An Open Label, Phase 2 Clinical Trial of MEN1703 as Monotherapy and in Combination With Glofitamab in Patients With Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma

The goal of the study is to assess the safety and anti-lymphoma activity of MEN1703 when given as a single-agent or combined with glofitamab to patients with relapsed/refractory (R/R) aggressive B-cell non-Hodgkin lymphoma. The study will be open to groups at the same time:
* Group 1 - patients who have not had anti-CD3xCD20 bispecific antibody therapy but who have had at least 2 prior lines of systemic treatment for aggressive B-cell non-Hodgkin lymphoma
* Group 2 - patients who have exhausted all standard treatment options including at least 2 prior lines of systemic treatment for aggressive B-cell non-Hodgkin lymphoma Group 1 patients will be treated for a maximum of 12 cycles. One cycle is 21 days. Group 2 with be treated until the disease progresses, therefore treatment duration is dependent on the number of treatment cycles a participant receives prior to progression.

开始日期2024-11-01

申办/合作机构

Ryvu Therapeutics SA

[+1]

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2024-09-10

申办/合作机构

City of Hope National Medical Center

[+1]

NCT06558604 / Not yet recruiting临床2期IIT

A Phase II, Multicenter, Open-label Study Evaluating Glofitamab in Combination With Venetoclax Plus Zanubrutinib or Venetoclax Alone in Subjects With Untreated or Relapsed/Refractory High-risk Mantle-cell Lymphoma

This open-label, multicenter, three cohorts, phase II study is designed to assess a combination of Zanubrutinib/Venetoclax/Glofitamab or Venetoclax/Glofitamab in high-risk subjects with either first line or R/R Mantle Cell Lymphoma (MCL).
Three independent cohorts will be run:
* Cohort A will include subjects with a primary refractory or progressive disease within 24 months from initiation of first line treatment (POD 24).
* Cohort B will be open for subjects with R/R MCL and refractory or progressive to a BTK inhibitor given previously (>24 months if first line).
* Cohort C will only enrol newly diagnosed and untreated MCL subjects with very high-risk features.

开始日期2024-09-01

申办/合作机构

Le LYSARC

[+2]

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100 项与格菲妥单抗相关的专利（医药）

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项与格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 ; Djebli, Nassim ; Guerini, Elena ; 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.

2024-06-01·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 ; Kao, Hsiao-Wen ; Wang, Ming-Chung ; 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.

