Adjuvant therapy with the immune checkpoint inhibitor nivolumab following surgery improved disease-free survival in patients with high-risk muscle-invasive urothelial carcinoma, according to new findings presented by Matthew D. Galsky, MD, FASCO, and colleagues at the 2023 ASCO Genitourinary Cancers Symposium (Abstract LBA443).
Matthew D. Galsky, MD, FASCO
Study Methods and Results
“Adjuvant nivolumab became a standard of care based on the initial results of [the] CheckMate 274 [trial],” explained Dr. Galsky, Professor of Medicine in the Department of Hematology and Oncology, Director of Genitourinary Medical Oncology, and Co-Director of the Center of Excellence for Bladder Cancer at The Tisch Cancer Institute at the Mount Sinai Icahn School of Medicine. “Normally, patients with this cancer face a high chance of recurrence, especially within the first 3 years after surgical removal of the bladder or kidney,” he added.
In the new phase III CheckMate 274 trial, the researchers randomly assigned 353 patients to receive nivolumab and 356 patients to receive placebo every 2 weeks for 1 year—and found that at approximately 3 years of follow-up, patients who underwent treatment with nivolumab had an improved disease-free survival after surgery compared with patients who received placebo (median = 22.0 months with nivolumab vs 10.9 months with placebo in intent-to-treat patients; 52.6 months with nivolumab vs 8.4 months with placebo in patients with PD-L1 ≥ 1%). No new safety signals were seen with nivolumab treatment.
“These results—showing patients’ continued survival 3 years out—reinforce adjuvant nivolumab as a standard of care for patients with muscle-invasive urothelial carcinoma [after radical resection],” concluded Dr. Galsky.
Disclosure: The research in this study was supported by Bristol Myers Squibb. For full disclosures of the study authors, visit coi.asco.org.
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