淋巴瘤患者治疗新选择:武田靶向CD30的创新抗体偶联药物(注射用维布妥昔单抗)正式获批

2020-05-15 MedSci原创 MedSci原创

淋巴瘤患者治疗新选择

− 安适利®(注射用维布妥昔单抗)正式获批用于成人CD30阳性的复发或难治性系统性间变性大细胞淋巴瘤(sALCL)和经典型霍奇金淋巴瘤(cHL)的治疗

− 淋巴瘤已是中国死亡率最高的十大恶性肿瘤之一1。针对复发或难治性系统性间变性大细胞淋巴瘤和经典型霍奇金淋巴瘤治疗手段有限,安适利®(注射用维布妥昔单抗)的获批将填补中国CD30阳性淋巴瘤治疗药物领域的空白,为患者带来治疗新选择

− 武田中国致力加速将更多国际前沿的创新药物引进中国满足广大患者未尽的医疗需求

 

2020年5月14日,中国上海 – 武田中国今天宣布旗下靶向创新药物安适利®(注射用维布妥昔单抗)经国家药品监督管理局正式批准进入中国,获批适应症为成人CD30阳性的复发或难治性系统性间变性大细胞淋巴瘤(sALCL)和 复发或难治性经典型霍奇金淋巴瘤(cHL的治疗。安适利®(注射用维布妥昔单抗)由靶向CD30的单克隆抗体连接一种抑制微管的细胞毒药物(单甲基澳瑞他汀E,MMAE)组成,可在血液中稳定存在,精准杀灭表达CD30的肿瘤细胞2。该产品临床使用经验丰富,真实世界循证依据充分,疗效久经验证。此前,美国国家综合癌症网络(NCCN)指南已将维布妥昔单抗推荐为标准治疗药物3,4,中国临床肿瘤学会(CSCO)指南亦将其纳入临床选择范围5

安适利®(注射用维布妥昔单抗)在中国的获批是基于三项临床研究SG035-0004、SG035-0003、C25007的数据。其中,在SG-035-0004研究中,针对复发或难治性间变大细胞淋巴瘤,58例患者中97%的复发或难治性系统性间变性大细胞淋巴瘤患者可实现肿瘤缩小6,其5年生存率提高至60%7;在SG035-0003研究中,94%的复发或难治性经典型霍奇金淋巴瘤的患者可实现肿瘤缩小8,其中位总生存期(OS)从历史27.6个月提升至40.5个月9;在C25007研究中,在既往至少接受一次化疗方案且开始维布妥昔单抗治疗时不适合进行干细胞移植(SCT)或多药化疗的复发或难治性经典型霍奇金淋巴瘤患者(n=60)中,客观缓解率(ORR)为50%(95% CI,37: 63%)10

淋巴瘤是一种起源于淋巴造血系统的恶性肿瘤,是70多种不同亚型的“淋巴瘤家族”的统称11。目前,淋巴瘤已是中国死亡率最高的十大恶性肿瘤之一。数据显示,中国每年大约有9.3万人被诊断为淋巴瘤,每年有超过5万人死于这种癌症1。目前,针对复发或难治性系统性间变性大细胞淋巴瘤和经典型霍奇金淋巴瘤治疗手段有限,患者生存状况不容乐观。

“数十年来,中国复发或难治性淋巴瘤的治疗方案选择范围较窄,患者普遍面临生存期短、生活质量差等问题。”北京大学肿瘤医院党委书记、淋巴肿瘤内科主任;中国抗癌协会CSCO专业委员会执委会委员;安适利®(注射用维布妥昔单抗)中国注册研究组首席研究专家朱军教授表示,“间变性大细胞淋巴瘤和经典型霍奇金淋巴瘤都是表达CD30的淋巴瘤亚型,我们期待,作为靶向CD30的创新抗体偶联药物,维布妥昔单抗能够填补中国CD30阳性淋巴瘤治疗药物领域的空白,全面开启淋巴瘤精准治疗的新时代。“

武田中国总裁单国洪先生则表示:“安适利®(注射用维布妥昔单抗)于去年6月获得优先审评审批,又于今日正式获批进入中国市场,这充分体现了中国政府加速引进靶向创新药物的坚定决心,对此我们表示由衷地赞赏。秉持着‘患者为先’的理念,未来,武田将发挥研发创新的优势,加速将更多国际前沿的创新药物引进中国,满足广大患者未尽的医疗需求,为实现‘健康中国2030’总目标做出贡献。”

作为一家以价值观为基础、以研发为驱动的全球领先生物制药公司,武田专注于在肿瘤、消化、神经科学及罕见病四大疾病领域的药物研发,并针对血液制品及疫苗领域进行专项研发投入。凭借在肿瘤领域的丰富产品组合和领先地位,武田自1994年进入中国以来,始终积极推动并参与中国肿瘤领域科研和诊疗的持续发展,不断践行科学创新的决心及造福患者的承诺。

 

参考文献:

1.The Global Cancer Observatory. China factsheets. 2019.

2.Francisco J. A., et al. cAC10-vcMMAE, an anti-CD30–monomethyl auristatin E conjugate with potent and selective antitumor activity. Blood 2003; 102 (4): 1458–1465.

3.NCCN Clinical Practice Guidelines in Oncology: Hodgkin Lymphoma (Version 1.2020)

4.NCCN Clinical Practice Guidelines in Oncology: T-Cell Lymphomas (Version 1.2020)

5.中国临床肿瘤学会(CSCO)淋巴瘤诊疗指南(2019)

6.Pro, B., et al. Brentuximab Vedotin (SGN-35) in Patients With Relapsed or Refractory Systemic Anaplastic Large-Cell Lymphoma: Results of a Phase II Study. Journal of Clinical Oncology 2012 30:18, 2190-2196.

7.Pro, B., et al. Five-year results of brentuximab vedotin in patients with relapsed or refractory systemic anaplastic large cell lymphoma. Blood vol. 130,25 (2017): 2709-2717.

8.Younes, A., et al. Results of a Pivotal Phase II Study of Brentuximab Vedotin for Patients With Relapsed or Refractory Hodgkin's Lymphoma. Journal of Clinical Oncology 2012 30:18, 2183-2189.

9.Chen R., et al. Five-year survival and durability results of brentuximab vedotin in patients with relapsed or refractory Hodgkin lymphoma. Blood 2016; 128 (12): 1562–1566.

10.Canadian Agency for Drugs and Technologies in Health. Brentuximab (Adcetris) for Hodgkin Lymphoma – Resubmission. 2019.

11.WHO Classification of Tumours of Haematopoietic and Lymphoid Tissues (2016)

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