{"id":36109,"date":"2021-09-18T09:00:00","date_gmt":"2021-09-18T07:00:00","guid":{"rendered":"https:\/\/www.ipsen.com\/press-releases\/esmo-2021-cabometyx-demontre-une-reduction-soutenue-de-78-du-risque-de-progression-de-la-maladie-ou-de-deces-chez-les-pa-tients-atteints-dune-forme-rare-de-cancer-de-la-thyroide\/"},"modified":"2024-07-23T10:02:26","modified_gmt":"2024-07-23T08:02:26","slug":"esmo-2021-cabometyx-demontre-une-reduction-soutenue-de-78-du-risque-de-progression-de-la-maladie-ou-de-deces-chez-les-pa-tients-atteints-dune-forme-rare-de-cancer-de-la-thyroide","status":"publish","type":"press_release","link":"https:\/\/www.ipsen.com\/fr\/press-releases\/esmo-2021-cabometyx-demontre-une-reduction-soutenue-de-78-du-risque-de-progression-de-la-maladie-ou-de-deces-chez-les-pa-tients-atteints-dune-forme-rare-de-cancer-de-la-thyroide\/","title":{"rendered":"ESMO 2021 : Cabometyx\u00ae d\u00e9montre une r\u00e9duction soutenue de 78 % du risque de progression de la maladie ou de d\u00e9c\u00e8s chez les pa-tients atteints d\u2019une forme rare de cancer de la thyro\u00efde"},"content":{"rendered":"<ul>\n<li style=\"margin-bottom:3px\">La demande d\u2019extension d\u2019indication d\u2019Ipsen pour Cabometyx\u00ae\u00a0(cabozantinib) sur la base des donn\u00e9es de l\u2019essai COSMIC-311 a \u00e9t\u00e9 approuv\u00e9e par l\u2019Agence europ\u00e9enne des m\u00e9dicaments en ao\u00fbt\u00a02021<\/li>\n<li style=\"margin-bottom:3px\">Les donn\u00e9es de suivi distinctes pr\u00e9sent\u00e9es au congr\u00e8s annuel de la\u00a0<em>European Society for Medical Oncology<\/em>\u00a0concernant la cohorte n\u00b06 de l\u2019essai de Phase Ib COSMIC-021 et l\u2019essai de Phase\u00a0III CheckMate-9ER \u00e9tayent le vaste potentiel de Cabometyx dans toutes ses indications2-4<\/li>\n<\/ul>\n<p><b>PARIS, FRANCE,\u00a0<\/b>le 18 septembre 2021 \u2013 Ipsen (Euronext\u00a0: IPN\u00a0; ADR\u00a0: IPSEY) a annonc\u00e9 aujourd\u2019hui la pr\u00e9sentation de nouvelles analyses lors de l\u2019\u00e9dition 2021 du congr\u00e8s de la\u00a0<em>European Society for Medical Oncology<\/em>\u00a0(ESMO) dans diff\u00e9rentes formes de cancer chez les personnes trait\u00e9es par Cabometyx\u00ae\u00a0(cabozantinib). L\u2019analyse finale de l\u2019\u00e9tude pivotale de Phase III COSMIC-311 (Abstract LBA67) sera pr\u00e9sent\u00e9e, Cabometyx d\u00e9montrant un b\u00e9n\u00e9fice d\u2019efficacit\u00e9 soutenu et cliniquement significatif par rapport au placebo chez les patients atteints d\u2019un cancer de la thyro\u00efde diff\u00e9renci\u00e9 r\u00e9fractaire \u00e0 l\u2019iode radioactif (RAI-R DTC).<\/p>\n<p>Sur une p\u00e9riode de suivi m\u00e9diane de 10,1 mois, Cabometyx a continu\u00e9 \u00e0 d\u00e9montrer une survie sans progression (PFS) m\u00e9diane sup\u00e9rieure avec une r\u00e9duction de 78\u00a0% du risque de progression de la maladie ou de d\u00e9c\u00e8s par rapport au placebo (rapport de risque [HR]\u00a0: 0,22, 96\u00a0% intervalle de confiance [IC]\u00a0: 0,15-0,32; p&lt;0,0001)1. Cette analyse finale est coh\u00e9rente avec les donn\u00e9es de l\u2019analyse interm\u00e9diaire, pr\u00e9sent\u00e9es lors de la r\u00e9union annuelle 2021 de l\u2019<em>American