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    Inicio > Historias > Sobre Provenge, un ATMP retirado por el titular 2019-01-26

    Sobre Provenge, un ATMP retirado por el titular

    Provenge lo fabrica Dendreon, que es propiedad en la actualidad de la china Nanjing Cenbest , tras varios cambios en su propiedad en pocos años.


    De la EPAR, emitida cuando se autorizó por la EMA en septiembre de 2013, extraemos varios aspectos:

    2.2 Composición cualitativa y cuantitativa

    Una bolsa contiene células mononucleares autólogas de sangre periférica activadas con FAP-GM-CSF (fosfatasa ácida prostática-factor estimulante de colonias de granulocitos y macrófagos), incluyendo un mínimo de 50 x 106 células CD54+ autologas.


    Los CD54 son PMN que expresan ICAM1 que tiene importancia en la transmigración celular en la respuesta inmunitaria. Hemos encontrado poca literatura en la que se hable de su importancia en cáncer de próstata, solo 14 referencias en Pubmed con la búsqueda "https://www.ncbi.nlm.nih.gov/pubmed/?term=cd54%2B+prostate+cancer"


    Cuando la EMA autorizó Provenge lo hizo para:

    4.1 Indicaciones terapéuticas

     Provenge está indicado para el tratamiento del cáncer de próstata metastásico resistente a la castración asintomático o mínimamente sintomático (no visceral) en varones adultos en los que la quimioterapia aún no está clínicamente indicada.


    5.1 Propiedades farmacodinámicas

    Mecanismo de acción

     Provenge es una inmunoterapia celular autóloga diseñada para inducir una respuesta inmunitaria frente a fosfatasa ácida prostática (FAP), un antígeno expresado en la mayoría de los cánceres de próstata. Las células mononucleares de sangre periférica obtenidas de los pacientes se cultivan con FAP-GM-CSF, una proteína de fusión que consiste en FAP unidas al factor estimulante de colonias de granulocitos y macrófagos (GM-CSF), un activador de células inmunitarias. Durante el cultivo ex vivo con FAP-GM-CSF, las CPA (células presentadoras de antígeno) activadas adquieren y procesan el antígeno diana recombinante en péptidos que, a continuación, se presentan a linfocitos T. La caracterización del producto muestra que durante el tratamiento se generan linfocitos T específicos frente a FAP y frente a la proteína de fusión FAP-GM-CSF y dichos linfocitos.


    Los CT en los que se basó la autorización fueron:

     D9902B (IMPACT), D9901, y D9902A


    Los pacientes incluidos en estos ensayos habían tenido fracasos en los tratamientos de castración quirúrgica o médica (p. ej. agonista de la hormona liberadora de hormona luteinizante [LHRH] o antagonista de la hormona liberadora de gonadotropina [GnRh]) y presentaron enfermedad  metastásica en tejidos blandos y/o huesos.


    D9902B (IMPACT)

    El criterio principal de valoración fue la supervivencia global. Los criterios secundarios de valoración consistieron en el tiempo hasta la progresión de la enfermedad objetiva, tiempo hasta la progresión clínica y tiempo de duplicación de PSA (PSADT).

    En la Tabla 2 se ven los resultados obtenidos en los tres  CT

    Resultados que hablan de solo 4 meses de incremento de supervivencia.


    Sobre los planes de futuro de la nueva propiedad decía FiercePharma en agosto de 2018:

    Dendreon is currently evaluating Provenge to treat prostate cancer at an early stage—a market Xu said is four times the size of the metastatic castration-resistant form of the disease—and is working to get the treatment approved in China. Also, because Dendreon has the entire infrastructure and R&D capabilities in immunotherapy, Xu said it could easily move into the hot area of cell therapies like CAR-T or TCR-T, and the company is actively looking to in-license or purchase a candidate in the field.

    Derivándose de ello una voluntad de reorientar las indicaciones desde cáncer metastásico a fases iniciales, desde T4 a T0. En ClinicalTrials.gov aparecen 5 CT  de Provenge en Fase 3. Los 3 mencionados arriba, más otro (P-11) iniciado en 2006, y un quinto (P17-1|ProVent) iniciado en octubre de 2018 y que se prevé terminar en mayo de 2023. Este tiene por objetivo:

    To assess the efficacy of sipuleucel-T in reducing histopathologic reclassification to a higher Gleason grade in prostate cancer subjects on active surveillance (AS)

    coherentemente con lo dicho por FiercePharma.

    2019-01-26 07:38 | 10 Comentarios


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