- Bristol Myers Squibb & Co BMY and Exelixis Inc EXEL announced three-year follow-up results from the Phase 3 CheckMate -9ER Phase 3 trial evaluating Opdivo (nivolumab) plus Cabometyx (cabozantinib) in renal cancer.
- The data demonstrated sustained survival and response rate benefits with the combination of Opdivo and Cabometyx (cabozantinib) versus sunitinib in the first-line treatment of advanced renal cell carcinoma (RCC).
- Additionally, a biomarker analysis showed sustained improvements in median progression-free survival (PFS) and overall survival (OS) with the combination of Opdivo and CABOMETYX, regardless of PD-L1 status.
- No new safety signals were seen with extended follow-up.
- Treatment with Opdivo in combination with Cabometyx continued to show a 30% reduction in the risk of death and improvement in median overall survival (OS) vs. sunitinib (49.5 months vs. 35.5 months, respectively).
- The median OS improved by 11.8 months since the previous data cut at 32.9 months median follow-up.
- Progression-free survival (PFS) benefits were sustained, with the combination continuing to double median PFS vs. sunitinib (16.6 months vs. 8.4 months, respectively).
- Objective response rate benefits were maintained, with nearly twice as many patients responding to Opdivo in combination with Cabometyx vs. sunitinib (55.7% vs. 28.4%).
- Responses were more durable with the combination, with a median duration of response of 23.1 months compared to 15.2 months with sunitinib.
- Complete response rates were also sustained, with 12.4% of those treated with Opdivo plus Cabometyx having a CR vs. 5.2% in the sunitinib arm.
- Price Action: BMY shares are down 0.02% at $73.17, and EXEL shares are up 0.45% at $17.77 on the last check Tuesday.
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