Phase III CheckMate -214 trial of Opdivo + Yervoy shows OS at 67 months in renal cell carcinoma.
After a median follow-up of 67.7 months, Opdivo plus Yervoy maintained superior overall survival (OS) and response benefits versus sunitinib in both patients with intermediate- and poor-risk prognostic factors, the primary endpoint population, and across all randomized patients.
In intermediate- and poor-risk patients (n=847), Opdivo plus Yervoy (n=425) maintained treatment effects over five years, with ongoing improvements in OS and overall response rate (ORR), two of the trial’s primary endpoints, as well as in supportive endpoints: OS: The median OS was 47.0 months for intermediate- and poor-risk patients treated with Opdivo plus Yervoy versus 26.6 months with sunitinib (Hazard Ratio [HR] 0.68; 95% Confidence Interval [CI]: 0.58 to 0.81), and five-year survival rates were 43% and 31%, respectively. ORR: ORR benefits were maintained with Opdivo plus Yervoy compared to sunitinib (42% vs. 27%).
In addition, more patients treated with the combination achieved complete responses (11% vs. 2%). Duration of response (DOR): For patients treated with Opdivo plus Yervoy, median DOR was not reached, compared to 19.7 months with sunitinib. An analysis of all randomized patients, or the intent-to-treat (ITT) population (n=1,096), similarly showed long-term benefits with Opdivo plus Yervoy (n=550): OS: Opdivo plus Yervoy demonstrated a median OS of 55.7 months in the ITT population, representing the longest survival outcome reported to date in a Phase III trial in advanced RCC, compared to 38.4 months with sunitinib (HR 0.72; 95% CI: 0.62 to 0.85). Five-year OS rates were 48% for patients treated with the dual immunotherapy combination and 37% for those receiving sunitinib. ORR: Opdivo plus Yervoy continued to show a higher ORR (39% vs. 32%) and complete response rate than sunitinib (12% vs. 3%). Also, more patients treated with the combination achieved complete responses and subsequently did not progress (9.6% vs. 2.4%). DOR: Median DOR was not reached with Opdivo plus Yervoy and was 24.8 months with sunitinib.
The safety profile of Opdivo plus Yervoy was manageable using established treatment algorithms, and no new safety signals emerged with extended follow-up. These data were published online during the European Society for Medical Oncology (ESMO) Virtual Congress 2021 on September 16, 2021, 08:30 CEST (Abstract #661P).
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