This phase II trial tests the safety and effectiveness of glofitamab given in combination with pirtobrutinib in treating patients with mantle cell lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Glofitamab and obinutuzumab are monoclonal antibodies that may interfere with the ability of cancer cells to grow and spread. Obinutuzumab may also reduce the risk of immune-related conditions from treatment. Pirtobrutinib is in a class of medications called kinase inhibitors. It works by blocking the action of the protein that signals cancer cells to multiply. Giving glofitamab in combination with pirtobrutinib may be safe, tolerable and/or effective in treating patients with relapsed or refractory mantle cell lymphoma.

开始日期2024-06-11

申办/合作机构

The University of California, San Francisco

[+3]

NCT06054776 / Recruiting临床2期IIT

A Phase 2 Study of Glofitamab With Acalabrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma

This phase II trial studies the side effects of acalabrutinib, obinutuzumab, and glofitamab and how well they work together for treating patients with mantle cell lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Acalabrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cell (a type of white blood cells) cancers such as mantel cell lymphoma at abnormal levels. This may help keep cancer cells from growing and spreading. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Glofitamab is a class of medications called bispecific antibodies. Bispecific antibodies are designed to simultaneously bind to T cells and cancer cell antigens, leading to T-cell activation, proliferation, and cancer cell death. Giving acalabrutinib, obinutuzumab, and glofitamab together may be a safe and effective treatment for patients with relapsed or refractory mantle cell lymphoma.

开始日期2024-06-10

申办/合作机构

City of Hope National Medical Center

[+1]

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项与格罗菲妥单抗相关的文献（医药）

2024-12-31·mAbs

Antibodies to watch in 2024

Article

作者: Reichert, Janice M ; Kaplon, Hélène ; Crescioli, Silvia ; Wang, Lin ; Visweswaraiah, Jyothsna ; Chenoweth, Alicia

The 'Antibodies to Watch' article series provides an annual summary of commercially sponsored monoclonal antibody therapeutics currently in late-stage clinical development, regulatory review, and those recently granted a first approval in any country. In this installment, we discuss key details for 16 antibody therapeutics granted a first approval in 2023, as of November 17 (lecanemab (Leqembi), rozanolixizumab (RYSTIGGO), pozelimab (VEOPOZ), mirikizumab (Omvoh), talquetamab (Talvey), elranatamab (Elrexfio), epcoritamab (EPKINLY), glofitamab (COLUMVI), retifanlimab (Zynyz), concizumab (Alhemo), lebrikizumab (EBGLYSS), tafolecimab (SINTBILO), narlumosbart (Jinlitai), zuberitamab (Enrexib), adebrelimab (Arelili), and divozilimab (Ivlizi)). We briefly review 26 product candidates for which marketing applications are under consideration in at least one country or region, and 23 investigational antibody therapeutics that are forecast to enter regulatory review by the end of 2024 based on company disclosures. These nearly 50 product candidates include numerous innovative bispecific antibodies, such as odronextamab, ivonescimab, linvoseltamab, zenocutuzumab, and erfonrilimab, and antibody-drug conjugates, such as trastuzumab botidotin, patritumab deruxtecan, datopotamab deruxtecan, and MRG002, as well as a mixture of two immunocytokines (bifikafusp alfa and onfekafusp alfa). We also discuss clinical phase transition and overall approval success rates for antibody therapeutics, which are crucial to the biopharmaceutical industry because these rates inform decisions about resource allocation. Our analyses indicate that these molecules have approval success rates in the range of 14-32%, with higher rates associated with antibodies developed for non-cancer indications. Overall, our data suggest that antibody therapeutic development efforts by the biopharmaceutical industry are robust and increasingly successful.

2024-03-01·CPT: pharmacometrics & systems pharmacology

Evaluation of the potential impact on pharmacokinetics of various cytochrome P450 substrates of increasing IL‐6 levels following administration of the T‐cell bispecific engager glofitamab

Article

作者: Jaminion, Felix ; Parrott, Neil ; Guerini, Elena ; Djebli, Nassim ; Carlile, David ; O'Jeanson, Amaury

Abstract:

Glofitamab is a novel T cell bispecific antibody developed for treatment of relapsed‐refractory diffuse large B cell lymphoma and other non‐Hodgkin's lymphoma indications. By simultaneously binding human CD20‐expressing tumor cells and CD3 on T cells, glofitamab induces tumor cell lysis, in addition to T‐cell activation, proliferation, and cytokine release. Here, we describe physiologically‐based pharmacokinetic (PBPK) modeling performed to assess the impact of glofitamab‐associated transient increases in interleukin 6 (IL‐6) on the pharmacokinetics of several cytochrome P450 (CYP) substrates. By refinement of a previously described IL‐6 model and inclusion of in vitro CYP suppression data for CYP3A4, CYP1A2, and 2C9, a PBPK model was established in Simcyp to capture the induced IL‐6 levels seen when glofitamab is administered at the intended dose and dosing regimen. Following model qualification, the PBPK model was used to predict the potential impact of CYP suppression on exposures of various CYP probe substrates. PBPK analysis predicted that, in the worst‐case, the transient elevation of IL‐6 would increase exposures of CYP3A4, CYP2C9, and CYP1A2 substrates by less than or equal to twofold. Increases for CYP3A4, CYP2C9, and CYP1A2 substrates were projected to be 1.75, 1.19, and 1.09‐fold following the first administration and 2.08, 1.28, and 1.49‐fold following repeated administrations. It is recommended that there are no restrictions on concomitant treatment with any other drugs. Consideration may be given for potential drug–drug interaction during the first cycle in patients who are receiving concomitant CYP substrates with a narrow therapeutic index via monitoring for toxicity or for drug concentrations.

Cancer

Glofitamab as a salvage treatment for B‐cell lymphomas in the real world: A multicenter study in Taiwan

Article

作者: Liao, Chun-Kai ; Hsu, Ya-Ting ; Chen, Tsai-Yun ; Wang, Ming-Chung ; Kao, Hsiao-Wen ; Wu, Shang-Ju ; Hsiao, Sheng-Yen

Abstract:

Background:

Glofitamab is a bispecific antibody with promise for treating relapsed/refractory B‐cell lymphoma according to a phase 1/2 clinical trial. This study examined its real‐world effectiveness.

Methods:

This was an investigator‐initiated, multicenter retrospective study including 34 patients who had relapsed/refractory B‐cell lymphomas after at least three prior lines of therapy and received glofitamab monotherapy in a compassionate use program in Taiwan between January 2021 and October 2022.

Results:

At a median follow‐up of 15.9 months, 56% of patients responded to glofitamab and 23% achieved complete remission. Response to the previous line of therapy significantly correlated with response to glofitamab (p = .020). Most responses were durable; only five out of the 19 responders had documented disease recurrence at the data cutoff date. The estimated progression‐free survival (PFS) was 3.2 months, and the estimated 1‐year PFS was 33% for the entire cohort. PFS was better for responders than nonresponders (median PFS, 16.9 vs. 1.8 months; 1‐year PFS, 60% vs. 0%). Forty‐three cytokine release syndrome (CRS) events were observed, three of which were grade 3; all were manageable without glofitamab discontinuation. No immune effector cell–associated neurotoxicity was reported. Among seven hepatitis B virus (HBV) carriers (six had antiviral prophylaxis) and 14 patients with remote HBV (four had antiviral prophylaxis), no HBV reactivation was observed.

Conclusions:

In this real‐world cohort, glofitamab exhibited effectiveness comparable to trial results without excessive CRS or new safety issues. With appropriate prophylaxis, glofitamab‐treated patients with chronic or remote HBV infection are unlikely to experience virus reactivation.

299

项与格罗菲妥单抗相关的新闻（医药）

2024-06-26

·drugs

Glofitamab + GemOx Superior to Rituximab + GemOx for Lymphoma

WEDNESDAY, June 26, 2024 -- Glofitamab (Glofit) plus gemcitabine and oxaliplatin (GemOx) is superior to rituximab (R)-GemOx for relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL), according to a study presented at the annual hybrid congress of the European Hematology Association, held from June 13 to 16 in Madrid. Jeremy Abramson, M.D., from the Massachusetts General Hospital Cancer Center in Boston, and colleagues examined the efficacy and safety of Glofit-GemOx versus R-GemOx in patients with R/R DLBCL after one or more prior lines of therapy. A total of 274 patients were randomly assigned in a 2:1 ratio to receive Glofit-GemOx or R-GemOx (183 and 91 individuals, respectively). The researchers observed a significant overall survival benefit with Glofit-GemOx versus R-GemOx at primary analysis (cutoff date, March 29, 2023). Median overall survival was not reached for Glofit-GemOx versus nine months for R-GemOx at a median follow-up of 11.3 months. Independent review committee-assessed progression-free survival and complete remission rate demonstrated a significant benefit for Glofit-GemOx. Glofit-GemOx continued to demonstrate superior median overall survival, median progression-free survival, and complete remission rates at follow-up analysis conducted once all patients had completed therapy (cutoff date, Feb. 16, 2024; median follow-up, 20.7 months) versus R-GemOx. Adverse event rates were higher with Glofit-Gemox than R-GemOx, including grade 3 to 4 and grade 5 adverse events and serious adverse events; however, the rates were similar after adjustment for exposure differences. "Glofitamab in combination with GemOx showed clinically significant improvement in overall survival, as well as key secondary end points, and the benefits were reinforced with an additional 11 months of follow-up," Abramson said in a statement. The study was funded by Genentech, the manufacturer of glofitamab. Press Release More Information Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

