LIGHTBEAM-U01 Substudy 01B: A Phase 1/2 Substudy to Evaluate the Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors

This study is a rolling arm study of pembrolizumab in combination with investigational agents in pediatric participants with relapsed or refractory classical Hodgkin lymphoma (cHL) solid tumors with microsatellite instability-high (MSI-H)/mismatch repair deficient (dMMR) or tumor mutational burden-high (TMB-H). This study will have 2 parts: a safety lead-in to demonstrate a tolerable safety profile and confirm a preliminary recommended phase 2 dose (RP2D) (Part 1) followed by an efficacy evaluation (Part 2). Participants will be assigned to a treatment arm (either Part 1 or Part 2) that is open for enrollment.
There will be no hypothesis testing in this study.

开始日期2025-01-15

申办/合作机构

Merck Sharp & Dohme LLC

NCT04303169

/ Active, not recruiting临床1/2期

A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Design of Investigational Agents With or Without Pembrolizumab or Pembrolizumab Alone in Participants With Melanoma (KEYMAKER-U02): Substudy 02C

Substudy 02C is part of a larger research study that is testing experimental treatments for melanoma, a type of skin cancer. The larger study is the umbrella study.
The goal of substudy 02C is to evaluate the safety and efficacy of investigational treatment arms in participants with Stage III melanoma who are candidates for neoadjuvant therapy to identify the investigational agent(s) that, when used in combination, are superior to the current treatment options/historical control available.
Arm 1: Pembrolizumab + Vibostolimab, Arm 2: Pembrolizumab + Gebasaxturev, and Arm 3: Pembrolizumab were added in the base protocol on 13-Nov-2019, and enrollment into those arms has been completed. Arm 4: Pembrolizumab + MK-4830 was added in Amendment 04 on 20-Dec-2021, and enrollment into that arm has been completed. Arm 5: Favezelimab + Pembrolizumab and Arm 6: Pembrolizumab + all-trans retinoic acid (ATRA) were added in Amendment 06 on 25-Jun-2022, and enrollment is ongoing.

开始日期2020-06-26

申办/合作机构

Merck Sharp & Dohme LLC

NCT04165070

/ Recruiting临床1/2期

KEYMAKER-U01 Substudy 01A: A Phase 1/2, Umbrella Study With Rolling Arms of Investigational Agents With Pembrolizumab With or Without Chemotherapy in Treatment-Naive Participants With Stage IV Non-small Cell Lung Cancer (NSCLC)

The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) with or without chemotherapy in combination with vibostolimab (MK-7684), boserolimab (MK-5890), MK-4830, MK-0482, I-DXd, or HER3-DXd in treatment-naïve participants with advanced squamous or non-squamous NSCLC.
This study is one of the pembrolizumab substudies being conducted under one pembrolizumab umbrella master protocol (MK-3475-U01/KEYMAKER-U01).

开始日期2019-12-19

申办/合作机构

Merck Sharp & Dohme Corp.

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100 项与维博利单抗相关的临床结果

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100 项与维博利单抗相关的转化医学

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100 项与维博利单抗相关的专利（医药）

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项与维博利单抗相关的文献（医药）

2025-01-01·NATURE MEDICINE

Neoadjuvant anti-PD-1 alone or in combination with anti-TIGIT or an oncolytic virus in resectable stage IIIB–D melanoma: a phase 1/2 trial

Article

作者: Menzies, Alexander M ; Hill, Andrew ; Long, Georgina V ; Grob, Jean-Jacques ; Khattak, Muhammad A ; Robert, Caroline ; Dummer, Reinhard ; Shapira-Frommer, Ronnie ; Mehmi, Inderjit ; Meyer, Nicolas ; Fukunaga-Kalabis, Mizuho ; Portnoy, David C ; Lebbe, Celeste ; Tetzlaff, Michael T ; Bar-Sela, Gil ; Cohen, Jonathan ; Krepler, Clemens ; Webber, Andrea L ; Ren, Yixin ; Scolyer, Richard A ; Taube, Janis M

