MSD’s Keytruda (pembrolizumab) has failed to hit key goals in a trial assessing its potential as a first-line treatment for bladder cancer.
The Phase III KEYNOTE-361 trial, which assessed the anti-PD-1 therapy in combination with chemotherapy, did not meet its pre-specified dual primary endpoints of overall survival (OS) or progression-free survival (PFS), compared with standard of care chemotherapy.
The final analysis of the study showed an improvement in OS and PFS for patients treated with Keytruda and chemotherapy, but the difference did not reach statistical significance.
The monotherapy arm of the study was not formally tested, since superiority was not reached for OS or PFS in the combination arm, the firm noted.
On the plus side, Keytruda’s safety profile was consistent with previously reported studies, and no new safety signals were identified.
“While we are disappointed in these study results, Keytruda has been established as an important option in the treatment of metastatic bladder cancer, and we are committed to continuing our research to help more patients with this disease,” commented Dr Roy Baynes, senior vice president and head of global clinical development, chief medical officer, at MSD.
Results are to be presented at an upcoming medical meeting and will be discussed with regulatory authorities.