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ES2629405T3 - Combinaciones de un conjugado de fármaco-anticuerpo anti-HER2 y docetaxel - Google Patents

Combinaciones de un conjugado de fármaco-anticuerpo anti-HER2 y docetaxel Download PDF

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Publication number
ES2629405T3
ES2629405T3 ES13158350.2T ES13158350T ES2629405T3 ES 2629405 T3 ES2629405 T3 ES 2629405T3 ES 13158350 T ES13158350 T ES 13158350T ES 2629405 T3 ES2629405 T3 ES 2629405T3
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Prior art keywords
cancer
her2
pertuzumab
drug
trastuzumab
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Leanne Berry
Gail Lewis Phillips
Mark X. Sliwkowski
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Genentech Inc
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Genentech Inc
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Abstract

Una combinación terapéutica para uso en un método para el tratamiento de cáncer que expresa ErbB2, en donde el método comprende la administración a un mamífero de una combinación terapéutica como una formulación combinada o de forma alterna, en donde la combinación terapéutica comprende una cantidad terapéuticamente eficaz de trastuzumab-MCC-DM1, y una cantidad terapéuticamente eficaz de docetaxel.

Description

imagen1
imagen2
imagen3
imagen4
imagen5
(6) GNE-390, 2,5 mg/kg, po, qd x21 + T-DM1, 3 mg/kg, iv, qd.
Descripción detallada de realizaciones a modo de ejemplo
5 A continuación se hará referencia con detalle a ciertas realizaciones de la invención, cuyos ejemplos se ilustran en las estructuras y fórmulas adjuntas. Un experto en la materia reconocerá muchos métodos y materiales similares o equivalentes a los que se describen el presente documento, que se podrían usar en la práctica de la presente invención.
DEFINICIONES
Los términos "comprenden”, "que comprende”, "incluyen”, "que incluye”, e "incluye", cuando se usan en la presente memoria descriptiva y en las reivindicaciones, pretenden especificar la presencia de características, números enteros, componentes, o etapas indicados, pero no excluyen la presencia o adición de una u otras características,
15 números enteros, componentes, etapas, o grupos más de los mismos.
Los términos "tratar" y "tratamiento" se refieren tanto al tratamiento terapéutico como a medidas profilácticas o preventivas, en los que el objeto es prevenir a ralentizar (disminuir) un cambio o trastorno fisiológico no deseado, tal como el crecimiento, desarrolló o diseminación de una afección hiperproliferativa, tal como cáncer. Para fines de la presente invención, algunos resultados clínicos beneficiosos o deseados incluyen, pero no se limitan a, alivio de síntomas, disminución del alcance de la enfermedad, patología estabilizada (es decir, que no empeora), retraso o ralentización del avance de la enfermedad, mejora o alivio de la patología, y remisión (ya sea parcial o total), ya sea detectable o no detectable. "Tratamiento" también puede hace referencia a prolongar la supervivencia en comparación con la supervivencia esperada sino se recibiera tratamiento. Los individuos con necesidad de
25 tratamiento incluyen que ya padecen la afección o trastorno así como los propensos a padecer la afección o trastorno o los individuos en los que se va a prevenir la afección o trastorno.
La expresión "cantidad terapéuticamente eficaz" se refiere una cantidad de un compuesto de la presente invención que (i) trata la enfermedad, afección, o trastorno en particular, (ii) atenúa, mejora, o elimina uno o más síntomas de la enfermedad, afección, o trastorno en particular, o (iii) previene o retrasa el inicio de uno o más síntomas de la enfermedad, afección, o trastorno en particular que se describen el presente documento. En el caso de cáncer, la cantidad terapéuticamente eficaz del fármaco puede reducir el número de células cancerígenas; reducir el tamaño del tumor; inhibir (es decir, ralentizar hasta cierto punto y preferentemente detener) la infiltración de células cancerígenas en órganos periféricos; inhibir (es decir, ralentizar hasta cierto punto y preferentemente detener) la
35 metástasis tumoral; inhibir, hasta cierto punto, el crecimiento tumoral; y/o aliviar hasta cierto punto uno o más de los síntomas asociados con el cáncer. En la medida en la que el fármaco puede prevenir el crecimiento y/o eliminar células cancerígenas existentes, éste puede ser citostático y/o citotóxico. Para terapia para el cáncer, la eficacia se puede medir, por ejemplo, evaluando el tiempo de la evolución de la enfermedad (TTP) y/o determinando la tasa de respuesta (RR).