Neoadjuvant immunotherapies have shown antitumor activity in melanoma. Substudy 02C of the global, rolling-arm, phase 1/2, adaptive-design KEYMAKER-U02 trial is evaluating neoadjuvant pembrolizumab (anti-PD-1) alone or in combination, followed by adjuvant pembrolizumab, for stage IIIB-D melanoma. Here we report results from the first three arms: pembrolizumab plus vibostolimab (anti-TIGIT), pembrolizumab plus gebasaxturev (coxsackievirus A21) and pembrolizumab monotherapy. Pathologic complete responses occurred in 10 of 26 patients (38%) with pembrolizumab plus vibostolimab, 7 of 25 (28%) with pembrolizumab plus gebasaxturev and 6 of 15 (40%) with pembrolizumab monotherapy. Major pathologic responses occurred in 13 (50%), 10 (40%) and 7 (47%) patients, respectively. Safety was manageable. Treatment-related adverse events occurred in 24 of 26 patients (92%) with pembrolizumab plus vibostolimab, 21 of 25 (84%) with pembrolizumab plus gebasaxturev and 12 of 15 (80%) with pembrolizumab monotherapy; grade 3 or 4 treatment-related adverse events occurred in 2 (8%), 7 (28%) and 1 (7%) patient in each arm, respectively. No deaths due to adverse events occurred. Exploratory objective responses per RECIST v1.1 were observed in 13 (50%), 8 (32%) and 4 (27%) patients, in each arm, respectively. In a post hoc analysis, scores for tumor mutational burden and an 18-gene T cell-inflamed gene expression profile were generally higher in patients with major pathologic response. Longer follow-up will provide insight into the incremental benefit of combining neoadjuvant pembrolizumab with other therapies in stage IIIB-D melanoma. ClinicalTrials.gov registration: NCT04303169 .

2024-08-26·Future Oncology

The KEYVIBE program: vibostolimab and pembrolizumab for the treatment of advanced malignancies

Article

作者: Ahn, Myung-Ju ; Peters, Solange ; Shouse, Geoffrey ; Lugowska, Iwona ; Garassino, Marina C. ; Zhao, Bin ; Sands, Jacob ; Niu, Jiaxin ; Keenan, Tanya ; Perets, Ruth ; Healy, Jane ; Shapira-Frommer, Ronnie

Vibostolimab, a humanized IgG1 monoclonal antibody, blocks the interaction between TIGIT and its ligands, preventing the immunosuppressive effects of TIGIT. The addition of vibostolimab to the PD-1 inhibitor pembrolizumab has shown promising antitumor activity, warranting further exploration of vibostolimab as a potential therapeutic option. The KEYVIBE program consists of nine trials that will evaluate the safety and efficacy of vibostolimab monotherapy and vibostolimab-based combination therapy in advanced solid tumors and hematological malignancies. These studies will also evaluate coformulated immunotherapy addressing issues that occur with the sequential administration of immunotherapy. The KEYVIBE program will provide further insight into the clinical utility of vibostolimab-based therapy across multiple indications and various stages of disease.

2023-08-01·Cancer letters

TIGIT immune checkpoint blockade enhances immunity of human peripheral blood NK cells against castration-resistant prostate cancer

Article

作者: Xing, Nianzeng ; Wang, Jing ; Li, Jianxing ; Ma, Jianlin ; Wang, Fangming ; Liu, Fei ; Yang, Feiya ; Xu, Tianli ; Liang, Jing ; Liu, Shuai ; Liu, Donghua

