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Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the first presentation of data from the Phase 2 waveLINE-007 trial evaluating zilovertamab vedotin, Merck’s investigational antibody drug conjugate (ADC) that targets receptor tyrosine kinase-like orphan receptor 1 (ROR1), in combination with cyclophosphamide, doxorubicin and prednisone plus rituximab (R-CHP) for the treatment of patients with previously untreated diffuse large B-cell lymphoma (DLBCL).
默克公司(纽约证券交易所代码:MRK),在美国和加拿大以外被称为MSD,今天宣布首次提交第二阶段waveLINE-007试验的数据,该试验评估了齐洛他玛维多汀,默克公司的研究性抗体-药物偶联物(ADC),靶向受体酪氨酸激酶样孤儿受体1(ROR1),与环磷酰胺,多柔比星和泼尼松加利妥昔单抗(R-CHP)联合治疗先前未治疗的弥漫性大B细胞淋巴瘤(DLBCL)患者。
At a pre-planned analysis, zilovertamab vedotin in combination with R-CHP achieved a 100% (n=15) complete response (CR) rate in patients treated with zilovertamab vedotin at 1.75 mg/kg. Based on the data, the study has established 1.75 mg/kg as the recommended Phase 3 dose of zilovertamab vedotin. These data are being presented for the first time today in an oral presentation (Abstract #578) at the 66.
在一项预先计划的分析中,使用1.75 mg/kg剂量的zilovertamab vedotin与R-CHP联合治疗的患者获得了100%(n=15)的完全应答(CR)率。根据这些数据,该研究已将 1.75 mg/kg 确定为 zilovertamab vedotin 的 3 期推荐剂量。这些数据将在今天的66大会上以口头报告(摘要号578)的形式首次公布。
“There is a need for additional first-line treatment options to help patients with diffuse large B-cell lymphoma, since, unfortunately, approximately 40% still experience relapsed or refractory disease after initial treatment with the current standard of care,” said Dr. Muhit Ozcan, the study’s principal investigator, Ankara University School of Medicine.
“需要额外的一线治疗选择来帮助弥漫性大B细胞淋巴瘤患者,因为不幸的是,大约40%的患者在使用目前的护理标准进行初始治疗后仍会复发或难治性疾病,”安卡拉大学医学院首席研究员Muhit Ozcan博士说。
“These data from the Phase 2 waveLINE-007 trial are promising and support further research in the first-line setting in a larger patient population to help address this significant unmet need for patients.”.
“来自第二阶段waveLINE-007试验的这些数据是有希望的,并支持在更大患者群体的一线环境中进行进一步研究,以帮助解决对患者的这一重大未满足需求。”。
“We are pleased to see these early positive results from the Phase 2 waveLINE-007 trial, in which zilovertamab vedotin demonstrated a highly promising response rate and a manageable safety profile in combination with standard of care,” said Dr. Gregory Lubiniecki, vice president, oncology clinical research, Merck Research Laboratories.
默克研究实验室肿瘤临床研究副总裁Gregory Lubiniecki博士说:“我们很高兴看到第二阶段waveLINE-007试验的这些早期积极结果,在该试验中,齐洛塔单抗维多汀与标准护理相结合,表现出非常有希望的缓解率和可控的安全性。”。
“We look forward to advancing our research of this investigational ROR1-directed antibody drug conjugate, which we believe has strong potential in multiple hematologic malignancies.”.
“我们期待着推进这种研究性ROR1定向抗体-药物偶联物的研究,我们认为它在多种血液恶性肿瘤中具有强大的潜力。”。
As
作为
announced, data from more than 20 abstracts are being presented from across a broad range of hematologic malignancies from Merck’s hematology pipeline, which includes a diverse range of investigational assets with novel modalities, at the 66
据宣布,来自默克公司血液学管道的广泛血液恶性肿瘤的20多篇摘要的数据正在66
Study design and additional data from waveLINE-007
waveLINE-007的研究设计和附加数据
WaveLINE-007 is a non-randomized, open-label Phase 2 trial (ClinicalTrials.gov,
WaveLINE-007是一项非随机,开放标签的2期临床试验(ClinicalTrials.gov,
NCT05406401
邮编05406401
) evaluating zilovertamab vedotin (MK-2140) in combination with R-CHP in patients with previously untreated DLBCL. The primary endpoints are safety (number of patients with dose limiting toxicity, adverse events and discontinuation due to adverse events) and CR rate based on investigator review per Lugano Response Criteria.
