GSK plc (LSE/NYSE: GSK) today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has accepted for review a new drug application (NDA) 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，日本厚生劳动省（MHLW）已接受审查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新药申请（NDA）。

MHLW also has granted orphan drug designation for Blenrep, which reflects the high unmet medical need and ensures priority NDA review in multiple myeloma..

MHLW还为Blenrep授予了孤儿药称号，这反映了高度未满足的医疗需求，并确保了多发性骨髓瘤的优先NDA审查。。

This is the third major regulatory filing acceptance for belantamab mafodotin combinations in the treatment of relapsed/refractory multiple myeloma, following marketing authorisation application acceptance2 by the European Medicines Agency (EMA) in July 2024 and by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK earlier this month..

这是继2024年7月欧洲药品管理局（EMA）和本月早些时候英国药品和医疗保健产品管理局（MHRA）接受上市许可申请2后，贝兰单抗-马福多汀联合治疗复发/难治性多发性骨髓瘤的第三次主要监管备案。。

Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: “Blenrep combinations show potential based on the results of the DREAMM-7 and DREAMM-8 trials to redefine the treatment of relapsed/refractory multiple myeloma. We are committed to working with health authorities worldwide to advance Blenrep along regulatory pathways so we can bring these additional treatment options to patients as quickly as possible.”.

葛兰素史克公司高级副总裁、全球肿瘤研发主管 Hesham Abdullah 说： “根据DREAMM-7和DREAMM-8试验的结果，Blenrep联合疗法显示出重新定义复发性/难治性多发性骨髓瘤治疗的潜力。我们致力于与全球卫生机构合作，推进Blenrep在监管途径上的发展，以便尽快为患者提供更多的治疗选择。

Multiple myeloma presents a growing health concern in Japan, where the number of patients diagnosed with multiple myeloma per year has increased continuously over the last five decades.3,4 This underscores the urgent need for more treatment options for patients in Japan, particularly those with progressing disease that has become resistant to the current standard of care..

多发性骨髓瘤在日本引起了越来越多的健康问题，在过去的五十年中，每年被诊断患有多发性骨髓瘤的患者数量不断增加。3,4这强调了日本患者迫切需要更多的治疗选择，特别是那些疾病进展已对当前的护理标准产生抵抗力的患者。。

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。

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. 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..

在两项试验中均观察到总生存率（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。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。。

Results from both trials 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. 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..

两项试验的结果还显示，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。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.1,5 There are approximately more than 180,000 new cases of multiple myeloma diagnosed globally each year.6 More than 7,200 new cases of multiple myeloma are diagnosed in Japan each year.1 Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments.7.

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[1,5]。全球每年诊断出约18万多例新发多发性骨髓瘤[6]。日本每年诊断出7200多例新发多发性骨髓瘤[1]。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[7]。

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, including Japanese patients, 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.

包括日本患者在内的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 presented8 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，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。

A Japan expansion cohort is set to further evaluate the DREAMM-7 protocol in Japanese patients. Results for Japanese participants will be presented at a future scientific meeting.

日本扩展队列将进一步评估日本患者的DREAMM-7方案。日本参与者的研究结果将在未来的科学会议上公布。

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, including Japanese patients, were randomised at a 1:1 ratio to receive either belantamab mafodotin plus PomDex, or bortezomib plus PomDex.

包括日本患者在内的总共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，患者报告和生活质量结果。

Results from DREAMM-8 were first presented9 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。

A Japan expansion cohort is set to further evaluate the DREAMM-8 protocol in Japanese patients. Results for Japanese participants will be presented at a future scientific meeting.

日本扩展队列将进一步评估日本患者的DREAMM-8方案。日本参与者的研究结果将在未来的科学会议上公布。

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。