Castration-resistant prostate cancer (CRPC) patients have a 14-month median survival, emphasizing the need for alternative treatments. Previously, we demonstrated that expanded high-dose natural killer (NK) cells derived from human peripheral blood exhibit therapeutic efficacy against CRPC. However, which immune checkpoint blockade promotes NK cell antitumor immunity against CRPC remains unknown. Here, we explored immune checkpoint molecule expression in NK and CRPC cells during their interactions, and identified that the T cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine-based inhibition motif domain (TIGIT) monoclonal antibody (mAb), vibostolimab, significantly enhanced NK cell cytotoxicity against CRPC cells and cytokine production in vitro, demonstrated by upregulation of degranulation marker CD107a and Fas-ligand (Fas-L) and increased interferon-gamma (IFN-γ) and tumor necrosis factor-alpha secretion. TIGIT blockade increased Fas-L expression and IFN-γ production via the NF-κB signaling pathway and restored degranulation via the mitogen-activated protein kinase ERK (extracellular signal-regulated kinase) kinase/ERK pathway in activated NK cells. Vibostolimab significantly enhanced NK cell antitumor effects against CRPC in two xenograft mouse models. Vibostolimab also increased T cell chemotaxis induced by activated NK cells in vitro and in vivo. Overall, blocking TIGIT/CD155 signaling enhances the antitumor effect of expanded NK cells against CRPC; this finding supports the translational application of TIGIT mAb and NK cell combination strategies from bench to bedside for CRPC treatment.

