AdvanTIG-211: A Randomized, Double-blind, Placebo-controlled, Phase II Study Evaluating the Efficacy and Safety of Ociperlimab (WCD118) Combined With Tislelizumab (VDT482) Plus Chemotherapy Versus Placebo Combined With Pembrolizumab Plus Chemotherapy as First-line Therapy for Participants With Advanced Triple Negative Breast Cancer (TNBC)

The primary scientific question of interest of this study is whether the combination of ociperlimab, tislelizumab and chemotherapy improves progression-free survival (PFS) compared to the combination of placebo, pembrolizumab and chemotherapy as first-line therapy for adult men and women with advanced triple negative breast cancer (TNBC) whose tumors express programmed death ligand 1 (PD - L1) [combined positive score (CPS) ≥10], regardless of study treatment discontinuation or start of new anti-neoplastic therapy.

开始日期2023-09-15

申办/合作机构

Novartis Pharmaceuticals Corp.

NCT05791097 / Withdrawn临床3期

AdvanTIG-306: A Randomized, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Ociperlimab (WCD118/BGB-A1217) Combined With Tislelizumab (VDT482/BGB-A317) Plus Platinum-based Doublet Chemotherapy Versus Placebo Combined With Pembrolizumab Plus Platinum-based Doublet Chemotherapy as First-line Therapy for Participants With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)

The primary scientific question of interest is whether the addition of ociperlimab to platinum-based chemotherapy and tislelizumab improve progression-free survival (PFS) or overall survival (OS) compared to pembrolizumab and platinum-based chemotherapy as first-line therapy for participants with locally advanced or metastatic squamous or non-squamous NSCLC with PD-L1 expression of ≥1%.

开始日期2023-07-28

申办/合作机构

Novartis Pharmaceuticals Corp.

NCT05577702 / Active, not recruiting临床2期

A Randomized, Open-Label, Multicenter, Phase 2, Umbrella Study to Evaluate the Preliminary Efficacy, Safety, and Pharmacodynamics of Tislelizumab Monotherapy and Multiple Tislelizumab-based Immunotherapy Combinations With and Without Chemotherapy as Neoadjuvant Treatment in Chinese Patients With Resectable Stage II to IIIA Non-Small Cell Lung Cancer

This is a randomized, open-label, multicenter, Phase 2, umbrella study to evaluate the preliminary efficacy, safety, and pharmacodynamics of tislelizumab as monotherapy and in combination with investigational agents as neoadjuvant treatment in Chinese participants with resectable Stage II to IIIA non-small cell lung cancer (NSCLC). The study is designed with the flexibility of adding treatment arms as new treatments become available or discontinuing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, and of modifying the participant population.

开始日期2023-02-16

申办/合作机构

BeiGene Ltd.

100 项与欧司珀利单抗相关的临床结果

登录后查看更多信息

100 项与欧司珀利单抗相关的转化医学

登录后查看更多信息

100 项与欧司珀利单抗相关的专利（医药）

登录后查看更多信息

项与欧司珀利单抗相关的文献（医药）

2024-05-01·Structure (London, England : 1993)

Structural insights into the unique pH-responsive characteristics of the anti-TIGIT therapeutic antibody Ociperlimab

Article

作者: Chen, Xin ; Li, Kang ; Zhang, Xiangxiang ; Xue, Liu ; Huang, Chichi ; Song, Jing ; Cheng, Liang ; Shen, Zhirong ; Sun, Jian ; Wang, Lai ; Zhang, Jing

TIGIT is mainly expressed on T cells and is an inhibitory checkpoint receptor that binds to its ligand PVR in the tumor microenvironment. Anti-TIGIT monoclonal antibodies (mAbs) such as Ociperlimab and Tiragolumab block the TIGIT-PVR interaction and are in clinical development. However, the molecular blockade mechanism of these mAbs remains elusive. Here, we report the crystal structures of TIGIT in complex with Ociperlimab_Fab and Tiragolumab_Fab revealing that both mAbs bind TIGIT with a large steric clash with PVR. Furthermore, several critical epitopic residues are identified. Interestingly, the binding affinity of Ociperlimab toward TIGIT increases approximately 17-fold when lowering the pH from 7.4 to 6.0. Our structure shows a strong electrostatic interaction between ASP103_HCDR3 and HIS76_TIGIT explaining the pH-responsive mechanism of Ociperlimab. In contrast, Tiragolumab does not show an acidic pH-dependent binding enhancement. Our results provide valuable information that could help to improve the efficacy of therapeutic antibodies for cancer treatment.

2023-10-01·Journal for immunotherapy of cancer

AdvanTIG-105: a phase I dose escalation study of the anti-TIGIT monoclonal antibody ociperlimab in combination with tislelizumab in patients with advanced solid tumors

Article

作者: Rizwan, Ahsan ; Frentzas, Sophia ; Budha, Nageshwar ; Tan, Wei ; Zheng, Hao ; Meniawy, Tarek ; Kao, Steven ; de la Hoz Pedroza, Luz ; Gao, Rang

Background:

Ociperlimab, a novel, humanized monoclonal antibody (mAb), binds to T-cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domains (TIGIT) with high affinity and specificity. Tislelizumab is an anti-programmed cell death protein 1 mAb. We report results from a phase I, first-in-human, dose escalation study evaluating the safety, pharmacokinetics (PK), and preliminary antitumor activity of ociperlimab plus tislelizumab in patients with advanced solid tumors.