)评估zilovertamab vedotin(MK-2140)联合R-CHP治疗先前未经治疗的DLBCL患者。主要终点是安全性(剂量限制性毒性,不良事件和因不良事件而停药的患者人数)和根据卢加诺反应标准的研究者评估的CR率。
Secondary endpoints include objective response rate (ORR) and duration of response (DOR) per Lugano Response Criteria. As of data cut-off, 36 patients were enrolled in the study to receive zilovertamab vedotin plus R-CHP intravenously on day 1 of each 21-day cycle (Q3W) for up to eight cycles. The treatment arms of the study included:.
次要终点包括每个卢加诺反应标准的客观反应率(ORR)和反应持续时间(DOR)。截至数据截止,36名患者参加了该研究,在每21天周期(Q3W)的第1天静脉注射齐洛塔单抗维多汀加R-CHP,最多8个周期。该研究的治疗部门包括:。
1.75 mg/kg (n=15); all 15 patients in this arm completed the trial (none discontinued)
1.75毫克/千克(n=15);该组的所有15名患者均完成了试验(无中断)
2.0 mg/kg (n=15); 14 patients in this arm completed treatment and one patient discontinued after cycle 1 due to physician decision and was entered to safety follow-up, or
2.0 mg/kg(n=15);该组中有14名患者完成了治疗,其中一名患者由于医生的决定在第1周期后停止治疗,并进入了安全随访,或
2.25 mg/kg (n=6); 5 patients in this arm completed treatment and one patient discontinued due to physician decision
2.25毫克/千克(n=6);该组中有5名患者完成了治疗,1名患者由于医生的决定而停药
The efficacy results showed a CR was achieved in combination with R-CHP in 100% (n=15) of patients receiving the 1.75 mg/kg dose of zilovertamab vedotin (CI: 95%, 78.2-100.0), 93.3% (n=14) of patients receiving the 2.0 mg/kg dose (CI: 95%, 68.1-99.8) and 100% (n=6) of patients receiving the 2.25 mg/kg dose (CI: 95%, 54.1-100.0).
疗效结果显示,100%(n=15)接受1.75 mg/kg剂量齐洛他玛维多汀(CI:95%,78.2-100.0)的患者,93.3%(n=14)接受2.0 mg/kg剂量(CI:95%,68.1-99.8)的患者和100%(n=6)接受2.25 mg/kg剂量(CI:95%,54.1-100.0)的患者联合R-CHP获得CR。
The total CR rate at the end of treatment was 97.2% (CI: 95%, 85.5-99.9). The median follow-up for all patients was 17.6 months (range, 7.1-24.6). The ORR was 100% (CI: 95%, 78.2-100.0) for patients receiving the 1.75 mg/kg dose, 93.3% (CI: 95%, 68.1-99.8) for patients receiving the 2.0 mg/kg dose, and 100% (CI: 95%, 54.1-100.0) for patients receiving the 2.25 mg/kg dose, all in combination with R-CHP.
治疗结束时总CR率为97.2%(CI:95%,85.5-99.9)。所有患者的中位随访时间为17.6个月(范围7.1-24.6)。接受1.75 mg/kg剂量的患者的ORR为100%(CI:95%,78.2-100.0),接受2.0 mg/kg剂量的患者的ORR为93.3%(CI:95%,68.1-99.8),接受2.25 mg/kg剂量的患者的ORR为100%(CI:95%,54.1-100.0),均与R-CHP联合使用。
The median DOR has not been reached for all patients, and the total 12-month DOR was 93.5%. Based on the data, the recommended zilovertamab vedotin dose was determined to be 1.75 mg/kg..
尚未达到所有患者的中位DOR,12个月的总DOR为93.5%。根据数据,推荐的齐洛塔单抗维多汀剂量确定为1.75 mg/kg。。
Serious treatment-related adverse events (TRAEs) occurred in 11% (n=4) of all patients (1.75 mg/kg [n=1], 2.0 mg/kg [n=1], 2.25 mg/kg [n=2]). Grade 3-4 TRAEs occurred in 58% (n=21) of all patients. The most common of these events were neutropenia, nausea, anemia and diarrhea.
所有患者中有11%(n=4)发生了严重的治疗相关不良事件(TRAEs)(1.75 mg/kg[n=1],2.0 mg/kg[n=1],2.25 mg/kg[n=2])。所有患者中有58%(n=21)发生3-4级TRAE。这些事件中最常见的是中性粒细胞减少,恶心,贫血和腹泻。
About diffuse large B-cell lymphoma
关于弥漫性大B细胞淋巴瘤
Lymphoma is cancer beginning in the lymphatic system – the network of organs, vessels and tissues that protects the body from infection. There are many subtypes of lymphoma, which are often categorized into two main types – Hodgkin lymphoma and non-Hodgkin lymphoma (NHL). DLBCL, the most common form of NHL, is derived from white blood cells that grow rapidly and uncontrollably, enlarging the lymph nodes and often migrating to other parts of the body.