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项与维博利单抗相关的新闻（医药）

2025-05-26

·抗体圈

“黄金靶点”再添败绩，这个潜力方向或可期待？

在K药的带领下，PD-1成为抗肿瘤市场主流。同时，随着PD-1市场陷入红海竞争，药企正在急切寻找“下一个PD-1”。而与该靶点有诸多相似之处的TIGIT引起业界关注，曾一度成为巨头药企们争相布局的“黄金靶点”。TIGIT全称为T细胞免疫球蛋白和ITIM结构域蛋白，属于PVR（脊髓灰质炎病毒受体）样蛋白家族，是一种主要在T细胞和NK细胞表面表达的免疫检查点蛋白。TIGIT或通过与配体CD155结合，间接阻碍T细胞功能；或通过阻碍免疫细胞表面的共刺激受体CD266的激活，从而抑制免疫细胞活性。理论上，通过TIGIT抗体既能解除T细胞的抑制，又能解除NK细胞的抑制，达到加倍解除免疫抑制的功能。但是，就是这样被寄予厚望的“黄金靶点”，在现实中却并未如业界期望的那般顺利。近日， GSK宣布，将终止与iTeos Therapeutics 合作研发的TIGIT单抗EOS-448（belrestotug）项目。至此，TIGIT靶点的坟场再多一具英雄骨。那么，TIGIT靶点还有破局可能吗？ 01 超6亿美元打水漂，EOS-448高开低走2021年，GSK与 iTeos Therapeutics 达成协议，双方将共同开发和商业化后者的EOS-448，这是一种具有 Fc 活性的人类免疫球蛋白 G1 (IgG1)单克隆抗体，通过与TIGIT（ T 细胞免疫球蛋白和免疫受体酪氨酸抑制基序结构域）和FcγR（免疫反应的关键调节因子）结合的多方面免疫调节机制，来增强抗肿瘤反应。根据协议条款，iTeos Therapeutics将收到6.25亿美元的预付款，以及最高 14.5亿美元的开发和商业里程碑付款。GSK由此切入TIGIT赛道。在研发初期，EOS-448一直很顺利。2024年5月，在iTeos Therapeutics发布的用于一线治疗 PD-L1 高表达NSCLC的II期临床研究GALAXIES Lung-201中，EOS-448超出了预设疗效标准，并具有临床意义的肿瘤缩小。试验结果显示，所有剂量的EOS-448+dostarlimab组合疗法与dostarlimab（抗PD-1单抗）单药治疗相比，显著改善了患者的客观缓解率（ORR）。组合疗法组的确认ORR约为60%，而单药组的确认ORR为28.1%。基于此，公司CEO甚至公开宣称，“我们的TIGIT是最为与众不同的”。但是在最新的公告中，iTeos表示EOS-448的两项临床研究结果均没有达到继续开发的既定疗效标准。在一项关键II期临床研究中，评估了EOS-448与GSK的PD-1抑制剂Jemperli联合用于未经治疗、局部晚期或转移性PD-L1高表达NSCLC患者。虽然该联合疗法在主要终点ORR方面有所改善，但无进展生存期（PFS）的结果却未达到具有临床意义的水平。而在另外一项针对PD-L1阳性头颈鳞状细胞癌的II期临床试验中，通过对中期分析发现，EOS-448与Jemperli联用，与Jemperli单药治疗组相比，反应率趋势低于有意义的阈值。基于以上研究结果，GSK和iTeos决定终止EOS-448项目及其合作，至此，所有包含EOS-448的试验都将终止。GSK的6.25亿美元首付款打了水漂。 02 挫折频现，TIGIT迎来至暗时刻TIGIT作为继PD-1/PD-L1之后的新一代免疫检查点，其能够通过与CD155等配体结合，调控T细胞和NK细胞的活性。这种“双重免疫激活”的理论模型，让TIGIT迅速成为肿瘤免疫领域的焦点。一众MNC早已下场入局，但大部分吃了败仗。首先是TIGIT靶点发现者——罗氏，也是TIGIT赛道的领军者。其旗下Tiragolumab 是一款靶向TIGIT的单抗，2016年开始启动临床试验。当时行业预测TIGIT药物市场规模将在2030年突破50亿美元。然而后续的研究进展并不顺利，Tiragolumab 在广泛期小细胞肺癌（ES-SCLC）和NSCLC两大适应症上连续失利，成为全球首个TIGIT III期临床失败案例。在 24 年财报中，罗氏放弃了Tiragolumab 的多项临床研究： 2 项 III 期临床、2 项 II 期临床、1 项 I 期联合治疗临床试验。2025 年 Q1 财报中，Tiragolumab 联合PD-L1单抗Tecentriq（阿替利珠单抗）治疗局部晚期食管癌的 III 期研究也被移除。诺华曾在2021年以3亿美元首付款引进百济神州的抗TIGIT疗法Ociperlimab（欧司珀利单抗，BGB-A1217），作为肺癌潜在治疗方法。但是2023年7月，由于“风险收益比不理想”，便将权益退还给了百济神州。