临床结果临床研究临床3期

2024-06-23

·药渡

欧洲杯来了！哪些国家最有望夺得“最佳药物管道”奖杯？

来源：药渡撰文：Maskey 编辑：哦呼欧洲杯激战正酣，各国球队为了荣誉和胜利而奋力拼搏。但如果换个角度，设想一下，若是让这些参加欧洲杯的国家在“最佳药物管道”这一特殊领域展开角逐，谁又将脱颖而出，问鼎桂冠呢？目前，世界各地的制药公司都在竞相开发最具创新性和最有效的常见人类疾病治疗方法。他们进行临床前研究和临床试验，希望他们的治疗方法能得到监管机构的批准。监管机构会为可能治疗严重疾病的新型试验药物授予突破性疗法认定和快速通道认定。近年来，越来越多的新型治疗方法（如细胞和基因疗法、单克隆抗体和抗体-药物偶联物）已获得监管机构的批准[1]。因此，制药公司正在加大对这些创新疗法的开发投入。一些最大的制药公司位于欧洲，所有这些公司都在建立庞大的创新疗法药物管线。图1.近年来美国食品药品监督管理局(FDA)批准的新分子实体（NME）和生物制剂的数量【1】图2.获得批准的单克隆抗体百分比【2】德国拜耳是德国领先的制药公司之一。老年性黄斑变性药物阿柏西普、前列腺癌药物达罗他胺、抗凝药物利伐沙班和慢性肾病药物Finerenone是其产品组合中最有价值的药物。该公司正在开发33种新疗法，其中19种疗法正在进行1期临床试验，3种疗法正在进行2期临床试验[3]。该公司正在测试几种创新的重组腺相关病毒 (rAAV) 基因疗法，用于治疗亨廷顿氏病、帕金森氏病和庞贝氏病。另一家德国制药公司勃林格殷格翰正在临床试验中测试40多种药物[4]。该公司已经开发出用于治疗多种疾病的小分子药物、T细胞接合剂和癌症疫苗。该公司的产品组合中包括有效的治疗药物，包括肺纤维化药物尼达尼布和抗糖尿病药物恩格列净。默克集团是另一家德国制药公司，正在开发10多种用于治疗癌症、自身免疫性疾病和疟疾的药物[5]。其药物管线中一些有前景的在研药物包括小分子药物Enpatoran、抗体药物偶联物M9140和免疫检查点抑制剂avelumab。 BioNtech也是一家德国大型生物制药公司，与辉瑞公司成功开发了COVID-19疫苗BNT162b2(Comirnaty)。该公司还在对患有不同类型癌症（如结直肠癌和胰腺导管腺癌）的患者测试癌症疫苗Autogene Cevumeran[6]。BioNTech SE正在临床试验中测试30多种治疗方法，包括mRNA治疗、细胞疗法、基于蛋白质的疗法和小分子免疫调节剂。这些治疗方法旨在治疗癌症和传染病。其管道中最有前途的候选药物之一是单克隆抗体Gotistobart，正在非小细胞肺癌患者中进行测试。该公司开发的其他重要药物包括双特异性抗体Acasunlimab、BNT312/GEN1042和BNT327/PM8002。德国规模较小的生物制药公司也在努力扩大其药物研发线。Ethris开发了一种新型吸入式mRNA治疗药物ETH47，用于治疗呼吸道病毒感染。海德堡制药公司研发线中的一种主要候选药物是用于治疗多发性骨髓瘤的抗体-药物偶联物HDP-101。Affimed开发了用于治疗非小细胞肺癌的双特异性先天细胞接合剂AFM24。Atai Life Sciences研发线中有几种用于治疗抑郁症和焦虑症的药物。法国法国最大的制药公司赛诺菲拥有庞大的药物管线，包括60多种临床阶段治疗药物[7]。该公司正在开发双特异性抗体、疫苗、单克隆抗体、NK细胞接合剂、酶替代疗法和基因疗法。其最畅销的药物是与Regeneron合作开发的单克隆抗体度匹鲁单抗。该药物已被批准用于多种适应症，例如特应性皮炎、嗜酸性食管炎和哮喘。其投资组合中的另一项重要资产是与阿斯利康合作开发的呼吸道合胞病毒 (RSV) 疫苗nirsevimab。其管线中的几种药物，如小分子药物SAR441566、单克隆抗体Amlitelimab和单克隆抗体Frexalimab，都有可能获得监管部门的批准并成为变革性的治疗方法。法国还有几家不太知名的制药公司，包括Genfit、Abivax和Enterome，它们正在研发新的创新疗法。Genfit正在开发治疗胆管癌和高氨血症的新疗法。今年6月，FDA加速批准其药物Elafibranor，用于治疗原发性胆汁性胆管炎。Amolyt Pharma的药物管线包括治疗肢端肥大症和甲状旁腺功能减退症的药物。Enterome正在开发新的基于肽的免疫疗法，用于治疗惰性非霍奇金淋巴瘤和胶质母细胞瘤。Abivax已开发小分子药物obefazimod，用于治疗溃疡性结肠炎和克罗恩病。Antabio正在开发治疗铜绿假单胞菌感染和医院内感染的药物。Ipen的临床阶段管线中有10多种药物，包括治疗偏头痛、阿拉吉耶综合征、多发性骨髓瘤和胆道闭锁的药物[8]。英国英国-瑞典制药公司阿斯利康拥有最大的药物管线之一，拥有超过90种不同的临床阶段治疗药物[9]。该公司正在开发用于治疗癌症、呼吸系统疾病、代谢疾病、肾脏疾病和心血管疾病的新药。它拥有非常强大的肿瘤学产品组合，包括抗体药物偶联物trastuzumab deruxtecan和酪氨酸激酶抑制剂奥希替尼。该公司还通过购买和公司收购在其管线中增加了嵌合抗原受体T细胞(CAR-T)疗法、呼吸道合胞病毒疫苗和2型糖尿病药物。其与第一三共联合开发的抗体药物偶联物Datopotamab deruxtecan可能很快会在美国获得监管部门的批准。葛兰素史克 (GSK) 已开发出60多种用于治疗艾滋病毒、癌症、传染病以及呼吸道和免疫疾病的药物。