淋巴瘤是始于淋巴系统的癌症,淋巴系统是保护身体免受感染的器官、血管和组织的网络。。DLBCL是非霍奇金淋巴瘤最常见的形式,它来源于白细胞,白细胞生长迅速且不受控制,扩大了淋巴结,并经常迁移到身体的其他部位。
DLBCL accounts for approximately 25-30% of all non-Hodgkin lymphomas worldwide. In the U.S., it is estimated that approximately 25,000 patients are diagnosed with DLBCL each year. The five-year relative survival rate for DLBCL is 60-70%..
DLBCL约占全球所有非霍奇金淋巴瘤的25-30%。在美国,估计每年约有25000名患者被诊断出患有DLBCL。DLBCL的五年相对生存率为60-70%。。
About zilovertamab vedotin (MK-2140)
关于齐洛塔马·韦多廷(MK-2140)
Zilovertamab vedotin is an investigational ADC that targets ROR1. ROR1 is a transmembrane protein that is overexpressed in multiple hematologic malignancies. Merck is committed to research with zilovertamab vedotin across B-cell malignancies and is establishing a robust program of clinical trials under the name waveLINE.
Zilovertamab vedotin是一种针对ROR1的研究性ADC。ROR1是一种跨膜蛋白,在多种血液系统恶性肿瘤中过表达。默克公司致力于在B细胞恶性肿瘤中使用齐洛塔单抗维多汀进行研究,并以waveLINE的名义建立了一个强大的临床试验计划。
The waveLINE program includes a Phase 2/3 study in patients with relapsed or refractory DLBCL (waveLINE-003, .
waveLINE计划包括一项针对复发或难治性DLBCL患者的2/3期研究(waveLINE-003,)。
NCT05139017
时间05139017
) and a Phase 3 study in treatment naïve patients with DLBCL (waveLINE-010,
)以及一项针对未接受过DLBCL治疗的患者的3期研究(waveLINE-010,
NCT06717347).
NCT06717347)。
About Merck in hematology
关于默克血液学
Merck is committed to advancing innovation and care for people with hematologic neoplasms and malignancies. Building on its leadership in oncology, the company has a broad clinical development program that evaluates novel mechanisms of action to address longstanding unmet needs for patients with hematologic disorders.
默克公司致力于推进血液肿瘤和恶性肿瘤患者的创新和护理。凭借其在肿瘤学领域的领先地位,该公司拥有广泛的临床开发计划,评估新的行动机制,以解决血液病患者长期未满足的需求。
Among Merck’s research efforts are studies evaluating multiple investigational medicines as monotherapy or in combination with other therapies across a range of hematologic neoplasms and malignancies..
默克公司的研究工作包括评估多种研究药物作为单一疗法或与其他疗法联合治疗一系列血液肿瘤和恶性肿瘤的研究。。
Merck’s focus on cancer
默克专注于癌症
Every day, we follow the science as we work to discover innovations that can help patients, no matter what stage of cancer they have. As a leading oncology company, we are pursuing research where scientific opportunity and medical need converge, underpinned by our diverse pipeline of more than 25 novel mechanisms.
每天,我们都在遵循科学,努力发现可以帮助患者的创新,无论他们处于癌症的哪个阶段。作为一家领先的肿瘤学公司,我们正在寻求科学机会和医疗需求相融合的研究,并以我们超过25种新型机制的多样化渠道为基础。
With one of the largest clinical development programs across more than 30 tumor types, we strive to advance breakthrough science that will shape the future of oncology. By addressing barriers to clinical trial participation, screening and treatment, we work with urgency to reduce disparities and help ensure patients have access to high-quality cancer care.
凭借跨越30多种肿瘤类型的最大临床开发项目之一,我们努力推进突破性科学,这将塑造肿瘤学的未来。通过解决临床试验参与,筛查和治疗的障碍,我们迫切需要减少差异,并帮助确保患者获得高质量的癌症护理。
Our unwavering commitment is what will bring us closer to our goal of bringing life to more patients with cancer. For more information, visit .
我们坚定不移的承诺将使我们更接近为更多癌症患者带来生命的目标。。
About Merck
默克
At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines.
在美国和加拿大以外被称为MSD的默克公司,我们的目标是团结一致的:我们利用尖端科学的力量来拯救和改善世界各地的生活。130多年来,我们通过开发重要的药物和疫苗给人类带来了希望。
We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities.
我们立志成为世界上领先的研究密集型生物制药公司,今天,我们处于研究的前沿,以提供创新的健康解决方案,促进人类和动物疾病的预防和治疗。我们培养了一支多元化和包容性的全球劳动力队伍,并每天负责任地运作,为所有人和社区创造一个安全、可持续和健康的未来。