GSK plc announced the authorisation of Blenrep by the Medicines and Healthcare products Regulatory Agency (MHRA)

GSK plc宣布，Blenrep已获得药品和健康产品管理局（MHRA）的授权。

In the UK, Blenrep is approved for the treatment of adults with multiple myeloma in combination with bortezomib plus dexamethasone (BVd) in patients who have received at least one prior therapy, and in combination with pomalidomide plus dexamethasone (BPd) in patients who have received at least one prior therapy including lenalidomide.

在英国，Blenrep 获批用于治疗成人多发性骨髓瘤，与硼替佐米加地塞米松（BVd）联合使用于接受过至少一种先前疗法的患者，以及与泊马度胺加地塞米松（BPd）联合使用于接受过至少一种先前疗法（包括来那度胺）的患者。

This UK regulatory authorisation marks the first in the world for Blenrep in this treatment setting..

英国监管机构的这项授权标志着Blenrep在全球范围内首次获得此类治疗的批准。

Superior efficacy results from the pivotal DREAMM-7 and DREAMM-8 phase III trials in relapsed or refractory multiple myeloma support MHRA authorisation of Blenrep combinations. These include statistically significant and clinically meaningful progression-free survival (PFS) results for Blenrep combinations versus standards of care in both trials and overall survival (OS) in DREAMM-7.

关键的DREAMM-7和DREAMM-8 III期试验在复发或难治性多发性骨髓瘤中表现出卓越的疗效，支持了Blenrep联合疗法获得MHRA授权。这些结果包括在两项试验中，Blenrep联合疗法对比标准治疗在无进展生存期（PFS）上均显示出统计学显著性及临床意义，并且在DREAMM-7试验中还体现出总生存期（OS）的优势。

The safety and tolerability profiles of the Blenrep combinations were broadly consistent with the known profiles of the individual agents..

Blenrep联合疗法的安全性和耐受性特征与各单一药物的已知特征基本一致。

Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: “Today's approval of Blenrep combinations in the UK is a transformative milestone for patients with multiple myeloma, a cancer marked by remission and relapse. As the only BCMA-targeted ADC therapy, Blenrep has the potential, supported by robust phase III data, to extend survival and remission versus standard of care and redefine treatment at or after first relapse.”.

GSK全球肿瘤研发高级副总裁兼负责人Hesham Abdullah表示：“今天Blenrep联合疗法在英国获批，这对多发性骨髓瘤患者来说是一个变革性的里程碑，这种癌症以缓解和复发为特征。作为唯一的BCMA靶向ADC疗法，Blenrep凭借强大的III期数据支持，有望在首次复发或之后延长生存期和缓解期，并重新定义标准治疗。”

Currently, most patients with multiple myeloma experience relapse, and in the UK only 55% remain alive five years after diagnosis. Blenrep is the only anti-BCMA (B-cell maturation antigen) antibody-drug conjugate (ADC) in multiple myeloma, providing patients at or after relapse with a differentiated mechanism of action.

目前，大多数多发性骨髓瘤患者会经历复发，在英国，只有55%的患者在诊断后五年仍然存活。Blenrep是多发性骨髓瘤中唯一的抗BCMA（B细胞成熟抗原）抗体药物偶联物（ADC），为复发时或复发后的患者提供了独特的作用机制。

Blenrep combinations can be administered to a range of patient types in any oncology treatment setting without complex pre-administration regimens or hospitalisation..

Blenrep组合可以在任何肿瘤治疗环境中给予各种类型的患者，无需复杂的预处理方案或住院治疗。

Joseph Mikhael, MD, Chief Medical Officer, International Myeloma Foundation and Professor, Translational Genomics Research Institute, City of Hope Cancer Center, said: “As patients with multiple myeloma increasingly receive combination therapies at diagnosis, treatment options available in the community setting that use different mechanisms like Blenrep are crucial to extending remission and ultimately survival.

约瑟夫·米哈伊尔医学博士，国际骨髓瘤基金会首席医疗官，希望之城癌症中心转化基因组学研究所教授表示：“由于多发性骨髓瘤患者在确诊时越来越多地接受联合治疗，在社区医疗环境中使用不同机制（如Blenrep）的治疗选择对于延长缓解期并最终提高生存率至关重要。”

We are pleased to see this advancement in the treatment landscape extended across both academic and community settings where many patients are treated.”.

我们很高兴看到这种治疗领域的进步扩展到许多患者接受治疗的学术和社区环境。

Both DREAMM-7 and DREAMM-8 showed statistically significant and clinically meaningful PFS improvements for the Blenrep combinations compared to standard of care triplet combinations in the second line or later treatment of multiple myeloma. In DREAMM-7, the Blenrep combination nearly tripled median PFS versus the daratumumab-based comparator (36.6 months versus 13.4 months, respectively (hazard ratio [HR]: 0.41 [95% confidence interval (CI): 0.31-0.53], p-value<0.00001).2 DREAMM-7 also met the key secondary endpoint of OS, showing a statistically significant and clinically meaningful 42% reduction in the risk of death at a median follow-up of 39.4 months favouring the Blenrep combination (n=243) versus the daratumumab-based comparator (n=251) (HR 0.58; 95% CI: 0.43-0.79; p=0.00023).