Society of Clinical Oncology<\/em>\u00a0(ASCO) et publi\u00e9es dans la revue\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=r6meIMnh--b5eVKUX3_DQ5N_6oPjc3xuk_Aqj47ukkAUYMH2pxUOwZBJFDFygQ878dPk8vcxWw6gEAXpQJ6snINQK2c4EWNtv-amOM3yiWscuTD3TDYOTCatSf4JvLCx6ExYv6KGugEIPiK7--gYdwxTRxDLKr59FPGBV7Yt3So=\" rel=\"nofollow noopener\" target=\"_blank\" title=\"\"><em><b>The Lancet Oncology<\/b><\/em><\/a><em>,\u00a0<\/em>(HR\u00a0: 0,22\u00a0;\u00a0IC 96 %\u00a0: 0,13-0,36; p&lt;0,0001)5,6. D\u2019autres donn\u00e9es issues de l\u2019analyse finale ont \u00e9galement confirm\u00e9 que l\u2019efficacit\u00e9 sup\u00e9rieure de Cabometyx \u00e9tait maintenue quelque que soit la th\u00e9rapie ciblant le facteur de croissance de l\u2019endoth\u00e9lium vasculaire (VEGF) utilis\u00e9e ant\u00e9rieurement.<\/p>\n<p>Le profil de tol\u00e9rance et d\u2019efficacit\u00e9 \u00e9tabli \u00e0 l\u2019issue de l\u2019analyse interm\u00e9diaire de COSMIC-311 a constitu\u00e9 la base d\u2019une demande de modification de type II aupr\u00e8s de l\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA) pour une extension d\u2019indication de Cabometyx dans le RAI-R DTC. Le 14 ao\u00fbt dernier, l\u2019EMA a valid\u00e9 la demande de modification de type II apr\u00e8s avoir confirm\u00e9 que le dossier de soumission \u00e9tait complet et entam\u00e9 la proc\u00e9dure centralis\u00e9e d\u2019examen.<br \/>Le profil d\u2019innocuit\u00e9 \u00e9tabli dans l\u2019essai COSMIC-311 \u00e9tait coh\u00e9rent avec celui pr\u00e9c\u00e9demment observ\u00e9 pour cabozantinib et les \u00e9v\u00e9nements ind\u00e9sirables (EI) ont \u00e9t\u00e9 g\u00e9r\u00e9s avec des modifications de dosages. Le taux d\u2019arr\u00eat du traitement en raison d\u2019EI survenus sous traitement \u00e9tait de 8,8\u00a0% pour le Cabometyx contre 0\u00a0% pour le placebo. Des EI de grade 3\/4 sont survenus chez 62\u00a0% des patients ayant re\u00e7u Cabometyx contre 28\u00a0% pour placebo, et aucun \u00e9v\u00e9nement de grade\u00a05 li\u00e9 au traitement n\u2019a \u00e9t\u00e9 signal\u00e9.<\/p>\n<p>Steven Hildemann, M.D., Vice-Pr\u00e9sident Ex\u00e9cutif, Chief Medical Officer, Affaires m\u00e9dicales Monde et S\u00e9curit\u00e9 Patients Monde, Ipsen a d\u00e9clar\u00e9\u00a0: \u00ab\u00a0Le potentiel de Cabometyx comme solution de traitement cl\u00e9 dans notre arsenal th\u00e9rapeutique contre un large \u00e9ventail de tumeurs continue d\u2019\u00eatre d\u00e9montr\u00e9. Les donn\u00e9es finales de l\u2019essai COSMIC-311 illustrent clairement les b\u00e9n\u00e9fices concrets que Cabometyx peut apporter aux patients atteints d\u2019un cancer et nous attendons avec impatience de recevoir la d\u00e9cision de l\u2019EMA l\u2019ann\u00e9e prochaine. Nous sommes r\u00e9solus \u00e0 explorer plus avant le r\u00f4le que Cabometyx peut continuer \u00e0 jouer contre les cancers difficiles \u00e0 traiter. Nos \u00e9quipes sont \u00e9galement mobilis\u00e9es sur les futurs r\u00e9sultats des essais de Phase III en cours dans le cancer du poumon non \u00e0 petites cellules (CONTACT-01) et le cancer de la prostate m\u00e9tastatique r\u00e9sistant \u00e0 la castration (CONTACT-02).