Opdivo + Cabometyx demonstrates significant survival benefits in patients with advanced renal cell carcinoma in pivotal phase III CheckMate -9ER Trial.- BMS + Exelixis

Bristol Myers Squibb and Exelixis, Inc announced the first presentation of results from the pivotal Phase III CheckMate -9ER trial , in which Opdivo (nivolumab)in combination with Cabometyx (cabozantinib) demonstrated significant improvements across all efficacy endpoints, including overall survival (OS), in previously untreated advanced renal cell carcinoma (RCC). 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 OS not reached in either arm). In patients receiving Opdivo in combination with Cabometyx median progression-free survival (PFS), the trial’s primary endpoint, was doubled compared to those receiving sunitinib alone: 16.6 months vs. 8.3 months, respectively (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 in combination with cabometyx was associated with a longer duration of response than sunitinib with a median duration of 20.2 months vs. 11.5 months. all of these key efficacy results were consistent across the pre-specified international metastatic renal cell carcinoma database consortium imdc risk and pd-l1 subgroups. opdivo combined with cabometyx was well tolerated and reflected the known safety profiles of the immunotherapy and tyrosine kinase inhibitor tki components in previously untreated advanced rcc. the incidence of treatment-related adverse events traes including any-grade and high-grade traes was slightly higher for opdivo in combination with cabometyx vs. sunitinib 97 vs. 93 for any-grade 61 vs. 51 for grade 3 and higher with a low rate of treatment-related discontinuations 6 for opdivo only 7 for cabometyx only and 3 for both opdivo and cabometyx vs. 9 for sunitinib. patients treated with opdivo in combination with cabometyx reported significantly better health-related quality of life than those treated with sunitinib at most time points according to national comprehensive cancer network-functional assessment of cancer therapy nccn-fact kidney symptom index 19 fksi-19 scores. these results presentation 696o_pr were featured as a proffered paper during a presidential symposium at the european society for medical oncology esmo virtual congress 2020 on september 19 2020 from 19:34-19:46 cest. while weve seen considerable progress in the treatment of metastatic renal cell carcinoma we must continue to research new options to help more patients achieve positive outcomes said dr. toni choueiri director of the lank center for genitourinary oncology at dana-farber cancer institute and jerome and nancy kohlberg professor of medicine at harvard medical school. the checkmate -9er data demonstrate meaningful efficacy benefits with nivolumab plus cabozantinib which significantly improved overall survival and doubled progression-free survival and objective response rate with consistent effects observed across pre-specified subgroups. these results along with a favorable tolerability profile and superior health-related quality of life highlight this regimens potential importance among combinations of immunotherapies and tyrosine kinase inhibitors. based on these efficacy and safety results from checkmate -9er bristol myers squibb and exelixis partner ipsen which has exclusive rights to commercialize and develop cabometyx outside of the u.s. and japan each submitted type ii variation applications for opdivo plus cabometyx to the european medicines agency ema. on september 12 the ema validated the type ii variations confirming the submissions are complete and beginning the emas centralized review process. in addition bristol myers squibb and exelixis recently completed their respective fda submissions for opdivo in combination with cabometyx and along with their partners plan to discuss the checkmate -9er data with regulatory authorities across the world.>