A GSK multiple myeloma medicine that was pulled from the market after failing its confirmatory test has new data from a Phase 3 study evaluating it an earlier line of treatment, and the latest results show the drug is helping patients live longer compared to a standard drug regimen. Clinical trial investigators and the company believe these results could support making the GSK drug, Blenrep, a new standard of care treatment for this type of blood cancer..

葛兰素史克（GSK）的一种多发性骨髓瘤药物在确认试验失败后退出市场，该药物有一项3期研究的新数据，该研究评估了该药物的早期治疗方案，最新结果显示，与标准药物方案相比，该药可帮助患者活得更长。临床试验研究人员和该公司认为，这些结果可能有助于使GSK药物Blenrep成为治疗此类血癌的新标准。。

The new trial results for Blenrep were presented Monday during the annual meeting of the American Society of Hematology. The FDA is reviewing data from the drug’s full Phase 3 program, which tested the drug head to head against two standard of care multiple myeloma drug regimens. An FDA decision is expected in July; Blenrep is also under regulatory review in six additional markets..

Blenrep的新试验结果于周一在美国血液学会年会上公布。FDA正在审查该药物完整的第三阶段计划的数据，该计划针对两种标准治疗多发性骨髓瘤药物方案对该药物进行了正面测试。FDA预计将于7月作出决定；Blenrep还在另外六个市场接受监管审查。。

While many treatments are available for multiple myeloma, frequent relapse in this type of blood cancer means patients need new treatment options that take different approaches to the disease. Blenrep is an antibody drug conjugate (ADC) designed to target BCMA, a protein abundant on the surface of multiple myeloma cells.

虽然多发性骨髓瘤有许多治疗方法，但这种血癌的频繁复发意味着患者需要采取不同方法治疗该疾病的新治疗选择。Blenrep是一种抗体-药物偶联物（ADC），旨在靶向BCMA，BCMA是多发性骨髓瘤细胞表面丰富的蛋白质。

The drug is administered as an intravenous infusion every three weeks..

该药每三周静脉滴注一次。。

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利用人工智能自动化减少临床和员工的职业倦怠

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随着技术的进步，人工智能工具将越来越多地减轻医疗保健提供者的行政负担。

By Dr. Michael Blackman, Chief Medical Officer at Greenway Health

由Dr。Greenway Health首席医疗官迈克尔·布莱克曼（MichaelBlackman）

The Blenrep results presented Monday are from a Phase 3 test, DREAMM-7, that enrolled nearly 500 patients whose multiple myeloma relapsed or was refractory to at least one earlier line of therapy. The open-label study evaluated Blenrep in combination with bortezomib, brand name Velcade, and the corticosteroid dexamethasone, a standard multiple myeloma drug regimen typically shortened to BorDex.

周一公布的Blenrep结果来自第三阶段测试DREAMM-7，该测试招募了近500名多发性骨髓瘤复发或至少对一种早期治疗方案无效的患者。这项开放标签研究评估了Blenrep联合硼替佐米，品牌Velcade和皮质类固醇地塞米松，这是一种标准的多发性骨髓瘤药物方案，通常缩短为BorDex。

Blenrep and BorDex were compared against the CD38-targeting Johnson & Johnson multiple myeloma drug daratumumab, brand name Darzalex, combined with BorDex..

将Blenrep和BorDex与针对强生多发性骨髓瘤药物daratumumab（品牌Darzalex）的CD38联合BorDex进行了比较。。

The main clinical trial goal was measuring progression-free survival. On this endpoint, results showed the study drug achieved a median 36.6 months of progression-free survival versus a median 13.4 months in the comparator arm. On the key secondary goal of duration of response, results showed 40.8 months for the Blenrep arm, more than double the duration of the comparator.

主要的临床试验目标是测量无进展生存期。在这一终点，结果显示研究药物的中位无进展生存期为36.6个月，而对照组的中位无进展生存期为13.4个月。关于反应持续时间的关键次要目标，结果显示Blenrep组为40.8个月，是对照组持续时间的两倍以上。

On overall survival, the median has not yet been reached in either arm, according to the primary analysis. But with a median follow-up of 39.4 months, GSK projects median overall survival for the Blenrep arm will be 84 months compared to 51 months for the comparator drug regimen..

根据初步分析，在总体生存率方面，两组的中位数尚未达到。但中位随访时间为39.4个月，GSK预计Blenrep组的中位总生存期为84个月，而对照药物方案为51个月。。

Dr. María-Victoria Mateos, principal investigator for DREAMM-7 and head of myeloma and clinical trials unit, hematology department, and professor of Medicine at the University of Salamanca, Spain, sees the new Blenrep results as potentially practice changing. If the drug reaches the market, it could become a new standard of care drug regimen for relapsed and refractory multiple myeloma after at least one prior line of therapy, she said, speaking during a Monday briefing with journalists..

