BMS’ Phase III combination trial for renal cell carcinoma meets endpoints


Bristol-Myers Squibb (BMS) has reported positive results from its Phase III clinical trial (CheckMate -214) of Opdivo and Yervoy combination for renal cell carcinoma (RCC).

The trial has been stopped early upon recommendation from an independent Data Monitoring Committee (DMC), as it has met the co-primary endpoint of superior overall survival (OS) when compared to current standard-of-care sunitinib in intermediate and poor-risk patients.

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor developed to leverage the body’s immune system to aid restoration of anti-tumour immune response, while Yervoy is a monoclonal antibody that stimulates the immune system by targeting CTLA-4 protein receptor.

The randomised, open-label Phase III CheckMate -214 trial included patients with previously untreated advanced or metastatic RCC.

Subjects were administered with four doses of 3mg/kg of Opdivo in combination with 1mg/kg of Yervoy every three weeks, followed by 3mg/kg of Opdivo every two weeks.

Sunitinib was given as a 50mg once-daily dose for four weeks, followed by two weeks off period before treatment continuation.

The trial’s primary endpoints are progression-free survival (PFS), OS and objective response rate (ORR) in intermediate to poor-risk patients, while the secondary endpoint is safety.

"The company looks forward to sharing the full results with regulatory authorities and will incorporate this data into the planned European Society for Medical Oncology (ESMO) Congress presentation later this week."

Bristol-Myers Squibb new asset development head Vicki Goodman said: “This overall survival result from CheckMate -214 highlights the potential of the combination of Opdivo and Yervoy to provide a new treatment option for first-line advanced renal cell carcinoma patients for whom there is a considerable unmet need.

“The company looks forward to sharing the full results with regulatory authorities and will incorporate this data into the planned European Society for Medical Oncology (ESMO) Congress presentation later this week.”

It is reported that the combination therapy has also met the secondary endpoint of improved OS compared to sunitinib in all participants.

The safety and tolerability of the combination observed during the CheckMate -214 trial was found to be consistent with existing data from the same dosing schedule and similar across subgroups.


Image: Micrograph of a renal cell carcinoma. Photo: courtesy of Nephron.