\u00a0\u00bb<\/p>\n<p>Les donn\u00e9es suppl\u00e9mentaires pr\u00e9sent\u00e9es \u00e0 l\u2019ESMO sur Cabometyx incluent les nouveaux r\u00e9sultats de la cohorte n\u00b06 de l\u2019\u00e9tude de Phase Ib COSMIC-021 \u00e9valuant Cabometyx en association avec l\u2019atezolizumab chez des patients atteints d\u2019un cancer de la prostate m\u00e9tastatique r\u00e9sistant \u00e0 la castration (CRPC) pr\u00e9c\u00e9demment trait\u00e9 (Abstract LBA24)2. Des analyses suppl\u00e9mentaires s\u2019appuient sur les donn\u00e9es interm\u00e9diaires pr\u00e9sent\u00e9es \u00e0 l\u2019ASCO 20207, avec une cohorte \u00e9largie n\u00b06 de 132 patients \u00e9valu\u00e9s132. Sur une p\u00e9riode de suivi m\u00e9diane de 15,2\u00a0mois, le crit\u00e8re d\u2019\u00e9valuation principal, \u00e0 savoir le taux de r\u00e9ponse objective (ORR) \u00e9valu\u00e9 par l\u2019investigateur selon les crit\u00e8res RECIST 1.1 (crit\u00e8res d\u2019\u00e9valuation de la r\u00e9ponse dans les tumeurs solides) \u00e9tait de 23\u00a0%, trois patients pr\u00e9sentant une r\u00e9ponse compl\u00e8te (RC)23.<\/p>\n<p>Le Prof. Dr. Gunhild von Amsberg, Centre hospitalier universitaire Hambourg-Eppendorf (UKE), investigateur de l\u2019essai CONTACT-02, a d\u00e9clar\u00e9\u00a0: \u00ab\u00a0<em>En tant qu\u2019uro-oncologue, je consid\u00e8re que les r\u00e9sultats pr\u00e9sent\u00e9s lors du congr\u00e8s ESMO 2021 sont encourageants.<\/em>\u00a0<em>Pour les personnes atteintes d\u2019un cancer avanc\u00e9 de la prostate m\u00e9tastatique r\u00e9sistant \u00e0 la castration, le pronostic est souvent d\u00e9favorable. C\u2019est pourquoi le potentiel de nouvelles th\u00e9rapies innovantes est d\u2019une importance cruciale.<\/em>\u00a0<em>Compte tenu des r\u00e9sultats cliniquement significatifs de Cabometyx en association avec l\u2019at\u00e9zolizumab dans la cohorte n\u00b06 de l\u2019essai COSMIC-021, nous attendons avec impatience les r\u00e9sultats de la Phase III CONTACT-02 en cours<\/em>.\u00a0\u00bb<\/p>\n<p>D\u2019autres analyses de l\u2019essai de Phase III CheckMate-9ER \u00e9valuant Cabometyx en association avec le nivolumab seront \u00e9galement pr\u00e9sent\u00e9es \u00e0 l\u2019ESMO, et constituent des preuves suppl\u00e9mentaires pour \u00e9clairer la prise de d\u00e9cision clinique dans le carcinome du rein (RCC) avanc\u00e9. Les nouvelles donn\u00e9es ont d\u00e9montr\u00e9 une efficacit\u00e9 accrue de Cabometyx en association avec le nivolumab que le patient ait b\u00e9n\u00e9fici\u00e9 ou pas d\u2019une n\u00e9phrectomie pr\u00e9alable, telle que mesur\u00e9e par la PFS, l\u2019ORR, la RC et la durabilit\u00e9 de la r\u00e9ponse par rapport au sunitinib (Abstract 663P)3. Une analyse de comparaison indirecte ajust\u00e9e par appariement sera \u00e9galement pr\u00e9sent\u00e9e, d\u00e9montrant une efficacit\u00e9 sup\u00e9rieure et des diff\u00e9rences statistiquement significatives dans la qualit\u00e9 de vie li\u00e9e \u00e0 la sant\u00e9 des patients pour tous les crit\u00e8res analys\u00e9s en faveur de Cabometyx associ\u00e9 au nivolumab, par rapport \u00e0 l\u2019axitinib associ\u00e9 au pembrolizumab (Abstract 668P)4.