Methods:

Eligible patients previously treated with standard systemic therapy, or for whom treatment was not available or tolerated, received ociperlimab intravenously on Cycle (C) 1 Day (D) 1 and tislelizumab 200 mg intravenously on C1 D8. If tolerated, patients received ociperlimab plus tislelizumab 200 mg sequentially on D29 and every 3 weeks (Q3W) thereafter until discontinuation. Dose escalation for ociperlimab was planned with four dose levels (50 mg, 150 mg, 450 mg, and 900 mg) according to a 3+3 design. An additional dose level of ociperlimab 1800 mg was also assessed. Primary endpoints were safety, determination of the maximum tolerated (or administered) dose, and the recommended phase II dose (RP2D). Secondary endpoints included overall response rate (ORR), duration of response (DoR), disease control rate (DCR) (Response Evaluation Criteria in Solid Tumors version 1.1), PK, and biomarker analysis.

Results:

At data cut-off (September 29, 2022), 32 patients had received ≥1 dose of ociperlimab plus tislelizumab 200 mg Q3W. The maximum administered dose was ociperlimab 1800 mg plus tislelizumab 200 mg Q3W. The median age of enrolled patients was 59.5 years (range: 31–79). Most patients (96.9%) experienced ≥1 treatment-emergent adverse event (TEAE); 62.5% of patients experienced ≥grade 3 TEAEs and 50.0% of patients experienced serious TEAEs. No dose limiting toxicity events were reported. The maximum tolerated dose was not reached. The RP2D was ociperlimab 900 mg plus tislelizumab 200 mg Q3W. Overall, ORR was 10.0%, median DoR was 3.6 months, and DCR was 50.0%.

Conclusions:

Ociperlimab plus tislelizumab was well tolerated in patients with advanced solid tumors, and preliminary antitumor activity was observed with 450 mg, 900 mg, and 1800 mg ociperlimab. Phase II/III trials of ociperlimab 900 mg plus tislelizumab 200 mg Q3W are underway in a range of solid tumors.

Trial registration number:

NCT04047862.

2022-11-01·Cancer control : journal of the Moffitt Cancer Center

Tislelizumab: A Modified Anti-tumor Programmed Death Receptor 1 Antibody

Article

作者: Geng, Qing ; Geng, Zhihua ; Zhang, Lin ; Hao, Bo

Tislelizumab is an anti-programmed death receptor 1 (PD-1) monoclonal immunoglobulin G 4 antibody developed by BeiGene. The structure of tislelizumab has been modified to maximally inhibit the binding of PD-1 to programmed death ligand 1 (PD-L1) and minimize the binding of tislelizumab to Fcγ receptors. In clinical studies, tislelizumab has shown preliminary anti-tumor effects in various solid tumors, such as Hodgkin’s lymphoma, urothelial carcinoma, lung cancer, gastric and esophageal cancer, liver cancer, nasopharyngeal carcinoma, colorectal cancer, and microsatellite instability-high/mismatch repair-deficient tumors. In addition, it also showed new promise in solid tumor treatment in combination with ociperlimab. Due to its satisfactory anti-tumor effects, tislelizumab has received approvals in China for the treatment of classical Hodgkin’s lymphoma, urothelial carcinoma, squamous non-small cell lung cancer, non-squamous non-small cell lung cancer, and hepatocellular carcinoma, and it is now under investigation for a new indication in microsatellite instability-high/mismatch repair-deficient tumors. Moreover, it has been granted orphan designations in hepatocellular carcinoma, esophageal cancer, and gastric cancer, including cancer of the gastroesophageal junction, by the US Food and Drug Administration. Tislelizumab has an acceptable safety profile; the most common adverse effects include fatigue, anemia, and decreased neutrophil count, while the most fatal events have been related to respiratory infection or failure, and hepatic injury. Tislelizumab has an economic advantage compared with other well-studied PD-1/PD-L1 inhibitors; thus, the introduction of it could provide clinical oncologists with an effective weapon against tumors and may alleviate the burden of cancer patients.