在与诺华终止合作后，百济神州曾独立推进该项目，但最终仍未能突破肺癌疗效瓶颈。今年4月，百济神州宣布，将不再继续投资Ociperlimab的研发。而截至2024年上半年，百济神州已在Ociperlimab项目累计投入20.9亿元。同样在2021年，BMS通过和Agenus公司合作，获得Agenus专有双特异性抗体项目AGEN1777 的全球独家许可。Agenus将获得2亿美元的预付款和高达13.6亿美元的开发、监管和商业里程碑等。AGEN1777 是一种潜在FIC双特异性抗 TIGIT 抗体，采用增强的 Fc 区进行设计，具有高结合亲和力并可提高 T 细胞和 NK 细胞活化能力。在临床前研究中，这种方法在单独使用抗PD-1或抗 TIGIT单特异性抗体无效的肿瘤模型中显示出巨大的潜力。但是在后续研发中，AGEN1777 并未达到预期。2024年，BMS终止与Agenus的合作，将AGEN1777“退货”。此外，2023年，默沙东宣布其PD-1+TIGIT 复方制剂MK-7684A二线治疗转移性NSCLC的II期KeyVibe-002研究未达预期。2024年5月，默沙东宣布暂停其TIGIT疗法——Vibostolimab和K药联合用于可手术高危黑色素瘤辅助治疗的III期临床研究KeyVibe-010，原因是免疫副作用导致的脱落率太高。2024年8月，默沙东再次终止了Vibostolimab联用K药用于一线治疗SCLC 的III期临床；2024年12月，默沙东正式宣告终止Vibostolimab的临床开发项目。至此，TIGIT作为曾经被寄予厚望的肿瘤免疫治疗靶点，如今已进入至暗时刻。不过，也可能是黎明前的黑暗。目前，仍有药企坚持在TIGIT赛道。 03 双抗会成为突围方向吗？尽管在TIGIT的坟场，尸骨累累，但仍有一些孤勇者在这条赛道上继续深耕。在TIGIT下半场，这些药企或将双抗、或将药物联用作为主要突破口。其中多家企业放弃TIGIT单抗，直接从PD-1/TIGIT双抗切入。进展最快的当属阿斯利康，其PD-1/TIGIT双抗Rilvegostomig目前正在开展联合贝伐珠单抗 ±Tremelimumab （抗CTLA-4单抗）一线治疗肝细胞癌（HCC）的 III 期研究。这是该药首次针对 HCC 启动的 III 期临床研究。在国内，阿斯利康还开展了在PD-L1 TPS ≥50%的一线NSCLC患者中头对头对比K药的III期研究ARTEMIDE-Lung04。礼来和信达合作，共同开发了PD-1/TIGIT双抗IBI321曾在2021年启动1期临床试验，暂无更多公开信息公布。国内泽璟生物则开发了PD-1/TIGIT双抗ZG005。2024年，泽璟生物公布了ZG005针对晚期实体瘤患者的I/II期研究结果：ZG005呈现出良好的耐受性和安全性。特别是在接受20 mg/kg剂量治疗的晚期宫颈癌患者中初步结果显示疗效更优，ORR达到63%。目前，ZG005还在开展针对肝癌、神经内分泌瘤、NSCLC等的I/II期研究。另外，罗氏虽然屡战屡败，但其管线中仍有TIGIT的位置。目前，tiragolumab联合Tecentriq用于一线治疗不可切除III期NSCLC，以及联合Tecentriq和贝伐珠单抗用于一线治疗HCC的临床研究，都在进行中。诚然，针对TIGIT的药物研发基本以失败告终，短短几年间，这一靶点便由资本热捧变为弃子，但业界并未完全放弃这一靶点，双抗是否是未来的突围方向，目前仍存在诸多疑问。但几乎任何一个靶点的药物研发都不是一帆风顺的，PD-1(L1)也不例外。何况，TIGIT直到2009年才被罗氏旗下基因泰克发现，仍是一个年轻的靶点，未来变数很大。参考：GSK, iTeos pull the plug on belrestotug as TIGIT stumbles again；firstworld.https://www.biospace.com/business/beigene-scraps-tigit-candidate-after-underwhelming-lung-cancer-data.Innovent Announces the First Patient Dosed in the Phase 1 Study of IBI321 (Anti-PD-1/TIGIT Bispecific Antibody) in Patients with Advanced Malignant Tumors. https://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c.识别微信二维码，添加抗体圈小编，符合条件者即可加入抗体圈微信群！请注明：姓名+研究方向！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。

