Bristol-Myers reports CheckMate-275 data on Opdivo in urothelial cancer
Bristol-Myers Squibb announced results from the CheckMate -275 trial, in which Opdivo had a confirmed objective response rate, the primary endpoint, of 19.6% in platinum-refractory patients with metastatic urothelial carcinoma. Responses were observed in both PD-L1 expressors and non-expressors. The confirmed ORR in patients expressing PD-L1 greater than or equal to 1% was 23.8%, and 16.1% in patients expressing PD-L1 less than 1%. In patients expressing PD-L1 greater than or equal to 5%, the confirmed ORR was 28.4%, and 15.8% in patients expressing PD-L1 less than 5%. The median duration of response was not reached in the overall population with a minimum follow-up of six months, and responses were ongoing in 77% of patients. Among the 52 patients who responded to treatment, the median time to a response was 1.9 months. The median PFS was 2.0 months in all treated patients, 1.87 months for patients with PD-L1 less than 1%, and 3.55 months in patients with PD-L1 greater than or equal to 1%. The median OS was 8.74 months in all treated patients, 5.95 months in patients with PD-L1 less than 1%, and 11.3 months in patients with PD-L1 expression greater than or equal to 1%. The safety profile of Opdivo in this study was consistent with the safety profile of Opdivo in other tumor types. Overall, 4.8% of patients discontinued therapy due to treatment-related AEs of any grade, and 3.0% discontinued therapy due to grade 3-4 treatment-related AEs. The data will be presented at the 2016 European Society for Medical Oncology Congress.