CN116997566A - 用PDGFRα抑制剂治疗癌症的方法 - Google Patents
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Abstract
用人血小板衍生生长因子受体α抑制化合物治疗癌症患者的方法,其中所述患者被鉴定为患有人血小板衍生生长因子受体β阴性的癌症。
Description
本发明涉及癌症领域。更具体地,本发明涉及用血小板衍生生长因子受体α(“PDGFRα”)抑制化合物治疗癌症患者。甚至更具体地,本发明涉及用PDGFRα抑制化合物治疗癌症患者,其中所述癌症患者被鉴定为PDGFRβ(“PDGFRβ”)阴性。
癌症是一种具有广泛组织临床异质性(包括肿瘤形态和生理学的巨大变异)的疾病。尽管一些常规的组织学和临床特征与预后相关,但范围从细胞水平到组织水平的各种癌症形式间的巨大异质性影响对疗法的响应以及随后对患者的益处。因此,选择性治疗将从特定治疗受益的癌症患者继续构成挑战。
PDGFRα抑制化合物已经在临床前和临床研究中显示作为癌症治疗剂的前景。尽管存在这种前景,PDGFRα抑制化合物在一些肿瘤学临床试验中未能达到治疗终点。例如,在治疗软组织肉瘤的临床试验中,(特异性结合人PDGFRα的抗体)未能达到某些治疗终点。因此,需要用PDGFRα抑制化合物治疗患者的改进方法。具体而言,此类方法应当为用PDGFRα抑制化合物治疗的癌症患者提供预后、诊断或预测价值。本公开通过提供用PDGFRα抑制化合物治疗癌症患者的方法解决了该需求。
尽管在一些情况下,用于治疗特定类型的癌症或用特定疗法治疗患者的方法已显示前景,但关于使用PDGFRα抑制性化合物治疗癌症患者,目前不存在可靠的方法。本公开令人惊讶地提供了用PDGFRα抑制化合物治疗癌症患者的方法,其为用PDGFRα抑制化合物治疗的癌症患者提供了预后、诊断或预测价值。更具体地,本公开的实施方案提供了通过施用PDGFRα抑制化合物来治疗患有人PDGFRβ阴性癌症的癌症患者的方法。
本公开的实施方案进一步提供了治疗有此需要的患者中的癌症的方法,其包括向所述患者施用有效量的PDGFRα抑制化合物。具体地,本公开的实施方案提供了治疗有此需要的患者中的癌症的方法,其包括向所述患者施用有效量的PDGFRα抑制化合物,其中所述患者被鉴定为患有人PDGFRβ阴性的癌症。在又另一个实施方案中,本公开提供了治疗患有人PDGFRβ阴性癌症的患者的方法,其包括向所述患者施用有效量的PDGFRα抑制化合物。
因此,本公开的实施方案提供了治疗患者中的癌症的方法,其包括将患者鉴定为患有人PDGFRβ阴性的癌症。在一个实施方案中,本公开提供了治疗有此需要的患者中的癌症的方法,其包括将所述患者鉴定为患有人PDGFRβ阴性的癌症,和向所述患者施用有效量的PDGFRα抑制化合物。在一个进一步实施方案中,本公开提供了通过向有此需要的患者施用有效量的PDGFRα抑制化合物来治疗所述患者中的癌症的方法,其中所述患者被鉴定为患有人PDGFRβ阴性和人PDGFRα阳性的癌症。
在本公开的一些实施方案中,将患者鉴定为患有人PDGFRβ阴性的癌症的方法包括,将来自所述患者的生物样品与特异性结合人PDGFRβ的抗体接触,和检测所述抗体与所述生物样品中的人PDGFRβ的结合。
根据本公开的实施方案,提供了检测生物样品中的PDGFRβ的方法。此类方法包括对来自所述患者的生物样品进行测定。本公开的实施方案进一步提供了这样的方法,其包括将所述生物样品与特异性结合人PDGFRβ的抗体接触,和检测所述抗体与所述生物样品中的人PDGFRβ的结合。
根据本公开的实施方案,提供了将具有癌症的患者诊断为需要用PDGFRα抑制化合物治疗的方法。此类方法包括将所述患者鉴定为患有人PDGFRβ阴性的癌症。此类方法进一步包括对来自所述患者的生物样品进行测定。本公开的实施方案进一步提供了这样的方法,其包括将所述生物样品与特异性结合人PDGFRβ的抗体接触,和检测所述抗体与所述生物样品中的人PDGFRβ的结合。
根据本公开的实施方案,提供了定量生物样品中的人PDGFRβ的方法。此类方法包括将来自患者的生物样品与特异性结合人PDGFRβ的抗体接触,和检测所述抗体与所述生物样品中的人PDGFRβ的结合。
在本公开的一个实施方案中,当生物样品中的PDGFRβ被确定为存在于生物样品的小于约10%的肿瘤细胞中时,所述生物样品被确定为PDGFRβ阴性。在还有其他实施方案中,当生物样品中的PDGFRβ被确定为存在于生物样品的大于或等于约10%的肿瘤细胞中时,所述生物样品被确定为PDGFRβ阳性。在本公开的一个进一步实施方案中,如果来自所述患者的生物样品被确定为PDGFRα阴性,则向所述患者施用PDGFRα抑制化合物。
在具体实施方案中,本公开提供了将癌症患者诊断为需要用PDGFRα抑制化合物治疗的方法,其包括以下步骤:从所述患者获得生物样品;使所述生物样品与特异性结合人PDGFRβ的抗体或其抗原结合片段接触,其中形成所述抗体或其抗原结合片段和人PDGFRβ的复合物;使人PDGFRβ抗体或其抗原结合片段和人PDGFRβ的复合物与第二抗体或其抗原结合片段接触,其中所述第二抗体包含可检测标记物;检测由所述可检测标记物提供的信号;和其中,如果来自所述癌症患者的生物样品被确定为PDGFRβ阴性,则所述癌症患者被诊断为需要用PDGFRα抑制化合物治疗。在一个进一步实施方案中,本公开包括如果所述生物样品被确定为PDGFRβ阴性,则向所述癌症患者施用有效量的PDGFRα抑制化合物的步骤。
本公开的一个实施方案提供了将癌症患者诊断为需要用特异性结合人PDGFRα的抗体或其抗原结合片段治疗的体外方法,其包括:从所述患者获得生物样品;使所述生物样品与特异性结合人PDGFRβ的抗体或其抗原结合片段接触,其中形成所述PDGFRβ抗体或其抗原结合片段和人PDGFRβ的复合物;除去任何非特异性结合的PDGFRβ抗体或其抗原结合片段;检测和定量生物样品中的人PDGFRβ;并且其中,如果来自所述癌症患者的生物样品被确定为PDGFRβ阴性,则所述癌症患者被诊断为需要用特异性结合人PDGFRα的抗体或其抗原结合片段治疗。在又进一步实施方案中,检测生物样品中的人PDGFRβ的步骤包括用第二抗体或其抗原结合片段检测所述PDGFRβ抗体或其抗原结合片段和所述生物样品中的人PDGFRβ的复合物。在本公开的又甚至进一步实施方案中,PDGFRβ抗体或其抗原结合片段、或第二抗体或其抗原结合片段中的至少一种包含可检测标记物。在又一个进一步实施方案中,所述检测生物样品中的人PDGFRβ的步骤包括在形成包含PDGFRβ抗体和人PDGFRβ或第二抗体和人PDGFRβ的复合物后,检测由所述可检测标记物提供的信号。在又一个进一步实施方案中,所述检测生物样品中的人PDGFRβ的步骤包括在形成包含所述抗体、人PDGFRβ和第二抗体的复合物后,检测由所述可检测标记物提供的信号。
本公开的进一步实施方案包括如果所述生物样品被确定为PDGFRβ阴性,则向所述癌症患者施用有效量的特异性结合PDGFRα的抗体的步骤。
在本公开的实施方案中,所述PDGFRα抑制化合物是抗体或其抗原结合片段。在本公开的其他实施方案中,所述PDGFRα抑制化合物是小分子抑制剂。在具体实施方案中,所述PDGFRα抑制化合物是特异性结合PDGFRα的抗体。在甚至更具体实施方案中,所述特异性结合PDGFRα的抗体是奥拉单抗。在一些实施方案中,所述PDGFRα抑制化合物是抗体药物缀合物。在一些实施方案中,所述PDGFRα抑制化合物是这样的抗体,其中所述抗体用放射性药物靶向剂标记。
