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EU approves Cabometyx + Opdivo for advanced renal cell carcinoma.- Ipsen

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Published:1st Apr 2021
Ipsen announced that the European Commission (EC) has approved Cabometyx (cabozantinib) in combination with Bristol Myers Squibb’s Opdivo (nivolumab) for the first-line treatment of advanced renal cell carcinoma (aRCC). This decision marks the first approval for Cabometyx in combination with another therapy in Europe and the third indication of Cabometyx in renal cell carcinoma (RCC). The EC approval is based on results from the pivotal Phase III CheckMate -9ER trial, presented during a Presidential Symposium at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 and published in the New England Journal of Medicine (NEJM) on 3 March 2021. In the trial, Cabometyx in combination with Opdivo demonstrated significant improvements across all efficacy endpoints. In patients receiving the combination, 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: 0.41–0.64; p<0.0001). overall survival (os) also demonstrated statistically significant improvements, reducing the risk of death by 40% versus sunitinib (hr: 0.60 [98.89% ci: 0.40-0.89]; p="0.001;" median os not reached in either arm). in addition, cabometyx in combination with opdivo demonstrated a superior objective response rate (orr), with twice as many patients responding compared to sunitinib (55.7% vs. 27.1%; p><0.0001) and 8.0% vs. 4.6% achieved a complete response respectively. key efficacy results were consistent across the pre-specified international metastatic renal cell carcinoma database consortium (imdc) risk and pd-l1 subgroups. the combination was well tolerated and reflected the known safety profiles of the immunotherapy and tyrosine kinase inhibitor components in first-line arcc.>
Condition: Renal Cell Carcinoma
Type: drug

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