GSK’s belantamab mafodotin meets primary objective in multiple myeloma trial

葛兰素史克抗体偶联药物治疗多发性骨髓瘤试验达到主要终点

2019-08-26 17:04:00 PHARMACEUTICAL

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GlaxoSmithKline’s (GSK) immuno-conjugate belantamab mafodotin (GSK2857916) has achieved its primary objective in the multiple myeloma trial. The company has reported positive headline results from the pivotal DREAMM-2 open-label and randomised study of two doses of belantamab mafodotin. Belantamab mafodotin is an immuno-conjugate, which included a humanised anti-B cell maturation antigen (BCMA) monoclonal antibody conjugated to the cytotoxic agent auristatin F via a non-cleavable linker. The 196 patients in the DREAMM-2 study had relapsed multiple myeloma, and were refractory to immunomodulatory drug, a proteasome inhibitor, and to treatment with an anti-CD38 antibody. Belantamab mafodotin has shown a clinically meaningful overall response rate in the patient population, and the safety and tolerability profile was in line with the results observed in DREAMM-1 human study. GSK will use the data from the study for regulatory filings, which will start later this year. Additional ongoing studies are evaluating the efficacy of belantamab mafodotin as third-line monotherapy in relapsed/refractory multiple myeloma, as well as a combination treatment in the first and second line setting under broader DREAMM clinical development programme. GSK has licenced the drug linker technology from Seattle Genetics. It also licenced the technology to produce monoclonal antibody from BioWa. Belantamab mafodotin is not yet secured approval for use in any part of the world. It is presently being studied in patients with multiple myeloma. GSK R&D president and chief scientific officer Dr Hal Barron said: “I am pleased with the results of the DREAMM-2 study and excited about what these data could mean for patients with multiple myeloma who have exhausted other lines of treatment. “We are on track to file belantamab mafodotin later this year and continue to investigate how it could help even more patients with this disease.” In July this year, GSK said that a phase 3 trial evaluating its polymerase (PARP) inhibitor Zejula (niraparib) as maintenance therapy for first-line ovarian cancer following platinum-based chemotherapy, has met its primary endpoint.
葛兰素史克(GlaxoSmithKline s, GSK)免疫结合蛋白belantamab mafodotin (GSK2857916)在多发性骨髓瘤试验中实现了其主要目标。 该公司报告了两剂抗疟药物的关键 DREAMM-2开放标签和随机研究的正面标题结果。 Belantama mafodotin 是一种免疫共轭物,它包括一种通过不可裂解的链接剂与细胞毒剂 Auistatin F 结合的人源抗 B 细胞成熟抗原( BCMA )单克隆抗体。 DREAMM-2研究中的196例患者复发了多发性骨髓瘤,对蛋白酶体抑制剂免疫调节药物和抗 CD38抗体治疗难耐药。 Belantamafodotin 在患者人群中显示了临床上有意义的整体反应率,其安全性和耐受性概况与 DREAMM-1人类研究中观察到的结果一致。 葛兰素史克(GSK)将把研究中的数据用于监管申报,监管申报将于今年晚些时候开始。 其他正在进行的研究正在评估 belantamafodotin 作为复发/难治性多发性骨髓瘤的第三系单一疗法的疗效,以及在更广泛的 DREAMM 临床开发方案下的第一和第二系联合治疗。 葛兰素史克(GSK)已经获得西雅图基因公司的药物连接技术许可。它还批准了从 BioWa 生产单克隆抗体的技术。 Belantamamafodotin 尚未获得在世界任何地方使用的批准。目前正在研究多发性骨髓瘤患者。 葛兰素史克(GSK)研发总裁兼首席科学官 Hal Barron 博士表示:“我对 DREAMM-2研究的结果感到满意,并对这些数据可能对已经用尽其他治疗方法的多发性骨髓瘤患者意味着什么感到兴奋。 “我们将在今年晚些时候提交 belantabmafodotin ,并继续研究它如何帮助更多的患者。” 今年7月,葛兰素史克(GSK)表示,一项评估其聚合酶( PARP )抑制剂 Zejula ( niraparib )作为铂类化疗后一线卵巢癌维持治疗的3期临床试验已经达到了主要终点。

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