Merck Inc., provides update on phase III KEYNOTE-867 trial of Keytruda (pembrolizumab) in combination with stereotactic body radiotherapy for NSCLC.
Merck Inc.(known as MSD outside of the United States and Canada, provided updates on two Phase III trials, KEYNOTE-867 and KEYNOTE-630. Merck is discontinuing the Phase III 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.
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