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ES2545977T3 - Combinaciones de un conjugado de anticuerpo-fármaco anti-HER2 y agentes quimioterapéuticos, y métodos de uso - Google Patents

Combinaciones de un conjugado de anticuerpo-fármaco anti-HER2 y agentes quimioterapéuticos, y métodos de uso Download PDF

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Publication number
ES2545977T3
ES2545977T3 ES09721522.2T ES09721522T ES2545977T3 ES 2545977 T3 ES2545977 T3 ES 2545977T3 ES 09721522 T ES09721522 T ES 09721522T ES 2545977 T3 ES2545977 T3 ES 2545977T3
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Prior art keywords
combinations
methods
chemotherapeutic agents
drug conjugate
her2 antibody
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ES09721522.2T
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Inventor
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 de una combinación terapéutica como una formulación combinada o de forma alterna a un mamífero, en donde la combinación terapéutica comprende una cantidad terapéuticamente eficaz de trastuzumab-MCC-DM1 y una cantidad terapéuticamente eficaz de un agente quimioterapéutico seleccionado entre GDC-0941 y GNE-390.

Description

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E09721522
24-08-2015
regular o inhibir la acción hormonal en tumores tales como antiestrógenos y modulador selectivos de receptores de estrógenos (SERM), que incluyen, por ejemplo, tamoxifeno (NOLVADEX®; citrato de tamoxifeno), raloxifeno, droloxifeno, 4-hidroxitamoxifeno, trioxifeno, keoxifeno, LY117018, onapristona, y FARESTON® (citrato de toremifina); (ii) inhibidores de aromatasas que inhiben la enzima aromatasa, que regula la producción de estrógenos 5 en las glándulas adrenales, tales como, por ejemplo, 4(5)-imidazoles, aminoglutetimida, MEGASE® (acetato de megestrol), AROMASIN® (exemestano; Pfizer), formestano, fadrozol, RIVISOR® (vorozol), FEMARA® (letrozol; Novartis), y ARIMIDEX® (anastrozol; AstraZeneca); (iii) antiandrógenos tales como flutamida, nilutamida, bicalutamida, leuprolida, y goserelina; así como troxacitabina (un análogo de citosina de nucleósido de 1,3dioxolano); (iv) inhibidores de la proteína quinasa tales como inhibidores MEK (documento de patente WO 2007/044515); (v) inhibidores de quinasa lípida; (vi) oligonucleótidos antisentido, en particular los que inhiben la expresión de genes en rutas de señalización implicadas en la proliferación celular anómala, por ejemplo, PKC-alfa, Raf y H-Ras, tal como oblimersén (GENASENSE®, Genta Inc.); (vii) ribozimas tales como inhibidores de la expresión de VEGF (por ejemplo, ANGIOZYME®) e inhibidores de la expresión de HER2; (viii) vacunas tales como vacunas para terapia genética, por ejemplo, ALLOVECTIN®, LEUVECTIN®, y VAXID®; PROLEUKIN® rIL-2;
15 inhibidores de la topoisomerasa 1 tales como LURTOTECAN®; ABARELIX® rmRH; (ix) agentes antiangiogénicos tales como bevacizumab (AVASTIN®, Genentech); y sales, ácidos y derivados farmacéuticamente aceptables de cualquiera de los mencionados anteriormente.
En la definición de "agente quimioterapéutico" también se incluyen anticuerpos terapéuticos tales como alemtuzumab (Campath), bevacizumab (AVASTIN®, Genentech); cetuximab (ERBITUX®, Imclone); panitumumab (VECTIBIX®, Amgen), rituximab (RITUXAN®, Genentech Biogen Idec), pertuzumab (OMNITARG™, 2C4, Genentech), trastuzumab (HERCEPTIN®, Genentech), tositumomab (Bexxar, Corixia), y el conjugado de anticuerpos-fármaco, gemtuzumab ozogamicina (MYLOTARG®, Wyet).