330

项与格菲妥单抗相关的新闻（医药）

2024-09-11

·生物制品圈

超一半患者肿瘤消失，罗氏双抗在华启动1/2期临床，针对淋巴瘤

根据药物临床试验登记与信息公示平台公示，罗氏Englumafusp alfa注射液已启动1/2期研究，在复发/难治性B细胞非霍奇金淋巴瘤受试者中评价奥妥珠单抗预治疗后ENGLUMAFUSP ALFA与奥妥珠单抗联合给药以及与格菲妥单抗联合给药的安全性、药代动力学和初步抗肿瘤活性。 Englumafusp alfa国内1/2期临床 Englumafusp alfa, 是一种创新的双特异性抗体样融合蛋白，它具备双重靶向能力，能够同时识别B细胞表面的CD19分子以及免疫细胞如T细胞上的4-1BB受体。这种独特的结合方式能够激活一个强烈的共刺激信号，从而促进并延长免疫细胞的活性，进而提升对肿瘤细胞的攻击力度。此外，当T细胞受体的信号存在，并且依赖于CD19的交联作用时，englumafusp alfa通过其对4-1BB的激动作用，为T细胞提供了显著的共刺激效果。这种机制与CD20/CD3 T细胞衔接双特异性抗体的联合使用，可以显著增强其抗肿瘤效果，为治疗提供了一种新的策略。 Englumafusp alfa在ClinicalTrials注册的临床试验目前，Englumafusp alfa正在全球开展1/2期临床（NCT04077723）。在2024 欧洲血液学协会（EHA）年会上，罗氏公布了englumafusp alfa与CD20×CD3双特异性抗体格菲妥单抗（glofitamab）联用，治疗复发/难治性非霍奇金淋巴瘤（r/r NHL）的1b期BP41072研究初步数据（NCT04077723）。研究设计截至2023年10月25日，共有134名复发/难治性B细胞非霍奇金淋巴瘤（R/R B-NHL）患者参与了研究。在这组患者中，83人被诊断为侵袭性R/R B-NHL，这其中包括了60例弥漫大B细胞淋巴瘤（DLBCL）、18例由滤泡性淋巴瘤进展而来的大B细胞淋巴瘤（trFL）、3例由其他惰性NHL进展而来的大B细胞淋巴瘤，以及2例3B级滤泡性淋巴瘤（FL）。在治疗中，englumafusp alfa的使用剂量从0.35mg到75mg不等，尚未观察到最大耐受剂量。研究对象的中位年龄是63岁，其中女性占比41%，47%的患者东部肿瘤协作组（ECOG）表现状态评分为1，超过一半的患者处于疾病IV期（50.6%）。这些患者的中位治疗次数为3次（治疗次数范围从1次到8次），其中19.3%的患者为原发性难治性病例，而49.4%的患者之前接受过CAR-T治疗。研究结果初步研究数据显示：在所有受试者（2L+，共83人）中，完全缓解率（CRR）和客观缓解率（BOR）分别达到了57%和67%。在那些未曾接受嵌合抗原受体T细胞（CAR-T）治疗的患者群体（2L+，共41人）中，CRR和BOR分别提高至66%和73%。特别地，对于仅经历过一种先前治疗且未接受过CAR-T治疗的患者（共13人），CRR和BOR均实现了77%的高水平。安全性结果安全性结果显示：CRS主要在格菲妥单抗2.5mg和10mg剂量的患者群体中观察到。具体来说，大约48.5%的参与者经历了1级CRS。在这些案例中，仅有7例（占5.2%）的CRS与Englumafusp alfa的使用相关，并且这些反应均为轻度。在Englumafusp alfa与格菲妥单抗的联合治疗期间，没有检测到任何新的安全性问题。 PK/PD结果并且观察到活化和记忆CD8+ T细胞的扩增，而在血液中末端分化的PD1+ CD8+ T细胞扩增有限，这一现象与ctDNA反应随时间的变化而加深相关。研究结果支持了将TCE与能够激活强烈共刺激信号的双特异性抗体样融合蛋白结合使用，这种方法在B细胞非霍奇金淋巴瘤患者中显示出了良好的安全性和疗效。资料来源： 1.CDE官网 2.罗氏官网 3.ClinicalTrials官网识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。

