Merck has discontinued two Phase 3 trials, KEYNOTE-867 and KEYNOTE-630.
The KEYNOTE-867 trial evaluated the combination of KEYTRUDA (pembrolizumab) and stereotactic body radiotherapy (SBRT) for stage I or II non-small cell lung cancer (NSCLC) patients ineligible for surgery. However, an interim analysis showed no improvement in event-free or overall survival compared to placebo and SBRT, prompting the discontinuation of the trial. The combination also exhibited a higher rate of adverse events, including fatalities.
Similarly, the KEYNOTE-630 trial, which evaluated KEYTRUDA for adjuvant treatment of high-risk locally advanced cutaneous squamous cell carcinoma (cSCC) after surgery and radiation, was terminated due to futility. A pre-planned analysis did not show statistical significance in recurrence-free survival, the primary endpoint. The safety profile of KEYTRUDA in this trial was consistent with its established profile.
Merck has notified study investigators and advised patients to consult with their healthcare teams for further treatment options. Data analyses are ongoing, and results will be shared with the scientific community and regulatory agencies.
Despite these setbacks, Merck remains committed to researching innovative treatments for cancers with unmet needs, such as NSCLC and cSCC, to improve patient outcomes.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.