Eight-year data for Opdivo (nivolumab) + Yervoy (ipilimumab) continue to demonstrate longest survival benefit vs. sunitinib reported in patients with previously untreated advanced or metastatic renal cell carcinoma

Patients treated with Opdivo plus Yervoy maintained superior survival and more durable response benefits compared to those who received sunitinib in both patients with intermediate- and poor-risk prognostic factors and across all randomized patients

These data will be presented in an oral presentation (Abstract #363) during the American Society of Clinical Oncology (ASCO) 2024 Genitourinary Cancers Symposium from January 25-27, 2024.

Among intermediate- and poor-risk patients (n=847), Opdivo plus Yervoy (n=425) maintained efficacy after eight years (99.1 months median), with improvements seen in overall survival (OS), progression-free survival (PFS), overall response rate (ORR) and duration of response (DOR) over sunitinib: i. OS: Median OS was 46.7 months for intermediate- and poor-risk patients treated with Opdivo plus Yervoy vs. 26.0 months with sunitinib (Hazard Ratio [HR] 0.69; 95% Confidence Interval [CI]: 0.59 to 0.81). The 90-month landmark OS rates were 32.9% vs. 22.0%, respectively. ii.DOR : Median DOR was 82.8 months for patients treated with Opdivo plus Yervoy compared to 19.8 months with sunitinib. iii. PFS: Median PFS by independent radiology review committee (IRRC) was 12.4 months with Opdivo plus Yervoy vs. 8.5 months with sunitinib (HR 0.73; 95% CI: 0.61 to 0.87), tripling the 90-month landmark PFS rate at 25.4% vs. 8.5%, respectively. iv. ORR: ORR benefits were maintained with Opdivo plus Yervoy compared to sunitinib (42% vs. 27%).

In addition, four times more patients treated with the combination achieved complete responses (CR) than with sunitinib (12% vs. 3%).

Additionally, in the intent-to-treat (ITT) population (n=1,096), Opdivo plus Yervoy (n=550) demonstrated long-term benefits across endpoints: i.OS: Among all randomized patients treated with Opdivo plus Yervoy, median OS was 52.7 months vs. 37.8 months with sunitinib (HR 0.72; 95% CI: 0.62 to 0.83).ii. DOR: For patients treated with Opdivo plus Yervoy, median DOR was 76.2 months compared to 25.1 months with sunitinib. iii. PFS: Median PFS by IRRC was 12.4 months with Opdivo plus Yervoy and 12.3 months with sunitinib (HR 0.88; 95% CI: 0.75 to 1.03). iv. ORR: ORR was better with Opdivo plus Yervoy compared to sunitinib (39% vs. 33%), and four times more patients treated with the combination achieved CR (12% vs. 3%).

“It is incredible to see that after eight years in the CheckMate -214 trial, which represents the longest reported follow up of any Phase III trial of a checkpoint inhibitor combination therapy in advanced renal cell carcinoma, the combination of nivolumab and ipilimumab continues to provide superior survival and durable responses for these patients,” said Nizar Tannir, M.D., F.A.C.P., professor, Department of Genitourinary Medical Oncology, Division of Cancer Medicine, The University of Texas, MD Anderson Cancer Center. “Not only are we seeing sustained benefits over sunitinib in the primary endpoint population of intermediate- and poor-risk patients, but also within the key secondary endpoint intent-to-treat population, which goes to show that this dual immunotherapy combination can potentially help patients achieve positive long-term outcomes, regardless of IMDC risk.”

The safety profile of Opdivo plus Yervoy was manageable using established treatment algorithms, and no new safety signals emerged with extended follow-up.

“The updated data from CheckMate -214 with Opdivo plus Yervoy in advanced or metastatic renal cell carcinoma to be presented at ASCO GU speak to our long-standing leadership with immunotherapy not only in genitourinary cancers, but across multiple tumor types. These extended results further exemplify to the scientific community the potential that we have long recognized for immunotherapy to transform treatment paradigms in oncology,” said Dana Walker, M.D., M.S.C.E., vice president, global program lead, gastrointestinal and genitourinary cancers, Bristol Myers Squibb. “We are proud to see the eight-year results, the longest survival benefit vs. sunitinib seen in any Phase III trial in this patient population, point toward sustained overall survival with this first-line dual immunotherapy approach and reinforce its role as the current standard of care in this setting.”