Adjuvant pembrolizumab extends DFS for localized bladder cancers
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Pembrolizumab significantly improved DFS compared with observation for the adjuvant treatment of patients with localized muscle-invasive urothelial carcinoma and locally advanced urothelial carcinoma, according to the agent’s manufacturer.
An interim analysis from the phase 3 AMBASSADOR/KEYNOTE-123 showed no new safety issues associated with the adjuvant use of pembrolizumab (Keytruda, Merck) — a PD-1 inhibitor previously approved for multiple bladder cancer indications.
“Up to half of patients with bladder cancer who undergo surgery will experience recurrence within a year, underscoring the need for new treatment options in the adjuvant setting,” Marjorie Green, MD, senior vice president and head of late-stage oncology development at Merck Research Laboratories, said in a company-issued press release “These positive results highlight the potential of Keytruda to prevent recurrence after surgery for patients with localized muscle-invasive or locally advanced urothelial carcinoma.”
The NCI-sponsored, open-label AMBASSADOR/KEYNOTE-123 trial enrolled 702 adults with localized muscle-invasive urothelial carcinoma and locally advanced urothelial carcinoma.
Investigators randomly assigned study participants to receive either pembrolizumab as adjuvant therapy after surgery or undergo observation.
The study met one of its dual primary endpoints by showing “statistically significant and clinically meaningful improvement in DFS” among those who received pembrolizumab compared with observation after surgical resection, the release stated.
The manufacturer said it plans to submit results for presentation at an upcoming major scientific meeting.
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