{"id":11672,"date":"2021-11-05T09:00:00","date_gmt":"2021-11-05T13:00:00","guid":{"rendered":"https:\/\/wfh.org\/la-fda-place-letude-de-phase-3-pfizer-sangamo-therapeutics-affine-sur-la-therapie-genique-dans-lhemophilie-a-en-suspension-clinique\/"},"modified":"2026-03-19T09:05:57","modified_gmt":"2026-03-19T13:05:57","slug":"la-fda-place-letude-de-phase-3-pfizer-sangamo-therapeutics-affine-sur-la-therapie-genique-dans-lhemophilie-a-en-suspension-clinique","status":"publish","type":"post","link":"https:\/\/wfh.org\/fr\/article\/la-fda-place-letude-de-phase-3-pfizer-sangamo-therapeutics-affine-sur-la-therapie-genique-dans-lhemophilie-a-en-suspension-clinique\/","title":{"rendered":"La FDA place l\u2019\u00e9tude de phase 3 Pfizer\/Sangamo Therapeutics AFFINE sur la th\u00e9rapie g\u00e9nique dans l\u2019h\u00e9mophilie A en suspension clinique"},"content":{"rendered":"\t\t
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Le mercredi 4 novembre, la Food and Drug Administration (FDA) des \u00c9tats-Unis a plac\u00e9 le programme Pfizer\/Sangamo sur la th\u00e9rapie g\u00e9nique dans l\u2019h\u00e9mophilie A, y compris son \u00e9tude pivotale de phase 3 AFFINE (NCT04370054<\/a>), par giroctocogene fitelparvovec (SB-525 ou PF-07055480), en suspension clinique jusqu\u2019\u00e0 l\u2019examen d\u2019une suggestion d\u2019amendement du protocole. (Communiqu\u00e9 de presse de Sangamo<\/a>). Cette d\u00e9cision a suivi le choix volontaire de Pfizer de mettre cette \u00e9tude en pause et son communiqu\u00e9 \u00e0 ce sujet le 2 novembre 2021.<\/p>\n

La suspension clinique a \u00e9t\u00e9 mise en place pour mettre en place un amendement du protocole, apr\u00e8s l\u2019observation de niveaux de facteur VIII sup\u00e9rieurs \u00e0 150\u00a0% chez certains participants \u00e0 l\u2019\u00e9tude. L\u2019amendement vise \u00e0 donner des recommandations pour la prise en charge clinique des niveaux \u00e9lev\u00e9s de facteur VIII.<\/p>\n

L\u2019essai AFFINE devrait regrouper environ 50 participants au total. Plus de 50\u00a0% des participants \u00e0 l\u2019essai ont re\u00e7u leur dose de giroctocogene fitelparvovec. \u00c0 ce jour, aucun participant ayant re\u00e7u cette th\u00e9rapie g\u00e9nique n\u2019a connu de r\u00e9action thrombotique, et certains re\u00e7oivent un traitement par anticoagulants (voie orale) pour r\u00e9duire le risque de thrombose.<\/p>\n

La prochaine \u00e9tape consiste pour les organismes de r\u00e9glementation \u00e0 \u00e9valuer le nouveau protocole ainsi que la reprise de l\u2019administration de doses suppl\u00e9mentaires.<\/p>\n

Sans rapport avec la suspension du programme de th\u00e9rapie g\u00e9nique dans l\u2019h\u00e9mophilie A, Pfizer et la FDA ont d\u00e9cid\u00e9 de ne pas mener d\u2019analyse interm\u00e9diaire dans deux essais de th\u00e9rapie g\u00e9nique dans l\u2019h\u00e9mophilie, et pr\u00e9voient plut\u00f4t d\u2019attendre les analyses compl\u00e8tes des 50 participants (ou plus) de l\u2019essai sur l\u2019h\u00e9mophilie A et des 40 participants de l\u2019essai sur l\u2019h\u00e9mophilie B. Cette d\u00e9cision va retarder l\u2019extraction finale des donn\u00e9es de ces deux essais.<\/p>\n

