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葛兰素史克抗癌药Arzerra关键III期头对头研究未达主要终点

  1. Arzerra
  2. 单抗
  3. 弥漫性大B细胞淋巴瘤
  4. 葛兰素史克

来源:生物谷 2014-05-21 09:51

葛兰素史克抗癌药Arzerra关键III期头对头研究未达主要终点。Arzerra是一种单抗药,已获批用于慢性淋巴细胞白血病(CLL)患者的治疗。

2014年5月21 /生物谷BIOON/ --葛兰素史克(GSK)和合作伙伴Genmab公司5月19日公布了一项举足轻重的头对头III期研究(ORCHARRD)的顶线数据。该项研究在复发性或难治性弥漫性大B细胞淋巴瘤(DLBCL)患者中开展,调查了Arzerra(ofatumumab)+化疗相对于美罗华(Rituxan)+化疗的疗效和安全性。研究数据表明,各治疗组疾病无进展生存期(PFS)无统计学显著差异,未能达到研究的主要终点。研究中,不良事件发生率无显著差异,但ofatumumab治疗组有更多的患者因输液反应而导致剂量中断或延迟,同时该组血清肌酐水平上升,这些数据还需要进一步的分析。

该项研究的完整数据将提交至今年晚些时候召开的医学会议。

关于Arzerra(ofatumumab):

Arzerra为单抗药ofatumumab的商品名,目前正由葛兰素史克(GSK)和Genmab制药联合开发,该药是一种创新的全人源化单克隆抗体,靶向于B细胞表面CD20分子的一个抗原表位,该表位包含了CD20分子的胞外大环和小环结构。

Arzerra分别于2009年和2010年获FDA和EMA批准,用于对标准药物【阿仑单抗(alemtuzumab,Campath)或氟达拉滨(fludarabine)】治疗无应答的慢性淋巴细胞白血病(CLL)患者的治疗。

目前,Arzerra尚未获批用于弥漫性大B细胞淋巴瘤(DLBCL)的治疗。(生物谷Bioon.com)

英文原文:GSK and Genmab announce top-line results from a pivotal head-to-head study of ofatumumab in combination with chemotherapy vs. rituximab in combination with chemotherapy for the treatment of relapsed or refractory diffuse large b-cell lymphoma

Issued: 19 May 2014, London UK

GlaxoSmithKline plc (LSE: GSK) and Genmab A/S (OMX: GEN) announced today that the Phase III study (ORCHARRD) of ofatumumab (Arzerra™) plus chemotherapy versus rituximab plus chemotherapy to treat relapsed or refractory diffuse large B-cell lymphoma (DLBCL) did not meet its primary endpoint as there was no statistically significant difference in progression free survival (PFS) between the treatment arms.

There were no differences in adverse events (AEs) leading to treatment discontinuation, Grade >3 AEs, severe adverse events (SAEs), or fatal SAEs between the treatment arms. However, there were more dose interruptions and delays due to infusion reactions and increased serum creatinine in the ofatumumab plus chemotherapy arm, which require further analysis.

“We are disappointed that the ORCHARRD study did not meet its primary endpoint. We will further analyze these results to better understand the findings and how they add to our collective knowledge of this disease,” said Dr. Rafael Amado, Head of Oncology R&D, GlaxoSmithKline.

“We plan to submit detailed data from the ofatumumab ORCHARRD study in DLBCL for presentation at a medical conference later this year, which we hope will provide further clarity on today’s headline results. Based on today’s results we are unlikely to move forward with a regulatory filing,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

About the ORCHARRD study

This pivotal Phase III randomized study included 447 patients who were refractory to, or had relapsed following, first-line treatment with rituximab in combination with a chemotherapy regimen containing   anthracycline or anthracenedione, and were eligible for autologous stem cell transplant (ASCT). Patients in the study were randomized 1:1 to receive three cycles of either ofatumumab or rituximab in combination with DHAP (dexamethasone, cytarabine and cisplatin) salvage chemotherapy. After the third treatment cycle, patients who obtained a complete or partial response received high dose chemotherapy followed by ASCT. The primary endpoint of the study was progression free survival.

The ORCHARRD study was conducted in collaboration with the following research groups:
HOVON-Dutch-Belgian Cooperative Trial Group for Hematology-Oncology
Grupo Español de Linfomas/Trasplante Autólogo de Médula Ósea (GELTAMO)
National Cancer Research Institute Lymphoma Clinical Studies Group
Nordic Lymphoma Group
Polish Lymphoma Research Group
The All Ireland Cooperative Oncology Research Group
About DLBCLDLBCL is the most common form of non-Hodgkin lymphoma (NHL), and is an aggressive (fast-growing) lymphoma or cancer of the B-cells.[i] DLBCL is the most common lymphoid malignancy in adults, accounting for 30% of all NHL in the Western world.[ii] Approximately 38,000 new cases of DLBCL occur annually in the US, Japan and five major European markets.[iii]

About Ofatumumab (Arzerra)Ofatumumab—a human monoclonal antibody which targets an epitope on the CD20 molecule encompassing parts of the small and large extracellular loops—is not approved or licensed anywhere in the world for the treatment of DLBCL.

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