该公司最近开发的最成功的治疗方法之一是呼吸道合胞病毒疫苗Arexvy，该疫苗已获得FDA批准用于50岁以上的人群[10]。该公司在开发高效疫苗方面有着良好的记录，例如Gardasil、Arexvy和 Shingrix。今年，GSK收购了一家新兴生物制药公司Aiolos Bio，该公司开发了一种新型哮喘药物。 Verona Pharma开发了一种用于治疗慢性阻塞性肺病的药物Ensifentrine，今年可能会获得FDA的批准。Ellipses Pharma正在对2期临床试验中的四种药物进行评估[11]。该公司正在研发不同类别的药物，例如用于治疗癌症的双重抑制剂、纳米颗粒-药物偶联物和选择性雄激素受体调节剂 (SARM)。Evox Therapeutics正在临床前研究中开发外泌体递送的腺相关病毒(AAV) 基因疗法，用于治疗苯丙酮尿症和心血管疾病[12]。瑞士罗氏的研发管线中有70多种药物[13]。该公司开发的转化疗法之一是双特异性单克隆抗体Faricimab，用于治疗糖尿病性黄斑水肿和新生血管性年龄相关性黄斑变性。其他成功获得监管部门批准的重要治疗方法是抗体-药物偶联物polatuzumab vedotin-piiq双特异性单克隆抗体Emicizumab和双特异性抗体glofitamab-gxbm。其阿尔茨海默氏症药物gantenerumab在3期临床试验中未能显示出疗效。该公司已将小分子抑制剂camonsertib和双特异性抗体RG6286等抗癌药物从其管线中移除。罗氏正在优先考虑那些更有可能获得监管机构批准的治疗方法。诺华是全球销售额最大的制药公司之一。其药物研发管线中有超过60种治疗方法[14]。其研发管线包括单克隆抗体、CAR-T疗法、基因疗法、小分子抑制剂、合成小干扰RNA (siRNA) 和其他治疗不同疾病的药物。其产品组合中的重要资产是心力衰竭组合药物Sacubitril/valsartan、多发性硬化症药物 Ofatumumab、乳腺癌药物ribociclib和高脂血症药物inclisiran。其布鲁顿氏酪氨酸激酶(BTK)抑制剂remibrutinib很有可能被批准用于治疗慢性自发性荨麻疹。 ADC Therapeutics正在临床试验中测试大约3种治疗方法[14]。该公司开发了抗体药物偶联物loncastuximab tesirine-lpyl，该药物已获得FDA加速批准，用于治疗大B细胞淋巴瘤。Alentis Therapeutics的研发管线中有大约4种治疗方法，包括抗体药物偶联物和单克隆抗体[15]。图3.销售额最高的制药公司和治疗方法【16】丹麦丹麦制药公司诺和诺德是欧洲最大的制药公司之一。诺和诺德的药物管线包括35多种药物，其中大多数药物正在对患有非酒精性脂肪性肝炎和糖尿病等慢性疾病的患者进行测试[17]。其最成功的药物是用于治疗肥胖症和糖尿病的索马鲁肽。诺和诺德开发了一种每周一次的糖尿病药物胰岛素Icodec，该药物已获准在欧洲使用。Genmab有10多种治疗方法正在临床试验中测试。它与辉瑞联合开发了抗体-药物偶联物tisotumab vedotin，该药物已获准用于治疗宫颈癌。其T细胞结合双特异性抗体epcoritamab也已获准用于治疗弥漫性大B细胞淋巴瘤。比利时比利时生物制药公司Union Chimique Belge (UCB)正在开发用于治疗系统性红斑狼疮和严重纤维肌痛综合征等神经和自身免疫性疾病的药物。其研发管线中有大约10种小分子药物和单克隆抗体[18]。其药物bimekizumab已在美国获批用于治疗斑块状银屑病。荷兰荷兰制药公司Argenx开发了抗体片段efgartigimod，该片段已获批用于治疗全身性重症肌无力。该公司正在对患有干燥综合征和特发性炎症性肌病的患者进行efgartigimod测试。该公司正在研发的另一种药物是单克隆抗体Empasiprubart，该药物已被开发用于治疗多灶性运动神经病。总之，欧洲几家大型制药公司正在开发用于多种疾病的一流和一流药物。这些公司通过研究、收购和与其他公司的联合合作建立了强大的药物管线。在这些欧洲国家中，德国、英国、瑞士和法国都有成熟和新兴的生物制药公司，专注于开发创新疗法。大多数公司都开发出了有效的治疗方法，并已在许多国家获准使用。编者按：在这场假想的“最佳药物管道”欧洲杯中，每个国家都有机会展现自己的实力和风采，我们都期待看到其在“赛场”上展现出最佳的状态。未来我们应给予各国更多在医药研究上付出与收获的关注，以及他们为全人类的健康福祉所作出的杰出贡献。参考文献（可上下滑动）： [1] Senior, M. (2023). Fresh from the biotech pipeline: fewer approvals, but biologics gain share. nature biotechnology, 41(2), 174. [2] Walsh, G., & Walsh, E. (2022). Biopharmaceutical benchmarks 2022. Nature Biotechnology, 40(12), 1722-1760. [3] Bayer (2024, 30 April ). Pharmaceuticals Pipeline Overview and Progress. https://www.bayer.com/sites/default/files/ph-rd-pipeline-2024-05-final-1.pdf [4] Boehringer Ingelheim (n.d.). Boehringer Ingelheim Human Pharma Clinical Pipeline. https://www.boehringer-ingelheim.com/bipdf/pipeline-february-2024 [5] Merck Group (n.d.). HEALTHCARE PIPELINE. https://www.merckgroup.com/en/research/healthcare-pipeline.html [6] BioNTech SE (2024, 7 April). Three-year Phase 1 Follow-Up Data for mRNA-based Individualized Immunotherapy Candidate Show Persistence of Immune Response and Delayed Tumor Recurrence in Some Patients with Resected Pancreatic Cancer. https://investors.biontech.de/news-releases/news-release-details/three-year-phase-1-follow-data-mrna-based-individualized [7] Sanofi (n.d.). Our Pipeline. https://www.sanofi.com/en/our-science/our-pipeline [8] Ipsen (n.d.). Pipeline. https://www.ipsen.com/pipeline/ [9] AstraZeneca (n.d.). Our pipeline. https://www.astrazeneca.com/our-therapy-areas/pipeline.html#cvrm [10] GSK. (2024, 7 June). US FDA approves expanded age indication for GSK’s Arexvy, the first respiratory syncytial virus (RSV) vaccine for adults aged 50-59 at increased risk. https://www.gsk.com/en-gb/media/press-releases/us-fda-approves-expanded-age-indication-for-gsk-s-arexvy-the-first-rsv-vaccine-for-adults-aged-50-59-at-increased-risk/#:~:text=GSK%20plc%20(LSE%2FNYSE%3A,who%20are%20at%20increased%20risk. [11] Ellipses Pharma (n.d.). PORTFOLIO. https://ellipses.life/portfolio/ [12] Evox Therapeutics (n.d.). Pipeline. https://www.evoxtherapeutics.com/pipeline/ [13] Johnston, I (2024, 24 April). Roche cuts drug pipeline in effort to revitalise business. Financial Times https://www.ft.com/content/d2dfc0c4-85e0-4cf5-b926-c10d630b2772 [14] ADC Therapeutics (n.d.). Our Pipeline. https://www.adctherapeutics.com/our-pipeline/ [15] Alentis Therapeutics (n.d.). Novel therapies for cancer and fibrosis. https://alentis.ch/pipeline/ [16] Verdin, P. (2024). Top companies and drugs by sales in 2023. Nature reviews. Drug Discovery. [17] Novo Nordisk (n.d.). R&D pipeline. https://www.novonordisk.com/science-and-technology/r-d-pipeline.html [18] UCB (n.d.). PIPELINE. https://www.ucb.com/our-science/pipeline *声明：本文仅是介绍医药疾病领域研究进展或简述研究概况或分享医药相关讯息，并非也不会进行治疗或诊断方案推荐，也不对相关投资构成任何建议。内容如有疏漏，欢迎沟通指出！点击下方“药渡“，关注更多精彩内容美国Arthrosi公司创新药AR882溶解痛风石，2期临床试验成果亮相2024欧洲风湿病学大会全球First-in-class！迪哲医药戈利昔替尼重磅获批 2024年上半年FDA批准药物或新适应症（下）点击蓝字关注我们

