The firm said that the Phase III CheckMate-214 study missed one of its co-primary endpoints in that there was no significant difference in PFS in intermediate and poor-risk patients with previously untreated advanced or metastatic renal cell carcinoma between the two treatment arms.

The data do show some improvement, however, with median PFS 11.56 months for the Opdivo (nivolumab) and Yervoy (ipilimumab) combination versus 8.38 months for Sutent (sunitinib).

The combination also met the co-primary endpoint of objective response rate (ORR), and achieving a 41.6 percent ORR versus 26.5 percent for Sutent.

"We are encouraged by the totality of the CheckMate-214 data," said Vicki Goodman, development lead, Melanoma and Genitourinary Cancers, BMS.

"The overall response rate and durability of response favoured 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. This is an important study in first-line renal cancer as these patients need new options."

The firm noted that the study will continue as planned to allow the third co-primary endpoint of overall survival to mature, and that the tolerability profile observed in CheckMate-214 "was consistent with that observed in previously reported studies of this dosing schedule".