoperable or have refused surgery. This decision is based on the recommendation of an independent Data Monitoring Committee (DMC), which reviewed data from a planned interim analysis. At the pre-specified interim analysis, KEYTRUDA in combination with SBRT did not demonstrate an improvement in event-free survival (EFS) or overall survival (OS), the study’s primary endpoint and key secondary endpoint, respectively, compared to placebo plus SBRT, and the benefit/risk profile of the combination did not support continuing the trial. KEYTRUDA in combination with SBRT was associated with higher rates of adverse events (AEs), including AEs leading to death, compared with SBRT and placebo.

Merck is also discontinuing the Phase 3 KEYNOTE-630 trial evaluating KEYTRUDA for the adjuvant treatment of patients with high-risk locally advanced cutaneous squamous cell carcinoma (cSCC) following surgery and radiation, based on the recommendation of an independent DMC. The DMC recommended that the study should be stopped for futility as the risk/benefit profile did not support continuing the trial. Data from a pre-planned analysis showed that KEYTRUDA did not cross the boundary for statistical significance in recurrence-free survival (RFS), the study’s primary endpoint. The study’s key secondary endpoint, OS, was not formally tested, but at the time of the analysis, the results did not favor KEYTRUDA compared to placebo. The safety profile of KEYTRUDA in this trial was consistent with the established safety profile of KEYTRUDA.

Merck has informed study investigators and advises patients in the studies to speak to their study team and physician regarding next steps and treatment options. Data analyses for KEYNOTE-867 and KEYNOTE-630 are ongoing, and the results will be shared with the scientific community and regulatory agencies.

“Our understanding of cancer and how it can be treated has rapidly evolved in recent years, but unmet needs remain across different types of cancer and stages of disease,” said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. “That is why we continue our rigorous exploration of innovative treatment approaches in cancers with high unmet need, such as non-small cell lung cancer and cutaneous squamous cell carcinoma, with the goal to help even more patients. We are extremely grateful to all of the patients, caregivers and investigators for their participation in these studies.”

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