GSK plc (LSE/NYSE: GSK) today announced statistically significant and clinically meaningful overall survival (OS) results from a planned interim analysis of the DREAMM-7 trial evaluating Blenrep (belantamab mafodotin) in combination with bortezomib plus dexamethasone (BVd) versus daratumumab in combination with bortezomib plus dexamethasone (DVd) as a second line or later treatment for relapsed or refractory multiple myeloma.

GSK plc（LSE/NYSE:GSK）今天宣布了DREAMM-7试验的计划中期分析结果，该试验评估了Blenrep（belantamab-mafodotin）联合硼替佐米加地塞米松（BVd）与达拉木单抗联合硼替佐米加地塞米松（DVd）作为复发或难治性多发性骨髓瘤的二线或晚期治疗。

These data were featured today in an oral presentation at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition..

这些数据今天在第66届美国血液学会（ASH）年会和博览会上的口头报告中得到了介绍。。

The OS findings from DREAMM-7 build on previous data from the DREAMM-71 and DREAMM-82 trials, which showed a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for both belantamab mafodotin-based combinations versus standard of care comparators.

DREAMM-7的OS研究结果建立在DREAMM-71和DREAMM-82试验的先前数据基础上，该试验显示，基于belantamab-mafodotin的组合与标准治疗对照组相比，无进展生存期（PFS）有统计学意义和临床意义的改善。

Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: “The compelling overall survival data from the DREAMM-7 trial establish the potential of Blenrep in combination to significantly extend the lives of patients with multiple myeloma at or after first relapse. This represents an important advancement that could redefine the treatment of relapsed or refractory multiple myeloma.”.

葛兰素史克公司研发全球肿瘤学负责人高级副总裁Hesham Abdullah表示：“DREAMM-7试验令人信服的总体生存数据确立了Blenrep联合应用的潜力，可显着延长多发性骨髓瘤患者首次复发时或复发后的寿命。这代表了一项重要进展，可能会重新定义复发或难治性多发性骨髓瘤的治疗。”。

With a median follow up of 39.4 months, the analysis presented today shows a statistically significant 42% reduction in the risk of death among patients receiving the belantamab mafodotin combination (n=243) versus the daratumumab-based comparator (n=251) (HR 0.58; 95% CI: 0.43-0.79; p=0.00023). Although the median overall survival (mOS) was not reached in either arm of the study, the projected mOS for BVd is 84 months compared to 51 months for DVd.3.

中位随访时间为39.4个月，今天的分析显示，接受belantamab-mafodotin联合治疗的患者（n=243）与基于daratumumab的对照组（n=251）相比，死亡风险降低了42%（HR 0.58；95%CI:0.43-0.79；p=0.00023）。虽然研究的任何一组均未达到中位总生存期（mOS），但BVd的预计mOS为84个月，而DVd为51个月。

The three-year OS rate was 74% in the belantamab mafodotin combination arm and 60% in the daratumumab combination arm. The survival benefit favouring BVd was seen as early as four months and was sustained over time as illustrated by the separation of the lines in the Kaplan-Meier curve shown here.

belantamab-mafodotin联合组的三年OS率为74%，daratumumab联合组为60%。早在四个月时就可以看到有利于BVd的生存益处，并且随着时间的推移持续存在，如这里所示的Kaplan-Meier曲线中的线的分离所示。

BVd, belantamab mafodotin, bortezomib, and dexamethasone; DVd, daratumumab, bortezomib, and dexamethasone; HR, hazard ratio; ITT, intention to treat; NR, not reached; OS, overall survival; R-ISS, Revised International Staging System.a Two patients in the ITT population were randomised, not treated, rescreened, and rerandomised.

BVd，belantamab-mafodotin，硼替佐米和地塞米松；DVd，达拉木单抗，硼替佐米和地塞米松；HR，风险比；ITT，意向治疗；NR，未达到；OS，总体生存；R-ISS，修订的国际分期系统。ITT人群中的两名患者被随机分组，未接受治疗，重新筛查并重新随机分组。

They are counted as 4 unique patients in this output. b CIs were estimated using the Brookmeyer-Crowley method. c HRs were estimated using a Cox proportional hazards model stratified by the number of lines of prior therapy (1 vs 2 or 3 vs ≥4), prior bortezomib (no vs yes), and R-ISS stage at screening (I vs II or III), with a covariate of treatment.

在此输出中，他们被视为4名独特的患者。使用Brookmeyer-Crowley方法估计b CI。c HR使用Cox比例风险模型进行估计，该模型按先前治疗的线数（1 vs 2或3 vs≥4），先前硼替佐米（无vs是）和筛查时的R-ISS阶段（I vs II或III）进行分层，具有治疗的协变量。

d P value is from a 1-sided stratified log-rank test. At 171 actual events (48.2% OS information fraction), OS was declared significant if the P value was <.00112..

d P值来自单侧分层对数秩检验。在171个实际事件（操作系统信息分数为48.2%）中，如果P值小于0.00112，则操作系统被宣布为重要。。

María-Victoria Mateos, MD, PhD, Head of Myeloma and Clinical Trials Unit, Haematology Department and Professor of Medicine at the University of Salamanca, Spain, and DREAMM-7 principal investigator, said: “The totality of evidence from DREAMM-7 represents a potential paradigm shift for multiple myeloma patients who have experienced a relapse or become refractory to initial treatment.

