Bristol Myers Squibb & Co BMY announced that Opdivo (nivolumab) plus Yervoy (ipilimumab) combination continued to demonstrate long-term survival results in the Phase 3 CheckMate -214 trial.
The Opdivo/Yervoy combo reduced the risk of death by 28% in patients with previously untreated advanced or metastatic renal cell carcinoma (RCC) vs. Pfizer Inc PFE Sutent (sunitinib) after eight years, regardless of International Metastatic RCC Database Consortium risk group.
The data will be presented at the American Society of Clinical Oncology 2024 Genitourinary Cancers Symposium.
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:
- Median OS was 46.7 months for intermediate- and poor-risk patients treated with Opdivo plus Yervoy vs. 26.0 months with sunitinib. The 90-month landmark OS rates were 32.9% vs. 22.0%, respectively.
- Median DOR was 82.8 months for patients treated with Opdivo plus Yervoy compared to 19.8 months with sunitinib.
- Median PFS was 12.4 months with Opdivo plus Yervoy vs. 8.5 months with sunitinib, tripling the 90-month landmark PFS rate at 25.4% vs. 8.5%, respectively.
- 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:
- Among all randomized patients treated with Opdivo plus Yervoy, the median OS was 52.7 months vs. 37.8 months with sunitinib.
- For patients treated with Opdivo plus Yervoy, the median DOR was 76.2 months compared to 25.1 months with sunitinib.
- Median PFS was 12.4 months with Opdivo plus Yervoy and 12.3 months with sunitinib.
- ORR was better with Opdivo plus Yervoy than sunitinib (39% vs. 33%), and four times more patients treated with the combination achieved CR (12% vs. 3%).
Price Action: BMY shares are up 0.52% at $49.83 premarket on the last check Tuesday.
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