根据一些实施方案,提供了特异性结合PDGFRα的抗体。在更具体实施方案中,特异性结合PDGFRα的抗体包含重链可变区(VH)和轻链可变区(VL),其中所述VH包含重链互补决定区(HCDR)HCDR1、HCDR2和HCDR3,且所述VL包含轻链互补决定区(LCDR)LCDR1、LCDR2和LCDR3,其中:HCDR1包含SEQ ID NO:5,HCDR2包含SEQ ID NO:6,HCDR3包含SEQ ID NO:7,LCDRI包含SEQ ID NO:8,LCDR2包含SEQ ID NO:9,且LCDR3包含SEQ ID NO:10。在一个进一步实施方案中,特异性结合PDGFRα的抗体的VH包含SEQ ID NO:3且VL包含SEQ ID NO:4。在又甚至进一步实施方案中,特异性结合PDGFRα的抗体包含重链(HC)和轻链(LC),其中HC包含SEQ ID NO:1且LC包含SEQ ID NO:2。在又一个具体实施方案中,所述特异性结合PDGFRα的抗体是奥拉单抗。
在本公开的又进一步实施方案中,将有效量的特异性结合PDGFRα的抗体或其抗原结合片段施用于被鉴定为患有人PDGFRβ阴性的癌症的患者。在此类实施方案中,向被鉴定为患有人PDGFRβ阴性的癌症的患者,在第一个21天周期的第1天和第8天的每一天或在第一个28天周期的第1天和第8天的每一天以约15mg/kg、或约20mg/kg、或约25mg/kg的负荷剂量施用有效量的抗体或其抗原结合片段,随后在后续21天周期的第1天和第8天的每一天或在后续28天周期的第1天和第8天的每一天以约15mg/kg、约20mg/kg或约25mg/kg向所述患者施用标准剂量的所述抗体或其抗原结合片段。在又一个进一步实施方案中,所述抗体或其抗原结合片段与一种或多种化疗剂同时、分开或依次组合施用。在一个实施方案中,所述化疗剂包括nab-紫杉醇、多柔比星、吉西他滨或多西他赛中的至少一种。
在本公开的又进一步实施方案中,将有效量的奥拉单抗施用于被鉴定为患有人PDGFRβ阴性的癌症的患者。在此类实施方案中,向被鉴定为患有人PDGFRβ阴性的癌症的患者,在第一个21天周期的第1天和第8天的每一天或在第一个28天周期的第1天和第8天的每一天以约15mg/kg、或约20mg/kg、或约25mg/kg的负荷剂量施用有效量的奥拉单抗,随后在后续21天周期的第1天和第8天的每一天或在后续28天周期的第1天和第8天的每一天以约15mg/kg、约20mg/kg或约25mg/kg向所述患者施用标准剂量的奥拉单抗。在又一个进一步实施方案中,奥拉单抗与一种或多种化疗剂同时、分开或依次组合施用。在一个实施方案中,所述化疗剂包括nab-紫杉醇、多柔比星、吉西他滨或多西他赛中的至少一种。
在本发明的一些实施方案中,被确定为PDGFRβ阴性的癌症是软组织肉瘤、胰腺癌、子宫内膜癌、卵巢癌、骨肉瘤、软骨肉瘤、横纹肌肉瘤、乳腺癌、骨癌或前列腺癌。在一些实施方案中,所述癌症是平滑肌肉瘤。在一些实施方案中,所述癌症是脂肪肉瘤。在本公开的一个实施方案中,所述癌症是原发性肿瘤。在一个实施方案中,所述癌症是转移性癌症。在还有其他实施方案中,所述癌症已经转移。在本公开的具体实施方案中,所述患者是女性,且所述女性被确定为患有PDGFRβ阴性癌症。
血小板衍生生长因子受体α(,PDGFRα)和血小板衍生生长因子受体β(PDGFRβ)属于III型酪氨酸激酶受体(RTK)家族,并且与各种癌症类型有关。PDGFRα已被认为是各种癌症类型中肿瘤增殖、血管生成和转移性播散中的相关因素。
如本文可互换使用的术语“PDGFRα抑制化合物”或“PDGFRα抑制剂”是减少、阻断、抑制、废除或干扰由PDGFRα与其配体或结合配偶体中的一种或多种相互作用产生的信号转导的化合物。PDGFRα抑制化合物可以是细胞外抑制剂或细胞内抑制剂,并且可以采用多于一种抑制剂。细胞外抑制剂包括但不限于结合PDGFRα或其配体(例如PDGF-AA、-AB、-BB、-CC)中的一种或多种的化合物。细胞内抑制剂包括但不限于小分子受体酪氨酸激酶抑制剂。PDGFRα抑制化合物的非限制性实例包括抗体、其抗原结合片段、小分子抑制剂、抗体药物缀合物、融合蛋白、免疫粘附素分子和寡肽。
如本文所用的术语“抗体”和“其抗原结合片段”是指特异性结合抗原的免疫球蛋白分子。在一个实施方案中,所述抗体或其抗原结合片段特异性结合PDGFRα。本公开的示例性抗体是免疫球蛋白G1型(IgG1)抗体或其抗原结合片段。根据具体实施方案,此类抗体或其抗原结合片段包含重链可变区(VH)和轻链可变区(VL),其中所述VH包含CDR HCDR1、HCDR2和HCDR3且所述VL包含互补决定区(CDR)LCDR1、LCDR2和LCDR3,其中HCDR1具有SEQ IDNO:3的氨基酸序列,HCDR2具有SEQ ID NO:4的氨基酸序列,且HCDR3具有SEQ ID NO:5的氨基酸序列,LCDR2具有SEQ ID NO:6的氨基酸序列,LCDR2具有SEQ ID NO:7的氨基酸序列,且LCDR3具有SEQ ID NO:8的氨基酸序列。根据本发明提供的抗体或其抗原结合片段的一些实施方案,所述VH具有SEQ ID NO:3的氨基酸序列,且所述VL具有SEQ ID NO:4的氨基酸序列。根据一些实施方案,本公开提供的抗体或其抗原结合片段包含轻链(LC)和重链(HC),其中所述HC具有SEQ ID NO:1的氨基酸序列,且所述LC具有SEQ ID NO:2的氨基酸序列。在本公开的一个实施方案中,所述抗体是奥拉单抗。
根据一些实施方案,本公开的抗体可以被人源化。在一些实施方案中,本公开的抗体包含IgG1重链。在一些实施方案中,本公开的抗体包含κ轻链。根据甚至进一步实施方案,本公开提供了药物组合物,其包含本公开的抗体和一种或多种药学上可接受的载体、稀释剂或赋形剂。
抗体的实施方案包括单克隆抗体、多克隆抗体、人抗体、人源化抗体、嵌合抗体、双特异性或多特异性抗体、或缀合抗体。所述抗体可以是任何类别(例如IgG、IgE、IgM、IgD、IgA)和任何亚类(例如,IgG1、IgG2、IgG3、IgG4)的。
可根据众所周知的方案(包括Kabat(Kabat等人,“Sequences of Proteins ofImmunological Interest,”National Institutes of Health,Bethesda,Md.(1991));Chothia(Chothia等人,“Canonical structures for the hypervariable regions ofimmunoglobulins”,Journal of Molecular Biology,196,901-917(1987);Al-Lazikani等人,“Standard conformations for the canonical structures of immunoglobulins”,Journal of Molecular Biology,273,927-948(1997));North(North等人,“A NewClustering of Antibody CDR Loop Conformations”,Journal of Molecular Biology,406,228-256(2011))或IMGT(在www.imgt.org可得的国际ImMunoGeneTics数据库;参见Lefranc等人,Nucleic Acids Res.1999;27:209-212)中描述的那些),将氨基酸残基分配给CDR。