204

项与欧司珀利单抗相关的新闻（医药）

2024-10-24

·艾美达医药咨询

中国药企正在变强 | iMeta观察

“iMeta观察” ：艾美达医药咨询聚焦行业发展趋势及痛点问题，以第三方站位综合多方视角提供深度思考。医药战场烽火连天，遭遇多方夹击的不只有K药，还有司美格鲁肽。近期，恒瑞医药启动了GLP-1R/GIPR双激动剂HRS9531头对头司美格鲁肽治疗2型糖尿病的III期试验。而这只是冰山一角，甘李药业、信达生物、博瑞医药都开展了头对头司美格鲁肽的临床研究。另一边，新晋“药王”K药也被各种疗法头对头围猎，其中不乏中国药企的身影，信达、恒瑞、百济神州、康方生物等均位列其中。可以清晰地看到，越来越多中国药企正勇敢地迈出跟随者的角色，积极开展头对头试验、挑战全球医药巨头的地位。这一趋势，无疑是中国药企崛起与蜕变的最佳注脚。 01 “头对头”大战医药行业的新常态当下的医药江湖，已是巨浪滔天。唯有在头对头试验中胜出，才能稳立潮头。近年来，“头对头”大战的竞技场不断涌现，从国产PD-1单抗、双抗接连挑战K药，到百济神州BTK抑制剂泽布替尼完胜强生/艾伯维的伊布替尼，再到恒瑞自免新药HRS5965与依库珠单抗的较量，中国药企不断展现新的实力和风采。例如，针对刚登顶全球“药王”宝座的K药，国内药企主要在非小细胞肺癌（NSCLC）领域进行头对头围猎，包括信达生物的信迪利单抗、百济神州的替雷利珠单抗联合TIGIT单抗BGB-A1217、恒瑞医药的卡瑞利珠单抗联合法米替尼，以及康方生物的PD-1/VEGF双抗依沃西（AK112）等。尤其是依沃西单抗，凭借惊艳全球的临床数据，成为全球首个在头对头III期试验中击败K药的药物。根据依沃西单药对比K药单药一线治疗PD-L1表达阳性的局部晚期或转移性NSCLC患者的III期临床研究 (HARMONi-2/AK112-303）：亚组分析显示，无论患者的年龄、性别、PD-L1表达、病理类型以及是否伴有肝转移、脑转移等，依沃西单抗组疗效均明显优于K药组。 “头对头”擂台赛打得热火朝天的，还有GLP-1药物赛道。遭遇多方夹击的不只有K药，还有潜在下一代全球“药王”司美格鲁肽：前有竞争对手礼来，后有甘李药业、信达生物、博瑞医药、恒瑞医药等中国药企接连开展了头对头试验。甘李药业GZR18注射液是国内首个与司美格鲁肽进行头对头试验的GLP-1RA的创新型产品，正在开展治疗2型糖尿病患者的Ⅱ期研究。 2023年12月，信达生物启动了GLP-1R/GCGR激动剂玛仕度肽（IBI362）头对头司美格鲁肽的III期临床试验，研究的人群为早期2型糖尿病合并肥胖患者。今年9月，翰宇药业在肥胖患者中启动了HY310注射液头对头对比司美格鲁肽治疗44周的疗效和安全性的III期研究。据insight数据库显示，目前共有27家国内企业布局司美格鲁肽类似药/改良型新药，其中有13款布局肥胖适应症，翰宇药业HY310是国内首个在肥胖适应症上进入III期临床的国产版司美格鲁肽。近期，恒瑞医药启动了GLP-1R/GIPR双激动剂HRS9531头对头司美格鲁肽治疗2型糖尿病的III期研究。值得一提的是，恒瑞在今年5月将包括HRS9531在内的GLP-1产品组合，以高达60亿美元的总交易额授权给了美国Hercules公司。在中国药企纷纷涉足头对头试验的浪潮中，一个全新的竞争时代已然开启。 02 出海的必由之路头对头试验的兴起，标志着中国药企已经准备好在全球医药舞台上大显身手，挑战MNC巨头的地位。这不仅仅是对药品疗效与安全性的直接较量，更是企业策略与实力的综合比拼。以BTK抑制剂为例，市场呈现出三代产品并存的局面，竞争相当激烈。其中，第一代BTK抑制剂伊布替尼是最畅销的产品，年销售额曾一度高达近百亿美元。不过，由于第一代BTK抑制剂并非完美，随着阿斯利康的阿卡替尼和百济神州的泽布替尼等第二代BTK抑制剂陆续上市，伊布替尼的市场占比持续下滑，从2019年的98%下降至2023年的63.35%，到2024年一季度再度下滑至56.57%。为了抢占市场蛋糕，阿斯利康和百济神州都开展了头对头试验。阿斯利康在2021年1月宣布阿卡替尼对比伊布替尼治疗既往接受过治疗的慢性淋巴细胞白血病（CLL）成年患者的头对头III期临床显示出积极结果；百济神州也针对2项适应症开展了泽布替尼头对头伊布替尼的临床试验，包括华氏巨球蛋白血症（WM）、CLL/小淋巴细胞淋巴瘤（SLL）。 2022年4月，百济神州宣布泽布替尼在复发或难治性CLL/SLL成人患者中，展示出了优于伊布替尼的总缓解率（ORR），而且安全性方面，泽布替尼的房颤或房扑发生率均低于伊布替尼。得益于出色的临床效果以及在全球超过70个市场获批，泽布替尼2023年全球销售额近13亿美元，成为国产创新药首个“十亿美元分子”，开创了历史先河。今年上半年，泽布替尼继续放量，全球销售额同比增长122%至11.26亿美元，仅用半年就突破十亿美元大关。瞄准全球市场的国内药企还有康方生物，采取“借船出海”策略，将PD-1/VEGF双抗依沃西以总额50亿美元授予Summit公司，之后双方又扩大合作更多全球市场的许可范围。随着依沃西单抗头对头击败K药的临床数据公布，不仅让合作伙伴Summit市值飙升，还极大提升了其国际知名度。更重要的是，通过头对头试验，康方生物拿到了打开国际市场大门的“金钥匙”，为未来全球市场的拓展创造了有利条件。 03 结语头对头试验的战火纷飞，见证了中国药企的崛起与成长。从最初的尝试到如今的广泛参与，中国药企在头对头试验中不断积累经验、提升实力。面对激烈的市场竞争，头对头试验将成为药企突围的重要战略选择。参考资料： 1.各家公司财报、公告、官微 2.安信证券、中信建投证券研报 *声明：本文不构成任何投资建议，仅出于传递更多信息之目的。 ------------------------------ 「长按」二维码添加小达「进群」与更多行业伙伴共探市场前沿资讯艾美达医药咨询艾美达（北京）医药信息咨询有限公司，成立于2014年4月，是一家专业的医药行业咨询服务提供商。公司致力于将产业政策研究与真实世界的数据挖掘深度结合，洞悉行业政策对市场的影响，通过专业的研究提供前瞻性的市场分析，为企业产品上市后的市场准入提供整体解决方案。

