NEW YORK – Merck on Thursday said it is discontinuing the Phase III KEYNOTE-630 trial of Keytruda (pembrolizumab) as adjuvant therapy in patients with high-risk, locally advanced cutaneous squamous cell carcinoma, in which researchers are looking at PD-L1 expression levels.
In the trial, Merck is comparing treatment with Keytruda to placebo following surgery and radiation. To be eligible for the trial, patients must have had a newly obtained tumor tissue sample adequate for PD-L1 testing at a central laboratory.
An independent data monitoring committee recommended that the study should be stopped for futility because the risk-benefit profile did not support continuing. A pre-planned analysis revealed that the benefits of treatment with Keytruda did not reach statistical significance in the study's primary endpoint, recurrence-free survival. The interim results also did not show an overall survival benefit compared to placebo.
At the same time, Merck said it is also terminating the Phase III KEYNOTE-867 trial of Keytruda with radiotherapy in non-small cell lung cancer, which also failed to show benefits in an interim analysis.
Merck has advised patients to discuss next steps and treatment options with their study team and physician. The company said it will share results from both studies with the scientific community and regulatory agencies.
Keytruda is approved in many cancer indications, including as a treatment for patients with advanced non-small cell lung cancers expressing PD-L1.