如本文所用的术语“特异性结合PDGFRα”或“结合PDGFRα”是指抗体与如例如NCBI参考序列P16234.1(SEQ ID NO:11)中提供的人PDGFRα的表位区域的相互作用。如本文所用,术语“特异性结合PDGFRβ”或“结合PDGFRβ”是指抗体与如例如NCBI参考序列P09619.1(SEQ ID NO:12)中提供的人PDGFRβ的表位区域的相互作用。
如本文所用的术语“PDGFRβ阴性”或“PDGFRβ阳性”是指患者的癌症形式是PDGFRβ阴性癌症形式还是PDGFRB阳性癌症形式。如本文详述,可以基于定性或定量测定来确定患者的癌症形式是PDGFRβ阴性癌症形式还是PDGFRβ阳性癌症形式。根据本文的实施方案,患者的癌症形式是PDGFRβ阴性癌症形式还是PDGFRβ阳性癌症形式可以基于当与参考值相比时来自癌症患者的生物样品中存在的PDGFRβ的近似水平的评价来确定。根据更具体的实施方案,当生物样品中存在的PDGFRβ的近似水平低于来自患者的生物样品中肿瘤细胞的约10%(如通过IHC测定法所确定)时,确定患者具有PDGFRβ阴性形式的癌症。在另一个实施方案中,基于如通过使用参考值的分级系统所确定的PDGFRβ水平,患者被确定为具有PDGFRβ阴性形式的癌症。
如通过本公开的测定法或本领域已知的测定法所提供的PDGFRβ水平可以是绝对值(例如,生物样品内的水平)或相对值(例如,与参考相比的水平)。肿瘤细胞中PDGFRβ的水平可以经由测定法评估,所述测定法包括但不限于免疫组织化学(IHC)、聚合酶链式反应(PCR)、定量、定性或半定量逆转录PCR(RT-PCR)、应用IHC的自动化或半自动图像分析或蛋白表达或mRNA表达的其他定量/半定量/定性评价、扫描载片或其他实验室获取的蛋白表达数据的人工智能分析、明场原位杂交(BRISH)、荧光原位杂交(RNA FISH)、蛋白免疫荧光、定量/半定量/定性蛋白质组学方法、细胞学测定和RNA测序。
如本文所用的“参考值”是指参考值的已知或近似水平,其可以是绝对或相对水平、范围、最低水平、平均水平、阈值水平和/或中值水平。另外,参考值也可以充当基线或阈值。根据如本文所用的一个具体实施方案,PDGFRβ的“参考值”表明患者的癌症形式是PDGFRβ阴性癌症形式还是阳性癌症形式。
本文可互换使用的术语“生物样品”或“患者样品”是指人样品。用于本发明中的生物样品的非限制性来源包括癌症、肿瘤、肿瘤活检样品、活检抽吸物、实体组织、肿瘤细胞和转移性、迁移性、循环肿瘤细胞。另外,生物样品还可以指血液、血浆、血清、淋巴液、腹水、流体提取物、皮肤外部切片、呼吸道、鼻腔、肠道和泌尿生殖道、泪液、唾液、乳汁、器官、细胞培养物和/或细胞培养成分。
如本文所用的术语“约”意指5%以内。
如本文所用的术语“癌症”是哺乳动物中病理学特征在于生理病况的疾病,其典型特征在于不受调节的细胞增殖、永生性、转移潜力、快速生长和增殖速率、和/或某些特征性形态学特征。通常,癌细胞呈肿瘤形式,但此类细胞可单独存在或可作为独立细胞在血流中循环,诸如白血病细胞,或转移性、迁移性或循环性肿瘤细胞。癌症可以是实体瘤或白血病。肿瘤可以是良性的、恶性的或休眠的,并且也可以被表征为原发性肿瘤或转移性肿瘤。在一些实施方案中,癌症的非限制性实例包括软组织肉瘤、胰腺癌、子宫内膜癌、骨肉瘤、软骨肉瘤、横纹肌肉瘤、乳腺癌、骨癌、前列腺癌、胃肠癌、结肠癌、鳞状细胞癌、头颈癌、小细胞肺癌、非小细胞肺癌、胶质母细胞瘤、宫颈癌、卵巢癌、膀胱癌、肝癌、结肠直肠癌、唾液腺癌、肾癌、外阴癌、甲状腺癌、肝癌和/或喉癌。
如本文所用的术语“软组织肉瘤”或“STS”是一种始于连接、支撑和包围其他身体结构的组织的癌症类型。这包括脂肪、肌肉、纤维组织、血管、神经、肌腱、关节内膜或深层皮肤组织和/或关节内膜。它们可以在身体的任何部位找到。存在超过50种亚型的软组织肉瘤。STS的类型包括但不限于血管肉瘤、隆突性皮肤纤维肉瘤、上皮样肉瘤、胃肠道间质瘤(GIST)、卡波西肉瘤、脂肪肉瘤、恶性外周神经鞘瘤、粘液纤维肉瘤、横纹肌肉瘤、孤立性纤维瘤、滑膜肉瘤或未分化的多形性肉瘤。
化疗剂是选择性破坏癌细胞和组织的化学剂或药物。化疗剂可包括但不限于化合物,诸如紫杉烷化合物、通过紫杉烷机制起作用的化合物、铂化合物、蒽环类化合物、抗代谢物、表鬼臼毒素化合物、喜树碱化合物或其任何组合。化疗药物可以单独施用或与其他治疗剂联合施用。在一些实施方案中,所述化疗剂包括nab-紫杉醇、多柔比星、多西他赛或吉西他滨。
如本文所用的术语“诊断”用于指分子或病理状态、疾病或病况(例如,癌症)的鉴定或分类。例如,“诊断”可以指特定类型癌症的鉴定。“诊断”也可以指特定亚型癌症的分类,例如通过组织病理学标准,或通过分子特征(例如,以一种生物标志物或生物标志物组合的表达为特征的亚型(例如,特定基因或由所述基因编码的蛋白,或特定基因或由所述基因编码的蛋白的表达水平))。
本公开的实施方案还涉及由医学专业人员使用本文公开的方法进行的受试者的临床诊断或预后的方法。如本文所述的方法可以例如由个体、健康专业人员或第三方(例如解释来自受试者的信息的服务提供者)进行。如本文所解释,医疗专业人员可以在接收关于本公开的诊断方法的信息后开始或修改治疗。例如,医疗专业人员可能推荐疗法、疗法改变或额外的诊断评价。
如本文所用的术语“治疗(treat)”或“治疗(treating)”或“治疗(treatment)”是指涉及减缓、中断、停滞、控制、停止、减少、消退和/或逆转现有疾病、诸如癌症的进展或严重程度的过程,但不一定涉及疾病或疾病状态的完全消除。
如本文所用的术语“有效量”是指将引起受试者的生物或医学应答、例如酶或蛋白活性的减少或抑制、或改善症状、减轻病况、减缓或延迟疾病进展、或预防疾病等的蛋白或核酸或载体或组合物或抑制性化合物的量。在一个非限制性实施方案中,术语“有效量”是指当施用于受试者时,有效地至少部分地减轻、抑制、预防和/或改善病况或病症或疾病以实现期望的治疗结果的蛋白或核酸或载体或组合物或抑制化合物的必需量(剂量和时间段以及施用方式)。蛋白或核酸或载体或组合物或抑制化合物的有效量可以根据诸如个体的疾病类型和状态、年龄、性别和体重以及蛋白或核酸或载体或组合物或治疗剂、诸如抗体在个体中引发期望的应答的能力等因素而变化。有效量也是其中本发明的蛋白或核酸或载体或组合物或抑制性化合物的任何毒性或有害作用被其治疗有益效果胜过的量。
如本文中可互换使用的术语“患者”、“受试者”和“个体”是指人。在某些实施方案中,患者的特征还在于疾病、病症或病况(例如,癌症)。在另一个实施方案中,患者的特征还在于处于发展病症、疾病或病况(癌症或肿瘤的转移、生长、扩散)的风险中并且将受益于癌症或肿瘤的转移、生长、扩散的风险的降低。
