Researchers have found that nivolumab in combination with a chemotherapy regimen may improve the rate of survival in patients with metastatic urothelial carcinoma, according to new findings simultaneously published by van der Heijden et al in The New England Journal of Medicine and presented at the European Society for Medical Oncology (ESMO) Congress 2023 (Abstract LBA7).
Study Methods and Results
In the new randomized phase III CheckMate 901 trial, the researchers assigned 608 patients to receive either nivolumab in combination with the chemotherapy regimen gemcitabine/cisplatin or gemcitabine/cisplatin alone.
After a follow-up of almost 3 years, the researchers discovered that the overall and progression-free survival rates were higher among the patients who received nivolumab plus chemotherapy compared with those who received chemotherapy alone. The patients in the nivolumab and combination group experienced a median duration of complete response of 37.1 months vs 13.2 months among those in the chemotherapy-alone group.
Further, nearly twice as many patients in the immunotherapy and chemotherapy group demonstrated no evidence of disease after treatment compared with those in the chemotherapy-alone group.
Conclusions
“No new agent when added to first-line standard-of-care cisplatin-based chemotherapy has improved overall survival in metastatic urothelial carcinoma until now,” highlighted senior study author Matthew Galsky, MD, Co-Director of the Center of Excellence for Bladder Cancer at The Tisch Cancer Institute at Mount Sinai. “These results support nivolumab plus cisplatin-based [chemotherapy] as a new standard approach for the treatment of metastatic urothelial [carcinoma],” he concluded.
Disclosure: The research in this study was funded by Bristol Myers Squibb in collaboration with Ono Pharmaceutical Company. For full disclosures of the study authors, visit nejm.org.