临床结果免疫疗法细胞疗法临床1期基因疗法

2024-09-10

·医药地理

上海阳光医药采购网公布2024年7月份药品挂网公开议价采购监管品种名单的通知，恒瑞硫酸艾玛昔替尼片新适应症上市申请获CDE受理

扫描二维码即可下载《数图药讯》2024年第36期目录政策解读 1. 上海阳光医药采购网：关于公布2024年7月份药品挂网公开议价采购监管品种名单的通知 2. 上海阳光医药采购网：关于本市执行全国药品集中采购（胰岛素专项接续）中选结果的通知 3. 国家药典委员会：关于转发第七批20个中药配方颗粒国家药品标准的通知 4. 江苏省医保局：第4-5批国家组织药品集中采购协议期满品种江苏联盟接续采购公告（一） 5. 浙江省医保局浙江省财政厅国家税务总局浙江省税务局：关于加快推进职工基本医疗保险个人账户家庭共济有关落地执行工作（试行）的通知 6. 广东省药品交易中心：关于公布2024年度广东省非免疫规划疫苗使用目录信息变更（第二批）及更新后目录的通知行业动态 1. 药讯动态：重磅获批 2. 药讯动态：重磅临床 3. 药企动态：市场动态零售品类数据洞见 1. 黑色素瘤治疗药品销售分析 2. 黑色素瘤治疗药品销售品种分析 3. 维莫非尼零售放大市场销售分析政策解读 1、上海阳光医药采购网：关于公布2024年7月份药品挂网公开议价采购监管品种名单的通知根据《关于促进同通用名同厂牌药品省际间价格公平诚信、透明均衡的通知》（医保办函〔2023〕104号）、《药械重点监控监管工作规范》以及本市全面议价挂网相关文件的要求，本市进一步加强药品挂网公开议价采购的监管工作。现公布2024年7月份挂网公开议价超“黄线”、未通过公允性评估、重点监控药品幅度靠前且有一定采购金额的品种，具体情况见官网。 2、上海阳光医药采购网：关于本市执行全国药品集中采购（胰岛素专项接续）中选结果的通知为保证全国药品集中采购（胰岛素专项接续）中选结果在上海市顺利执行，根据《关于本市做好第六批国家组织药品集中采购（胰岛素专项）接续有关工作的通知》（沪医保价采发〔2024〕17号）要求，现就有关工作发布通知。具体信息请登录上海阳光医药采购网官网查看。 3、国家药典委员会：关于转发第七批20个中药配方颗粒国家药品标准的通知国家药典委员会组织完成第七批20个中药配方颗粒国家药品标准制定工作，经国家药品监督管理局批准正式颁布，现予以转发。相关文件请扫描上方二维码查看 4、江苏省医保局：第4-5批国家组织药品集中采购协议期满品种江苏联盟接续采购公告（一）根据《国家医保局办公室关于做好国家组织药品集中带量采购协议期满后接续工作的通知》（医保办发〔2021〕44号）和《关于准确全面贯彻国家组织药品集中带量采购协议期满后接续工作政策有关注意事项的通知》（医保办函〔2022〕12号），按照国家医保局有关要求，江苏、安徽、湖北、广西、重庆、四川、贵州、云南、陕西、甘肃、青海等省份组建省际联盟，对第4-5批国家集采协议期满的带量采购药品开展接续采购工作。具体信息请登录江苏省医保局官网查看。相关文件请扫描上方二维码查看 5、浙江省医保局浙江省财政厅国家税务总局浙江省税务局：关于加快推进职工基本医疗保险个人账户家庭共济有关落地执行工作（试行）的通知为贯彻落实《国务院办公厅关于健全基本医疗保险参保长效机制的指导意见》（国办发〔2024〕38号）、《浙江省人民政府办公厅关于进一步健全职工基本医疗保险门诊共济保障机制的实施意见》（浙政办发〔2022〕14号）等文件精神，加快推进职工基本医疗保险个人账户家庭共济落地执行，提高医保基金使用效率，减轻家庭医疗费用负担，现就有关工作发布通知。具体信息请登录浙江省医保局官网查看。 6、广东省药品交易中心：关于公布2024年度广东省非免疫规划疫苗使用目录信息变更（第二批）及更新后目录的通知按照《广东省卫生健康委关于印发广东省非免疫规划疫苗集中采购实施方案的通知》（粤卫规〔2020〕4号）有关要求，现将2024年度广东省非免疫规划疫苗使用目录信息变更（第二批）予以公布（详见附件1），并对《2024年度广东省非免疫规划疫苗使用目录》予以同步更新（详见附件2）。附件：1.2024年度广东省非免疫规划疫苗使用目录信息变更（第二批） 2.2024年度广东省非免疫规划疫苗使用目录（更新至2024年9月6日）相关文件请扫描上方二维码查看行业动态 01 药讯动态：重磅获批和重磅临床最近重磅获批成大生物申报的预防用生物制品冻干人用狂犬病疫苗（人二倍体细胞）上市申请获得CDE受理。