临床3期临床2期临床1期引进/卖出

2024-10-18

·微信

药王被围殴

此次医博会由同写意策划，以“发展新质生产力，共享健康新未来”为主题，用全新的视角瞄准国内外医药及大健康产业发展前沿。诚邀海内外医药及大健康各界嘉宾齐聚中国医药城，共赴时代之约。展位/报告火热征集中！药王正在被各大新型疗法群起而攻。 K药遍布实体瘤的一线疗法，自然头对头K药成为了如今的潮流。前有信达的信迪利单抗早早进行尝试，并在II期临床——CTONG1901做出了微弱的优势，后有各个双抗摩拳擦掌“枕戈待旦”，除了AK112外，也不乏其它靶点的双抗下了头对头的决心。头对头优效数据本身便是迭代的最硬证据，现如今迭代速度如此之快的情况下，一个趋势值得着重思考：新时代的双抗，有成为新药王的潜力吗？ 1 单抗头对头——证明自身高于基准线 K药目前被批了多少项适应症？截至2024年6月17日，在美国获批适应症已经达到了40个。截至如今，在中国获批适应症为13个。癌症治疗中的“万金油”并不是在开玩笑，绝大多数癌种适应症，K药都能在其市场占有一席之地。换句话说，一项新的肿瘤疗法要想在某个癌种低线适应症市场出头，与K药竞争都是大概率的。如何能够在竞争中获得优势？当然是在头对头的双盲试验中击败K药，用疗效来证明自身疗法的价值。一开始对K药的头对头，是其他PD-(L)1单抗为了证明自身的疗效，证明自身至少不是me worse而启动的。信达的信迪利单抗便是早期如此操作的典型，虽然做的并不是III期大样本量的临床，但也具有非常直观可以比较的数据。在信迪利单抗VS K药的一线治疗非小细胞肺癌II期临床——CTONG1901中，患者被分为四组，以对PD-1单抗的敏感指标PD-L1 TPS是否大于50%为标准，大于百分之五十的两组分别接受信迪利单抗和K药的单药治疗（A组和B组），小于百分之五十的两组分别接受信迪利单抗和K药的联用化疗治疗（C组和D组）。（图片来源：Si Yang Maggie Liu,et al. ASCO 2022 Abstract # 9032）最后结果来看（以随访更新的数据为准），主要终点ORR的对比显示出了微弱的优势，单药组治疗来看，ORR分别为46.2%和42.9%，联用治疗来看，ORR分别为54.5%和45.5%。作为III期之前的临床，该临床可能样本量较小，无法直接形成获批的证据，但这次试验的意义在于开了与K药头对头打擂台的起点。后续的各大肿瘤疗法，接踵而至。在单抗 VS K药的设计来证明自身不比K药弱之后，单抗＋其它药物 VS K药来证明自身相对K药的优越性也开始普遍。比较经典的有两种设计：“PD-1+TIGIT两大单抗”去头对头K药、“PD-1+小分子”头对头K药。两种方式国内药企都有涉及。（图片来源：insight数据库）对于PD-1+TIGIT联用疗法而言，有百济的替雷利珠单抗+BGB-A1217，对于PD-1＋小分子药物而言，有恒瑞的卡瑞利珠单抗+法米替尼。而有意思的是，目前做的这些适应症，大部分是一线非小细胞肺癌，其次是K药的首发适应症——黑色素瘤。 TIGIT靶点本身和PD-1类似，通过多重作用抑制免疫反应。目前主流的设计是将TIGIT单抗＋PD-1联用对照PD-1单药。近年来的吉利德针对NSCLC的ARC-7二期临床结果为该疗法打了一剂强心针：从PFS这一指标来看，双药方案相较于PD-1 单抗实现了非常大幅度的提升，从5.4个月爬坡提升至12个月。而小分子化药的联用则也是典型，法米替尼本身是多靶点的TKI抑制剂，在非小细胞肺癌上的III期临床或许只是小试牛刀，但其适应症在拓得更宽，目前联用布局包括结直肠癌、宫颈癌、非小细胞肺癌、肾细胞癌，乳腺癌等。 2 双靶点头对头——为了迭代如果说单抗的头对头是为了自身相比K药并不差，那么双抗或者双靶点融合蛋白头对头就一定要做出极其明显的优势，来证明自身相对单抗的迭代性了。这点K药已经给后面随之而来的双抗开了一个好头，在一线治疗非小细胞肺癌方面做出了极其差异化的效果。这次III期临床试验已经在《闭上嘴巴，国产肺癌分子踢出7:0》文章中进行了详细的数据解读。在对该临床试验评价中也提到了AK112头对头K药成功非常值得注意的一点是，目前在一线非小细胞肺癌市场中，还没有VEGF和PD-1两种单抗联用的疗法获批，之后一段时间AK112在1线治疗中只需要面对PD-1单抗这一个对手。当然，这只是开头，后面还有其它双抗头对头K药的III期临床紧随而至。前文提到，PD-1＋TIGIT两种单抗联用头对头K药有数家药企在做，而PD-1/TIGIT双抗去头对头K药，亦有药企在进行尝试。阿斯利康的PD-1/TIGIT双抗Rilvegostomig目前已经注册了一线PD-L1阳性的非鳞状非小细胞肺癌适应症，与K药进行头对头。