Adjuvant nivolumab extends DFS in urothelial carcinoma subset
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Adjuvant nivolumab significantly prolonged DFS compared with placebo for patients with high-risk, muscle-invasive urothelial carcinoma, according to topline data released by the agent’s manufacturer.
Researchers observed the benefit in the entire cohort, as well as among patients whose tumors expressed PD-L1.
The randomized phase 3 CheckMate -274 trial included 709 patients with muscle-invasive urothelial cancer at high risk for recurrence after radical surgery. Eligibility criteria allowed patients who received neoadjuvant chemotherapy to enroll.
Investigators randomly assigned patients 1:1 to the anti-PD-1 antibody nivolumab (Opdivo, Bristol Myers Squibb) or placebo for up to 1 year.
DFS in the intention-to-treat population and the subgroup of patients with 1% or higher PD-L1 expression in tumor cells served as the primary endpoints. Key secondary endpoints included OS, nonurothelial tract RFS and disease-specific survival.
Interim analysis results of the double-blind, multicenter study showed the trial met both primary endpoints.
Despite treatment advances, more than 50% of patients with urothelial carcinoma develop recurrence after surgery. CheckMate -274 is the first phase 3 trial to show adjuvant immunotherapy reduced relapse risk for these patients.
“Advances like immunotherapy have helped bring hope to patients across a growing number of cancer types, including previously treated advanced urothelial carcinoma,” Matthew Galsky, MD, director of genitourinary medical oncology, director of the novel therapeutics unit and co-director of Center of Excellence for Bladder Cancer at The Tisch Cancer institute and Icahn School of Medicine at Mount Sinai, said in a Bristol Myers Squibb-issued press release. “The positive results from CheckMate -274 point to the potential for nivolumab to become a new standard of care in the adjuvant setting, extending DFS for post-surgery patients with muscle-invasive urothelial cancer without the use of chemotherapy.”
Nivolumab exhibited a safety profile consistent with that observed in prior studies of the agent for treatment of solid tumors.
CheckMate -274 will continue so researchers can conduct analyses of secondary endpoints.
Complete data from the trial will be submitted for presentation at a medical conference and shared with regulatory authorities, according to the release.
The FDA previously approved nivolumab for several indications, including treatment of certain patients with melanoma, lung cancer, renal cell carcinoma, classical Hodgkin lymphoma or squamous cell carcinoma of the head and neck.
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