本发明的抗体可以掺入药物组合物中,所述药物组合物可以通过本领域众所周知的方法制备,并且包含本发明的抗体和一种或多种药学上可接受的载体和/或稀释剂(例如,Remington,The Science and Practice of Pharmacy,第22版,Loyd V.编,Pharmaceutical Press,2012,其提供了从业者通常已知的制剂技术汇编)。用于药物组合物的合适载体包括当与本发明的抗体组合时保留分子活性并且不与患者的免疫系统反应的任何材料。包含本发明的抗体的药物组合物可以通过肠胃外途径(例如,静脉内、皮下、腹膜内、肌内或经皮)施用于处于如本文所述的疾病或病症的风险中或表现出如本文所述的疾病或病症的患者。
实施例
实施例1:PDGFRβ阴性晚期或转移性软组织肉瘤患者中的总生存期的评价
研究设计:具有晚期或转移性软组织肉瘤的患者用奥拉单抗(周期1中的21天周期的第1天和第8天为20mg/kg负荷剂量,随后在后续的21天周期中第1天和第8天为15mg/kg)联合多柔比星(在第1天75mg/m2)(“研究群组”)治疗并与用安慰剂(在第1天和第8天)加多柔比星(在第1天75mg/m2)治疗的患者(“对照群组”)进行比较。患者治疗8个周期,随后为奥拉单抗单药疗法或安慰剂,直到存在疾病进展、毒性不可接受或死亡的证据。基本上如本文所述确定患者的PDGFR肿瘤表达状态。
评价患者的中位总生存期(OS)。
测定PDGFRβ表达的方法:肿瘤细胞中的PDGFRβ表达可以经由包括但不限于如下的方法评估:免疫组织化学、定量、定性或半定量逆转录PCR(RT-PCR)、应用IHC的自动或半自动图像分析或其他蛋白表达的定量/半定量/定性评价、扫描载片或其他实验室获得的蛋白表达数据的人工智能分析、明场原位杂交(BRISH)、荧光原位杂交(RNA FISH)、蛋白免疫荧光、定量/半定量/定性蛋白质组学方法和RNA测序。
免疫组织化学测定以测定PDGFRβ表达:为了进行免疫组织化学分析,收集来自患者的肿瘤组织,福尔马林固定在10%中性缓冲福尔马林中,并进行石蜡包埋(FFPE)。通过免疫组织化学评价肿瘤细胞上的PDGFRβ蛋白表达。简而言之,从含有患者肿瘤组织的FFPE组织块获得4-6微米切片,并放置在带正电的载玻片上。抗PDGFRβ小鼠单克隆抗体2B3用于检测PDGFRβ的表达(克隆2B3,Cell Signaling 目录号3175S),在含有背景降低组分的Dako一抗稀释液(Dako/Agilent目录号S3022)中稀释至0.25μg/mL。免疫组织化学在Dako Autostainer Link 48/PT Link孵育箱上进行。用Link 48/PT Link孵育箱的脱蜡在97℃经20分钟完成。接下来,将未染色的载片浸入Dako Link48/PT Link孵育箱上的EnVisionTM FLEX目标修复溶液高pH(Dako)中,完成目标修复。在RT EnVisionTM FLEX洗涤缓冲液(1x)中冲洗后,通过FLEX过氧化物酶块进行2B3抗体的特异性免疫组织化学染色5分钟,应用0.25ug/mL浓度的抗人PDGFRβ抗体2B3并孵育60分钟,随后应用FLEX/HRP并孵育20分钟,然后应用FLEX DAB+底物显色剂10分钟,且最后应用FLEX苏木精5分钟。即用型FLEX小鼠阴性对照(Dako/Agilent目录号IR750)与PDGFRβ染色一起进行,并用作测定的质量对照(阴性对照)。然后由经过培训的人员使用明场显微镜对染色的载玻片进行评估。PDGFRβ肿瘤表达状态二分为“阳性”或“阴性”提供,其中“阳性”结果被定义为其中至少10%存在的肿瘤细胞(四舍五入到最接近的十分位)表现出至少较弱但特异性膜染色(0、1+、2+、3+染色强度等级上的1+,其中1+为最弱但仍为特异性膜染色,而3+为强且弥散的膜染色)的样品。“阴性”对应于不符合这些标准的染色。
结果:
STS患者:如表1中所表明,在研究群组中,被鉴定为具有PDGFRβ阴性肿瘤状态的STS患者具有中位OS的显著改善,为28.32个月,相比之下,对照群组中的患者为20.57个月(HR=0.85[95%CI:0.54-1.33]p=0.4861)。此外,研究群组中被鉴定为同时具有PDGFRβ阴性肿瘤状态和PDGFRα阳性肿瘤状态的患者也显示中位OS的显著改善,为28.5个月(N=66),相比之下,对照群组中为20.6个月(N=75)。然而,在其肿瘤状态被鉴定为PDGFRβ阳性(研究和对照群组分别为18.8个月和19.9个月)、PDGFRα阳性(研究和对照群组分别为17.2个月和19.1个月)和PDGFRα阴性(研究和对照群组分别为23.6个月和21.9个月)的患者中,没有观察到研究和对照群组之间的中位OS的显著差异。
表1:sTS患者的中位OS
N=在研究群组或对照群组中治疗的患者;OS=总生存期;HR=危险比:CI=置信区间,p-值=分层对数秩p-值。
LMS患者:如表2中所表明,研究群组中被鉴定为具有PDGFRβ阴性肿瘤状态的LMS患者具有中位OS显著改善,为29.11个月(N=29),相比之下,对照群组中为21.88个月(N=37)(HR=0.65[95%CI:0.33-1.25;p=0.1970)。然而,在研究群组(20.14个月;N=77)和对照群组(21.39个月;N=73)之间,被鉴定为具有PDGFRβ阳性肿瘤状态的LM S患者的中位OS没有观察到差异(HR=1.05[95%]CI0.71-1.55;p=0.7951)。
LMS女性患者:对LMS女性患者的PDGFRβ状态的分析显示,当与被鉴定为具有PDGFRβ阳性肿瘤状态的LMS女性患者的OS HR(1.34;N=115;p=0.20)相比时,被鉴定为具有PDGFRβ阴性肿瘤状态的LMS女性患者亚群的OS HR显著改善(0.55;N=53;p=0.14)。针对ECOG PS进一步调整,具有LMS的PDGFRβ阳性女性的OS HR为1.34(N=115;p=0.20),而具有LMS的PDGFRβ阴性女性的OS HR为0.55(N=53;p=0.14)。PDGFRβ阳性和阴性的LMS女性之间这种OS HR的差异导致统计学上显著的“PDGFRβ治疗”相互作用(N=168;p=0.040)。
LMS患者,其中排除具有PDGFRβ阳性肿瘤状态的LMS女性患者:如表2(其中从LMS中位0S分析中排除被鉴定为具有PDGFRβ阳性肿瘤状态的LMS女性患者的LMS患者)中所表明,观察到研究群组中28.5个月(N=58)的显著总体生存期益处,相比之下,对照群组中为20.9个月(N=61)(HR=0.60;N=119;p=0.035)。对于具有LMS的男性,没有观察到PDGFRβ表达状态的这种相互作用。
表2.LMS患者的中位OS
N=在研究群组或对照群组中治疗的患者;OS=总生存期;HR=危险比;CI=置信区间,p-值=分层对数秩p-值。
实施例2:PDGFRβ阴性不可切除的转移性胰腺癌患者的总生存期评价
研究设计:具有PDGFRβ阴性不可切除转移性胰腺癌的患者的中位总生存期,其中用剂量递增方案的奥拉单抗(在28天周期的第1天、第8天和第15天施用15mg/kg、20mg/kg或25mg/kg)联合nab-紫杉醇和吉西他滨(根据USPI插页,对于28天周期,在第1天、第8天和第15天施用)治疗。具有不可切除的转移性胰腺癌的患者在28天周期的第1天、第8天和第15天用奥拉单抗治疗,随后在每个28天周期的第1天、第8天和第15天施用nab-紫杉醇(125mg/m2)和吉西他滨(1000mg/m2)。评价患者的总体生存期。