根据今年WCLC大会上报道的Artemide-01早期临床研究，750mg剂量组以及TPS大于等于50%组的疗效最佳，ORR确认和未确认人数加起来，达到了61.8%，而在TPS小于50%的表现或许没有这么惊艳。患者基线上，可以基本等同于一线治疗（大部分患者此前未经任何药物治疗）。（图片来源：Abstract #OA11.03 Dral Session）当然，不是所有迭代性验证的III期临床都能得到差异化的结果，其中不乏失败教训。默克的M7824是靶向PD-L1和TGF-β的融合蛋白。其中，TGF-β是典型的多通路抑制免疫的靶点，理论上说二者结合成多靶点融合蛋白是可行的思路，但最后III期试验并不如人意。（图源：癌度）在III期临床最后结果上，PFS和OS的HR均大于1，且不良反应上M7824发生率远高于K药。该试验最终宣告了M7824一线治疗NSCLC的死刑。双抗做出在头对头III期临床中，无疑药比单抗面临更加巨大的压力，一方面是行业内人士和投资者对双抗普遍抱有更高的预期，期待看到HR更加明显的结果；另一方面，双抗或者双靶点融合蛋白由于涉及到多靶点，可能会涉及到更多的不良反应事件，例如M7824三级以上不良反应的概率是42.4%，而帕博利珠单抗发生三级以上不良反应的概率为13.2%。此外，AK112头对头试验期间也曾被担忧相关不良反应，毕竟此前VEGF单抗用在NSCLC鳞癌亚型上，发生了严重的不良反应如咯血等，这可能与VEGF对于血管的特殊作用有关。当然，最后康方的AK112的安全性结果是非常超出预期的。安全性追根溯源，是初期的抗体结构设计和改良的问题。最后临床试验的安全性结果只是一种印证。初期的结构设计，需要投资者去关注。 3 K药被围剿与双抗未来正如前文所述，目前对K药的头对头III期主要还是集中在非小细胞肺癌的一线治疗适应症上。其中有商业因素的考虑。但投资者有所疑惑的可能是，双抗未来能否拓展出类似于K药这么宽的适应症范围？商业化因素上，肺癌发病率是5.7人/万人，居于国内癌症首位，而非小细胞肺癌占了肺癌中的85%左右。根据亿欧智库的测算，中国非小细胞癌市场规模在2021年达到230亿元，预计将在2025年达到434亿元，复合年增长约17%。发病率以排名第十左右的膀胱癌比较，国内男性发病率为1人/万人，而且只有男性发病，人数还要再除以2，发病率的差距达到了10倍。以康方为例，在做出了卡度尼利在宫颈癌适应症市场回了一波血后，优先选择NSCLC市场去拓展，无疑可以大大加快其商业化放量的步伐。其它药企的战略构想也大致相似：优先拿下最大的那块适应症市场。从这个角度来说，先在一线治疗NSCLC上进行推进，无疑是回收药物开发成本的最快方式。而在适应症拓展上，双抗需要考虑的则更加多。一方面，K药能够批如此多的适应症，与其可以和诸多药物联用有关。近年来，随着ADC药物的兴起，PD-1单抗和ADC药物联用也成为了潮流之一，例如K药和Padcev在尿路上皮癌适应症上联用的成功。而双抗与ADC的联用目前来看还处于较为早期的阶段。但也不只有ADC联用一条路。康方AK112可预期未来的联用趋势是其CD47单抗——AK117。如康方生物官网的管线所示，其将在胃癌，胆道癌，乳腺癌和头颈癌和结直肠癌上联用AK117，布局非常广泛。 AK117作为CD47单抗，主要对于巨噬细胞的免疫抑制起到作用，能够大大提高其免疫活性，从这个角度来说，这是与AK112进行差异化的疗效优势，从免疫过程的不同通路上进行协同，促进对肿瘤细胞的杀伤。而AK117作为CD47单抗的一类，也在前人的基础上做出了非常大的优化：在前人基础上进行分子张角的改进后，结合红细胞的能力大幅度减弱，从而大幅度削弱了其溶血效应。这在宜明昂科的CD47融合蛋白与替雷利珠单抗联用治疗实体瘤的进度推进上也得到了侧面印证。CD47的大分子在增强PD-1类药物药效上，是被给出很高预期的。如果能顺利成药，未来联用疗法能够打出非常漂亮的组合拳。（图片来源：康方生物官网）此外，双抗之间也可以进行联用，例如AK112和AK104在一线治疗肝癌上的联用，大大加强了免疫效应。此外，AK104自身也在不断进行宫颈癌之外适应症的拓宽，例如最近获批的胃癌适应症，而其与VEGFR2抑制剂AK109在后期打出的组合拳也值得期待。过去IO单抗之间的联合，出现了不同的结果，包括在疗效增加的同时大大增加毒性、未能实现“1+1大于2”等情况，如今双抗不仅能够在提升疗效同时避免单抗联合的毒性，以及还有望在双抗+IO免疫单抗的连用上开花结果；尽管有人提出会不会“胜之不武”或者加重患者负担的质疑，但只要能切实提升患者的OS获益，那么它的意义将被充分体现，这也是MNC近来加快对双抗管线的BD和收购步伐的重要原因。结语：围剿K药是一种市场表现形式，其中值得深思的东西有很多，对于双抗在适应症拓展上的未来，涉及到它能否有成为下一代药物的潜力。但至少目前从康方断代领先的AK112来看，还是可以给出较为乐观预期的。同写意媒体矩阵，欢迎关注↓↓↓