El "trastorno hiperproliferativo" se indica con tumores, cánceres, y tejido neoplásico, que incluye estadios premalignos y no neoplásicos, y también incluye psoriasis, endometriosis, pólipos y fibroadenoma.
Los términos "cáncer" y "cancerígeno" se refiere a o describen la afección fisiológica en mamíferos que por lo
45 general se caracteriza por un crecimiento celular desregulado. Un "tumor" comprende una o mas células cancerígenas. Algunos ejemplos de cáncer incluyen, pero no se limitan a, carcinoma, linfoma, blastoma, sarcoma, y leucemia o neoplasias linfoides. Algunos ejemplos más particulares de tales cánceres incluyen cáncer de células escamosas (por ejemplo, cáncer de células escamosas epitelial), cáncer de pulmón que incluye cáncer de pulmón microcítico, cáncer de pulmón no microcítico ("NSCLC"), adenocarcinoma del pulmón y carcinoma escamoso del pulmón, cáncer del peritoneo, cáncer hepatocelular, cáncer gástrico o de estómago que incluye cáncer gastrointestinal, cáncer pancreático, glioblastoma, cáncer de cuello uterino, cáncer de ovario, cáncer de hígado, cáncer de vejiga, hepatoma, cáncer de mama, cáncer de colon, cáncer rectal, cáncer colorrectal, carcinoma de endometrio o uterino, carcinoma de glándulas salivales, cáncer de riñón o renal, cáncer de próstata, cáncer de vulva, cáncer de tiroides, carcinoma hepático, carcinoma anal, carcinoma de pene, así como cáncer de cabeza y cuello.
55 Un "agente quimioterapéutico" es un compuesto químico útil en el tratamiento del cáncer, independientemente del mecanismo de acción. Algunas clases de quimioterapéuticos incluyen, pero no se limitan a: agentes de alquilación, antimetabolitos, alcaloides vegetales con actividad antimitótica, antibióticos citotóxicos/antitumorales, inhibidores de la topoisomerasa, anticuerpos, fotosensibilizadores, e inhibidores de quinasa. Algunos agentes quimioterapéuticos incluyen compuestos usados en "terapia dirigida" y quimioterapia convencional. Algunos ejemplos de agentes quimioterapéuticos incluyen: erlotinib (TARCEVA®, Genentech/OSI Pharm.), docetaxel (TAXOTERE®, Sanofi-Aventis), 5-FU (fluorouracilo, 5-fluorouracilo, CAS Nº 51-21-8), gemcitabina (GEMZAR®, Lilly), PD-0325901 (CAS Nº 391210-10-9, Pfizer), cisplatino (cis-diamina, dicloroplatino (II), CAS Nº 15663-27-1), carboplatino (CAS Nº 4157594-4), paclitaxel (TAXOL®, Bristol-Myers Squibb Oncology, Princeton, N.J.), trastuzumab (HERCEPTIN®,
65 Genentech), temozolomida (4-metil-5-oxo-2,3,4,6,8-pentazabiciclo[4.3.0]nona-2,7,9-trieno-9-carboxamida, CAS Nº 85622-93-1, TEMODAR®, TEMODAL®, Schering Plough), tamoxifeno ((Z)-2-[4-(1,2-difenilbut-1-enil)fenoxi]-N,N
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familia de receptores HER, es decir, HER1/EGFR, HER3, y HER4 (Agus et al (2002) Cancer Cell 2: 127-37; Jackson et al (2004) Cancer Res 64: 2601-9; Takai et al (2005) Cancer 104: 2701-8; documento de Patente de Estados Unidos N. US 6949245). En las células cancerosas, la interferencia con la capacidad de HER2 para colaborar con otros receptores de la familia HER bloquea la señalización celular y por último puede conducir a la inhibición del
5 crecimiento de células cancerosas y a la muerte de la célula cancerosa. Los HDI, debido a su modo de acción único, tienen el potencial de trabajar en una amplia diversidad de tumores, incluyendo los que no sobreexpresan HER2 (Mullen et al (2007) Molecular Cancer Therapeutics 6: 93-100).
El pertuzumab se basa en las secuencias de armazón de la IgG1 (K) humana. Consiste en dos cadenas pesadas y dos cadenas ligeras. Al igual que el trastuzumab, el pertuzumab se dirige contra el dominio o extracelular de HER2. Sin embargo, se diferencia del trastuzumab en las regiones de unión al epítopo de la cadena ligera y de la cadena pesada. Como resultado, el pertuzumab se une a un epítopo dentro de lo que se conoce como un subdominio 2 de HER2, mientras que el epítopo del trastuzumab se localiza en el subdominio 4 (Cho et al. 2003; Franklin et al. 2004). El pertuzumab actúa bloqueando la asociación de HER2 con otros miembros de la familia HER, incluyendo a HER1
15 (receptor del factor de crecimiento epidérmico; EGFR), HER3, y HER4. Esta asociación se requiere para la señalización en presencia de ligando a través de MAP-quinasa y PI3-quinasa. Como resultado, el pertuzumab inhibe la señalización intracelular iniciada por ligando. La inhibición de estas rutas de señalización puede dar como resultado una parada del crecimiento y apoptosis, respectivamente (Hanahan y Weinberg 2000). Dado que pertuzumab y trastuzumab se unen a distintos epítopos en el receptor HER2, la señalización corriente abajo activada por ligando se bloquea con pertuzumab pero no con trastuzumab. Por lo tanto, el pertuzumab puede no requerir la sobreexpresión de HER2 para ejercer su actividad como un agente antitumoral. Además, debido a sus modos de acción complementarios, la combinación de pertuzumab y T-DM1 puede tener un papel potencial enfermedades que sobreexpresan HER2.