实施例3:PDGFRβ阴性晚期软组织肉瘤患者的总生存期的评价
研究设计:具有PDGFRβ阴性晚期或转移性软组织肉瘤的患者的中位总生存期,其中在剂量递增研究中用奥拉单抗(以15mg/kg奥拉单抗(在第1天和第8天施用)或20mg/kg奥拉单抗(在第1天和第8天施用))联合在第1天和第8天以900mg/m2施用的吉西他滨和在21天周期的第8天以75mg/m2施用的多西他赛治疗。评价患者的总体生存期。
序列
SEQ ID NO:1(人PDGFRα抗体的HC)
SEQ ID NO:2(人PDGFRα抗体的LC)
SEQ ID NO:3(人PDGFRα抗体的VH)
SEQ ID NO:4(人PDGFRα抗体的VL)
SEQ ID NO:5(人PDGFRα抗体的HCDR1)
SEQ ID NO:6(人PDGFRα抗体的HCDR2)
SEQ ID NO:7(人PDGFRα抗体的HCDR3)
SEQ ID NO:8(人PDGFRα抗体的LCDR1)
SEQ ID NO:9(抗人PDGFRα抗体的LCDR2)
SEQ ID NO:10(人PDGFRα抗体的LCDR3)
SEQ ID NO:11(人PDGFRα)
SEQ ID NO:12(人PDGFRβ)
/>
序列表
<110> Eli Lilly and Company
<120> 用PDGFRα抑制剂治疗癌症的方法
<130> X22894
<150> US 63/163,426
<151> 2021-03-19
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Arg Ser Thr Val Glu Gly Arg Val Thr Phe Ala Lys Val Glu Glu Thr
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Ile Ala Val Arg Cys Leu Ala Lys Asn Leu Leu Gly Ala Glu Asn Arg
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Leu Val Val Ile Trp Lys Gln Lys Pro Arg Tyr Glu Ile Arg Trp Arg
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Leu Met Ser Glu Leu Lys Ile Met Thr His Leu Gly Pro His Leu Asn
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Ile Val Asn Leu Leu Gly Ala Cys Thr Lys Ser Gly Pro Ile Tyr Ile
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Asn Arg Asp Ser Phe Leu Ser His His Pro Glu Lys Pro Lys Lys Glu
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Leu Asp Ile Phe Gly Leu Asn Pro Ala Asp Glu Ser Thr Arg Ser Tyr
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Val Ile Leu Ser Phe Glu Asn Asn Gly Asp Tyr Met Asp Met Lys Gln
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Ala Asp Thr Thr Gln Tyr Val Pro Met Leu Glu Arg Lys Glu Val Ser
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Lys Tyr Ser Asp Ile Gln Arg Ser Leu Tyr Asp Arg Pro Ala Ser Tyr
755 760 765
Lys Lys Lys Ser Met Leu Asp Ser Glu Val Lys Asn Leu Leu Ser Asp
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Asp Asn Ser Glu Gly Leu Thr Leu Leu Asp Leu Leu Ser Phe Thr Tyr
785 790 795 800
Gln Val Ala Arg Gly Met Glu Phe Leu Ala Ser Lys Asn Cys Val His
805 810 815
Arg Asp Leu Ala Ala Arg Asn Val Leu Leu Ala Gln Gly Lys Ile Val
820 825 830
Lys Ile Cys Asp Phe Gly Leu Ala Arg Asp Ile Met His Asp Ser Asn
835 840 845
Tyr Val Ser Lys Gly Ser Thr Phe Leu Pro Val Lys Trp Met Ala Pro
850 855 860
Glu Ser Ile Phe Asp Asn Leu Tyr Thr Thr Leu Ser Asp Val Trp Ser
865 870 875 880
Tyr Gly Ile Leu Leu Trp Glu Ile Phe Ser Leu Gly Gly Thr Pro Tyr
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Pro Gly Met Met Val Asp Ser Thr Phe Tyr Asn Lys Ile Lys Ser Gly
900 905 910
Tyr Arg Met Ala Lys Pro Asp His Ala Thr Ser Glu Val Tyr Glu Ile
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Met Val Lys Cys Trp Asn Ser Glu Pro Glu Lys Arg Pro Ser Phe Tyr
930 935 940
His Leu Ser Glu Ile Val Glu Asn Leu Leu Pro Gly Gln Tyr Lys Lys
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Ser Tyr Glu Lys Ile His Leu Asp Phe Leu Lys Ser Asp His Pro Ala
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980 985 990