DREAMM-7 和 DREAMM-8 均显示，与用于多发性骨髓瘤二线或后续治疗的标准三联疗法相比，Blenrep 联合疗法在无进展生存期（PFS）方面取得了具有统计学意义和临床意义的显著改善。在 DREAMM-7 中，Blenrep 联合疗法的中位 PFS 几乎是基于达雷妥尤单抗的对照组的三倍（分别为 36.6 个月和 13.4 个月，风险比 [HR]：0.41 [95% 置信区间 (CI)：0.31-0.53]，p 值<0.00001）。DREAMM-7 还达到了总生存期（OS）的关键次要终点，在中位随访时间为 39.4 个月时，相较于基于达雷妥尤单抗的对照组（n=251），Blenrep 联合疗法（n=243）显示出死亡风险统计学显著且临床意义重大的 42% 降低（HR 0.58；95% CI：0.43-0.79；p=0.00023）。

The three-year OS rate was 74% in the Blenrep combination arm and 60% in the daratumumab combination arm. In DREAMM-8, at a median follow-up of 21.8 months, the median PFS was not yet reached with the Blenrep combination compared to 12.7 months in the bortezomib combination..

三年总生存率（OS）在Blenrep联合治疗组为74%，在daratumumab联合治疗组为60%。在DREAMM-8试验中，中位随访时间为21.8个月，Blenrep联合治疗组的中位无进展生存期（PFS）尚未达到，而bortezomib联合治疗组为12.7个月。

Blenrep combinations consistently benefited a broad range of patients, including those with poor prognostic features or outcomes, such as high-risk cytogenetics or those refractory to lenalidomide. Both trials also showed clinically meaningful improvements across all other secondary efficacy endpoints, including deeper and more durable responses versus the respective comparators..

Blenrep联合疗法持续使广泛的患者群体受益，包括那些具有不良预后特征或结果的患者，例如高危细胞遗传学患者或对来那度胺耐药的患者。两项试验还显示，在所有其他次要疗效终点上均表现出有临床意义的改善，包括相较于各自对照组更深入且更持久的缓解。

Eye-related side effects, a known side effect of treatment with Blenrep, were generally resolvable, manageable with extended time between infusions and dose reductions while maintaining efficacy, and led to low (≤9%) treatment discontinuations in both trials. The most commonly reported non-ocular adverse events (>30% of participants) in the Blenrep combination arm were thrombocytopenia (87%) and diarrhoea (32%) in DREAMM-7, and neutropenia (63%), thrombocytopenia (55%) and COVID-19 (37%) in the Blenrep combination arm of DREAMM-8..

与眼睛相关的副作用是布伦普治疗的已知副作用，通常可以通过延长输注间隔和减少剂量来解决和管理，同时保持疗效，并且在两项试验中导致的治疗中断率较低（≤9%）。在DREAMM-7试验中，布伦普联合治疗组最常见的非眼部不良事件（>30%的参与者）为血小板减少症（87%）和腹泻（32%）；而在DREAMM-8试验的布伦普联合治疗组中，最常见的为中性粒细胞减少症（63%）、血小板减少症（55%）和新冠肺炎（37%）。

Blenrep combinations are currently under review in 14 countries, including in the US with a Prescription Drug User Fee Act (PDUFA) date of 23 July 2025, European Union, Japan (with priority review), China (based on the results of DREAMM-7, with Breakthrough Therapy Designation for the combination and priority review for the application), Canada, and Switzerland (with priority review for DREAMM-8)..

Blenrep联合疗法目前正在14个国家接受审查，包括美国（处方药使用者费用法案（PDUFA）日期为2025年7月23日）、欧盟、日本（优先审查）、中国（基于DREAMM-7的结果，该组合获得突破性疗法认定，并且申请获得优先审查）、加拿大和瑞士（DREAMM-8获得优先审查）。

DREAMM-7 is a multicentre, open-label, randomised phase III clinical trial evaluating the efficacy and safety of belantamab mafodotin combined with bortezomib plus dexamethasone (BVd) compared to daratumumab combined with bortezomib plus dexamethasone (DVd) 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是一项多中心、开放标签、随机的III期临床试验，评估了贝兰他单抗马福多汀联合硼替佐米和地塞米松（BVd）与达雷妥尤单抗联合硼替佐米和地塞米松（DVd）在既往接受过至少一种多发性骨髓瘤治疗、并在最近一次治疗期间或之后有记录疾病进展的复发/难治性多发性骨髓瘤患者中的疗效和安全性。

The trial enrolled 494 participants who were randomised 1:1 to receive either BVd or DVd. Belantamab mafodotin was administered at a dose of 2.5mg/kg intravenously every three weeks. The primary endpoint was PFS as per an independent review committee, with secondary endpoints including OS, duration of response (DOR), and minimal residual disease (MRD) negativity rate as assessed by next-generation sequencing.