引进/卖出临床2期免疫疗法

2025-05-19

·BioSpace

Deep Dive: Checkpoint Inhibitors at a Crossroads

A new generation of checkpoint inhibitors is emerging, with some showing more promise than others. From recent TIGIT failures to high-potential targets like VEGF, BioSpace explores what’s on the horizon in immuno-oncology. Eleven years after Merck’s Keytruda transformed the treatment space for several cancers, immuno-oncology—and checkpoint inhibitors (CPI) especially—are, optimistically speaking, at a crossroads. For those who see the glass as half empty, on the other hand, the space is frustratingly stalled. “The first wave of immuno-oncology has passed us by,” Jeremy Levin, CEO of Ovid Therapeutics, told BioSpace in March. As of April 2025, the FDA had approved 14 checkpoint inhibitors, but response rates to this type of immunotherapy have plateaued at around 30% , leaving 70% of patients out in the cold. Once highly touted checkpoints, such as TIGIT, have largely failed, while CTLA-4 hasn’t yielded nearly the number of therapies as PD-1/PD-L1. There is hope, however. Bristol Myers Squibb broke through in March 2022 with the FDA approval of relatlimab (marketed in combination with Opdivo as Opdualag ), the first LAG-3-blocking antibody, and today, much of the excitement centers on ivonescimab, a PD-1/VEGF bispecific antibody being developed by Summit Therapeutics. With the overall immuno-oncology market projected to reach some $284 billion by 2033 , these companies and more are actively vying for a piece of the pie. DATA SOURCE: MERCK EARNINGS , BIOPHARMA DIVE TIGIT Trouble Companies targeting TIGIT have been riding a rollercoaster the past five years. Roche spurred excitement for this novel checkpoint in December 2021 with promising Phase II results from its anti-TIGIT tiragolumab in combination with its anti-PD-L1 Tecentriq in metastatic non-small cell lung cancer (NSCLC). It was not to last, however, as last year the combo failed to significantly improve progression-free and overall survival versus Keytruda and chemotherapy in NSCLC in a Phase II/III study. This followed similarly disappointing news from Merck, whose anti-TIGIT antibody vibostolimab, when paired with Keytruda, also failed in a Phase II NSCLC trial. The field was somewhat revived last September when iTeos Therapeutics’ anti-TIGIT belrestotug, in combination with GSK’s anti-PD-1 therapy Jemperli, bested Jemperli monotherapy in terms of confirmed objective response rate by 30% in NSCLC. Other players in this space include BeiGene, AstraZeneca, Gilead and Arcus Biosciences. VEGF in the Spotlight Many industry observers extol the value of combination therapies in immuno-oncology. One such combo generating particular attention is a PD-1/VEGF bispecific antibody being developed by Summit Therapeutics. Last September, Summit set the cancer space ablaze when it announced that ivonescimab beat Keytruda in a Phase III trial in advanced NSCLC. Ivonescimab “is really the new . . . wave of checkpoint inhibitors,” Christiana “Chris” Bardon, co-managing partner of MPM BioImpact, told BioSpace in March. Analysts cautioned, however, that the “results may or may not be generalizable beyond the China-focused patient population,” where the trial was conducted. Summit is currently running another Phase III trial in NSCLC in the U.S., with an expected primary completion date of April 2028, according to ClinicalTrials.gov . BioNTech is also a contender in this space, gaining full rights to PD-L1/VEGF-A bispecific antibody BNT327/PM8002 in the November 2024 acquisition of partner Biotheus. How will AI further the development of novel checkpoint inhibitors? Editor’s note: This article was originally published as a special edition of ClinicaSpace, BioSpace’ s weekly newsletter covering clinical trial results and research news, on April 21. You can subscribe here .

