Nivolumab failed to meet the main objectives in stage III bladder cancer The addition of Nivolumab (Opedivo) to the perioperative treatment of muscle invasive bladder cancer did not provide a statistically significant improvement in the main outcome measures. Results from a phase III stimulatory trial of 653 patients presented at ESMO 2026. In a study organized by Bristol Myers Squibb, nivolumab was used together with gemcitabine and cisplatin before surgery, followed by immunotherapy after the bladder was removed. In the control group, patients received chemotherapy followed by surgery. According to published data, with a median follow-up of 54.5 months, the median event-free survival in the nivolumab group was not reached, while in the control group it was 67.6 months. The hazard ratio was 0.94 (p=0.6697), which does not indicate a statistically significant advantage of combined treatment. The complete pathological response rate reached 39.1% with the addition of nivolumab compared to 29.6% in the control group. However, the difference also did not meet the predetermined threshold for statistical significance. Therefore, the study did not meet the two primary endpoints. Treatment-related adverse reactions of grade three or higher were recorded in 50% of patients in the nivolumab group and 49.5% in the comparison group. In Russia, nivolumab is registered under the trade name Opdivo. Depending on the clinical situation, the drug is used for melanoma, non-small cell lung cancer, renal cell cancer, classical Hodgkin's lymphoma, squamous cell carcinoma of the head and neck, urothelial cancer, colon cancer and esophageal cancer. Specific indications and treatment regimens are determined according to the instructions.

Nivolumab failed to meet the main objectives in stage III bladder cancer The addition of Nivolumab (Opedivo) to the perioperative treatment of muscle invasive bladder cancer did not provide a statistically significant improvement in the main outcome measures. Results from a phase III stimulatory trial of 653 patients presented at ESMO 2026. In a study organized by Bristol Myers Squibb, nivolumab was used together with gemcitabine and cisplatin before surgery, followed by immunotherapy after the bladder was removed. In the control group, patients received chemotherapy followed by surgery. According to published data, with a median follow-up of 54.5 months, the median event-free survival in the nivolumab group was not reached, while in the control group it was 67.6 months. The hazard ratio was 0.94 (p=0.6697), which does not indicate a statistically significant advantage of combined treatment. The complete pathological response rate reached 39.1% with the addition of nivolumab compared to 29.6% in the control group. However, the difference also did not meet the predetermined threshold for statistical significance. Therefore, the study did not meet the two primary endpoints. Treatment-related adverse reactions of grade three or higher were recorded in 50% of patients in the nivolumab group and 49.5% in the comparison group. In Russia, nivolumab is registered under the trade name Opdivo. Depending on the clinical situation, the drug is used for melanoma, non-small cell lung cancer, renal cell cancer, classical Hodgkin's lymphoma, squamous cell carcinoma of the head and neck, urothelial cancer, colon cancer and esophageal cancer. Specific indications and treatment regimens are determined according to the instructions.