DREAMM-7首席研究员、血液学系骨髓瘤和临床试验部门负责人、西班牙萨拉曼卡大学医学教授玛丽亚·维多利亚·马特奥斯（María-Victoria Mateos）博士认为，Blenrep的新结果可能会改变实践。她在周一的新闻发布会上说，如果该药物上市，它可能成为至少一种先前治疗方案后复发和难治性多发性骨髓瘤的新标准治疗药物方案。。

In the same briefing, Hesham Abdullah, GSK’s senior vice president, global head oncology, highlighted the near tripling of progression-free survival achieved by Blenrep versus the comparator regimen, along with a strong duration of response to the therapy. He also noted the important marks for overall survival benefit — how long patients live while receiving treatment.

在同一次简报中，GSK全球肿瘤主管高级副总裁Hesham Abdullah强调，与对照方案相比，Blenrep实现的无进展生存率几乎增加了三倍，并且对治疗的反应持续时间很长。他还指出了总体生存获益的重要标志-患者在接受治疗时能活多久。

Blenrep led to a 42% reduction in the risk of death versus the comparator. Abdullah noted this survival benefit is in line with results from an interim analysis reported earlier this year..

与对照组相比，Blenrep导致死亡风险降低了42%。阿卜杜拉指出，这种生存益处与今年早些时候报告的中期分析结果一致。。

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癌症创新的资助模式被打破了-我们可以修复它

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缩小癌症健康公平差距需要通过新的资助方法实现医学突破。

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作者Eve McDavid，任务驱动技术公司首席执行官

Blenrep’s 2020 accelerated FDA approval covered the use of the drug as a fifth-line multiple myeloma therapy, making it the first approved BCMA-targeting therapy. But after the drug, tested as a montotherapy, failed to show statistically signficiant improvement on the main goal of progression-free survival in its confirmatory Phase 3 test, GSK in 2022 withdrew the product from the market..

Blenrep 2020年加速FDA批准将该药物用作第五线多发性骨髓瘤治疗，使其成为首个获得批准的BCMA靶向治疗。但是，在该药物作为一种月疗法进行测试后，在其确认的第3阶段测试中，在无进展生存的主要目标方面没有显示出统计学上的显着改善，葛兰素史克于2022年将该产品从市场上撤回。。

Abdullah said that despite failing the confirmatory trial, results showed Blenrep was an active drug that behaved similarly to two other drug multiple myeloma combination regimens. The company proceeded to test Blenrep again, but as an earlier line of therap and in combination with existing multiple myeloma therapies.

阿卜杜拉说，尽管验证性试验失败，但结果显示Blenrep是一种活性药物，其行为与其他两种药物-多发性骨髓瘤联合治疗方案相似。该公司继续再次测试Blenrep，但作为早期的治疗方案，并与现有的多发性骨髓瘤疗法相结合。

In addition to the DREAMM-7 Phase 3 test against the Darzalex/BorDex combination, the Blenrep regimen was tested separately against the Bristol Myers Squibb drug Pomalyst and dexamethasone. In this Phase 3 study, DREAMM-8, results presented this past June during the annual meeting of the American Society of Clinical Oncology showed the Blenrep regimen led to a 48% reduction in the risk of disease progression or death..

除了针对Darzalex/BorDex组合的DREAMM-7 3期测试外，Blenrep方案还分别针对百时美施贵宝药物聚催化剂和地塞米松进行了测试。在这项第三阶段研究DREAMM-8中，今年6月在美国临床肿瘤学会年会上公布的结果显示，Blenrep方案可使疾病进展或死亡风险降低48%。。

The multiple myeloma market has become more crowded in Blenrep’s absence. There are now two FDA-approved cell therapies that target BCMA: Abecma from Bristol Myers Squibb and 2SeventyBio, and Carvykti from Johnson & Johnson and Legend Biotech. Both were initially approved as fifth-line treatments. Earlier this year, the FDA expanded the approvals of both products, permitting Abecma to be used as a third-line therapy and Carvytki as a second-line treatment.

在Blenrep缺席的情况下，多发性骨髓瘤市场变得更加拥挤。现在有两种FDA批准的针对BCMA的细胞疗法：来自百时美施贵宝和2SeventyBio的Abecma，以及来自强生和联想生物技术的Carvykti。两者最初都被批准为第五线治疗。今年早些时候，FDA扩大了这两种产品的批准范围，允许将Abecma用作三线治疗，将Carvytki用作二线治疗。

J&J’s multiple myeloma portfolio also includes Tecvayli, a BCMA-targeting bispecific antibody..

