Bristol-Myers Squibb's Opdivo, Yervoy combination fails to improve progression-free survival in renal cancer study

Bristol-Myers Squibb announced top-line results from a Phase III trial showing that the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) failed to significantly improve progression-free survival (PFS) versus Pfizer's Sutent (sunitinib) in intermediate and poor-risk patients with previously untreated advanced or metastatic renal cell carcinoma, missing one of the study's co-primary endpoints.

The CheckMate -214 trial randomised patients with previously untreated advanced or metastatic renal cell carcinoma to receive Opdivo plus Yervoy, or Sutent alone. The main goals of the study are PFS, objective response rate and overall survival, with Bristol-Myers Squibb noting that "the majority of alpha was allocated" to overall survival.

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According to Bristol-Myers Squibb, median PFS was 11.56 months for the Opdivo and Yervoy combination compared to 8.38 months for Sutent. Meanwhile, the drugmaker noted that Opdivo plus Yervoy achieved a 41.6 percent objective response rate versus 26.5 percent for Sutent, meeting one of the trial's co-primary endpoints. Data showed that the median duration of response was not reached for the combination of Opdivo and Yervoy, and was 18.17 months for Pfizer's drug.

Bristol-Myers Squibb added that the study will continue as planned to allow the third co-primary endpoint of overall survival to mature. Commenting on the results, Vicki Goodman, development lead, melanoma and genitourinary cancers at Bristol-Myers Squibb, said "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."

Goodman indicated that "the company plans to share these important first-line data with regulatory authorities and we look forward to reporting overall survival when these data mature."

For related analysis, read ViewPoints: CheckMate-214 results add new layer of complexity to PD-1/CTLA-4 debate, and see KOL Views: Making sense of CheckMate-214 results for RCC, PD-(L)1/CTLA-4 combos.

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