Bristol-Myers’ Opdivo and Exelixis’ Cabometyx show durable survival in carcinoma

Bristol Myers Squibb (BMY) and Exelixis (EXEL) announced three-year follow-up results from the Phase 3 CheckMate -9ER trial, demonstrating sustained survival and response rate benefits with the combination of Opdivo and Cabometyx versus sunitinib in the first-line treatment of advanced renal cell carcinoma – RCC -. Additionally, a biomarker analysis showed that improvements in median progression-free survival and overall survival were sustained with the combination of Opdivo and Cabometyx regardless of PD-L1 status. No new safety signals were seen with extended follow-up. Within the full study population: treatment with Opdivo in combination with Cabometyx continued to show a 30% reduction in the risk of death and improvement in median OS vs. sunitinib. Additionally, median OS improved by 11.8 months since the previous data cut at 32.9 months median follow-up. The combination continuing to double median PFS vs. sunitinib. CR rates were also sustained, with 12.4% of those treated with Opdivo in combination with Cabometyx having a CR vs. 5.2% of those treated with sunitinib. 97% of patients treated with Opdivo in combination with CABOMETYX experienced a treatment-related adverse event of any grade compared to 93% of patients treated with sunitinib; 67% vs. 55% had a grade greater than or equal to3 TRAE, respectively.