Rapid and durable response in bladder cancer observed with nivolumab
Data were presented at the 2016 European Society for Medical Oncology Congress.
Bristol-Myers Squibb (BMS) has announced results from an investigational Phase II CheckMate -275 study looking at nivolumab in platinum-refractory patients with metastatic urothelial carcinoma (advanced bladder cancer). Data presented show nivolumab had a confirmed objective response rate (ORR) – the primary endpoint – of 19.6%. The median duration of response was not reached in the overall population with a minimum follow-up of 6 months and ongoing responses were observed in 77% of patients. The safety profile of nivolumab in this study was consistent with other tumour types. These investigational data were presented at the 2016 European Society for Medical Oncology Congress (Abstract #LBA31_PR).
“The prognosis for patients with metastatic urothelial carcinoma progressing despite platinum-based chemotherapy is poor, and treatment options have historically been quite limited,” said Matthew Galsky, professor of medicine and director of Genitourinary Medical Oncology, The Tisch Cancer Institute at Icahn School of Medicine at Mount Sinai. “In the CheckMate -275 study, we observe that with nivolumab, patients who responded experienced rapid and durable responses, including patients with PD-L1 expressing and non-expressing tumors. These results are encouraging and provide new information to the scientific community on the potential of nivolumab as a treatment option for this type of advanced bladder cancer.”
Responses were observed in both PD-L1 positive and negative expressors. The confirmed ORR in patients expressing PD-L1 ≥1% was 23.8% and 16.1% in patients expressing PD-L1 <1%. In patients expressing PD-L1 ≥5% the confirmed ORR was 28.4% and 15.8% in patients expressing PD-L1 <5%.
Vicki Goodman, Development Lead, Melanoma and Genitourinary Cancers, BMS, commented: “There is a significant unmet need for improvement in response rates with the existing standard of care. The results from CheckMate -275 show that treatment with nivolumab resulted in durable and clinically meaningful objective response of 19.6% in all-treated patients. Based on these findings, we believe nivolumab has the potential to become an important new treatment option for patients with platinum-refractory advanced bladder cancer.”
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