免疫疗法临床2期临床3期上市批准并购

2025-05-14

·Pharmaceutical Technology

GSK and iTeos drop anti-TIGIT drug following trial failure

GSK and iTeos have said they are stopping all development programmes for their anti-TIGIT antibody belrestotug. Image credit: Shutterstock / FON’s Fasai. GSK and iTeos are the latest companies to scrap a jointly developed anti-TIGIT drug after it failed to demonstrate a meaningful benefit in two Phase II trials. Belrestotug, a human IgG1 antibody created to bind with high-affinity T cell immunoglobulin and ITIM domains (TIGIT), was being developed as part of a partnership harnessed between the companies in June 2021 . The companies announced on 13 May that they were slashing the programme after receiving new interim analyses from the Phase II GALAXIES Lung-201 (NCT05565378) and GALAXIES H&N-202 (NCT06062420) studies, which did not meet their efficacy endpoints. Both trials were investigating the drug in combination with the PD-1 monoclonal antibody Jemperli (dostarlimab). However, the GALAXIES Lung-201 study was in patients with previously untreated, advanced/metastatic non-small-cell lung cancer (NSCLC). Meanwhile, the GALAXIES H&N-202 trial was in patients with PD-L1 positive recurrent/metastatic squamous cell carcinoma of the head and neck. iTeos reported that while the GALAXIES Lung-201 trial demonstrated clinically meaningful improvements in the primary endpoint of objective response rate (ORR), however, the analysis did not meet established criteria for clinically meaningful improvements in the secondary endpoint of progression-free survival (PFS). Analysis from the GALAXIES H&N-202 trial showed a trend below the meaningful threshold for ORR in the combination cohort. In a company statement, GSK says that due to the failures, the collaboration and all belrestotug study cohorts are ending. iTeos clarified that this includes enrolment in the ongoing GALAXIES Lung-301 Phase III trial. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence iTeos’ president and chief executive officer Dr Michel Detheux said: “We are truly disappointed by the results from GALAXIES Lung-201. Following the analysis of the TIGIT data generated to date with GSK, we have made the mutual decision to discontinue the development of all ongoing TIGIT studies.” GSK joins pharma giants dropping anti-TIGIT drugs The news may come as a shock to the oncology field, as GSK and iTeos provided the first data for the GALAXIES Lung-201 study at the European Society for Medical Oncology (ESMO) Congress 2024 last September. The data seemed to show a positive trend with an ORR of between 63.3% and 76.7% versus 37.5% for Jemperli as a monotherapy. The mechanism has proven challenging, with GSK and iTeos becoming the latest companies to terminate an anti-TIGIT asset. Last month, BeiGene announced it was terminating development of ociperlimab , which it had been manufacturing as a treatment for lung cancer. In December 2024, MSD scrapped the development of its anti-TIGIT antibody vibostolimab after the Phase III KeyVibe-003 and KeyVibe-007 trials met the pre-specified futility criteria for the primary endpoint of overall survival (OS) in patients with NSCLC. The company stopped the KeyVibe-008 trial last year . In November 2024, Roche reported a failure with its candidate tiragolumab , which was being trialled in the Phase III Skyscraper-01 study. This came after earlier setbacks in the SKYSCRAPER-02 (NCT04256421) study and the Phase II/III SKYSCRAPER-06 (NCT04619797) trial. Some anti-TIGIT programmes are still steaming ahead, including one by Gilead and Arcus Biosciences; who are investigating domvanalimab , and another by AstraZeneca with its PD-1/TIGIT bispecific antibody rilvegostomig .

