Nivolumab with chemotherapy and pembrolizumab with enfortumab vedotin-ejfv, an antibody-drug conjugate, are superior to standard chemotherapy as initial treatment for patients with advanced bladder cancer, researchers reported in study results from the Checkmate-901 and EV-302 clinical trials. The studies represent major strides in treatment for advanced bladder cancer, which has not seen changes in standard initial therapy for many years.

For the EV-302 trial, researchers randomly assigned 886 patients to receive either pembrolizumab and enfortumab vedotin-ejfv (n = 442) or platinum chemotherapy (n = 444), with some in the chemotherapy group also receiving avelumab. In their study results presented at the European Society for Medical Oncology Congress 2023, the researchers showed that 67% of patients in the pembrolizumab group had a treatment response compared to 44% in the chemotherapy group. Approximately 30% of patients in the pembrolizumab group experienced a complete response versus 12% in the chemotherapy group. Median progression-free survival in the pembrolizumab group (12.5 months) was nearly twofold higher than in the chemotherapy group (6.3 months). Researchers concluded that their findings support the combination of pembrolizumab and enfortumab vedotin as a new standard of care, and the results led to the U.S. Food and Drug Administration’s approval of the combination therapy for initial treatment of advanced bladder cancer.

For Checkmate-901, researchers randomized 608 patients to receive either a nivolumab, gemcitabine, and cisplatin combination (n = 304) or a gemcitabine and cisplatin combination (n = 304). In findings published in the New England Journal of Medicine, they reported that the nivolumab group had a superior median survival of 21.7 months compared to 18.9 months with chemotherapy. The nivolumab group also had a 57.6% overall and 21.7% complete response versus 43.1% and 11.8%, respectively, for chemotherapy. Among patients with a complete response, the median duration was 37.1 months in the nivolumab group—more than double the median duration for chemotherapy (13.2 months). The nivolumab group was more likely to experience grade 3 or higher adverse events (61.8% and 51.7% of patients, respectively), yet “combination therapy with nivolumab plus gemcitabine–cisplatin resulted in significantly better outcomes in patients with previously untreated advanced urothelial carcinoma than gemcitabine–cisplatin alone,” the researchers concluded.

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