ASCO会议临床结果临床3期临床2期

2024-08-13

·Business Wire

Anti TIGIT Antibodies Clinical Trials & Market Opportunity Outlook 2028: First Anti TIGIT Antibody to Get Approval Within Next 5 Years - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "Anti TIGIT Antibodies Clinical Trials & Market Opportunity Outlook 2028" report has been added to ResearchAndMarkets.com's offering. Anti TIGIT antibodies have emerged a promising approach in cancer immunotherapy, offering new hope for patients with various types of cancers, particularly solid cancers. TIGIT (T cell immunoreceptor with Ig and ITIM domains) is an inhibitory receptor expressed on T cells and natural killer (NK) cells, playing a crucial role in modulating immune responses. By targeting TIGIT, researchers aim to enhance the immune system's ability to recognize and eliminate cancer cells, potentially revolutionizing cancer treatment strategies. The therapeutic potential of TIGIT as a target for cancer immunotherapy lies in its function as an immune checkpoint molecule. When TIGIT interacts with its ligands, such as CD155 and CD112, it suppresses T cell sand NK cell activation, potentially allowing cancer cells to evade immune surveillance. By blocking this interaction with anti-TIGIT therapeutic approaches, researchers hope to reinvigorate the immune response against tumors, leading to improved clinical outcome for cancer patients. Among the various approaches for targeting TIGIT, monoclonal antibodies have emerged as the most widely used and promising agents. These antibodies are designed to specifically bind to TIGIT, preventing its interaction with its ligands and thus releasing the "breaks" on the immune system. Their high specificity and relatively low toxicity of antibodies make them attractive candidates for clinical development. The field of anti-TIGIT antibody development has seen rapid progress, with over 50 candidates currently in clinical development. This robust pipeline underscores the significant interest and potential of this approach in cancer treatment. Among these, more than five anti TIGIT antibodies have advanced to phase 3 clinical trials, representing the most advanced stage of clinical development before potential regulatory approval. These include Vibostolimab, Tiragolumab and Ociperlimab, developed by the pharmaceutical marker leaders, Merck Genentech and BeiGene, respectively. These phase 3 clinical trials are assessing the safety and efficacy of these anti-TIGIT antibodies in various cancer types, with a particular focus on non-small cell lung cancer (NSCLC). The emphasis on NSCLC is not surprising, given its high prevalence and the need for more effective treatment options. NSCLC represents a significant portion of lung cancer cases and has shown promising responses to immunotherapy approaches in the past. Several key factors are driving the market potential of anti-TIGIT antibodies. Firstly, there remains a substantial unmet medical need in cancer treatment, especially for patients who do not respond to or develop resistance to existing immunotherapies. Anti-TIGIT antibodies offer a novel mechanism of action that could address these challenges. Moreover, these antibodies show promising results in combination with established therapies like PD-1/L1 inhibitors, potentially expanding the market for both drug classes and improving treatment outcomes. This becomes visible in Merck's vision of developing a coformulation of its anti-TIGIT antibody Vibostolimab with its blockbuster anti-PD-1 antibody pembrolizumab for the treatment of various solid tumors. The broad applicability of anti-TIGIT antibodies across various cancer forms presents another significant market opportunity. While a majority of clinical trials currently focus on NSCLC, many other ongoing clinical trials are exploring their efficacy in other solid cancers tumors and hematological malignancies, which could lead to multiple approved indications, consequently increasing the anti-TIGIT antibody market size. As evident from the examples above, the competitive landscape for the anti-TIGIT antibody market is dynamic, with major pharmaceutical companies and biotechnology firms vying for market share. While Vibostolimab leverages the company's strong position in the immuno-oncology market, another, Domvanalimab, being developed by Gilead Sciences and Arcus Biosciences, benefits from a partnership between a major pharmaceutical company and a competent biopharmaceutical company. In conclusion, anti-TIGIT antibodies not only represent a significant advancement in cancer immunotherapy, but also present many opportunities for drug development and market expansion. With its potential to address unmet medical needs, broad applicability and alignment with personalized medicine, this emerging class of drugs is poised to capture a substantial portion of cancer immunotherapy market. Anti TIGIT Antibodies Clinical Trials & Market Opportunity Outlook 2028 Report Highlights: Anti TIGIT Antibodies in Clinical Trials: > 50 Antibodies First Anti TIGIT Antibody to Get Approval Within Next 5 Years Global Anti TIGIT Antibodies Clinical Pipeline Insight by Company, Indication and Phase Insight on More Than 50 Anti TIGIT Antibodies in Clinical Trials Anti TIGIT Antibodies Market Trends by Indication & Country Global Anti TIGIT Antibodies Market Dynamics Key Topics Covered: 1. Introduction to Anti TIGIT Antibody 1.1 Overview 1.2 Mechanism of Anti TIGIT Antibodies 1.3 Clinical Approaches to Target TIGIT 2. Global Anti TIGIT Antibodies Clinical Trials Overview 2.1 By Company 2.2 By Country 2.3 By Indication 2.4 By Patient Segment 2.5 By Phase 3. Global Anti TIGIT Antibodies Clinical Pipeline By Company, Indication and Phase 3.1 Research 3.2 Preclinical 3.3 Phase I 3.4 Phase I/II 3.5 Phase II 3.6 Phase III 4. Global Anti TIGIT Antibodies Market Outlook 4.1 Current Clinical & Market Trends 4.2 Future Market Outlook 5. Anti TIGIT Antibodies Market Trends by Indication 5.1 Cancer 5.2 Autoimmune & Inflammatory Disorders 5.3 Microbial Infections 6. Anti TIGIT Antibodies Market by Country 6.1 US 6.2 China 6.3 South Korea 6.4 Australia 6.5 UK 7. Combinations Approaches for TIGIT Therapy 8. TIGIT Co Inhibition with PD1 or PDL1 9. Global Anti TIGIT Antibodies Market Dynamics 9.1 Market Drivers 9.2 Commercialization Challenges 10. Competitive Landscape Akeso Biopharma BeiGene Bio-Thera Solutions Biotheus Compugen FutureGen Biopharmaceutical Merck Sharp & Dohme Nanjing Sanhome Pharmaceutical OriCell Therapeutics Phio Pharmaceuticals Roche Shanghai Henlius Biotech Shanghai Junshi Biosciences Simcere Pharmaceutical Group Tasrif Pharmaceutical For more information about this report visit https://www.researchandmarkets.com/r/sebifx About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