试验共招募了494名参与者，他们以1:1的比例随机分配接受BVd或DVd治疗。Belantamab mafodotin以每三周一次2.5mg/kg的剂量静脉注射给药。主要终点是由独立审查委员会评估的无进展生存期（PFS），次要终点包括总生存期（OS）、反应持续时间（DOR）以及通过下一代测序评估的微小残留病（MRD）阴性率。

Other secondary endpoints include overall response rate (ORR), safety, and patient reported and quality of life outcomes. Results were first presented at the American Society of Clinical Oncology (ASCO) Plenary Series in February 2024 and published in the New England Journal of Medicine..

其他次要终点包括总缓解率 (ORR)、安全性以及患者报告和生活质量结果。该结果于2024年2月首次在美国临床肿瘤学会 (ASCO) 全体会议系列上公布，并发表在《新英格兰医学杂志》上。

DREAMM-8 is a multicentre, open-label, randomised phase III clinical trial evaluating the efficacy and safety of belantamab mafodotin in combination with pomalidomide plus dexamethasone (BPd) compared to bortezomib and pomalidomide plus dexamethasone (PVd) 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 是一项多中心、开放标签、随机 III 期临床试验，评估 belantamab mafodotin 联合泊马度胺和地塞米松（BPd）对比硼替佐米联合泊马度胺和地塞米松（PVd）在复发性/难治性多发性骨髓瘤患者中的疗效和安全性。这些患者之前至少接受过一种包括含来那度胺方案在内的多发性骨髓瘤治疗，并且在最近一次治疗期间或之后有明确的疾病进展记录。

The trial included 302 participants who were randomised 1:1 to receive either BPd or PVd. 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, 78% were refractory to lenalidomide, 25% had prior daratumumab exposure and of those most were daratumumab refractory.

该试验包括302名参与者，他们以1:1的比例随机分配接受BPd或PVd治疗。与DREAMM-7试验中研究的患者群体相比，DREAMM-8中的患者接受过更密集的预治疗，所有人均曾接触过来那度胺，78%对来那度胺耐药，25%曾接触过达拉图单抗，其中大多数人对达拉图单抗耐药。

Belantamab mafodotin was administered at a dose of 2.5mg/kg intravenously for the first cycle and 1.9mg/kg intravenously every four weeks. The primary endpoint was PFS as per an independent review committee, with key secondary endpoints including OS and MRD negativity rate as assessed by next-generation sequencing.

Belantamab mafodotin 在第一个周期以2.5mg/kg的剂量静脉注射，之后每四周以1.9mg/kg的剂量静脉注射。主要终点是由独立审查委员会评估的无进展生存期（PFS），关键的次要终点包括总生存期（OS）和通过下一代测序评估的微小残留病阴性率。

Other secondary endpoints include ORR, DOR, safety, and patient reported and quality of life outcomes. Results were first presented at the 2024 ASCO Annual Meeting and published in the New England Journal of Medicine..

其他次要终点包括客观缓解率（ORR）、缓解持续时间（DOR）、安全性以及患者报告和生活质量结果。结果首次在2024年ASCO年会上公布，并发表在《新英格兰医学杂志》上。

Citation: Belantamab Mafodotin, Bortezomib, and Dexamethasone for Multiple Myeloma. Authors: Hungria V, Robak P, Hus M et al.  N Engl J Med. 2024 Aug 1;391(5):393-407. doi: 10.1056/NEJMoa2405090. Epub 2024 Jun 1. PMID: 38828933.

引用：Belantamab Mafodotin、硼替佐米和地塞米松治疗多发性骨髓瘤。作者：Hungria V、Robak P、Hus M 等。《新英格兰医学杂志》。2024年8月1日；391(5):393-407。doi: 10.1056/NEJMoa2405090。电子版发表于2024年6月1日。PMID: 38828933。

Citation: Belantamab Mafodotin, Pomalidomide, and Dexamethasone in Multiple Myeloma. Authors: Dimopoulos MA, Beksac M, Pour L, Delimpasi S et al. N Engl J Med. 2024 Aug 1;391(5):408-421. doi: 10.1056/NEJMoa2403407. Epub 2024 Jun 2. PMID: 38828951.

引用：Belantamab Mafodotin、Pomalidomide 和 Dexamethasone 治疗多发性骨髓瘤。作者：Dimopoulos MA、Beksac M、Pour L、Delimpasi S 等。《新英格兰医学杂志》。2024年8月1日；391(5):408-421。doi: 10.1056/NEJMoa2403407。在线发表于2024年6月2日。PMID: 38828951。

Condition:

条件：

Multiple Myeloma

多发性骨髓瘤

Type:

类型：

drug

药物