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995 1000 1005
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1010 1015 1020
Asp Ile Asp Pro Val Pro Glu Glu Glu Asp Leu Gly Lys Arg Asn
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Arg His Ser Ser Gln Thr Ser Glu Glu Ser Ala Ile Glu Thr Gly
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Ser Ser Ser Ser Thr Phe Ile Lys Arg Glu Asp Glu Thr Ile Glu
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Asp Ile Asp Met Met Asp Asp Ile Gly Ile Asp Ser Ser Asp Leu
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Val Glu Asp Ser Phe Leu
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Met Arg Leu Pro Gly Ala Met Pro Ala Leu Ala Leu Lys Gly Glu Leu
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Leu Leu Leu Ser Leu Leu Leu Leu Leu Glu Pro Gln Ile Ser Gln Gly
20 25 30
Leu Val Val Thr Pro Pro Gly Pro Glu Leu Val Leu Asn Val Ser Ser
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Thr Phe Val Leu Thr Cys Ser Gly Ser Ala Pro Val Val Trp Glu Arg
50 55 60
Met Ser Gln Glu Pro Pro Gln Glu Met Ala Lys Ala Gln Asp Gly Thr
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Phe Ser Ser Val Leu Thr Leu Thr Asn Leu Thr Gly Leu Asp Thr Gly
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Glu Tyr Phe Cys Thr His Asn Asp Ser Arg Gly Leu Glu Thr Asp Glu
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His Glu Lys Lys Gly Asp Val Ala Leu Pro Val Pro Tyr Asp His Gln
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Thr Ile Gly Asp Arg Glu Val Asp Ser Asp Ala Tyr Tyr Val Tyr Arg
195 200 205
Leu Gln Val Ser Ser Ile Asn Val Ser Val Asn Ala Val Gln Thr Val
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Val Arg Gln Gly Glu Asn Ile Thr Leu Met Cys Ile Val Ile Gly Asn
225 230 235 240
Glu Val Val Asn Phe Glu Trp Thr Tyr Pro Arg Lys Glu Ser Gly Arg
245 250 255
Leu Val Glu Pro Val Thr Asp Phe Leu Leu Asp Met Pro Tyr His Ile
260 265 270
Arg Ser Ile Leu His Ile Pro Ser Ala Glu Leu Glu Asp Ser Gly Thr
275 280 285
Tyr Thr Cys Asn Val Thr Glu Ser Val Asn Asp His Gln Asp Glu Lys
290 295 300
Ala Ile Asn Ile Thr Val Val Glu Ser Gly Tyr Val Arg Leu Leu Gly
305 310 315 320
Glu Val Gly Thr Leu Gln Phe Ala Glu Leu His Arg Ser Arg Thr Leu
325 330 335
Gln Val Val Phe Glu Ala Tyr Pro Pro Pro Thr Val Leu Trp Phe Lys
340 345 350
Asp Asn Arg Thr Leu Gly Asp Ser Ser Ala Gly Glu Ile Ala Leu Ser
355 360 365
Thr Arg Asn Val Ser Glu Thr Arg Tyr Val Ser Glu Leu Thr Leu Val
370 375 380
Arg Val Lys Val Ala Glu Ala Gly His Tyr Thr Met Arg Ala Phe His
385 390 395 400
Glu Asp Ala Glu Val Gln Leu Ser Phe Gln Leu Gln Ile Asn Val Pro
405 410 415
Val Arg Val Leu Glu Leu Ser Glu Ser His Pro Asp Ser Gly Glu Gln
420 425 430
Thr Val Arg Cys Arg Gly Arg Gly Met Pro Gln Pro Asn Ile Ile Trp
435 440 445
Ser Ala Cys Arg Asp Leu Lys Arg Cys Pro Arg Glu Leu Pro Pro Thr
450 455 460
Leu Leu Gly Asn Ser Ser Glu Glu Glu Ser Gln Leu Glu Thr Asn Val
465 470 475 480
Thr Tyr Trp Glu Glu Glu Gln Glu Phe Glu Val Val Ser Thr Leu Arg
485 490 495
Leu Gln His Val Asp Arg Pro Leu Ser Val Arg Cys Thr Leu Arg Asn
500 505 510
