publication date: Oct. 20, 2016

Bladder Cancer Phase III Trial Confirms ORR in Previously Treated Patients who Received Opdivo

Results from the CheckMate -275 trial, in which Opdivo confirmed objective response rate (ORR), the primary endpoint, of 19.6% (95% CI 15.0 – 24.9) in platinum-refractory patients with metastatic urothelial carcinoma, said Bristol-Myers Squibb, the drug’s sponsor.

Responses were observed in both PD-L1 expressors and non-expressors, the company said.

The confirmed ORR in patients expressing PD-L1 ≥1% was 23.8% (95% CI 16·5–32·3) and 16.1% (95% CI 10.5–23.1) in patients expressing PD-L1 <1%. In patients expressing PD-L1 ≥5%, the confirmed ORR was 28.4% (95% CI 18·9–39·5) and 15.8% (95% CI 10.8-21.8) in patients expressing PD-L1 <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. The safety profile of Opdivo in this study was consistent with the safety profile of Opdivo in other tumor types.

These data were presented at the 2016 European Society for Medical Oncology (ESMO) Congress during an oral proffered paper session from 9:15 – 9:30 a.m.

  “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 … Continue reading CCL Oct 2016 – Phase III Trial Confirms ORR in Previously Treated Patients who Received Opdivo

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