GSK plc (LSE/NYSE: GSK) today announced the authorisation of Blenrep by the Medicines and Healthcare products Regulatory Agency (MHRA). 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. This UK regulatory authorisation marks the first in the world for Blenrep in this treatment setting.

葛兰素史克公司 (GSK plc) (伦敦证券交易所/纽约证券交易所代码：GSK) 今日宣布，英国药品和保健产品监管局 (MHRA)已批准Blenrep用于治疗多发性骨髓瘤成人患者，可与硼替佐米联合地塞米松 (BVd) 方案联合治疗，适用于既往接受过至少一项治疗的患者；也可与泊马度胺联合地塞米松 (BPd) 方案联合治疗，适用于既往接受过至少一项包括来那度胺在内的治疗的患者。此次英国监管部门的批准标志着 Blenrep 在全球首次获得此类治疗方案的批准。

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-7.2,3,4 The safety and tolerability profiles of the Blenrep combinations were broadly consistent with the known profiles of the individual agents.

关键的DREAMM-7和DREAMM-8 III期临床试验在治疗复发或难治性多发性骨髓瘤方面取得了卓越的疗效，支持英国药品监督管理局（MHRA）批准Blenrep联合疗法。这些结果包括： Blenrep联合疗法与标准疗法相比，在两项试验中均获得了具有统计学意义和临床意义的无进展生存期(PFS)结果，以及DREAMM-7试验中的总生存期(OS) 。2,3,4 Blenrep联合疗法的安全性和耐受性与已知的单个药物的概况大致一致。

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.”

葛兰素史克公司高级副总裁、全球肿瘤研发主管 Hesham Abdullah 表示：“ Blenrep组合疗法在英国获得批准，对多发性骨髓瘤患者来说是一个变革性的里程碑，多发性骨髓瘤是一种以缓解和复发为特征的癌症。作为唯一针对 BCMA 的 ADC 疗法， Blenrep有潜力在可靠的 III 期数据支持下，比标准治疗延长生存期和缓解期，并重新定义首次复发时或复发后的治疗。

Currently, most patients with multiple myeloma experience relapse, and in the UK only 55% remain alive five years after diagnosis.5 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. Blenrep combinations can be administered to a range of patient types in any oncology treatment setting without complex pre-administration regimens or hospitalisation.

”目前，大多数多发性骨髓瘤患者都会经历复发，在英国，只有 55% 的患者在确诊五年后仍然存活。5 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差异化​​的作用机制。Blenrep组合疗法可用于任何肿瘤治疗环境中的多种患者类型，无需复杂的给药前方案或住院治疗。

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

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 Joseph Mikhael 医学博士表示：“随着多发性骨髓瘤患者在确诊时越来越多地接受联合治疗，社区环境中采用Blenrep等不同机制的治疗方案对于延长缓解期并最终存活至关重要。我们很高兴看到这一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.2,3 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).4 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

与多发性骨髓瘤二线或后续治疗中的标准三联疗法相比， DREAMM-7 和 DREAMM-8 均显示出Blenrep疗法组合的 PFS 改善具有统计学意义和临床意义。 2,3在 DREAMM-7 中，Blenrep组合的中位 PFS 几乎是 daratumumab 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）。2 DREAMM -7 还达到了 OS 的关键次要终点，在 39.4 个月的中位随访中，Blenrep组合 (n=243) 与 daratumumab 对照组 (n=251) 相比，死亡风险降低了 42%，具有统计学意义和临床意义 (HR 0.58；95% CI：0.43-0.79；p=0.00023)。4 Blenrep组合组的三年 OS 率为 74% ，达雷妥尤单抗联合治疗组。在 DREAMM-8 研究中，中位随访时间为 21.8 个月， Blenrep联合治疗组尚未达到中位 PFS，而硼替佐米联合治疗组为 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联合疗法持续惠及广泛患者，包括预后特征或预后不良的患者，例如高危细胞遗传学患者或对来那度胺耐药的患者。两项试验均显示，所有其他次要疗效终点均有临床意义的改善，包括与相应的对照药物相比，疗效更显著、更持久。

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.2,3 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Blenrep治疗的已知副作用，通常可以解决，可以通过延长输注间隔时间和减少剂量来控制，同时保持疗效，并且导致两项试验中的治疗停止率较低（≤9%）。2,3在 DREAMM-7 中， Blenrep组合组中最常见的报告非眼部不良事件（>30% 的参与者）是血小板减少症（87%）和腹泻（32%），在 DREAMM-8 的 Blenrep 组合组中最常见的报告非眼部不良事件（>30% 的参与者）是中性粒细胞减少症（63%）、血小板减少症（55%）和 COVID-19（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 2025,6 European Union,7 Japan (with priority review),8 China (based on the results of DREAMM-7, with Breakthrough Therapy Designation for the combination and priority review for the application),9 Canada, and Switzerland (with priority review for DREAMM-8).

Blenrep组合目前正在 14 个国家接受审查，包括美国（处方药使用者付费法案 (PDUFA) 的生效日期为 2025 年 7 月 23 日）、欧盟6 个 国家、日本7 个国家（优先审查）、中国8 个国家（基于 DREAMM-7 的结果，组合获得突破性疗法认定，申请获得优先审查）、加拿大9 个国家和瑞士（DREAMM-8 获得优先审查）。