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Keytruda improves OS in advanced bladder cancer, study closes early
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A phase 3 study comparing pembrolizumab to chemotherapy for patients with advanced, previously treated urothelial cancer met its primary OS endpoint and has closed early, according to a press release from the drug’s manufacturer.
Pembrolizumab (Keytruda, Merck) — an anti–PD-1 therapy currently approved for the treatment of melanoma, head and neck cancer, and lung cancer — is the first immunotherapy agent to show improved OS outcomes over chemotherapy in this patient population.
KEYNOTE-045 included data from 542 patients with metastatic or inoperable bladder cancer, randomly assigned to single-agent pembrolizumab (200 mg every 3 weeks) or investigator’s choice of paclitaxel (175 mg/m2 every 3 weeks), docetaxel (75 mg/m2 every 3 weeks) or vinflunine (320 mg/m2 every 3 weeks).
OS and PFS served as co-primary endpoints; secondary endpoints included overall response rate, duration of response and safety.
Results from a prespecified interim analysis showed a clear OS benefit for patients assigned pembrolizumab, with a safety profile consistent with previously reported bladder cancer trials. As such, the study’s independent data monitoring committee recommended the study’s early closure.
“The results of KEYNOTE-045 represent a major breakthrough and will be welcome news for patients dealing with previously treated advanced urothelial cancer,” Roger M. Perlmutter, MD, PhD, executive vice president of Merck and president of Merck Research Laboratories, said in a press release. “We look forward to sharing the findings from this study with the medical community and with regulatory authorities around the world.”
Perspective
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Daniel M. Geynisman, MD
With this announcement, pembrolizumab (Keytruda, Merck) becomes the first new therapy for bladder cancer to show an OS improvement over chemotherapy in decades. Prior to this, atezolizumab (Tecentriq, Genentech/Roche) was approved for bladder cancer; however, its approval was based on a phase 2 trial that did not include a head-to-head comparison with chemotherapy, and that trial’s primary endpoint was not OS. This is a significant moment for the bladder cancer community.
Pembrolizumab and other immunotherapies for bladder cancer are developed primarily for patients with metastatic and inoperable disease. Hopefully, it will offer this difficult-to-treat patient population another option, but it’s important to remember that this is a preliminary press release. We will need to see full study details and the extent of the benefit pembrolizumab provided. When we see those data, the question will then become which immunotherapeutic agent to use for their patients, and what biomarkers can be developed to guide therapy choices.
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