{"id":36122,"date":"2023-08-22T20:59:03","date_gmt":"2023-08-22T18:59:03","guid":{"rendered":"https:\/\/www.ipsen.com\/press-releases\/european-commission-approves-cabometyx-in-combination-with-opdivo-as-a-first-line-treatment-for-patients-living-with-advanced-renal-cell-carcinoma\/"},"modified":"2024-08-09T07:36:01","modified_gmt":"2024-08-09T05:36:01","slug":"european-commission-approves-cabometyx-in-combination-with-opdivo-as-a-first-line-treatment-for-patients-living-with-advanced-renal-cell-carcinoma-2","status":"publish","type":"press_release","link":"https:\/\/www.ipsen.com\/press-releases\/european-commission-approves-cabometyx-in-combination-with-opdivo-as-a-first-line-treatment-for-patients-living-with-advanced-renal-cell-carcinoma-2\/","title":{"rendered":"European Commission approves Cabometyx\u00ae in combination with Opdivo\u00ae as a first-line treatment for patients living with advanced renal cell carcinoma"},"content":{"rendered":"<ul>\n<li style=\"margin-bottom:3px\">Approval based on pivotal Phase III CheckMate -9ER trial data, also recently published in the\u00a0<em>New England Journal of Medicine1<\/em><\/li>\n<li style=\"margin-bottom:3px\">Trial data showed Cabometyx\u00ae\u00a0(cabozantinib) in combination with Opdivo\u00ae\u00a0(nivolumab) doubled median progression-free survival and significantly improved overall survival and disease control rates with a lower rate of discontinuation versus sunitinib1<\/li>\n<li style=\"margin-bottom:3px\">These data showed consistent efficacy benefits across key subgroups of patients1<\/li>\n<\/ul>\n<p><b>PARIS, FRANCE, 31 March 2021 \u2013\u00a0<\/b>Ipsen (Euronext: IPN; ADR: IPSEY) today announced that the European Commission (EC) has approved Cabometyx\u00ae\u00a0(cabozantinib) in combination with Bristol Myers Squibb\u2019s Opdivo\u00ae\u00a0(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).<br \/><em>\u201cToday\u2019s EC approval for the use of Cabometyx in combination with Opdivo\u00ae provides an important new first-line treatment option for patients living with advanced renal cell carcinoma,\u201d<\/em>\u00a0said Howard Mayer, Executive Vice President and Head of Research and Development, Ipsen.\u00a0<em>\u201cAt Ipsen, we\u2019re proud that this, now approved, treatment option not only addresses key efficacy benefits, but also the need to maintain quality of life for patients. We look forward to collaborating with a broad range of European stakeholders to bring this unique combination to eligible patients living with advanced renal cell carcinoma.\u201d<\/em><br \/>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\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=2ZYIhoHAtChjNiKSAoVQ1BAt6wnQv5axkpDp7AkrlGf4SQDwg57Ap8jmr6Ju8sHnOwFruBj4f_-hxceqc6yOW-SclieSlnLjh-izh3n5kqDTvAUxG8pkHpqzRJyd7gyn\" rel=\"nofollow noopener\" target=\"_blank\" title=\"\"><b>published<\/b><\/a>\u00a0in the\u00a0<em>New England Journal of Medicine<\/em>\u00a0(NEJM) on 3 March 2021. In the trial, Cabometyx in combination with Opdivo\u00ae demonstrated significant improvements across all efficacy endpoints. In patients receiving the combination, median progression-free survival (PFS), the trial\u2019s 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\u20130.64; p&lt;0.0001).1\u00a0Overall 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).1\u00a0In addition, Cabometyx in combination with Opdivo\u00ae demonstrated a superior objective response rate (ORR), with twice as many patients responding compared to sunitinib (55.7% vs. 27.1%; p&lt;0.0001) and 8.0% vs. 4.6% achieved a complete response respectively.1\u00a0Key efficacy results were consistent across the pre-specified International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk and PD-L1 subgroups.1\u00a0The combination was well tolerated and reflected the known safety profiles of the immunotherapy and tyrosine kinase inhibitor components in first-line aRCC.1<br \/>Additional data from the CheckMate -9ER trial were also presented in February at the recent American Society of Clinical Oncology 2021 Genitourinary Cancers Symposium (ASCO GU). These data highlighted sustained superior efficacy of Cabometyx in combination with Opdivo\u00ae\u00a0versus sunitinib for the first-line treatment of aRCC with a median follow-up of 23.5 months, as well as data suggesting significantly improved health-related quality of life (HRQoL) outcomes for the combination versus sunitinib.2,3\u00a0These HRQoL data, also included as part of the recently published NEJM publication, demonstrated that the combination was associated with a lower treatment burden, a decline in the risk of confirmed deterioration in HRQoL and a reduction of disease-related symptoms compared to sunitinib.1,3<em>\u201cThe combination of nivolumab and cabozantinib pairs two proven agents for advanced renal cell carcinoma that together have shown superior efficacy across key endpoints and subgroups of patients compared to sunitinib in the CheckMate -9ER trial. Additionally, the combination\u2019s safety profile was manageable with known protocols, leading to a low rate of treatment-related discontinuations.\u201d said MarcOliver Grimm, M.D., Professor of Medicine and Urology Department Head, Jena University Hospital. \u201cWith today\u2019s approval, clinicians in the EU will be able to offer patients with advanced renal cell carcinoma an additional combination therapy that may help them achieve early control of their disease and improve survival outcomes.\u201d<\/em><br \/>This approval allows for the marketing of Cabometyx in combination with Opdivo\u00ae\u00a0in this indication in all 27 member states of the European Union, Norway, Liechtenstein and Iceland. The U.S. Food and Drug administration approved Cabometyx for patients with aRCC as a first-line treatment in combination with Opdivo\u00ae in January 2021.<br \/>Ipsen thanks the patients and investigators involved in the CheckMate -9ER clinical trial.<\/p>\n<p id=\"gnw_attachments_section-header\">\n    <strong>Attachment<\/strong>\n<\/p>\n<ul id=\"gnw_attachments_section-items\">\n<li>\n        <a target=\"_blank\" href=\"https:\/\/www.globenewswire.com\/Tracker?data=4oAWeS8s1UhCwb0pBYWLwqWPqFvwVwhzn2-jKqsB9wT4cGnWlALeZdTozjsRejOwoiDSM6Up33M8oIBn0FPLyvIaURMzk0vdhL6XMtoI38N_7IqTWJ0qb_2IT1GaKIuACH-c47Xi36EZq0iX4vOncXG17f3x4cYIAA5cFd4TQGyilm98yVO4zmnFxgB6Yd3nxNGLWwrHGz8QYGl9Wj2L0A==\" title=\"Ipsen-Cabometyx-Opdivo-EMA-Release-31-March-2021\" rel=\"nofollow noopener\">Ipsen-Cabometyx-Opdivo-EMA-Release-31-March-2021<\/a>\n      <\/li>\n<\/ul>\n<p><img src='https:\/\/ml-eu.globenewswire.com\/media\/ZWM2N2Y0ZjMtM2MzYy00MDBmLTg0OGYtZjBjNmFiMmY5OTBmLTEwMTA5NDM=\/tiny\/Ipsen-SA.png' 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