Bristol-Myers Squibb (BMS) has reported additional positive data from the Phase III CheckMate-214 clinical trial of Opdivo (nivolumab) in combination with Yervoy (ipilimumab) in patients with treatment-naïve advanced or metastatic renal cell carcinoma (RCC).
During a minimum follow-up of 42 months, the combination demonstrated a superior overall survival (OS), objective response rates (ORR), duration of response (DOR) and complete response (CR) rates.
The drug combination was compared to sunitinib in the CheckMate-214 study.
Opdivo plus Yervoy led to an OS rate of 52% at 42 months, while the rate was 39% in the sunitinib group. The ORR was observed to be 42% with the combination versus 26% for sunitinib.
Patients treated with BMS’ combination did not reach median DOR, which was 19.7 months in patients on sunitinib alone.
Safety analysis revealed a profile consistent with previous data, without any new safety signals or drug-related deaths identified during the extended follow-up period.
Bristol-Myers Squibb genitourinary cancers development lead Brian Lamon said: “These positive findings from CheckMate -214 continue to demonstrate the complementary nature of dual immuno-therapy and reinforce the depth and durability of response the combination of Opdivo plus Yervoy can deliver for patients.
“We look forward to continuing to explore the potential that this combination holds for patients with difficult-to-treat cancers.”
The company has also reported five-year follow-up data from the Phase III CheckMate -025 trial of Opdivo in patients with advanced or metastatic renal cell carcinoma (RCC).
When compared to everolimus, Opdivo showed superior OS and ORR at 64 months in previously treated patients.
In November last year, Opdivo plus Yervoy failed to meet one of the co-primary endpoints of recurrence-free survival (RFS) in melanoma patients.