Phase 3 trials of pembrolizumab for lung cancer, skin cancer halted due to lack of efficacy
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Two randomized phase 3 trials of pembrolizumab — one in lung cancer and one in skin cancer — have been discontinued due to lack of efficacy, according to the agent’s manufacturer.
Pembrolizumab (Keytruda, Merck) — an anti-PD-1 antibody — is approved for several oncology indications in the United States.
The KEYNOTE-867 trial had been designed to evaluate stereotactic body radiotherapy plus pembrolizumab or placebo for patients with stage I or stage II non-small cell lung cancer, including those who refused or were ineligible for surgery.
Merck discontinued the trial at the recommendation of an independent data monitoring committee. A prespecified interim analysis showed no improvement in EFS or OS — the trial’s primary endpoints — with pembrolizumab. Researchers also observed higher rates of adverse events, as well as adverse events that led to death, among patients assigned pembrolizumab vs. placebo.
The KEYNOTE-630 trial had been designed to compare pembrolizumab vs. placebo as adjuvant therapy for patients with high-risk locally advanced cutaneous squamous cell carcinoma who underwent surgery and radiation.
A pre-planned analysis showed no significant improvement in RFS — the study’s primary endpoint — with pembrolizumab. An independent data monitoring committee recommended the trial be stopped for futility.
Results of both trials will be shared with the scientific community, according to a Merck press release.
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