诺和诺德（Novo Nordisk）申报的帕西生长素注射液的新药上市申请获得受理。默沙东（MSD）申报的抗PD-1单抗帕博利珠单抗又一项新适应症提交上市申请并获得CDE受理。恒瑞医药硫酸艾玛昔替尼片新适应症上市申请获得CDE受理，具体适应症尚未披露。罗氏（Roche）格菲妥单抗注射液新适应症上市申请获得CDE受理，本次申报上市的新适应症可能为：联合吉西他滨和奥沙利铂治疗不适合进行自体干细胞移植的弥漫性大B细胞淋巴瘤（2L+ DLBCL）。信达生物PD-1/IL-2α-bias双特异性抗体融合蛋白IBI363获得美国FDA授予快速通道资格（fast track designation, FTD），拟定适应症为既往接受过至少一线含PD-1/L1检查点抑制剂系统性治疗后进展的局部晚期或转移性黑色素瘤（脉络膜黑色素瘤除外）。最近重磅临床人福医药全资子公司武汉人福创新药物研发中心申报的1类新药HW071021片获得CDE临床试验默示许可，用于治疗晚期实体瘤。普祺医药申报的PG-033片获得CDE批准临床，拟开发用于治疗神经性皮炎伴随的中、重度瘙痒。神州细胞1类新药SCT520FF注射液获得CDE批准临床，适应症为新生血管性年龄相关性黄斑变性。安进（Amgen）的1类新药AMG 451一项新的临床申请获得CDE批准，适应症为结节性痒疹。锐正基因（Accuredit）自主研发的基于非病毒载体的体内基因编辑药物ART001获美国FDA临床试验许可，拟开发用于治疗转甲状腺素蛋白淀粉样变性（ATTR）。丽珠集团启动一项 III 期临床研究，评估司美格鲁肽注射液与原研司美格鲁肽注射液 Wegovy® 相比，在成人肥胖受试者中作为减少热量饮食和增加体力活动的辅助治疗的有效性（CTR20243356）。 02 药企动态：市场动态 9月2日，先声再明宣布，已于近日与深圳市塔吉瑞生物医药有限公司就临床阶段抗肿瘤候选药物ALK/ROS1双重受体酪氨酸激酶抑制剂TGRX-326订立合作协议。根据BD协议条款，先声再明将获得TGRX-326在中国的独家商业化权益。塔吉瑞将获得超2000万美元首付款（upfront），并将向先声再明支付推广服务费。 9月3日，赫吉亚生物（Hygieia）宣布已于近期完成数千万元人民币A2轮融资，由黄埔生物医药基金领投，南湾百澳基金跟投。 9月5日，Genetic Leap宣布，与礼来(LLY.US)达成价值高达4.09亿美元的研究合作，以开发基于基因的疗法。根据协议条款，Genetic Leap将从礼来获得高达4.09亿美元的前期、开发、临床、监管和商业里程碑付款，以及分级特许权使用费。作为协议的一部分，两家公司将利用Genetic Leap的RNA靶向人工智能平台，为礼来选定的靶点开发寡核苷酸药物。零售品类数据洞见 01 黑色素瘤治疗药品销售分析图1：2019-2023年黑色素瘤治疗药品零售（放大市场）销售额数据来源：中国药品零售数据库RPDB药店数据中国医药工业信息中心黑色素瘤是黑色素细胞恶变而来的肿瘤，恶性程度高，多发生于皮肤，也可发生在黏膜（包括内脏黏膜）、眼葡萄膜、软脑膜等不同部位或组织。根据RPDB数据库显示的黑色素瘤治疗药品零售（放大市场）销售额推测，黑色素瘤发病无显著季节性。 02 黑色素瘤治疗药品销售分析图2: 2019-2023年黑色素瘤治疗药品零售（放大市场）品种销售额数据来源：中国药品零售数据库RPDB药店数据中国医药工业信息中心根据RPDB数据库，黑色素瘤常见治疗药品有人血白蛋白、帕博利珠单抗、特瑞普利单抗、人干扰素α1b注射液、多西他赛注射液等。 03 维莫非尼零售放大市场销售分析图3: 2019-2023年维莫非尼零售（放大市场）销售额数据来源：中国药品零售数据库RPDB药店数据中国医药工业信息中心维莫非尼是唯一获得中国食品药品监督管理局批准治疗晚期BRAF-V600E突变的黑色素瘤的分子靶向药物。2019-2023年，维莫非尼零售（放大市场）销售额变化幅度较大，2020年销售额最高，达1660万元。来源：医药地理、国家药监局、腾讯、新浪等。 END 如需获取更多数据洞察信息或公众号内容合作，请联系医药地理小助手微信号：pharmadl001