25 El pertuzumab se ha evaluado como un solo agente en cinco estudios en Fase II realizados en diversos tipos de cáncer, incluyendo MBC que expresa niveles bajos de HER2, cáncer de pulmón no microcítico, cáncer de próstata resistente a hormonas, y cáncer de ovarios. Un ensayo en Fase II evaluó al pertuzumab como un agente solo en el tratamiento de segunda o tercera línea de pacientes con cáncer de mama metastásico (MBC) con una expresión normal de HER2 (Cortes et al. (2005) J. Clin. Oncol. 23: 3068). El pertuzumab se ha evaluado in dos estudios en Fase II en combinación con trastuzumab (Baselga J, et al. "A Phase II trial of trastuzumab and pertuzumab in patients with HER2-positive metastatic breast cancer that had progressed during trastuzumab therapy: full response data", European Society of Medical Oncology, Estocolmo, Suecia, 12-16 de septiembre de 2008; Gelmon et al (2008)
J. Clin. Oncol. 26: 1026). El primer estudio incluyó a 11 pacientes con MBC positivo para HER2 que previamente recibieron hasta tres regímenes anteriores que contenían trastuzumab (Portera et al. 2007).
35 El bevacizumab (N.º de Reg. CAS 216974-75-3, AVASTIN®, Genentech) es un anticuerpo monoclonal anti-VEGF contra el factor de crecimiento del endotelio vascular (documentos de Patente de Estados Unidos N.ºs US 7227004; US 6884879; US 7060269; US 7169901; US 7297334) usada en el tratamiento de cáncer, en el que inhibe el crecimiento del tumor mediante el bloqueo de la formación de nuevos vasos sanguíneos. El bevacizumab fue el primer inhibidor de la angiogénesis clínicamente disponible en Estados Unidos, aprobado por la FDA en 2004 para su uso en combinación con quimioterapia convencional en el tratamiento de cáncer de colon metastásico en la mayoría de las formas de cáncer de pulmón no microcítico metastásico. Se realizaron varios estudios clínicos del estadio tardío para determinar su seguridad y eficacia para pacientes con: cáncer de colon adyuvante / no metastásico, cáncer de mama metastásico, carcinoma de células renales metastásico, glioblastoma multiforme
45 metastásico, cáncer de ovarios metastásico, cáncer de próstata resistente a hormonas metastásico, y cáncer pancreático localmente avanzado metastásico o no extirpable.
Un anticuerpo anti-VEGF normalmente no se unirá a otros homólogos de VEGF tales como VEGF-B o VEGF-C, ni a otros factores de crecimiento tales como P1GF, PDGF o bFGF. Los anticuerpos anti-VEGF preferentes incluyen un anticuerpo monoclonal que se une al mismo epítopo que el anticuerpo anti-VEGF monoclonal A4.6.1 producido por ATCC HB 10709 de hibridoma; un anticuerpo monoclonal anti-VEGF humanizado recombinante generado de acuerdo con Presta et al. (1997) Cancer Res. 57: 4593-4599, que incluye, pero no se limita a, bevacizumab. El bevacizumab incluye regiones marco conservadas de IgG1 humana mutada y regiones determinantes de la complementariedad de unión a antígeno a partir del anticuerpo monoclonal anti-hVEGF murino, A.4.6.1, que bloquea
55 la unión del VEGF humano a sus receptores. Aproximadamente un 93 % de la secuencia de aminoácidos de bevacizumab, incluyendo la mayor parte de las regiones marco conservadas, se obtiene a partir de IgG1 humana, y aproximadamente un 7 % de la secuencia se obtiene a partir del anticuerpo murino A4.6.1. El bevacizumab tiene una masa molecular de aproximadamente 149.000 daltons y está glicosilado. El bevacizumab y otros anticuerpos anti-VEGF humanizados se describen adicionalmente en el documento de Patente de Estados Unidos N.º 6884879. Los anticuerpos anti-VEGF adicionales incluyen los anticuerpos de la serie G6 o B20 (por ejemplo, G6-31, B20-4.1), como se describe en una cualquiera de las Figuras 27-29 del documento WO2005/012359. En una realización, el anticuerpo de la serie B20 se une a un epítopo funcional en epi VEGF humano que comprende los restos F17, M18, D19, Y21, Y25, Q89, I91, K101, E103, y C104.
65 Las líneas de células de hibridoma que expresan anti-VEGF A 4.6.1 (ATCC HB 10709) y B 2.6.2 (ATCC HB 10710) se han depositado y mantenido en la Colección Americana de Cultivos Tipo (ATCC), 10801 University Boulevard,
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