强生的多发性骨髓瘤投资组合还包括Tecvayli，一种针对BCMA的双特异性抗体。。

Besides Carvykti, the other BCMA-targeting therapies are approved only for use as later-line therapies, Mateos said. In the second-line setting, not all multiple myeloma patients will be eligible for a CAR T-cell therapy. Also, Carvykti, made by harvesting and engineering a patient’s own immune cells, takes weeks to manufacture, she said.

Mateos说，除Carvykti外，其他BCMA靶向疗法仅被批准用作后期治疗。在二线治疗中，并非所有多发性骨髓瘤患者都有资格接受CAR T细胞治疗。此外，她说，通过采集和改造患者自身的免疫细胞制成的Carvykti需要数周的时间才能制造出来。

By contrast, Blenrep provides multiple myeloma patients a readily available off-the-shelf treatment option. Abdullah added that Blenrep offers more flexibility compared with CAR T-therapy, which is offered only in certain hospitals equipped to administer these therapies and manage their complications..

相比之下，Blenrep为多发性骨髓瘤患者提供了现成的治疗选择。阿卜杜拉补充说，与CAR T疗法相比，Blenrep提供了更大的灵活性，CAR T疗法仅在某些配备了这些疗法并管理其并发症的医院中提供。。

“We know that the majority of multiple myeloma patients sit within the community setting and oftentimes don’t have access to these more specialized technologies that require hospitalization and carry a different risk/benefit profile,” Abdullah said.

阿卜杜拉说：“我们知道，大多数多发性骨髓瘤患者都在社区环境中，往往无法获得这些更专业的技术，这些技术需要住院治疗，并且具有不同的风险/收益特征。”。

Blurred vision and vision loss are known complication risks of ADCs as a drug class. When Blenrep was initially approved, its label carried a black box warning for ocular toxicity. GSK said eye-related side effects were generally manageable in the clinical trial and resolved with dose modification. These complications led to a discontinuation rate of about 10% in DREAMM-7..

视力模糊和视力丧失是ADC作为药物类别的已知并发症风险。Blenrep最初获得批准时，其标签上带有眼部毒性的黑匣子警告。葛兰素史克说，在临床试验中，与眼睛有关的副作用通常是可以控制的，并且可以通过剂量调整来解决。这些并发症导致DREAMM-7的停药率约为10%。。

GSK has broader plans for Blenrep, which the company estimates could achieve £3 billion (about $3.8 billion) in peak sales. By comparison, J&J’s Darzalex posted $8.5 billion in revenue in the first nine months of 2024, a 19.3% increase compared to the same period in the prior year. GSK believes Blenrep could take some of the J&J product’s market share by securing additional approval as a first-line multiple myeloma treatment.

葛兰素史克（GSK）对Blenrep有更广泛的计划，该公司估计其峰值销售额可能达到30亿英镑（约38亿美元）。相比之下，强生的Darzalex在2024年前9个月实现了85亿美元的收入，与上年同期相比增长了19.3%。葛兰素史克认为，Blenrep作为一线多发性骨髓瘤治疗药物获得额外批准，可能会占据强生产品的部分市场份额。

A Phase 1 test is ongoing in newly diagnosed patients to identify the dose and drug combination to evaluate in a pivotal study. As GSK explores moving Blenrep into frontline use, Abdullah said the company is focused on improving the overall profile of the drug — maintaining efficacy while enhancing tolerability..

正在对新诊断的患者进行1期测试，以确定在关键研究中评估的剂量和药物组合。随着葛兰素史克（GSK）探索将Blenrep应用于一线，阿卜杜拉（Abdullah）表示，该公司专注于改善该药物的整体状况，在保持疗效的同时提高耐受性。。

Mateos said based on the DREAMM-7 data, BCMA is the better target than the CD38 target hit by Darzalex. The next step is comparing the two drugs in a first-line setting. Positive results for Blenrep could potentially change the treatment landscape for multiple myeloma, she said.

Mateos说，根据DREAMM-7的数据，BCMA是比Darzalex击中的CD38更好的目标。下一步是在一线环境中比较这两种药物。她说，Blenrep的阳性结果可能会改变多发性骨髓瘤的治疗前景。

Photo by GSK

葛兰素史克照片

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American Society of Hematology

美国血液学会

antibody drug conjugate

抗体-药物偶联物

Blenrep

布伦雷普

cancer

癌症

Clinical Trials

临床试验

GSK

GSK

multiple myeloma

多发性骨髓瘤

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