{"id":36463,"date":"2018-12-05T15:07:00","date_gmt":"2018-12-05T13:07:00","guid":{"rendered":"https:\/\/www.ipsen.com\/press-releases\/exelixis-et-ipsen-lancent-un-essai-pivotal-de-phase-3-cosmic-312-sur-le-cabozantinib-en-association-avec-latezolizumab-versus-sorafenib-dans-le-traitement-du-carcinome-hepatocellulaire-avan\/"},"modified":"2024-07-25T10:48:58","modified_gmt":"2024-07-25T08:48:58","slug":"exelixis-et-ipsen-lancent-un-essai-pivotal-de-phase-3-cosmic-312-sur-le-cabozantinib-en-association-avec-latezolizumab-versus-sorafenib-dans-le-traitement-du-carcinome-hepatocellulaire-avan","status":"publish","type":"press_release","link":"https:\/\/www.ipsen.com\/fr\/press-releases\/exelixis-et-ipsen-lancent-un-essai-pivotal-de-phase-3-cosmic-312-sur-le-cabozantinib-en-association-avec-latezolizumab-versus-sorafenib-dans-le-traitement-du-carcinome-hepatocellulaire-avan\/","title":{"rendered":"Exelixis et Ipsen lancent un essai pivotal de phase 3 (COSMIC-312) sur le cabozantinib en association avec l\u2019atezolizumab versus soraf\u00e9nib dans le traitement du carcinome h\u00e9patocellulaire avanc\u00e9 non trait\u00e9 ant\u00e9rieurement"},"content":{"rendered":"

\u2013 L\u2019essai clinique explorera \u00e9galement l\u2019activit\u00e9 du cabozantinib en monoth\u00e9rapie et en 1<\/b>\u00e8re<\/b>\u00a0ligne de traitement \u2013<\/b><\/em>
ALAMEDA, Calif. & PARIS \u2013 le 5 d\u00e9cembre, 2018 \u2013<\/b>\u00a0Exelixis, Inc.<\/b><\/a>\u00a0(Nasdaq\u00a0: EXEL) et Ipsen (Euronext\u00a0: IPN\u00a0; ADR\u00a0: IPSEY)\u00a0ont annonc\u00e9 aujourd\u2019hui le lancement de l\u2019\u00e9tude pivotale de phase 3 COSMIC-312, portant sur l\u2019utilisation de cabozantinib (CABOMETYX\u00ae) en association avec l\u2019atezolizumab (TECENTRIQ\u00ae) versus soraf\u00e9nib dans le traitement du carcinome h\u00e9patocellulaire (CHC) avanc\u00e9 non trait\u00e9 ant\u00e9rieurement. Les principaux crit\u00e8res d\u2019\u00e9valuation de l\u2019\u00e9tude sont la survie sans progression et la survie globale. Un groupe exploratoire \u00e9valuera \u00e9galement le cabozantinib en monoth\u00e9rapie dans cet essai initial.
\u00ab\u00a0Le cancer du foie est la cause de d\u00e9c\u00e8s par cancer qui conna\u00eet la plus forte croissance aux \u00c9tats-Unis. Pour ces patients, le besoin de nouvelles options th\u00e9rapeutiques est donc particuli\u00e8rement important\u00a0\u00bb, a d\u00e9clar\u00e9 Gisela Schwab, M.D., Pr\u00e9sidente, D\u00e9veloppement produit et Affaires m\u00e9dicales et Chief Medical Officer chez Exelixis. \u00ab\u00a0Sur la\u00a0base\u00a0des\u00a0donn\u00e9es\u00a0ant\u00e9rieures relatives aux synergies potentielles du cabozantinib et des anticorps monoclonaux inhibiteurs\u00a0de\u00a0checkpoint, cette association semble \u00eatre tr\u00e8s prometteuse pour les patients atteints de cancer du foie avanc\u00e9 n\u2019ayant pas re\u00e7u de traitement ant\u00e9rieur.\u00a0\u00bb
COSMIC-312 est un essai pivotal de phase 3, multicentrique, randomis\u00e9 et contr\u00f4l\u00e9 qui a pour objectif de recruter environ 640\u00a0patients r\u00e9partis sur 200\u00a0sites dans le monde. Les patients seront randomis\u00e9s 6:3:1 dans l\u2019un des 3 groupes\u00a0: cabozantinib (40\u00a0mg) et atezolizumab, soraf\u00e9nib ou cabozantinib (60\u00a0mg).
Exelixis sponsorise COSMIC-312 et Ipsen co-financera l\u2019essai. Ipsen aura acc\u00e8s aux r\u00e9sultats de l\u2019\u00e9tude pour appuyer ses potentielles soumissions r\u00e9glementaires \u00e0 venir, hors \u00c9tats-Unis et Japon. Genentech, membre du groupe Roche, fournit l\u2019atezolizumab utilis\u00e9 dans cet essai.
\u00ab\u00a0Avec plus de 800\u00a0000 nouveaux cas diagnostiqu\u00e9s chaque ann\u00e9e dans le monde et un mauvais pronostic pour les patients atteints de la forme avanc\u00e9e de la maladie, il est urgent d\u2019identifier de nouvelles options th\u00e9rapeutiques pour le traitement du cancer du foie\u00a0\u00bb, a d\u00e9clar\u00e9 le Professeur Kate Kalley, M.D., Professeur associ\u00e9e de m\u00e9decine clinique, d\u00e9partement H\u00e9matologie\/Oncologie, Universit\u00e9 de Californie San Francisco et Investigateur principal de l\u2019\u00e9tude COSMIC312.\u00a0<\/em>\u00ab\u00a0Nous sommes impatients de savoir si l\u2019association du cabozantinib et de l\u2019atezolizumab am\u00e9liorera les r\u00e9sultats pour les patients non trait\u00e9s ant\u00e9rieurement.\u00a0\u00bb<\/p>\n

\u00a0<\/p>\n

\u00a0<\/p>\n

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