Phase 3 trials of pembrolizumab in prostate, lung cancer miss primary endpoints
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Two phase 3 trials evaluating pembrolizumab in combination with additional agents failed to meet their primary endpoints, according to the agent’s manufacturer.
One of the trials, KEYNOTE-641, will be discontinued at the recommendation of an independent data safety monitoring committee, a Merck press release stated.
The randomized, double-blind KEYNOTE-641 trial assessed pembrolizumab (Keytruda, Merck), an anti-PD-1 therapy, vs. placebo among 1,240 men with metastatic castration-resistant prostate cancer who also received enzalutamide (Xtandi; Astellas, Pfizer) and androgen deprivation therapy. The men had not previously received chemotherapy for their disease and were abiraterone-naive or intolerant to or progressed on abiraterone acetate.
Results did not show improvement in either of the trial’s dual primary endpoints of radiographic PFS or OS per blinded independent central review with the pembrolizumab regimen, and crossed a prespecified boundary for futility for OS, according to the press release.
KEYNOTE-789, a randomized, double-blind phase 3 trial, investigated pemetrexed plus platinum-based chemotherapy with and without pembrolizumab for treatment of patients with metastatic nonsquamous non-small cell lung cancer.
The study enrolled 492 patients with EGFR mutations who previously progressed on a tyrosine kinase inhibitor, including osimertinib (Tagrisso, AstraZeneca).
Although researchers observed longer OS in the pembrolizumab group, the results failed to achieve statistical significance per the prespecified statical plan, according to the press release.
Both trials produced safety results consistent with those reported in prior studies of pembrolizumab, with no new safety signals identified. Data will be presented at a future medical meeting.
“Throughout the clinical development of Keytruda, we have asked the tough questions in an effort to fully explore the potential of this breakthrough immunotherapy and determine how we could help as many patients as possible,” Eliav Barr, MD, senior vice president and head of global clinical development for Merck, said in the press release. “Science is rarely a straight line, and while we are disappointed in these study results, our research to investigate Keytruda in many difficult-to-treat types of cancer continues in earnest.”
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