María-Victoria Mateos医学博士、博士、血液学系骨髓瘤和临床试验室主任、西班牙萨拉曼卡大学医学教授和DREAMM-7首席研究员表示：“DREAMM-7的全部证据代表了多发性骨髓瘤患者复发或对初始治疗难治的潜在范式转变。

The OS results shown with the belantamab mafodotin combination in DREAMM-7 further cement the potential of this regimen to prolong the lives of patients with relapsed or refractory multiple myeloma compared to a standard of care daratumumab combination.”.

与标准治疗daratumumab组合相比，在DREAMM-7中使用belantamab-mafodotin组合显示的OS结果进一步巩固了该方案延长复发或难治性多发性骨髓瘤患者寿命的潜力。”。

The belantamab mafodotin combination also showed statistically significant superiority on the key secondary endpoint of minimal residual disease (MRD) negativity (no detectable cancer cells) compared to the daratumumab combination. The greater than 2.5-fold improvement in the rate of MRD negativity seen at the time of the primary analysis for patients who received BVd can now be declared as statistically significant (p<0.00001) after the positive OS readout based on the predefined testing procedure.

与daratumumab组合相比，belantamab-mafodotin组合在最小残留病（MRD）阴性（无可检测的癌细胞）的关键次要终点上也显示出统计学上显着的优势。根据预定义的测试程序，在接受BVd的患者进行初步分析时，MRD阴性率提高了2.5倍以上，现在可以宣布其在OS读数为阳性后具有统计学意义（p<0.00001）。

This further underscores the transformative potential of this belantamab mafodotin combination for multiple myeloma patients at or after their first relapse..

这进一步强调了这种belantamab-mafodotin组合在多发性骨髓瘤患者首次复发时或复发后的转化潜力。。

In addition to OS and MRD negativity, the belantamab mafodotin combination resulted in clinically meaningful improvements in all key secondary efficacy endpoints compared to the daratumumab combination, including duration of response (DOR) and progression-free survival 2 (PFS 2). The results indicate deeper and more durable responses among patients treated with BVd compared to DVd..

除了OS和MRD阴性外，与daratumumab组合相比，belantamab-mafodotin组合在所有关键次要疗效终点方面都有临床意义的改善，包括反应持续时间（DOR）和无进展生存期2（PFS 2）。结果表明，与DVd相比，接受BVd治疗的患者反应更深，更持久。。

The safety and tolerability of the belantamab mafodotin regimen were consistent with the primary analysis and known safety profile of the individual agents. Grade 3 or higher adverse events of clinical interest in the belantamab mafodotin combination and daratumumab combination arms, respectively included thrombocytopenia (56% versus 35%; 34 versus 25 patients/100 person-years); anaemia (9% versus 10%; exposure-adjusted rate [per 100 person-years] not reported); and neutropenia (14% versus 10%; 8 versus 7 patients/100 person-years).Eye-related side effects, a known risk of treatment with belantamab mafodotin, were generally manageable and resolvable with dose modification, and led to a low (10%) treatment discontinuation rate..

belantamab-mafodotin方案的安全性和耐受性与个体药物的主要分析和已知安全性一致。belantamab-mafodotin联合组和daratumumab联合组临床感兴趣的3级或更高级别不良事件分别包括血小板减少症（56%比35%；34比25患者/100人年）；贫血（9%对10%；未报告暴露调整率[每100人年]）；和中性粒细胞减少症（14%对10%；8对7患者/100人年）。与眼睛相关的副作用是用belantamab-mafodotin治疗的已知风险，通常可以通过剂量调整来控制和解决，并且导致治疗中断率低（10%）。。

Key Secondary Endpoints

关键次要端点

Endpoint

端点

belantamab mafodotin + bortezomib + dexamethasone (BVd) n=243

贝兰特单抗-镁氟丁+硼替佐米+地塞米松（BVd）n=243

daratumumab + bortezomib + dexamethasone (DVd) n=251

达他单抗+硼替佐米+地塞米松（DVd）n=251

OS (overall survival), HR (95% CI)

OS（总生存率），HR（95%置信区间）

0.58 (0.43-0.79)

0.58 (0.43-0.79)

P-value1

P值1

p=0.00023

p=0.00023

OS, median (95% CI), months

OS，中位数（95%置信区间），月

NR (NR-NR)

NR（NR-NR）

NR (41.0-NR)

NR（41.0-NR）

OS rate at 24 months, % (95% CI)

24个月时的OS率，%（95%置信区间）

79% (73-84)

79% (73-84)

67% (61-73)

67% (61-73)