Nous vous rapportons cette information, qui a \u00e9t\u00e9 rendue publique, et nous continuerons \u00e0 informer nos communaut\u00e9s de patients de toute \u00e9volution pertinente. Si vous avez la moindre question, contactez votre m\u00e9decin traitant et votre centre de traitement de l\u2019h\u00e9mophilie.<\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\u00c0 propos de l\u2019\u00e9tude AFFINE<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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L\u2019\u00e9tude de phase 3 AFFINE (efficAcy and saFety Factor vIii geNe thErapy in haemophilia A patients\u00a0; NCT04370054) est une \u00e9tude mono-bras ouverte et multicentrique qui \u00e9value l\u2019efficacit\u00e9 et la s\u00e9curit\u00e9 d\u2019une injection unique de giroctocogene fitelparvovec chez plus de 50 sujets masculins adultes (\u00e2g\u00e9s de 18 \u00e0 64 ans) pr\u00e9sentant une h\u00e9mophilie A mod\u00e9r\u00e9e \u00e0 s\u00e9v\u00e8re.\u00a0<\/strong><\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\u00c0 propos du giroctocogene fitelparvovec<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Le giroctocogene fitelparvovec (SB-525 ou PF-07055480) est compos\u00e9 d\u2019un vecteur viral ad\u00e9no-associ\u00e9 de s\u00e9rotype 6 (AAV2\/6) qui encode l\u2019acide d\u00e9soxyribonucl\u00e9ique compl\u00e9mentaire du g\u00e8ne humain FVIII d\u00e9l\u00e9t\u00e9 du domaine B. La cassette d\u2019expression du giroctocogene fitelparvovec a \u00e9t\u00e9 con\u00e7ue pour une expression h\u00e9pato-sp\u00e9cifique optimale de la prot\u00e9ine FVIII, et permet la production d\u2019une grande quantit\u00e9 du vecteur. La cassette transcriptionnelle du giroctocogene fitelparvovec regroupe des modifications multifactorielles du module promoteur h\u00e9pato-sp\u00e9cifique, du transg\u00e8ne FVIII, du signal de polyad\u00e9nylation de synth\u00e8se ainsi que de la s\u00e9quence squelette du vecteur.<\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Sources\u00a0:<\/p>\n

    \n
  1. Communication de Pfizer<\/a>\u00a0\u00ab\u00a0Pfizer giroctocogene fitelparvovec (Hemophilia A gene therapy) AFFINE Phase 3 Study Update\u00a0\u00bb, 5 novembre 2021.<\/li>\n
  2. Sangamo Therapeutics Reports Recent Business and Clinical Highlights and Third Quarter 2021 Financial Results, 4 novembre 2021 (communiqu\u00e9 de presse<\/a>)<\/li>\n<\/ol>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"

    Le mercredi 4 novembre, la Food and Drug Administration (FDA) des \u00c9tats-Unis a plac\u00e9 le programme Pfizer\/Sangamo sur la th\u00e9rapie g\u00e9nique dans l\u2019h\u00e9mophilie A, y compris son \u00e9tude pivotale de phase 3 AFFINE (NCT04370054), par giroctocogene fitelparvovec (SB-525 ou PF-07055480), en suspension clinique jusqu\u2019\u00e0 l\u2019examen d\u2019une suggestion d\u2019amendement du protocole.<\/p>\n","protected":false},"author":3,"featured_media":19564,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[169,122,157,159,34],"tags":[],"search-category":[85],"class_list":["post-11672","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-events-2","category-gene-therapy","category-medical-news","category-gtrt","category-wfh-statements-and-advisories","search-category-article"],"yoast_head":"\nLa FDA place l\u2019\u00e9tude de phase 3 Pfizer\/Sangamo Therapeutics AFFINE sur la th\u00e9rapie g\u00e9nique dans l\u2019h\u00e9mophilie A en suspension clinique | FMH - 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