Bristol-Myers Squibb's Opdivo, Yervoy combination extends survival in renal cell carcinoma trial

Bristol-Myers Squibb announced Thursday that the Phase III CheckMate -214 study evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) in patients with previously untreated advanced or metastatic renal cell carcinoma (RCC) will be stopped early after meeting its co-primary endpoint. The company said the combination of the PD-1 inhibitor and CTLA-4 inhibitor demonstrated superior overall survival (OS) versus Pfizer's Sutent (sunitinib) in intermediate- and poor-risk patients. 

According to Bristol-Myers Squibb, the trial also achieved a secondary goal of improved OS compared to Sutent in all randomised patients. Vicki Goodman, head of new asset development at Bristol-Myers Squibb, said "the company looks forward to sharing the full results with regulatory authorities and will incorporate these data into the planned European Society for Medical Oncology (ESMO) congress presentation later this week." 

In the randomised study, patients were treated with either Opdivo plus Yervoy or Sutent until disease progression or unacceptable toxic effects. Primary endpoints included OS, progression-free survival (PFS) and objective response rate (ORR) in an intermediate- and poor-risk patient population, which encompassed about 75 percent of the study's participants, while safety was also assessed. 

Bristol-Myers Squibb previously released top-line data from CheckMate -214 showing that the combination met the co-primary endpoint of ORR at 41.6 percent, versus 26.5 percent for Sutent, in poor- and intermediate-risk patients, but failed to achieve the PFS co-primary endpoint. In the latest results, the company reported that PFS among intermediate- and poor-risk patients improved 18 percent for those receiving the combination treatment, but reiterated that this did not reach statistical significance compared to Sutent. Median PFS for the combination group was 11.6 months, compared to 8.4 months for Sutent.

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The combination of Opdivo plus Yervoy is approved in the US for use in patients with BRAF V600 wild-type unresectable or metastatic melanoma. Bristol-Myers Squibb revealed earlier this year that it would not seek accelerated approval of the regimen for the treatment of first-line lung cancer. 

In 2015, the FDA expanded Opdivo's label to include treatment of patients with RCC who were previously treated with a certain type of therapy. 

For related analysis, see Physician Views Poll Results: Interest in Opdivo/Yervoy remains high in wake of initial CheckMate-214 findings. See also ViewPoints: CheckMate-214 results add new layer of complexity to PD-1/CTLA-4 debate.

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