基因疗法疫苗突破性疗法信使RNA临床1期

2024-06-20

·BioSpace

NIH Finds Non-Chemo Drug Combo Induces Lasting Remission in DLBCL Patients

Pictured: The National Institutes of Health's main building in Maryland/iStock, Grandbrothers Researchers from the National Institutes of Health have identified a novel, non-chemotherapy combination regimen for treating relapsed diffuse large B-cell lymphoma, reporting full remission for some patients no longer responding to standard treatments. Detailing their findings Wednesday in The New England Journal of Medicine, the NIH scientists combined five common anti-cancer agents—AbbVie and Genentech’s Vencelxta (venetoclax), Johnson & Johnson’s Imbruvica (ibrutinib), Genentech’s Gazyva (obinutuzumab), Bristol Myers Squibb’s Revlimid (lenalidomide) and the corticosteroid prednisone. The treatment combo, dubbed ViPOR, was tested in a Phase Ib/II study that included 50 patients with diffuse large B-cell lymphoma (DLBCL). Results showed that the investigational regimen “substantially” shrank tumors in 28 of 48 evaluable patients, according to the NIH. This corresponded to a 54% objective response rate. Overall, 18 patients saw their tumors completely disappear, resulting in a 38% complete response rate for ViPOR. At the end of treatment, circulating tumor DNA was undetectable in 33% of patients. After two years of follow-up, 34% of treated patients showed no signs of the disease while 36% remained alive. In terms of safety, the Phase Ib portion of the study detected a single dose-limiting case of grade 3 intracranial hemorrhage. In the Phase II portion, adverse events of note included grade 3 or 4 neutropenia, thrombocytopenia, anemia and febrile neutropenia. “DLBCL is one of the most genetically heterogeneous forms of cancer, and as a result we don't yet have the ability to identify exactly which combination of drugs would be most effective for any given patient,” Christopher Melani, from the National Cancer Institute’s Center for Cancer Research, said in a statement. Melani co-led the study. “By putting five drugs together, we believe that there will be some drug combination—either two, three, or more drugs—that will be particularly effective against the patient’s tumor,” Melani said. The NIH researchers are working on a larger Phase II study, which they plan to conduct in multiple centers. The mid-stage trial will assess the activity of ViPOR in various genetic subtypes of DLBCL. Accounting for around 25% to 30% of all non-Hodgkin lymphomas, DLBLC is the most common type of lymphoma, according to the NIH. It is typically characterized as the enlargement of lymph nodes or the rapid growth of a mass in a nodal or extranodal site. DLBCL is often aggressive, though it responds reasonably well to a regimen called R-CHOP, which consists of rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone. Several pharma players are working on potentially better therapies for DLBCL to improve safety and efficacy, as well as provide patients more options in case of disease progression or treatment intolerance. Pfizer is advancing its antibody-drug conjugate Adcetris (brentuximab vedotin) for DLBCL and in March 2024 reported that it significantly improved survival in patients enrolled in the Phase III ECHELON-3 study. Roche is also targeting DLBCL with its bispecific T-cell engager Columvi (glofitamab) boosting survival in the Phase III STARGLO trial, according to an April 2024 readout. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