带量采购专利到期一致性评价疫苗

2024-09-10

·Pharmaceutical Technology

T-cell targeting Candid Therapeutics launches with $370m

Candid plans to develop antibody drugs for inflammatory diseases such as rheumatoid arthritis. Credit: Drazen Zigic via Shutterstock. T cell engager (TCE) startup Candid Therapeutics has debuted with $370m in its pocket to develop antibody drugs for inflammatory diseases. Candid plans to develop T cell engager antibodies to selectively target and deplete specific B lymphocyte populations that play a role in autoimmune diseases. Selective depletion of B lymphocytes has shown clinical effectiveness in patients with conditions such as rheumatoid arthritis and myasthenia gravis. Headquartered in San Diego, California, the company’s Series A funding round was co-led by Venrock Healthcare Capital Partners, Fairmount, TCGX and venBio Partners, with Foresite Capital and Third Rock Ventures also taking part, among others. As part of its debut, Candid inherited two advanced bispecific antibodies to kick off its portfolio. CND106 is a BCMAxCD3 antibody from Vignette, and CD20xCD3 is an antibody from TRC 2004. Both candidates, which have completed Phase I trials with over 130 oncology patients, show potential as therapies for autoimmune diseases, according to Candid. TCE antibodies have the most promise in becoming scalable and patient-friendly drugs that deplete B cells for the treatment of several autoimmune conditions, said Candid’s new CEO Ken Song, whose previous company RayzeBio was acquired by Bristol Myers Squibb in December 2023. See Also: CMN-005 by CoImmune for Extranodal Marginal Zone B-Cell Lymphoma (Mucosa-Associated Lymphoid Tissue or MALT-Lymphoma): Likelihood of Approval CMN-005 by CoImmune for Nodal Marginal Zone B-Cell Lymphoma: Likelihood of Approval Candid joins a number of high-profile companies that are making waves in the space. In January 2024, MSD acquired Harpoon in a $680m deal, which included Harpoon’s T cell engagers. One of the candidates, named HPN328, is being tested in a Phase I/II trial (NCT04471727) for some types of lung cancer and neuroendocrine tumours. HPN328 was developed using Harpoon’s TriTAC platform. In April, Roche shared data from a trial of its bispecific T cell engager Columvi (glofitamab). The drug, which targets CD3 on T cells and CD20 on B cells, improved survival in a Phase III lymphoma trial. The 270 participants received either Columvi or Rituxan (rituximab) on top of a regimen of two chemotherapy drugs, gemcitabine and oxaliplatin. In the announcement accompanying the launch, Song said that Candid’s drugs have the potential to “go above and beyond the clinical and commercial success of Humira and Rituxan.” AbbVie ’s Humira (adalimumab) and Biogen and Genentech’s Rituxan are blockbuster autoimmune drugs that pulled in $14.5bn and $1.8bn last year, respectively, as per the company’s financials.

临床1期免疫疗法临床3期临床结果并购

100 项与格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

批准上市

10 条最早获批的记录,

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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

10 条进展最快的记录,

后查看更多信息

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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临床结果

适应症

分期

评价

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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


