GSK plc (LSE/NYSE: GSK) today announced that the European Medicines Agency (EMA) has accepted the marketing authorisation application (MAA) for Blenrep (belantamab mafodotin) in combination with bortezomib plus dexamethasone (BorDex) or pomalidomide plus dexamethasone (PomDex) as a treatment for relapsed or refractory multiple myeloma.

葛兰素史克股份有限公司（伦敦证交所/纽约证交所：葛兰素史克）今天宣布，欧洲药品管理局（EMA）已接受Blenrep（belantamab mafodotin）联合硼替佐米加地塞米松（BorDex）或pomalidomide加地塞米松（PomDex）治疗复发或难治性多发性骨髓瘤的上市许可申请（MAA）。

The EMA’s Committee for Medicinal Products for Human Use (CHMP) will begin the formal review process to make a recommendation to the European Commission regarding this potential authorisation..

欧洲药品管理局（EMA）的人用药品委员会（CHMP）将开始正式审查程序，就这一潜在授权向欧盟委员会提出建议。。

The application is based on interim results from the DREAMM-7 and DREAMM-8 phase III trials, which both met their primary endpoints, showing statistically significant and clinically meaningful improvements in progression-free survival (PFS) for the belantamab mafodotin combinations compared to standard of care combinations in relapsed or refractory multiple myeloma.

该应用基于DREAMM-7和DREAMM-8 III期临床试验的中期结果，两者均达到了主要终点，与复发或难治性多发性骨髓瘤的标准治疗组合相比，belantamab-mafodotin组合的无进展生存期（PFS）有统计学意义和临床意义的改善。

The DREAMM-7 trial is evaluating belantamab mafodotin combined with BorDex versus daratumumab plus BorDex, while the DREAMM-8 trial is evaluating belantamab mafodotin in combination with PomDex versus bortezomib plus PomDex..

DREAMM-7试验正在评估belantamab-mafodotin联合BorDex与daratumumab加BorDex，而DREAMM-8试验正在评估belantamab-mafodotin联合PomDex与硼替佐米加PomDex。。

A positive overall survival (OS) trend was observed in both trials but was not statistically significant at the time of interim analysis. Follow-up for OS continues. Results also showed clinically meaningful improvements across all other secondary efficacy endpoints, including deeper and more durable responses compared to the respective standard of care combinations.

在两项试验中均观察到积极的总生存期（OS）趋势，但在中期分析时无统计学意义。操作系统的后续行动仍在继续。结果还显示，与相应的标准护理组合相比，所有其他次要疗效终点都有临床意义的改善，包括更深更持久的反应。

The safety and tolerability profiles of the belantamab mafodotin combinations in DREAMM-7 and DREAMM-8 trials were broadly consistent with the known profiles of the individual agents..

在DREAMM-7和DREAMM-8试验中，belantamab-mafodotin组合的安全性和耐受性概况与个体药物的已知概况大致一致。。

About multiple myeloma

关于多发性骨髓瘤

Multiple myeloma is the third most common blood cancer globally and is generally considered treatable but not curable.1,2 There are approximately more than 180,000 new cases of multiple myeloma diagnosed globally each year, including approximately 50,000 new cases in Europe.3,4 Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments.5.

多发性骨髓瘤是全球第三大最常见的血癌，通常被认为是可治疗但不可治愈的[1,2]。全球每年诊断出约18万多例多发性骨髓瘤新病例，其中包括欧洲约5万例新病例[3,4]。由于多发性骨髓瘤通常对现有治疗难以治愈，因此需要对新疗法进行研究。

About DREAMM-7

关于DREAMM-7

The DREAMM-7 phase III clinical trial is a multicentre, open-label, randomised trial evaluating the efficacy and safety of belantamab mafodotin in combination with BorDex compared to a combination of daratumumab and BorDex in patients with relapsed/refractory multiple myeloma who previously were treated with at least one prior line of multiple myeloma therapy, with documented disease progression during or after their most recent therapy..

DREAMM-7 III期临床试验是一项多中心，开放标签，随机试验，评估了belantamab-mafodotin联合BorDex与daratumumab和BorDex联合治疗复发/难治性多发性骨髓瘤患者的疗效和安全性，这些患者以前曾接受过至少一种多发性骨髓瘤治疗，并在最近的治疗期间或之后记录了疾病进展。。

A total of 494 participants were randomised at a 1:1 ratio to receive either belantamab mafodotin in combination with BorDex or a combination of daratumumab and BorDex. Belantamab mafodotin was scheduled to be dosed at 2.5mg/kg intravenously every three weeks.

共有494名参与者以1:1的比例随机接受belantamab-mafodotin联合BorDex或daratumumab和BorDex的组合。Belantamab-mafodotin计划每三周静脉注射2.5mg/kg。

The primary endpoint is PFS as per an independent review committee. The key secondary endpoints include OS, duration of response (DOR), and minimal residual disease (MRD) negativity rate as assessed by next-generation sequencing. Other secondary endpoints include overall response rate (ORR), safety and patient reported and quality of life outcomes..