Ala Val Gly Gln Asp Thr Gln Glu Val Ile Val Val Pro His Ser Leu
515 520 525
Pro Phe Lys Val Val Val Ile Ser Ala Ile Leu Ala Leu Val Val Leu
530 535 540
Thr Ile Ile Ser Leu Ile Ile Leu Ile Met Leu Trp Gln Lys Lys Pro
545 550 555 560
Arg Tyr Glu Ile Arg Trp Lys Val Ile Glu Ser Val Ser Ser Asp Gly
565 570 575
His Glu Tyr Ile Tyr Val Asp Pro Met Gln Leu Pro Tyr Asp Ser Thr
580 585 590
Trp Glu Leu Pro Arg Asp Gln Leu Val Leu Gly Arg Thr Leu Gly Ser
595 600 605
Gly Ala Phe Gly Gln Val Val Glu Ala Thr Ala His Gly Leu Ser His
610 615 620
Ser Gln Ala Thr Met Lys Val Ala Val Lys Met Leu Lys Ser Thr Ala
625 630 635 640
Arg Ser Ser Glu Lys Gln Ala Leu Met Ser Glu Leu Lys Ile Met Ser
645 650 655
His Leu Gly Pro His Leu Asn Val Val Asn Leu Leu Gly Ala Cys Thr
660 665 670
Lys Gly Gly Pro Ile Tyr Ile Ile Thr Glu Tyr Cys Arg Tyr Gly Asp
675 680 685
Leu Val Asp Tyr Leu His Arg Asn Lys His Thr Phe Leu Gln His His
690 695 700
Ser Asp Lys Arg Arg Pro Pro Ser Ala Glu Leu Tyr Ser Asn Ala Leu
705 710 715 720
Pro Val Gly Leu Pro Leu Pro Ser His Val Ser Leu Thr Gly Glu Ser
725 730 735
Asp Gly Gly Tyr Met Asp Met Ser Lys Asp Glu Ser Val Asp Tyr Val
740 745 750
Pro Met Leu Asp Met Lys Gly Asp Val Lys Tyr Ala Asp Ile Glu Ser
755 760 765
Ser Asn Tyr Met Ala Pro Tyr Asp Asn Tyr Val Pro Ser Ala Pro Glu
770 775 780
Arg Thr Cys Arg Ala Thr Leu Ile Asn Glu Ser Pro Val Leu Ser Tyr
785 790 795 800
Met Asp Leu Val Gly Phe Ser Tyr Gln Val Ala Asn Gly Met Glu Phe
805 810 815
Leu Ala Ser Lys Asn Cys Val His Arg Asp Leu Ala Ala Arg Asn Val
820 825 830
Leu Ile Cys Glu Gly Lys Leu Val Lys Ile Cys Asp Phe Gly Leu Ala
835 840 845
Arg Asp Ile Met Arg Asp Ser Asn Tyr Ile Ser Lys Gly Ser Thr Phe
850 855 860
Leu Pro Leu Lys Trp Met Ala Pro Glu Ser Ile Phe Asn Ser Leu Tyr
865 870 875 880
Thr Thr Leu Ser Asp Val Trp Ser Phe Gly Ile Leu Leu Trp Glu Ile
885 890 895
Phe Thr Leu Gly Gly Thr Pro Tyr Pro Glu Leu Pro Met Asn Glu Gln
900 905 910
Phe Tyr Asn Ala Ile Lys Arg Gly Tyr Arg Met Ala Gln Pro Ala His
915 920 925
Ala Ser Asp Glu Ile Tyr Glu Ile Met Gln Lys Cys Trp Glu Glu Lys
930 935 940
Phe Glu Ile Arg Pro Pro Phe Ser Gln Leu Val Leu Leu Leu Glu Arg
945 950 955 960
Leu Leu Gly Glu Gly Tyr Lys Lys Lys Tyr Gln Gln Val Asp Glu Glu
965 970 975
Phe Leu Arg Ser Asp His Pro Ala Ile Leu Arg Ser Gln Ala Arg Leu
980 985 990
Pro Gly Phe His Gly Leu Arg Ser Pro Leu Asp Thr Ser Ser Val Leu
995 1000 1005
Tyr Thr Ala Val Gln Pro Asn Glu Gly Asp Asn Asp Tyr Ile Ile
1010 1015 1020
Pro Leu Pro Asp Pro Lys Pro Glu Val Ala Asp Glu Gly Pro Leu
1025 1030 1035
Glu Gly Ser Pro Ser Leu Ala Ser Ser Thr Leu Asn Glu Val Asn
1040 1045 1050
Thr Ser Ser Thr Ile Ser Cys Asp Ser Pro Leu Glu Pro Gln Asp
1055 1060 1065
Glu Pro Glu Pro Glu Pro Gln Leu Glu Leu Gln Val Glu Pro Glu
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Pro Glu Leu Glu Gln Leu Pro Asp Ser Gly Cys Pro Ala Pro Arg
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Ala Glu Ala Glu Asp Ser Phe Leu
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Claims (40)
1.治疗有此需要的患者中的癌症的方法,其包括向所述患者施用有效量的PDGFRα抑制化合物,其中所述患者被鉴定为患有人PDGFRβ阴性的癌症。
2.治疗患有人PDGFRβ阴性癌症的患者的方法,其包括向所述患者施用有效量的PDGFRα抑制化合物。