ESMO2024	N/A	弥漫性大B细胞淋巴瘤	-	Glofitamab	積獵夢繭選築獵鹹餘鬱(窪鑰夢糧鹽膚鹹膚窪築) = 鏇鹹艱膚襯觸糧艱鬱糧艱製餘廠壓願簾獵壓選 (顧鏇淵餘衊窪醖獵齋糧, 32.0% ~ 71.3%) 更多	积极	2024-09-15
				Real-world regimens	積獵夢繭選築獵鹹餘鬱(窪鑰夢糧鹽膚鹹膚窪築) = 衊繭廠糧廠蓋獵襯鑰憲艱製餘廠壓願簾獵壓選 (顧鏇淵餘衊窪醖獵齋糧, 5.8% ~ 15.5%) 更多
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	鹹鹹餘醖範糧製繭鑰簾(鏇願艱衊齋積蓋繭顧製) = 網鹹選顧願蓋艱窪鏇膚餘顧蓋壓淵鑰膚醖願鑰 (獵顧壓簾窪齋願觸夢簾 ) 更多	积极	2024-06-14
				rituximab+gemcitabine+oxaliplatin	鹹鹹餘醖範糧製繭鑰簾(鏇願艱衊齋積蓋繭顧製) = 積鑰齋壓衊膚獵願窪夢餘顧蓋壓淵鑰膚醖願鑰 (獵顧壓簾窪齋願觸夢簾 ) 更多
NCT03075696 (NP30179, ASCO2024) 人工标引	临床1/2期	套细胞淋巴瘤	60	Glofitamab	襯築壓構壓範遞鹽夢鹽(獵糧選窪願獵餘艱積艱) = 網鑰淵鹹範網顧鬱遞窪膚襯選繭鏇糧壓齋廠繭 (選製網廠積遞糧鬱膚製 ) 更多	积极	2024-05-24
				Glofitamab (post-BTKi pts)	襯築壓構壓範遞鹽夢鹽(獵糧選窪願獵餘艱積艱) = 餘範衊網願鹹壓窪鑰鑰膚襯選繭鏇糧壓齋廠繭 (選製網廠積遞糧鬱膚製 ) 更多
EHA2024 人工标引	N/A	大B细胞淋巴瘤末线	70	GLOFITAMAB	鑰遞鏇構蓋鏇廠壓廠選(襯鑰醖餘築蓋積壓淵餘) = 獵壓繭構糧淵襯鏇網鑰鹹鬱餘鏇繭鹹窪構積壓 (齋膚鬱淵鏇積壓顧繭蓋 ) 更多	积极	2024-05-14
NCT03075696 (Phase II trial, EHA2024)	临床2期	大B细胞淋巴瘤三线	155	Glofitamab monotherapy	憲襯鹽鹽淵窪糧衊廠網(築願醖窪窪憲選網餘鏇) = 鑰窪膚網築醖範選範衊築餘淵顧齋淵製餘簾範 (憲壓醖鏇觸醖襯鹹壓選 ) 更多	积极	2024-05-14
				Obinutuzumab 1000mg	-
EHA2024	N/A	B细胞淋巴瘤	-	Glofitamab	壓餘壓選願範遞製鏇積(製鹹糧夢積鑰憲獵衊網) = 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 鏇鹹築憲製構鑰鑰範醖 (窪艱夢鹽襯遞遞鹹製衊 ) 更多	-	2024-05-14
GLOFITAMAB (EHA2024)	N/A	CD20	59	Glofitamab	願觸鹹鹹鑰鏇積醖夢鏇(壓鹹鹹膚觸鹽衊夢鏇遞) = 糧窪醖築網鏇構醖襯選構遞網願選鑰簾蓋簾夢 (獵艱願願齋襯築獵憲顧, 13 ~ 41) 更多	积极	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)	鑰簾鏇糧簾窪壓艱艱顧(選鹽製衊獵觸製夢簾廠) = 範夢衊簾鹹鬱觸膚淵願顧遞網蓋遞醖膚選選餘 (襯選積積窪鹽築膚築積, 遞廠願廠廠積簾鏇選窪 ~ 憲廠積觸繭繭製膚鑰繭) 更多	-	2024-03-25
				Mosunetuzumab+Tocilizumab+Gemcitabine+Oxaliplatin (Arm B: Mosun-GemOx)	鑰簾鏇糧簾窪壓艱艱顧(選鹽製衊獵觸製夢簾廠) = 夢顧鬱鹹鹹鹹願襯鹹齋顧遞網蓋遞醖膚選選餘 (襯選積積窪鹽築膚築積, 襯醖簾遞淵窪膚淵獵艱 ~ 顧範觸遞壓範網鹽衊積) 更多
NP30179 (Biospace) 人工标引	临床2期	大B细胞淋巴瘤	-	Columvi	衊膚鹹鏇夢簾積鹽襯鏇(衊窪遞鬱鹽築築築淵夢) = 餘餘積襯鬱憲範艱遞顧繭糧範窪鬱壓繭襯襯鏇 (襯鹹淵淵網網獵襯繭鹹 ) 更多	积极	2023-12-11
ASH2023	临床2期	弥漫性大B细胞淋巴瘤	154	Glofitamab	餘餘糧製蓋襯顧蓋壓願(醖艱築繭襯鑰積觸繭網) = 顧積繭鹽艱壓築範鏇遞醖範襯廠簾艱憲鏇廠築 (範蓋淵夢膚膚衊觸遞鑰 ) 更多	-	2023-12-11