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赛诺菲CD38单抗关键III期研究成功,显著延长多发性骨髓瘤患者PFS

医药魔方 医药魔方 来源:医药魔方
2019-02-06
CD38单抗
原文

2月5日,赛诺菲宣布isatuximab治疗复发难治性多发性骨髓瘤的关键III期ICARIA-MM研究到达主要终点,isatuximab联合标准疗法(泊马度胺+低剂量地塞米松)相比单独使用标准疗法可以显著延长患者的无进展生存期(PFS)。


这项多中心、开标标签研究是首个评估在标准疗法基础上添加单抗药物对复发难治多发性骨髓瘤患者临床获益的随机III期研究,在24个国家的96个中心入组307例多发性骨髓瘤患者。所有入组患者之前均接受过包括来那度胺和一种蛋白酶体抑制剂单独使用或联用在内的2种以上的治疗方案,每周1次静脉注射isatuximab 10mg/kg,连续4周,之后给予28天一周期的泊马度胺联合地塞米松标准治疗。研究的详细结果将在不久后的学术会议上公布,并作为isatuximab上市申请的关键资料。


多发性骨髓瘤是第2常见的血液恶性肿瘤类型,全球每年有大约13.8万例新确诊病例。对于大多数患者而言,多发性骨髓瘤仍无法治愈,是一种非常重的疾病负担。

 

isatuximab 是一种CD38单抗,获得过FDA和EMA授予的治疗复发难治性多发性骨髓瘤的孤儿药资格。ICARIA-MM研究是赛诺菲开展的isatuximab用于复发难治或新确诊多发性骨髓瘤患者的4个III期研究中的一个。除了MM之外,赛诺菲还在开展isatuximab 用于治疗其他血液恶性肿瘤和实体瘤的临床研究。


目前全球仅有强生Daratumumab一个CD38单抗药物上市,从最早的多发性骨髓瘤四线疗法到现在的一线疗法,Daratumumab在上市3年后的年销售额已经达到20.25亿美元。isatuximab是目前唯一处于III期的CD38单抗类在研药物。


机器翻译

On February 5, Sanofi announced that the pivotal phase III ICARIA-MM study of isatuximab in relapsed and refractory multiple myeloma reached the primary endpoint and that isatuximab in combination with standard therapy (pomalidomide + low-dose dexamethasone) significantly prolonged progression-free survival (PFS) compared to standard therapy alone.

The open-label study, the first randomized phase III study to assess the clinical benefit of adding a monoclonal antibody to standard therapy in patients with relapsed or refractory multiple myeloma, enrolled 307 patients at 96 centers in 24 countries.All enrolled patients had previously received more than 2 treatment regimens including lenalidomide and a proteasome inhibitor alone or in combination, intravenous isatuximab 10 mg/kg once weekly for 4 weeks, followed by a 28-day cycle of pomalidomide plus dexamethasone.The detailed results of the study will be presented at a conference shortly and will serve as key data for the isatuximab marketing application.

Multiple myeloma is the second most common type of hematologic malignancy, with approximately 13 per year worldwide.80,000 newly diagnosed cases.For most patients, multiple myeloma remains incurable and represents a significant burden of disease.

isatuximab is a CD38 monoclonal antibody that has been granted orphan drug status by the FDA and EMA for the treatment of relapsed and refractory multiple myeloma.The ICARIA-MM study is one of four phase III studies of isatuximab in patients with relapsed or refractory or newly diagnosed multiple myeloma conducted by Sanofi.In addition to MM, Sanofi is conducting clinical studies of isatuximab in other hematologic malignancies and solid tumors.

Currently, there is only one CD38 monoclonal antibody drug marketed by Johnson & Johnson in the world. From the earliest fourth-line therapy for multiple myeloma to the current first-line therapy, the annual sales of Daratumumab have reached 20 years after its launch.$2.5 billion.Isatuximab is the only CD38 monoclonal antibody currently in phase III development.

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