3.治疗有此需要的患者中的癌症的方法,其包括:
将所述患者鉴定为患有人PDGFRβ阴性的癌症;和
向所述患者施用有效量的PDGFRα抑制化合物。
4.将具有癌症的患者诊断为需要用PDGFRα抑制化合物治疗的方法,其包括将所述患者鉴定为患有人PDGFRβ阴性的癌症。
5.权利要求4的方法,其中如果所述患者被鉴定为患有人PDGFRβ阴性的癌症,则向所述患者施用有效量的PDGFRα抑制化合物。
6.权利要求1、3和4中任一项的方法,其中将所述患者鉴定为患有人PDGFRβ阴性的癌症包括对来自所述患者的生物样品进行测定。
7.权利要求6的方法,其中所述生物样品包括组织或体液。
8.权利要求7的方法,其中所述组织包括肿瘤组织。
9.权利要求7的方法,其中所述体液包括血液、血浆或血清。
10.权利要求6至9中任一项的方法,其中所述测定包括对所述生物样品进行体外测定。
11.权利要求10的方法,其中所述体外测定包括组织学测定或细胞学测定。
12.权利要求10的方法,其中所述体外测定包括免疫测定或聚合酶链式反应测定。
13.权利要求6至11中任一项的方法,其中所述测定包括,使所述生物样品与抗体接触,其中所述抗体特异性结合人PDGFRβ,和检测所述抗体与所述生物样品中的人PDGFRβ的结合。
14.权利要求13的方法,其中所述测定进一步包括,定量所述生物样品中的人PDGFRβ,和确定所述生物样品是否为PDGFRβ阴性。
15.权利要求14的方法,其中当生物样品中的PDGFRβ被确定为存在于生物样品的小于约10%的肿瘤细胞中时,所述生物样品被确定为PDGFRβ阴性。
16.权利要求1至15中任一项的方法,其中所述PDGFRα抑制化合物是抗体、其抗原结合片段或小分子抑制剂。
17.权利要求16的方法,其中所述PDGFRα抑制化合物是抗体,其中所述抗体特异性结合PDGFRα。
18.权利要求17的方法,其中所述特异性结合PDGFRα的抗体包含重链可变区(VH)和轻链可变区(VL),其中所述VH包含重链互补决定区(HCDR)HCDR1、HCDR2和HCDR3,且所述VL包含轻链互补决定区(LCDR)LCDR1、LCDR2和LCDR3,其中:
所述HCDR1包含SEQ ID NO:5,
所述HCDR2包含SEQ ID NO:6,
所述HCDR3包含SEQ ID NO:7,
所述LCDR1包含SEQ ID NO:8,
所述LCDR2包含SEQ ID NO:9,且
所述LCDR3包含SEQ ID NO:10。
19.权利要求18的方法,其中所述VH包含SEQ ID NO:3,且所述VL包含SEQ ID NO:4。
20.权利要求17的方法,其中所述特异性结合PDGFRα的抗体包含重链(HC)和轻链(LC),其中所述HC包含SEQ ID NO:1,且所述LC包含SEQ ID NO:2。
21.权利要求17至20中任一项的方法,其中所述特异性结合PDGFRα的抗体是奥拉单抗。
22.权利要求21的方法,其中在第一个21天周期的第1天和第8天的每一天或在第一个28天周期的第1天和第8天的每一天以约15mg/kg、或约20mg/kg、或约25mg/kg的负荷剂量向所述患者施用有效量的奥拉单抗,随后在后续21天周期的第1天和第8天的每一天或在后续28天周期的第1天和第8天的每一天以约15mg/kg、约20mg/kg或约25mg/kg施用标准剂量的奥拉单抗。
23.权利要求22的方法,其中奥拉单抗与一种或多种化疗剂同时、分开或依次组合施用。
24.权利要求23的方法,其中所述化疗剂包括nab-紫杉醇、多柔比星、吉西他滨或多西他赛中的至少一种。
25.权利要求1至24中任一项的方法,其中所述癌症是软组织肉瘤、胰腺癌、子宫内膜癌、卵巢癌、骨癌、骨肉瘤、软骨肉瘤、横纹肌肉瘤或前列腺癌。
26.权利要求25的方法,其中所述软组织肉瘤是平滑肌肉瘤。
27.权利要求25的方法,其中所述软组织肉瘤是脂肪肉瘤。
28.权利要求1至27中任一项的方法,其中所述癌症是转移性癌症。
29.权利要求1至28中任一项的方法,其中所述患者是女性,且其中所述女性被确定为患有PDGFRβ阴性癌症。
30.鉴定来自癌症患者的生物样品中具有PDGFRβ的癌症患者的方法,其包括以下步骤:
将所述样品与特异性结合人PDGFRβ的抗体接触;和
检测所述抗体与所述样品中的人PDGFRβ的结合。
31.将癌症患者诊断为需要用PDGFRα抑制化合物治疗的方法,其包括以下步骤:
从所述患者获得生物样品;
使所述生物样品与特异性结合人PDGFRβ的第一抗体或其抗原结合片段接触,其中形成所述第一抗体或其抗原结合片段和人PDGFRβ的复合物;
使人PDGFRβ抗体或其抗原结合片段和人PDGFRβ的复合物与第二抗体或其抗原结合片段接触,其中所述第二抗体包含可检测标记物;
检测由所述可检测标记物提供的信号;和
其中,如果来自所述癌症患者的生物样品被确定为PDGFRβ阴性,则所述癌症患者被诊断为需要用PDGFRα抑制化合物治疗。
32.将癌症患者诊断为需要用特异性结合人PDGFRα的抗体或其抗原结合片段治疗的体外方法,其包括:
a.从所述患者获得生物样品;
b.使所述生物样品与特异性结合人PDGFRβ的抗体或其抗原结合片段接触,其中形成所述PDGFRβ抗体或其抗原结合片段和人PDGFRβ的复合物;
c.除去任何非特异性结合的第一抗体或其抗原结合片段;
d.检测和定量生物样品中的人PDGFRβ;并且
其中,如果来自所述癌症患者的生物样品被确定为PDGFRβ阴性,则所述癌症患者被诊断为需要用特异性结合人PDGFRα的抗体或其抗原结合片段治疗。
33.权利要求32的方法,其中检测的步骤包括用第二抗体检测所述PDGFRβ抗体或其抗原结合片段和所述生物样品中的人PDGFRβ的复合物。
34.权利要求32或33中任一项的方法,其中所述抗体或第二抗体中的至少一种包含可检测标记物,且其中所述检测的步骤包括在包含所述抗体和人PDGFRβ或所述第二抗体和人PDGFRβ的复合物形成后检测由所述可检测标记物提供的信号。
35.权利要求32或33中任一项的方法,其中所述第二抗体包含可检测标记物,且其中所述检测的步骤包括在包含所述抗体、人PDGFRβ和所述第二抗体的复合物形成后检测由所述可检测标记物提供的信号。
36.权利要求30至35中任一项的方法,其进一步包括,如果所述生物样品被确定为PDGFRβ阴性,则向所述癌症患者施用有效量的特异性结合PDGFRα的抗体的步骤。
37.权利要求36的方法,所述抗体是奥拉单抗。
38.权利要求37的方法,其中在第一个21天周期的第1天和第8天的每一天或在第一个28天周期的第1天和第8天的每一天以约15mg/kg、或约20mg/kg、或约25mg/kg的负荷剂量向有此需要的患者施用有效量的奥拉单抗,随后在后续21天周期的第1天和第8天的每一天或在后续28天周期的第1天和第8天的每一天以约15mg/kg、或约20mg/kg或约25mg/kg施用标准剂量的奥拉单抗。
39.权利要求38的方法,其中奥拉单抗与一种或多种化疗剂同时、分开或依次组合施用。
40.权利要求39的方法,其中所述化疗剂包括nab-紫杉醇、多柔比星、吉西他滨或多西他赛中的至少一种。
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