<br \/>Nous communiquerons plus en d\u00e9tail sur ces r\u00e9sultats lors des sessions de pr\u00e9sentation, r\u00e9sum\u00e9es ci-dessous\u00a0:<\/p>\n<table style=\"border-collapse: collapse;width:731px;border-collapse:collapse\">\n<tr>\n<td style=\"width:391px\"><b>Titre<\/b><\/td>\n<td style=\"width:232px\"><b>Date et heure<\/b><\/td>\n<\/tr>\n<tr>\n<td style=\"width:391px;border-top: solid black 1pt;border-right: solid black 1pt;border-bottom: solid black 1pt;border-left: solid black 1pt\">Cabozantinib in combination with atezolizumab in patients with metastatic castration-resistant prostate cancer (mCRPC): results of expanded cohort 6 of the COSMIC-021 Study<\/td>\n<td style=\"width:232px;border-top: solid black 1pt;border-right: solid black 1pt;border-bottom: solid black 1pt;border-left: solid black 1pt\">Samedi 18 septembre<br \/>13:30-13:40 CEST<\/td>\n<\/tr>\n<tr>\n<td style=\"width:391px;border-top: solid black 1pt;border-right: solid black 1pt;border-bottom: solid black 1pt;border-left: solid black 1pt\">Cabozantinib Versus Placebo in Patients With Radioiodine-Refractory Differentiated Thyroid Cancer (DTC) Who Have Progressed After Prior VEGFR-Targeted Therapy: Updated Results From the Phase 3 COSMIC-311 Trial<\/td>\n<td style=\"width:232px;border-top: solid black 1pt;border-right: solid black 1pt;border-bottom: solid black 1pt;border-left: solid black 1pt\">Lundi 20 septembre<br \/>17:30-17:35 CEST<\/td>\n<\/tr>\n<tr>\n<td style=\"width:391px;border-top: solid black 1pt;border-right: solid black 1pt;border-bottom: solid black 1pt;border-left: solid black 1pt\">First-line nivolumab + cabozantinib (NIVO+CABO) vs sunitinib (SUN) in patients (pts) with advanced renal cell carcinoma (aRCC) in subgroups based on prior nephrectomy in the CheckMate 9ER trial<\/td>\n<td style=\"width:232px;border-top: solid black 1pt;border-right: solid black 1pt;border-bottom: solid black 1pt;border-left: solid black 1pt\">Pr\u00e9sentation de poster \u2013 Disponible sur demande \u00e0 partir du 16 septembre \u00e0 8h30 CEST<\/td>\n<\/tr>\n<tr>\n<td style=\"width:391px;border-top: solid black 1pt;border-right: solid black 1pt;border-bottom: solid black 1pt;border-left: solid black 1pt\">Matching-adjusted indirect comparison (MAIC) of health-related quality of life (HRQoL) of nivolumab plus cabozantinib (N+C) vs pembrolizumab plus axitinib (P+A) in previously untreated advanced renal cell carcinoma (aRCC)<\/td>\n<td style=\"width:232px;border-top: solid black 1pt;border-right: solid black 1pt;border-bottom: solid black 1pt;border-left: solid black 1pt\">Pr\u00e9sentation de poster \u2013 Disponible sur demande \u00e0 partir du 16 septembre \u00e0 8h30 CEST<\/td>\n<\/tr>\n<\/table>\n<p><b>R\u00e9f\u00e9rences\u00a0<\/b><\/p>\n<ol>\n<li style=\"margin-bottom:3px\">Capdevila\u00a0<em>et al.,\u00a0<\/em>ESMO 2021. Cabozantinib (C) versus placebo (P) in patients (pts) with radioiodine-refractory (RAIR) differentiated thyroid cancer (DTC) who have progressed after prior VEGFR-targeted therapy: updated results from the phase 3 COSMIC-311 trial and prespecified subgroup analyses based on prior VEGFR-targeted therapy<\/li>\n<li style=\"margin-bottom:3px\">Agarwal\u00a0<em>et al.,\u00a0<\/em>ESMO 2021. Cabozantinib (C) in combination with atezolizumab (A) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC): primary analysis of cohort 6 of the COSMIC-021 study<\/li>\n<li style=\"margin-bottom:3px\">Porta\u00a0<em>et al.,<\/em>\u00a0ESMO 2021. First-line nivolumab + cabozantinib (NIVO+CABO) vs sunitinib (SUN) in patients (pts) with advanced renal cell carcinoma (aRCC) in subgroups based on prior nephrectomy in theCheckMate 9ER trial<\/li>\n<li style=\"margin-bottom:3px\">Porta\u00a0<em>et al.,<\/em>\u00a0ESMO 2021. Matching-adjusted indirect comparison (MAIC) of health-related quality of life (HRQoL) of nivolumab plus cabozantinib (N+C) vs pembrolizumab plus axitinib (P+A) in previously untreated advanced renal cell carcinoma (aRCC)<\/li>\n<li style=\"margin-bottom:3px\">Brose\u00a0<em>et al<\/em>., ASCO 2021. Cabozantinib versus placebo in patients with radioiodine-refractory differentiated thyroid cancer who have progressed after prior VEGFR-targeted therapy: results from the phase 3 COSMIC-311 trial.<\/li>\n<li style=\"margin-bottom:3px\">Brose\u00a0<em>et al<\/em>., Cabozantinib for radioiodine-refractory differentiated thyroid cancer (COSMIC-311): a randomised, double-blind, placebo-controlled, phase 3 trial.\u00a0<em>Lancet Oncology<\/em>. 2021; 22:8. DOI:<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=f0lZjb3geSYcHtjaSCKmO6xjjd7iSbcKFC-Tbugcdx_Wfrn4nB5V-_4tF0AkPOP-rcSBEJOBNzw6w3z9ucIwiGSPKjL9ZTaqcMFQMVv33hwPiD-kCi3ddQZlrSbySsZitupgqs6xxklgc11kTFjedg==\" rel=\"nofollow noopener\" target=\"_blank\" title=\"\">https:\/\/doi.org\/10.1016\/S1470-2045(21)00332-6<\/a><\/li>\n<li style=\"margin-bottom:3px\">Agarwal\u00a0<em>et al<\/em>., ASCO 2020. Cabozantinib in combination with atezolizumab in patients with metastatic castration-resistant prostate cancer: Results of cohort 6 of the COSMIC-021 study.<\/li>\n<\/ol>\n<p id=\"gnw_attachments_section-header\">\n    <strong>Pi\u00e8ce jointe<\/strong>\n<\/p>\n<ul id=\"gnw_attachments_section-items\">\n<li>\n        <a target=\"_blank\" href=\"https:\/\/www.globenewswire.com\/Tracker?data=ki05A99x8ufG9Y48tLVG0SC1ehkIKhiPd-1HUwNZC_BjPQlbtlHOHQBUx3E4nSSJO7CBtco5t8zwd_6ZAYnHzjbvgth4qCMHwQdPNVW4mSrlkL7TL8WvwOx8y3PcNu3HpbRJY2V2QWh1Ob_jLZUGyqrP5RS8JwqYRFCnceoEI_AOXK_II6q51LNrXD0_tg0J\" title=\"Ipsen-ESMO-2021-18-Fevrier-2021\" rel=\"nofollow noopener\">Ipsen-ESMO-2021-18-Fevrier-2021<\/a>\n      <\/li>\n<\/ul>\n<p><img src='https:\/\/ml-eu.globenewswire.com\/media\/NTY1YjVlZGUtMzczNy00MzIyLWFiZDktMGM3NmM5OTljNjliLTEwMTA5NDM=\/tiny\/Ipsen-SA.png' \/><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"template":"","categories":[1233,3556,3560],"tags":[],"class_list":["post-36109","press_release","type-press_release","status-publish","hentry","category-pressrelease-fr","category-corporate-pressrelease-fr","category-oncology-pressrelease-fr","entry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.5 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>ESMO 2021 : Cabometyx\u00ae d\u00e9montre une r\u00e9duction soutenue de 78 % du risque de progression de la maladie ou de d\u00e9c\u00e8s chez les pa-tients atteints d\u2019une forme rare de cancer de la thyro\u00efde<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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