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GSK单抗药Arzerra III期显著改善复发性CLL无进展生存期

  1. Arzerra
  2. ofatumumab
  3. 单抗
  4. 复发性CLL
  5. 淋巴细胞
  6. 白血病
  7. 葛兰素史克

来源:生物谷 2014-08-03 13:31

葛兰素史克单抗药物Arzerra III期PROLON研究显著改善复发性慢性淋巴细胞白血病(CLL)患者无进展生存期(PFS),达到了研究的主要终点,目前,尚无药物获批用于复发性CLL的治疗。

2014年8月3日讯 /生物谷BIOON/ --葛兰素史克(GSK)和合作伙伴Genmab制药7月31日宣布,独立数据监测委员会(IDMC)针对抗癌药Arzerra(ofatumumab)一项关键性III期PROLONG研究(OMB 112517)进行的一项既定中期分析表明,该项研究达到了改善疾病无进展生存期(PFS)的主要终点。该项研究在复发性慢性淋巴细胞白血病(CLL)患者中开展,评估了Arzerra维持疗法与未进一步治疗(观察)的差异。该项研究中,IDMC未发现任何新的安全性信号,但会继续监测患者的安全,直到所有患者均完成治疗。该项研究的疗效和安全性数据正在进一步的分析中,详细数据将提交至监管机构及未来的科学会议。

PROLONG研究是在复发性慢性淋巴细胞白血病(CLL)群体中评估Arzerra维持疗法的首个III期研究,该中期分析数据表明,Arzerra具有治疗复发性CLL的潜力,而目前尚无药物获批用于复发性CLL。

PROLONG研究在532例病情复发时对治疗仍有响应的复发性CLL患者中开展,研究中,患者随机接受ofatumumab维持治疗或观察(不进行进一步治疗),ofatumumab治疗组初始剂量为300mg,一周后进行第二次给药(剂量为1000mg),随后每8周给药1000mg,治疗期为2年;而观察组不接受进一步的治疗。该项研究的主要终点是无进展生存期(PFS),次要终点包括评估临床受益、安全性、耐受性、健康相关生活质量、药代动力学。

关于慢性淋巴细胞白血病(CLL):

在西方国家,CLL是成人白血病中最常见的类型,约占所有白血病病例的三分之一。在美国,估计目前有10.5万CLL或经治CLL患者,2013年中新增1.568万病例。CLL的平均确诊年龄为72岁,大约有90%的患者年龄超过55岁。大多数患者至少患有一种合并症(comorbidity),如高血压、糖尿病、心血管疾病或慢性阻塞性肺病(COPD)。

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。(生物谷Bioon.com)

英文原文:GSK and Genmab announce positive interim result for phase III study of ofatumumab as maintenance therapy for relapsed CLL

GlaxoSmithKline plc (LSE/NYSE: GSK) and Genmab A/S (OMX: GEN) announced today that an Independent Data Monitoring Committee (IDMC) interim analysis of a phase III study, PROLONG (OMB 112517), reached the predefined significance level for efficacy (p≤0.001). The interim analysis demonstrated that treatment with ofatumumab (Arzerra™) met the primary endpoint of improving progression free survival (PFS). The study evaluated ofatumumab maintenance therapy versus no further treatment (observation) in patients with relapsed chronic lymphocytic leukaemia (CLL) who responded to treatment at relapse.

The IDMC did not identify any new safety signals and will continue to monitor patients for safety until all study patients complete therapy. Further analysis of the safety and efficacy data is underway and will be shared with regulators and the scientific community in the coming months.

“This interim result from the PROLONG study demonstrated that maintenance therapy with ofatumumab lowered the risk of disease progression in patients who responded to treatment at relapse. We look forward to sharing the results of the interim analysis with regulatory agencies to evaluate the potential for future regulatory filings,” said Dr. Rafael Amado, Head of Oncology R&D, GSK.

“We are very pleased that this study of ofatumumab, the first phase III study to evaluate maintenance therapy for relapsed CLL, met the primary endpoint at the interim analysis. This result indicates the potential of ofatumumab in this setting where there are currently no approved treatments. We look forward to presenting the detailed data from this study at a future medical conference,” said Jan van de Winkel, PhD, Chief Executive Officer of Genmab.

About PROLONG

This pivotal phase III study was designed to randomise up to 532 patients with relapsed CLL who have responded to treatment at relapse, to either ofatumumab maintenance treatment or no further treatment (observation). Patients in the ofatumumab arm receive an initial dose of 300 mg of ofatumumab, followed one week later by a second dose of 1,000 mg, then doses of 1,000 mg every 8 weeks for up to two years, while patients in the observation treatment arm receive no further treatment.

The primary endpoint of the study is PFS. Secondary objectives will evaluate clinical benefit, safety, tolerability, the health-related quality of life of subjects treated with ofatumumab versus no further treatment, and pharmacokinetics among relapsed CLL patients receiving maintenance therapy with ofatumumab.

about CLL

CLL, the most commonly diagnosed adult leukaemia in western countries, accounts for approximately one-third of all cases of leukaemia.[i],[ii],[iii] In the USA, it is estimated that more than 105,000 people currently live with or have been previously treated for CLL and an estimated 15,680 new cases of CLL were diagnosed in the past year.3,[iv]  The average age of diagnosis is 72 years, and approximately 90 per cent of patients with CLL are estimated to be over the age of 55 years.3,[v] The majority of patients with CLL have at least one comorbidity such as hypertension, diabetes, cardiovascular disease, or COPD.

About ofatumumab (Arzerra)

Ofatumumab—a monoclonal antibody that is designed to target the CD20 molecule found on the surface of CLL cells and normal B lymphocytes—is not approved or licensed anywhere in the world as maintenance treatment for relapsed CLL.

In the USA, ofatumumab is approved for use in combination with chlorambucil for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate. In the EU, ofatumumab is approved for use in combination with chlorambucil or bendamustine for the treatment of patients with CLL who have not received prior therapy and who are not eligible for fludarabine-based therapy. Ofatumumab is also approved for first-line use in Russia.

In more than 50 countries worldwide, ofatumumab is indicated as monotherapy for the treatment of patients with CLL refractory to fludarabine and alemtuzumab.

Ofatumumab is being developed under a co-development and collaboration agreement between Genmab and GSK.

Arzerra is a trademark of the GSK group of companies.

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