25 Algunos anticuerpos monoclonales humanizados con potencial terapéutico como agentes quimioterapéuticos en combinación con trastuzumab-MCC-DM1 incluyen: alemtuzumab, apolizumab, aselizumab, atlizumab, bapineuzumab, bevacizumab, bivatuzumab mertansina, cantuzumab mertansina, cedelizumab, certolizumab pegol, cidfusituzumab, cidtuzumab, daclizumab, eculizumab, efalizumab, epratuzumab, erlizumab, felvizumab, fontolizumab, gemtuzumab ozogamicin, inotuzumab ozogamicina, ipilimumab, labetuzumab, lintuzumab, matuzumab, mepolizumab, motavizumab, motovizumab, natalizumab, nimotuzumab, nolovizumab, numavizumab, ocrelizumab, omalizumab, palivizumab, pascolizumab, pecfusituzumab, pectuzumab, pertuzumab, pexelizumab, ralivizumab, ranibizumab, reslivizumab, reslizumab, resivizumab, rovelizumab, ruplizumab, sibrotuzumab, siplizumab, sontuzumab, tacatuzumab tetraxetano, tadocizumab, talizumab, tefibazumab, tocilizumab, toralizumab, trastuzumab, tucotuzumab celmoleuquina, tucusituzumab, umavizumab, urtoxazumab, y visilizumab.
35 Un "metabolito" es un producto producido durante el metabolismo en el organismo de un compuesto o sal específicos del mismo. Algunos metabolitos de un compuesto se pueden identificar usando técnicas de rutina conocidas en la técnica y de terminar sus actividades usando ensayos tales como los que se describen en el presente documento. Tales productos pueden resultar por ejemplo de la oxidación, reducción, hidrólisis, amidación, desamidación, esterificación, desesterificación, escisión enzimática, y similares, del compuesto administrado. Por consiguiente, la invención incluye metabolitos de compuestos de la invención, que incluyen compuestos producidos mediante un proceso que comprende poner en contacto un compuesto de la presente invención con un mamífero durante un periodo de tiempo suficiente para proporcionar un producto metabólico del mismo.
45 La expresión "prospecto" se usa para hacer referencia a instrucciones incluidas habitualmente en envases comerciales de productos terapéuticos, que contienen información aproximada sobre las indicaciones, uso, dosificación, administración, contraindicaciones y/o advertencias con respecto al uso de tales productos terapéuticos.
La expresión "sal farmacéuticamente aceptable" como se usa en el presente documento, se refiere a sales orgánicas
o inorgánicas farmacéuticamente aceptables de un compuesto de la invención. Algunas sales a modo de ejemplo incluyen, pero no se limitan a, sales de sulfato, citrato, acetato, oxalato, cloruro, bromuro, yoduro, nitrato, bisulfato, fosfato, fosfato ácido, isonicotinato, lactato, salicilato, citrato ácido, tartrato, oleato, tannato, pantotenato, bitartrato, ascorbato, succinato, maleato, gentisinato, fumarato, gluconato, glucuronato, sacarato, formato, benzoato,
55 glutamato, metanosulfonato "mesilato", etanosulfonato, bencenosulfonato, p-toluenosulfonato, y pamoato (es decir, 1,1’-metilen-bis-(2-hidroxi-3-naftoato)). Una sal farmacéuticamente aceptable puede implicar la inclusión de otra molécula tal como un ión acetato, un ión succinato u otro contraión. El contraión puede ser cualquier resto orgánico o inorgánico que estabiliza la carga en el compuesto precursor. Además, una sal farmacéuticamente aceptable puede tener más de un átomo cargado en su estructura. Algunos ejemplos en los que múltiples átomos cargados forman parte de la sal farmacéuticamente aceptable pueden tener múltiples contraiones. Por lo tanto, una sal farmacéuticamente aceptable puede tener uno o más átomos cargados y/o uno o más contraiones.
Si el compuesto de la invención es una base, la sal farmacéuticamente aceptable deseada se puede preparar mediante cualquier método adecuado disponible en la técnica, por ejemplo, tratamiento de la base libre con un ácido 65 inorgánico, tal como ácido clorhídrico, ácido bromhídrico, ácido sulfúrico, ácido nítrico, ácido metanosulfónico, ácido fosfórico y similares, o con un ácido orgánico, tal como ácido acético, ácido maleico, ácido succínico, ácido
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