BMY - BMY/Exelixis Opdivo + Cabometyx shows survival benefits in late-stage kidney cancer study
Bristol Myers Squibb (BMY) and Exelixis (EXEL) announce results from the pivotal Phase 3 CheckMate -9ER trial evaluating patients with previously untreated advanced or metastatic renal cell carcinoma ((RCC)).A total of 651 patients were randomized to Opdivo (nivolumab) plus CABOMETYX (cabozantinib) (n=323) vs. sunitinib (n=328). Opdivo in combination with CABOMETYX reduced the risk of death by 40% vs. sunitinib (Hazard Ratio [HR] 0.60; 98.89% Confidence Interval [CI]: 0.40 to 0.89; p=0.0010; median overall survival ((OS)) not reached in either arm).Median progression-free survival ((PFS)), the trial’s primary endpoint, was 16.6 months in patients receiving Opdivo + CABOMETYX vs. 8.3 months in those receiving sunitinib alone (HR 0.51; 95% CI: 0.41 to 0.64; p<0.0001). In addition, Opdivo in combination with CABOMETYX demonstrated a superior objective response rate ((ORR)), with twice as many patients responding compared to sunitinib (56% vs. 27%), and 8% vs. 5% achieved a complete response.Opdivo + CABOMETYX was associated with a longer duration of response than
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BMY/Exelixis Opdivo + Cabometyx shows survival benefits in late-stage kidney cancer study