免疫疗法临床3期

100 项与欧司珀利单抗相关的药物交易

登录后查看更多信息

研发状态

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
转移性非小细胞肺癌	临床3期	-	Novartis Pharmaceuticals Corp.	2023-07-28
局部晚期非小细胞肺癌	临床3期	美国	BeiGene Ltd.	2021-06-17
局部晚期非小细胞肺癌	临床3期	中国	BeiGene Ltd.	2021-06-17
局部晚期非小细胞肺癌	临床3期	澳大利亚	BeiGene Ltd.	2021-06-17
局部晚期非小细胞肺癌	临床3期	西班牙	BeiGene Ltd.	2021-06-17
局部晚期非小细胞肺癌	临床3期	中国台湾	BeiGene Ltd.	2021-06-17
不可切除的非小细胞肺癌	临床3期	美国	BeiGene Ltd.	2021-06-17
不可切除的非小细胞肺癌	临床3期	中国	BeiGene Ltd.	2021-06-17
不可切除的非小细胞肺癌	临床3期	澳大利亚	BeiGene Ltd.	2021-06-17
不可切除的非小细胞肺癌	临床3期	西班牙	BeiGene Ltd.	2021-06-17

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04866017 (CTgov)	临床3期	不可切除的非小细胞肺癌 \| 局部晚期非小细胞肺癌	63	Radiotherapy+Tislelizumab+Ociperlimab (Ociperlimab + Tislelizumab + cCRT)	製憲蓋膚鹽顧憲製願顧(鬱顧壓願積構遞廠築鑰) = 構願廠餘簾膚窪繭顧積餘繭鏇鏇淵網鑰餘壓衊 (糧廠鏇選網積願餘築膚, 醖觸餘顧膚衊鬱膚選鑰 ~ 觸簾築築襯積窪鏇艱築) 更多	-	2024-10-31
				Radiotherapy+Tislelizumab (Tislelizumab + cCRT)	製憲蓋膚鹽顧憲製願顧(鬱顧壓願積構遞廠築鑰) = 餘鑰襯願夢製蓋糧淵衊餘繭鏇鏇淵網鑰餘壓衊 (糧廠鏇選網積願餘築膚, 遞窪繭鏇鬱鑰鬱蓋簾獵 ~ 廠齋鑰顧積製鹽齋壓醖) 更多
NCT04952597 (AdvanTIG-204, CTgov)	临床2期	小细胞肺癌	126	Concurrent Chemoradiotherapy+Tislelizumab+Ociperlimab (Arm A: Ociperlimab + Tislelizumab)	膚積鹽觸衊繭顧積獵範(壓鹹網鹽顧願構膚膚選) = 衊蓋獵窪鏇鏇簾鏇糧鹹醖齋蓋襯網顧夢遞願遞 (糧築艱顧壓衊鹽願壓網, 齋選廠醖積鏇觸糧築壓 ~ 齋鬱淵糧齋淵艱範鹹蓋) 更多	-	2024-09-19
				Concurrent Chemoradiotherapy+Tislelizumab (Arm B: Tislelizumab)	膚積鹽觸衊繭顧積獵範(壓鹹網鹽顧願構膚膚選) = 廠襯艱鏇憲鹽願簾鬱壓醖齋蓋襯網顧夢遞願遞 (糧築艱顧壓衊鹽願壓網, 蓋夢艱繭糧顧遞夢膚齋 ~ 繭鬱蓋構鑰選獵選衊窪) 更多
NCT04952597 (AdvanTIG-204, AACR2024) 人工标引	临床2期	小细胞肺癌	126	ociperlimab 900 mg + tislelizumab 200 mg+ cCRT	廠齋範窪艱簾憲築憲襯(齋憲窪積艱繭齋廠艱餘) = 齋觸範製鏇糧餘夢築構獵壓鹹蓋膚簾糧夢築繭 (醖簾鹹觸觸艱醖廠鏇夢 ) 更多	积极	2024-04-05
				tislelizumab + cCRT	廠齋範窪艱簾憲築憲襯(齋憲窪積艱繭齋廠艱餘) = 顧鏇簾選壓願鹽壓鬱膚獵壓鹹蓋膚簾糧夢築繭 (醖簾鹹觸觸艱醖廠鏇夢 ) 更多
NCT04693234 (AdvanTIG-202, ESMO2023) 人工标引	临床2期	宫颈癌二线 PD-L1	178	Tislelizumab 200 mg + Ociperlimab 900 mg	築願網選鏇窪鹹製壓獵(膚壓積廠艱壓鏇積廠鹹) = 鑰衊糧鹽鹽醖淵鬱築襯鹽衊鏇醖鏇繭餘壓範製 (鏇鑰繭獵簾製鬱蓋築窪, 15.8 ~ 30.3) 更多	积极	2023-10-22
