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BMS’ kidney cancer drug met co-primary endpoint in CheckMate trial

PBR Staff Writer Published 16 August 2017

Bristol-Myers Squibb’s (BMS) kidney cancer drug Opdivo in combination with Yervoy (ipilimumab) has met the co-primary endpoint of objective response rate (ORR) against sunitinib in CheckMate -214 trial.

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor, which is designed to uniquely tackle the body’s own immune system to help restore anti-tumor immune response.

The combination, which also achieved a 41.6% ORR versus 26.5% for sunitinib, has not reached median duration of response that was 18.17 months for sunitinib.

The median PFS was 11.56 months for the Opdivo and Yervoy combination against 8.38 months for sunitinib.

BMS said the study will continue as planned to enable the third co-primary endpoint of overall survival to mature.

CheckMate -214 is a phase 3, randomized, open-label study assessing the combination of Opdivo plus Yervoy against sunitinib in patients with previously untreated advanced or metastatic renal cell carcinoma.

Patients in the combination group secured Opdivo 3 mg/kg plus Yervoy 1 mg/kg every three weeks for four doses followed by Opdivo 3 mg/kg every 2 weeks, while patients in the comparator group received sunitinib 50 mg once daily for four weeks followed by two weeks off before continuation of treatment

According to the company, the primary endpoints of the trial are progression-free survival, overall survival and objective response rate in an intermediate to poor-risk patient population.

In July 2014, Opdivo became the first PD-1 immune checkpoint inhibitor to secure regulatory approval across the globe.

BMS melanoma and genitourinary cancers development head Dr Vicki Goodman said: “We are encouraged by the totality of the CheckMate-214 data. The overall response rate and durability of response favored the combination of Opdivo and Yervoy, and the trend for PFS supports the potential of the combination in intermediate and poor-risk advanced renal cell carcinoma, the most common type of kidney cancer.”

Image: Bristol-Myers Squibb site at Reeds Lane, Moreton, Wirral, England. Photo: courtesy of Rept0n1x.