GSK plc (LSE/NYSE: GSK) today announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China has granted Breakthrough Therapy Designation (BTD) for Blenrep (belantamab mafodotin) combined with bortezomib plus dexamethasone (BorDex) for the treatment of 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，中国国家医药产品管理局（NMPA）药物评估中心（CDE）已授予Blenrep（belantamab mafodotin）联合硼替佐米加地塞米松（BorDex）治疗复发或难治性多发性骨髓瘤的突破性治疗指定（BTD）。

NMPA BTD is intended to expedite the development of therapies for serious and life-threatening diseases for which there are no existing treatments or where initial evidence has shown an improvement in patient outcomes over available treatment options.2.

NMPA BTD旨在加速严重和危及生命的疾病的治疗方法的开发，这些疾病没有现有的治疗方法，或者初步证据表明患者预后优于可用的治疗方案。

Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: “Breakthrough Therapy Designation in China underscores the potential for Blenrep to redefine outcomes for patients with multiple myeloma at or after their first relapse. We look forward to continuing to work with the health authority in China and others worldwide to bring Blenrep-based combinations to patients as expeditiously as possible.”.

葛兰素史克研发全球肿瘤学负责人高级副总裁Hesham Abdullah表示：“中国的突破性治疗方案突显了Blenrep在首次复发时或复发后重新定义多发性骨髓瘤患者预后的潜力。我们期待着继续与中国卫生局和全球其他机构合作，尽快为患者提供基于Blenrep的组合。”。

BTD was granted based on the interim results of the phase III head-to-head DREAMM-7 trial, which met its primary endpoint, showing statistically significant and clinically meaningful improvements in progression-free survival (PFS) for belantamab mafodotin combined with BorDex compared to daratumumab plus BorDex in relapsed or refractory multiple myeloma..

BTD是根据III期头对头DREAMM-7试验的中期结果授予的，该试验符合其主要终点，与达拉木单抗加BorDex相比，belantamab-mafodotin联合BorDex在复发或难治性多发性骨髓瘤中的无进展生存期（PFS）有统计学意义和临床意义的改善。。

A positive overall survival (OS) trend was observed 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 standard of care combination.

观察到总生存率（OS）呈阳性趋势，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 profile of the belantamab mafodotin combination in the DREAMM-7 trial was broadly consistent with the known profiles of the individual agents..

在DREAMM-7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。。

Multiple myeloma is a growing health concern in China with approximately 30,000 new cases each year.3 The incidence in China has doubled and mortality has increased 1.5-fold in the past three decades.4 This underscores the need for novel, efficacious treatment options for patients in China, particularly those with progressing disease that has become resistant to the current standard of care..

在中国，多发性骨髓瘤是一个日益严重的健康问题，每年约有30000例新病例。3在过去的三十年中，中国的发病率翻了一番，死亡率增加了1.5倍。4这强调了中国患者需要新颖有效的治疗选择，特别是那些对当前护理标准产生耐药性的疾病进展患者。。

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.5,6 There are approximately more than 180,000 new cases of multiple myeloma diagnosed globally each year.7 Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments.8.

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[5,6]。全球每年约有超过180000例新诊断的多发性骨髓瘤病例[7]。由于多发性骨髓瘤通常难以治疗，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，患者报告和生活质量结果。。

Results from DREAMM-7 were first presented9 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）全体会议上发表，并在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 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。。

Blenrep is approved as monotherapy in Hong Kong, Israel and Singapore. Refer to the local Summary of Product Characteristics for a full list of adverse events and complete important safety information.

Blenrep在香港、以色列和新加坡被批准为单一疗法。有关不良事件的完整列表和完整的重要安全信息，请参阅产品特性的本地摘要。

GSK in oncology

葛兰素史克与肿瘤学

Oncology is an emerging therapeutic area for GSK where we are committed to maximising patient survival with a current focus on haematologic malignancies, gynaecologic cancers, and other solid tumours through breakthroughs in immuno-oncology and tumour-cell targeting therapies.

肿瘤学是GSK的一个新兴治疗领域，我们致力于通过免疫肿瘤学和肿瘤细胞靶向治疗的突破，最大限度地提高患者的生存率，目前专注于血液系统恶性肿瘤，妇科癌症和其他实体瘤。

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。