OS rate at 36 months, % (95% CI)

36个月时的OS率，%（95%置信区间）

74% (68-79)

74% (68-79)

60% (54-66)

60% (54-66)

MRD (minimal residual disease) negativity rate for patients with CR or better, % (95% CI)

CR或更好患者的MRD（最小残留病）阴性率，%（95%CI）

25.1% (19.8-31.0)

25.1% (19.8-31.0)

10.4% (6.9-14.8)

10.4% (6.9-14.8)

ORR (overall response rate), % (95% CI)

ORR（总体回应率），%（95%置信区间）

83.1% (77.8-87.6)

83.1% (77.8-87.6)

71.3% (65.3-76.8)

71.3% (65.3-76.8)

CR (complete response), or better, % (95% CI)

CR（完全缓解），或更好，%（95%置信区间）

35.8% (29.8-42.2)

35.8% (29.8-42.2)

17.5% (13.0-22.8)

17.5% (13.0-22.8)

VGPR (very good partial response), or better, % (95% CI)

VGPR（非常好的部分响应），或更好，%（95%置信区间）

66.3% (59.9-72.2)

66.3% (59.9-72.2)

46.2% (39.9-52.6)

46.2% (39.9-52.6)

Median DOR (duration of response) (95% CI), months

中位DOR（反应持续时间）（95%置信区间），月

40.8 (30.5-NR)

40.8（30.5-NR）

17.8 (13.8-23.6)

17.8 (13.8-23.6)

Median PFS 2 (progression-free survival 2), months

中位PFS 2（无进展生存期2），月

NR (45.6-NR)

NR（45.6-NR）

33.4 (26.7-44.9)

33.4 (26.7-44.9)

HR

人力资源

0.59 (0.45-0.77)

0.59 (0.45-0.77)

1One-sided p-value based on stratified log-rank test.

1基于分层对数秩检验的单侧p值。

In 2024, regulatory filings for belantamab mafodotin combinations for the treatment of relapsed or refractory multiple myeloma based on the results of the DREAMM-7 and DREAMM-8 trials have been accepted in the US4, European Union5, Japan6 (with priority review), China (for DREAMM-7 only, with priority review; Breakthrough Therapy Designation7 also granted), United Kingdom, Canada and Switzerland (with priority review for DREAMM-8)..

2024年，根据DREAMM-7和DREAMM-8试验的结果，针对用于治疗复发或难治性多发性骨髓瘤的belantamab-mafodotin组合的监管申请已被美国4、欧盟5、日本6（优先审查）、中国（仅限DREAMM-7，优先审查；还授予突破性治疗指定7）、英国、加拿大和瑞士（优先审查DREAMM-8）接受。。

About the DREAMM clinical development programme

关于DREAMM临床开发计划

The DREAMM (DRiving Excellence in Approaches to Multiple Myeloma) clinical development programme continues to evaluate the potential of belantamab mafodotin in early lines of treatment and in combination with novel therapies and standard of care treatments. In addition to DREAMM-7 and DREAMM-8, a phase III study in newly diagnosed transplant ineligible multiple myeloma, DREAMM-10, is expected to be initiated by the end of 2024..

DREAMM（推动多发性骨髓瘤治疗方法的卓越）临床开发计划继续评估belantamab-mafodotin在早期治疗中以及与新疗法和标准治疗相结合的潜力。除DREAMM-7和DREAMM-8外，一项针对新诊断的移植不合格多发性骨髓瘤DREAMM-10的III期研究预计将于2024年底启动。。

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 bortezomib plus dexamethasone (BVd) compared to a combination of daratumumab and 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 III期临床试验是一项多中心，开放标签，随机试验，评估belantamab-mafodotin联合硼替佐米加地塞米松（BVd）与daratumumab和硼替佐米加地塞米松（DVd）联合治疗复发/难治性多发性骨髓瘤患者的疗效和安全性，这些患者之前至少接受过一种多发性骨髓瘤治疗，在最近的治疗期间或之后有疾病进展的记录。。

A total of 494 participants were randomised at a 1:1 ratio to receive either BVd or DVd. 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BVd或DVd。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 presented1 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。

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.8,9 There are approximately more than 180,000 new cases of multiple myeloma diagnosed globally each year.10 Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments.11 Many patients with multiple myeloma, including approximately 65% in the US, are treated in a community cancer setting, leaving an urgent need for new, effective therapies with manageable side effects that can be administered outside of an academic centre.12,13,14.

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[8,9]。每年全球约有18万多例新诊断的多发性骨髓瘤病例[10]。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[11]。许多多发性骨髓瘤患者，包括美国约65%的患者，都在社区癌症环境中接受治疗，因此迫切需要新的有效疗法，可以在学术中心之外进行管理。12,13,14。

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. Refer to the local Summary of Product Characteristics for a full list of adverse events and complete important safety information.

Blenrep在香港被批准为单一疗法。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的生物制药公司，旨在联合科学、技术和人才共同战胜疾病。更多信息请访问gsk.com。