根据独立审查委员会的规定，主要终点是PFS。通过下一代测序评估，关键的次要终点包括OS，反应持续时间（DOR）和最小残留病（MRD）阴性率。其他次要终点包括总体缓解率（ORR），安全性和患者报告以及生活质量结果。。

Results from DREAMM-7 were first presented6 at the American Society of Clinical Oncology (ASCO) Plenary Series in February 2024, shared in an encore presentation at the 2024 ASCO Annual Meeting, and published in the New England Journal of Medicine.

DREAMM-7的结果于2024年2月首次在美国临床肿瘤学会（ASCO）全体系列会议上发表6，在2024年ASCO年会上的一次encore演讲中分享，并发表在《新英格兰医学杂志》上。

About DREAMM-8

关于DREAMM-8

The DREAMM-8 phase III clinical trial is a multicentre, open-label, randomised trial evaluating the efficacy and safety of belantamab mafodotin in combination with PomDex compared to a combination of bortezomib and PomDex in patients with relapsed/refractory multiple myeloma previously treated with at least one prior line of multiple myeloma therapy, including a lenalidomide-containing regimen, and who have documented disease progression during or after their most recent therapy.

DREAMM-8 III期临床试验是一项多中心，开放标签的随机试验，评估了belantamab-mafodotin联合PomDex与硼替佐米和PomDex联合治疗复发/难治性多发性骨髓瘤患者的疗效和安全性，这些患者先前至少接受过一种多发性骨髓瘤治疗，包括含来那度胺的方案，并且在最近的治疗期间或之后记录了疾病进展。

Compared to the patient population studied in the DREAMM-7 trial, patients in DREAMM-8 were more heavily pre-treated in that all had prior exposure to lenalidomide, 75% were refractory to lenalidomide, 25% had prior daratumumab exposure and of those most were daratumumab refractory..

与DREAMM-7试验中研究的患者人群相比，DREAMM-8患者的预处理程度更高，因为所有患者都曾接触过来那度胺，75%对来那度胺难治，25%曾接触过达拉木单抗，其中大多数是达拉木单抗难治性的。。

A total of 302 participants were randomised at a 1:1 ratio to receive either belantamab mafodotin plus PomDex, or bortezomib plus PomDex.

共有302名参与者以1:1的比例随机接受belantamab-mafodotin加PomDex或硼替佐米加PomDex。

The primary endpoint is PFS as per an independent review committee. The key secondary endpoints include OS and MRD negativity rate as assessed by next-generation sequencing. Other secondary endpoints include ORR, DOR, safety and patient reported and quality of life outcomes.

根据独立审查委员会的规定，主要终点是PFS。关键的次要终点包括通过下一代测序评估的OS和MRD阴性率。其他次要终点包括ORR，DOR，安全性和患者报告以及生活质量结果。

Results from DREAMM-8 were first presented7 at the 2024 ASCO Annual Meeting and published in the New England Journal of Medicine.

DREAMM-8的结果首次在2024年ASCO年会上发表，并发表在《新英格兰医学杂志》上。

About Blenrep

关于Blenrep

Blenrep is an antibody-drug conjugate comprising a humanised B-cell maturation antigen monoclonal antibody conjugated to the cytotoxic agent auristatin F via a non-cleavable linker. The drug linker technology is licensed from Seagen Inc.; the monoclonal antibody is produced using POTELLIGENT Technology licensed from BioWa Inc., a member of the Kyowa Kirin Group..

Blenrep是一种抗体-药物缀合物，其包含通过不可切割的接头与细胞毒性剂auristatin F缀合的人源化B细胞成熟抗原单克隆抗体。drug linker技术由Seagen Inc.许可。；单克隆抗体是使用由协和麒麟集团成员BioWa Inc.许可的POTELLIGENT技术生产的。。

Refer to the Blenrep UK Summary of Product Characteristics8 for a full list of adverse events and the complete important safety information in the United Kingdom.

有关英国不良事件的完整列表和完整的重要安全信息，请参阅Blenrep UK产品特性摘要8。

GSK in oncology

葛兰素史克与肿瘤学

GSK is committed to maximising patient survival through transformational medicines, with a current focus on breakthroughs in immuno-oncology and tumour-cell targeting therapies, and development in haematologic malignancies, gynaecologic cancers, and other solid tumours.

葛兰素史克致力于通过转化药物最大限度地提高患者的生存率，目前专注于免疫肿瘤学和肿瘤细胞靶向治疗的突破，以及血液系统恶性肿瘤，妇科癌症和其他实体瘤的发展。

About GSK

GSK

GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com.

葛兰素史克是一家全球性生物制药公司，旨在将科学、技术和人才团结起来，共同战胜疾病。更多信息请访问gsk.com。