临床结果临床2期抗体药物偶联物临床3期临床1期

100 项与格罗菲妥单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11833	-	-	DB16371

研发状态

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适应症	国家/地区	公司	日期
复发性弥漫性大B细胞淋巴瘤	加拿大	Hoffmann-La Roche Ltd.	2023-03-25
难治性弥漫性大 B 细胞淋巴瘤	加拿大	Hoffmann-La Roche Ltd.	2023-03-25

未上市

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适应症	最高研发状态	国家/地区	公司	日期
纵隔大b细胞淋巴瘤	申请上市	中国	Roche Pharma (Schweiz) AG	2023-02-01
纵隔大b细胞淋巴瘤	申请上市	中国	Genentech, Inc.	2023-02-01
弥漫性大B细胞淋巴瘤	申请上市	欧盟	Roche Holding AG	2022-07-21
套细胞淋巴瘤	临床3期	美国	Roche Holding AG	2023-10-22
套细胞淋巴瘤	临床3期	中国	Roche Holding AG	2023-10-22
套细胞淋巴瘤	临床3期	澳大利亚	Roche Holding AG	2023-10-22
套细胞淋巴瘤	临床3期	巴西	Roche Holding AG	2023-10-22
套细胞淋巴瘤	临床3期	加拿大	Roche Holding AG	2023-10-22
套细胞淋巴瘤	临床3期	法国	Roche Holding AG	2023-10-22
套细胞淋巴瘤	临床3期	意大利	Roche Holding AG	2023-10-22