				Tislelizumab 200 mg + Ociperlimab 900 mg (PD-L1 +)	築願網選鏇窪鹹製壓獵(膚壓積廠艱壓鏇積廠鹹) = 積膚衊廠顧構遞範構廠鹽衊鏇醖鏇繭餘壓範製 (鏇鑰繭獵簾製鬱蓋築窪, 17.2 ~ 36.9) 更多
NCT04732494 (AdvanTIG-203, ESMO2023) 人工标引	临床2期	PD-L1阳性食管鳞状细胞癌二线 PD-L1 High Expression	125	Ociperlimab (OCI) + Tislelizumab (TIS)	鏇鹹艱繭願選膚壓積憲(壓蓋蓋願鏇製艱淵鬱鬱) = 築淵鑰鹽簾衊鹹鬱鹽鹽鹽憲鑰憲積製齋製鏇構 (獵構繭鬱膚淵鏇壓鏇衊 ) 更多	不佳	2023-10-21
				Placebo + Tislelizumab (TIS)	鏇鹹艱繭願選膚壓積憲(壓蓋蓋願鏇製艱淵鬱鬱) = 構憲夢築顧壓顧餘膚鏇鹽憲鑰憲積製齋製鏇構 (獵構繭鬱膚淵鏇壓鏇衊 ) 更多
NCT04948697 (AdvanTIG-206, ESMO2023) 人工标引	临床2期	晚期肝细胞癌	94	Ociperlimab + Tislelizumab + BAT1706	鑰鏇顧糧簾蓋獵窪獵壓(艱築鬱遞鑰衊製廠選獵) = 積鑰衊願願構膚範憲遞廠夢築鬱蓋鑰願積夢獵 (壓醖範艱襯齋衊膚網顧, 23.7 ~ 48.7) 更多	积极	2023-10-21
				Tislelizumab + BAT1706	鑰鏇顧糧簾蓋獵窪獵壓(艱築鬱遞鑰衊製廠選獵) = 築餘遞築鬱觸蓋網簾襯廠夢築鬱蓋鑰願積夢獵 (壓醖範艱襯齋衊膚網顧, 21.1 ~ 56.3) 更多
NCT04047862 (AdvanTIG-105, Pubmed \| J Immunother Cancer)	临床1期	晚期恶性实体瘤	32	Ociperlimab 50 mg	構夢網壓觸餘獵醖願鹽(製夢鑰艱構願願鏇齋觸) = 鑰獵糧製淵憲繭鹽糧遞餘鹽夢窪構鹽構襯憲齋 (襯壓積繭積築鬱構廠遞 ) 更多	积极	2023-10-01
				Ociperlimab 150 mg	構夢網壓觸餘獵醖願鹽(製夢鑰艱構願願鏇齋觸) = 齋膚窪鹹鹽艱餘鑰壓選餘鹽夢窪構鹽構襯憲齋 (襯壓積繭積築鬱構廠遞 ) 更多
NCT04047862 (BGB-900-105, ASCO2023) 人工标引	临床1期	胃腺癌 \| 胃食管交界处恶性肿瘤	60	Ociperlimab+Tislelizumab+chemotherapy	鬱繭蓋獵齋鹽膚壓糧鏇(願網繭積鏇築醖膚廠遞) = 淵糧窪築鹽遞壓鏇遞鹹糧選遞膚簾醖觸願獵簾 (艱獵獵願夢鏇餘膚選願, 37.5 ~ 64.1) 更多	积极	2023-05-26
				Ociperlimab+Tislelizumab+chemotherapy (PD-L1 tumor area positivity (TAP) score ≥5%)	鬱繭蓋獵齋鹽膚壓糧鏇(願網繭積鏇築醖膚廠遞) = 窪廠獵衊襯鏇選鹽簾膚糧選遞膚簾醖觸願獵簾 (艱獵獵願夢鏇餘膚選願, 38.8 ~ 77.6)
NCT04047862 (AdvanTIG-105, ESMO_IO2022) 人工标引	临床1期	广泛期小细胞肺癌	42	Chemotherapy+Ociperlimab+Tislelizumab	夢鬱製鹽繭鹹醖餘艱鹹(憲艱糧鹹蓋衊襯窪簾襯) = 鬱蓋遞積範糧範膚選鑰觸製蓋膚範廠鏇顧簾鹽 (餘鹽範窪醖膚繭醖鏇醖, 48.3 ~ 79.4) 更多	积极	2022-12-08
NCT04047862 (AdvanTIG-105, ESMO_IO2022) 人工标引	临床1期	非小细胞肺癌	26	ociperlimab+tislelizumab	夢繭蓋構鏇鬱願壓壓窪(餘鹽獵餘製鏇遞積膚範) = 憲蓋觸艱顧壓鬱膚蓋窪選鑰顧積壓鹹鏇簾鑰餘 (製膚淵願艱積衊壓蓋夢, 1.0 ~ 26.0) 更多	积极	2022-12-08