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适应症	最高研发状态	国家/地区	公司	日期
非小细胞肺癌	临床3期	美国	Merck Sharp & Dohme Corp.	2021-04-07
非小细胞肺癌	临床3期	中国	Merck Sharp & Dohme Corp.	2021-04-07
非小细胞肺癌	临床3期	智利	Merck Sharp & Dohme Corp.	2021-04-07
非小细胞肺癌	临床3期	危地马拉	Merck Sharp & Dohme Corp.	2021-04-07
非小细胞肺癌	临床3期	俄罗斯	Merck Sharp & Dohme Corp.	2021-04-07
非小细胞肺癌	临床3期	韩国	Merck Sharp & Dohme Corp.	2021-04-07
非小细胞肺癌	临床3期	土耳其	Merck Sharp & Dohme Corp.	2021-04-07
非小细胞肺癌	临床3期	乌克兰	Merck Sharp & Dohme Corp.	2021-04-07
Turcot综合征	临床2期	美国	Merck Sharp & Dohme LLC	2025-01-15
Turcot综合征	临床2期	中国台湾	Merck Sharp & Dohme LLC	2025-01-15

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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


NCT04303169 (KEYMAKER-U02, ESMO2024) 人工标引	临床1/2期	黑色素瘤	117	Pembrolizumab + Vibostolimab	鹽膚鹽襯鏇夢繭窪構繭(蓋膚鹽夢遞範夢觸簾壓) = 窪餘遞艱壓鑰淵膚鑰構憲繭鑰製壓觸醖獵獵鹽 (窪遞餘繭襯鬱鹽願憲蓋 ) 更多	积极	2024-09-14
				Pembrolizumab + Gebasaxturev	鹽膚鹽襯鏇夢繭窪構繭(蓋膚鹽夢遞範夢觸簾壓) = 糧餘窪餘顧蓋壓鹽網醖憲繭鑰製壓觸醖獵獵鹽 (窪遞餘繭襯鬱鹽願憲蓋 ) 更多
TIGIT (NEWS) 人工标引	临床2期	转移性非小细胞肺癌	-	vibostolimab+Keytruda	膚鹽繭選膚糧鏇窪積網(願襯齋壓觸願鬱選構鏇) = 鏇獵糧積範鹹蓋鹽醖鹽夢鑰艱鹽網壓築簾獵膚 (憲淵夢構壓淵鹹顧糧鹽 ) 更多	不佳	2023-12-07
				docetaxel	膚鹽繭選膚糧鏇窪積網(願襯齋壓觸願鬱選構鏇) = 憲繭膚淵製範網網壓鑰夢鑰艱鹽網壓築簾獵膚 (憲淵夢構壓淵鹹顧糧鹽 ) 更多
NCT04303169 (KEYMAKER-U02 substudy 02C \| 3475-02C \| KEYMAKER-U02 \| MK-3475-02C, AACR2023) 人工标引	临床1/2期	黑色素瘤新辅助	66	pembrolizumab+vibostolimab (arm 1)	顧製觸製簾選壓艱蓋膚(艱構遞艱鬱壓醖觸選獵) = 糧願鬱壓廠鑰艱齋顧艱壓築願範艱獵糧衊網醖 (鹹廠壓鑰獵衊鏇蓋遞鬱 ) 更多	积极	2023-04-14
				pembrolizumab+gebasaxturev (arm 2)	顧製觸製簾選壓艱蓋膚(艱構遞艱鬱壓醖觸選獵) = 鬱觸齋網製選窪鹹觸網壓築願範艱獵糧衊網醖 (鹹廠壓鑰獵衊鏇蓋遞鬱 ) 更多
NCT02964013 (KEYVIBE-001, ESMO_GI2022)	临床1期	晚期胃癌 PD-L1-positive	27	Vibostolimab 200mg + Pembrolizumab 200mg	鹽範遞憲糧夢衊壓鏇構(鏇鑰網艱繭積蓋觸齋壓) = 鏇願網窪蓋艱願觸繭鏇壓簾獵鏇製蓋壓獵艱餘 (獵醖積顧蓋糧獵淵齋構 ) 更多	积极	2022-07-02
NCT02964013 (MK-7684-001, AACR2022) 人工标引	临床1期	宫颈癌三线	80	vibostolimab 200 mg+pembrolizumab	製襯齋廠壓夢夢鹹鬱壓(築願壓醖齋艱觸蓋範範) = 襯鬱淵淵衊選鏇鑰淵壓壓願糧淵願窪廠淵窪鹽 (憲積襯繭網鑰願餘糧淵 ) 更多	积极	2022-06-15
				vibostolimab 700 mg+pembrolizumab	製襯齋廠壓夢夢鹹鬱壓(築願壓醖齋艱觸蓋範範) = 衊觸簾獵廠繭鏇鹹憲鹹壓願糧淵願窪廠淵窪鹽 (憲積襯繭網鑰願餘糧淵 ) 更多
NCT02964013 (MK-7684-001 \| KEYVIBE-001 \| 7684-001, AACR2022) 人工标引	临床1期	卵巢癌二线 PD-L1 Expression	61	vibostolimab+pembrolizumab	-	积极	2022-06-15
				vibostolimab/pembrolizumab
NCT02964013 (MK-7684-001 \| KEYVIBE-001 \| 7684-001, ESMO2020) 人工标引	临床1期	非小细胞肺癌	79	Vibostolimab	觸窪廠鹹餘繭齋鬱鏇遞(願鹹餘繭壓憲淵壓壓選) = 齋醖鹽網鹹鑰艱鹽顧艱蓋鏇製襯願築餘積鏇築 (餘獵積顧簾顧夢築鏇壓 ) 更多	积极	2020-09-17
				Vibostolimab+pembrolizumab	觸窪廠鹹餘繭齋鬱鏇遞(願鹹餘繭壓憲淵壓壓選) = 觸衊糧齋積構蓋製壓衊蓋鏇製襯願築餘積鏇築 (餘獵積顧簾顧夢築鏇壓 ) 更多
NCT02964013 (MK-7684-001 \| KEYVIBE-001 \| 7684-001, ESMO2020) 人工标引	临床1期	非小细胞肺癌	41	Pembrolizumab+vibostolimab	觸壓鏇鑰鏇築網築顧獵(醖襯衊簾憲鬱願糧遞築) = 壓醖獵餘簾鏇鬱襯窪願齋襯艱廠遞製憲餘願壓 (壓醖餘觸鑰積鬱觸構獵 ) 更多	积极	2020-09-17