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04408638 (STARGLO, EHA2024) 人工标引	临床3期	复发性原发性玻璃体视网膜弥漫性大B细胞淋巴瘤 \| 难治性原发性玻璃体视网膜弥漫性大B细胞淋巴瘤二线 \| 三线	274	Glofitamab+gemcitabine+oxaliplatin	積範齋願鏇鑰製顧蓋鑰(鹹壓製範窪廠襯淵製艱) = 淵繭衊窪繭窪簾構膚繭構繭憲窪願鑰積鹽網獵 (淵壓蓋範衊築糧廠製遞 ) 更多	积极	2024-06-14
NCT04408638 (STARGLO, EHA2024) 人工标引	临床3期	复发性原发性玻璃体视网膜弥漫性大B细胞淋巴瘤 \| 难治性原发性玻璃体视网膜弥漫性大B细胞淋巴瘤二线 \| 三线	274	rituximab+gemcitabine+oxaliplatin	積範齋願鏇鑰製顧蓋鑰(鹹壓製範窪廠襯淵製艱) = 遞積衊糧窪醖積鬱鹽網構繭憲窪願鑰積鹽網獵 (淵壓蓋範衊築糧廠製遞 ) 更多	积极	2024-06-14
NCT03075696 (NP30179, ASCO2024) 人工标引	临床1/2期	套细胞淋巴瘤	60	Glofitamab	夢遞窪選構網範遞獵壓(艱鬱鏇衊顧齋鏇鹽網構) = 選蓋餘範簾窪鑰繭簾夢糧襯遞顧蓋積醖鬱餘遞 (憲膚夢夢廠艱鬱襯鑰衊 ) 更多	积极	2024-05-24
NCT03075696 (NP30179, ASCO2024) 人工标引	临床1/2期	套细胞淋巴瘤	60	Glofitamab (post-BTKi pts)	夢遞窪選構網範遞獵壓(艱鬱鏇衊顧齋鏇鹽網構) = 觸範積鏇膚夢獵繭膚廠糧襯遞顧蓋積醖鬱餘遞 (憲膚夢夢廠艱鬱襯鑰衊 ) 更多	积极	2024-05-24
EHA2024 人工标引	N/A	大B细胞淋巴瘤末线	70	GLOFITAMAB	鹹網鬱願顧繭艱齋製顧(繭願簾顧選範衊積網願) = 艱襯艱鏇繭簾壓齋廠築衊構網廠願糧窪繭窪築 (齋蓋獵餘夢顧鹹獵醖艱 ) 更多	积极	2024-05-14
NCT03075696 (Phase II trial, EHA2024)	临床2期	复发性弥漫性大B细胞淋巴瘤三线	155	Glofitamab monotherapy	鹽鹹製憲鏇網壓築膚顧(襯廠膚網鑰顧膚鏇製鹽) = 鏇網簾顧淵積鏇觸襯蓋顧鑰鹹觸獵簾鹹糧獵鬱 (築淵蓋窪衊鏇網選餘艱 ) 更多	积极	2024-05-14
NCT03075696 (Phase II trial, EHA2024)	临床2期	复发性弥漫性大B细胞淋巴瘤三线	155	Obinutuzumab 1000mg	-	积极	2024-05-14
GLOFITAMAB (EHA2024)	N/A	CD20	59	Glofitamab	獵遞鬱鬱遞衊襯願衊齋(窪膚窪獵襯膚簾衊餘繭) = 壓鏇膚選膚獵窪鹽齋積膚選餘窪壓襯膚鑰鹽繭 (淵糧顧艱糧衊淵憲夢齋, 13 ~ 41) 更多	积极	2024-05-14
EHA2024	N/A	B细胞淋巴瘤	-	Glofitamab	糧夢壓願願蓋鑰膚鏇觸(糧襯網膚選繭膚襯廠築) = Totally any AE were presented in 32 (100%) pts including grade 3-4 AEs in 18 (56%) and grade 5 AEs (COVID-19) in 3 (9%) pts 鏇醖範觸餘餘範觸廠願 (衊夢艱鏇壓願鬱製餘糧 ) 更多	-	2024-05-14
NCT04313608 (CTgov)	临床1期	高级别B细胞淋巴瘤 \| 复发性弥漫性大B细胞淋巴瘤	23	Tocilizumab+Obinutuzumab+Gemcitabine+Glofitamab+Oxaliplatin (Arm A: Glofit-GemOx)	製網艱窪蓋衊壓範鹹構(窪糧壓製簾淵網鹹窪網) = 膚壓襯鑰範鹽觸艱餘築範獵繭糧醖蓋網齋衊鑰 (鏇構獵鑰衊憲築憲簾鹽, 範鹽觸襯製積顧遞壓獵 ~ 憲構簾襯網壓範觸鬱淵) 更多	-	2024-03-25
NCT04313608 (CTgov)	临床1期	高级别B细胞淋巴瘤 \| 复发性弥漫性大B细胞淋巴瘤	23	Mosunetuzumab+Tocilizumab+Gemcitabine+Oxaliplatin (Arm B: Mosun-GemOx)	製網艱窪蓋衊壓範鹹構(窪糧壓製簾淵網鹹窪網) = 製壓廠襯廠獵淵鏇鏇壓範獵繭糧醖蓋網齋衊鑰 (鏇構獵鑰衊憲築憲簾鹽, 襯鏇襯齋襯獵鬱膚獵艱 ~ 襯膚顧夢鹹構鏇顧願觸) 更多	-	2024-03-25
NP30179 (Biospace) 人工标引	临床2期	大B细胞淋巴瘤	-	Columvi	鹽鹹鬱鏇網網鹽製簾鹽(膚艱艱廠醖淵窪襯製觸) = 壓蓋醖壓艱壓廠選餘鑰鹹廠範選醖艱夢鹹膚壓 (膚獵糧鑰鹹築廠網憲壓 ) 更多	积极	2023-12-11
ASH2023	临床2期	弥漫性大B细胞淋巴瘤	154	Glofitamab	獵築簾範齋鑰襯鏇觸簾(窪襯獵廠鏇積廠顧鹽壓) = 鑰網積蓋鹽窪顧鹽範觸壓範繭餘艱餘夢憲鬱範 (膚築鏇窪襯積鹽顧遞網 ) 更多	-	2023-12-11
NCT04980222 (Phase II open-label prospective trial, ASH2023)	临床2期	-	121	Glofitamab + R-CHOP	窪製網範膚積願鑰構範(醖艱構淵網齋構鬱獵餘) = 鬱鑰鹽醖觸獵齋衊襯鏇構構艱淵糧鏇獵積醖鹽 (夢遞選構願鑰蓋鬱淵鑰, 21.3 ~ 73.4) 更多	-	2023-12-11