多塔利单抗(Dostarlimab-gxly) - 药物靶点：PD-1_在研适应症：晚期子宫内膜癌，复发性子宫内膜癌，MMRD实体瘤_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

Dostarlimab、Immunoglobulin G4, anti-programmed cell death protein 1 (PDCD1) (humanized clone ABT1 gamma4-chain), disulfide with humanized clone ABT1 kappa-chain, dimer、多斯塔利单抗

+ [10]

靶点

PD-1

作用机制

PD-1抑制剂(细胞程序性死亡-1抑制剂)

治疗领域

肿瘤泌尿生殖系统疾病神经系统疾病+ [6]

在研适应症

晚期子宫内膜癌复发性子宫内膜癌MMRD实体瘤+ [68]

非在研适应症

晚期胆道癌胆管癌透明细胞肉瘤+ [6]

原研机构

AnaptysBio, Inc.

在研机构

GSK PlcGlaxoSmithKline LLC

Tesaro, Inc.

+ [8]

非在研机构-

最高研发阶段批准上市

首次获批日期

欧盟 (2021-04-21),

MSI-H 子宫内膜癌错配修复缺陷子宫内膜癌

最高研发阶段(中国)临床3期

特殊审评优先审评 (美国)、突破性疗法 (美国)、快速通道 (美国)、加速批准 (美国)、优先审评 (澳大利亚)

登录后查看时间轴

结构/序列

Sequence Code 315609369H

来源: *****

Sequence Code 315609370L

来源: *****

关联

97

项与多塔利单抗相关的临床试验

NCT06762405

/ Not yet recruiting临床3期IIT

PRODIGE 90 - (FFCD 2204) - PREDIR-NEOREC Neoadjuvant Dostarlimab with Short Course Radiotherapy in a Watch-and-wait Strategy for Microsatellite Unstable or Mismatch Repair-deficient Locally Advanced Rectal Cancer Patients: a Randomized Phase II Trial Phase II Randomized Study Non-comparative - Multicenter

Total neoadjuvant treatment (TNT) including radiotherapy and induction or consolidation systemic chemotherapy has become the standard treatment for patients with stage II and III rectal adenocarcinoma. Along with the improvement of DFS, this preoperative treatment has paved the way to a paradigm-shifting nonoperative management. Indeed, rectal preservation has become a new goal for patients without detectable residual cancer after TNT with the option to reserve surgery for those with cancer regrowth (25-40%). Five to 10% of non-metastatic rectal cancer patients are molecularly characterized as microsatellite unstable (MSI) or mismatch repair-deficient (dMMR), and present a decreased response to systemic chemotherapy. As this tumor phenotype is associated with high immunogenicity, immunotherapy with anti-PD1 molecules has recently emerged as the new standard first line treatment in the metastatic setting, with long duration of cancer control for at least 40% of patients. In patients with localized rectal tumors, it has been suggested that immunotherapy alone may induce complete clinical response and may allow these patients to be considered for nonoperative therapeutic approaches.
Finally, given the efficacy of immunotherapy in MSI rectal patients, we did not want to differ for 5 weeks this treatment with the risk of disease progression by given long-course RT. In the present trial, radiotherapy is evaluated as a " potentiating " treatment for immunotherapy rather than as a " local treatment " in a TNT strategy.

开始日期2025-05-01

申办/合作机构

Centre Hospitalier Universitaire de Dijon

NCT06365970

/ Withdrawn临床2期IIT

Phase II Study of Niraparib and Dostarlimab for Patients with MMR-D/MSI-H Colorectal Cancers: a Proof of Concept Study

The second line of therapy for patients with MSI-H CRC who experience disease progression on anti-PD1 based therapies is not well defined and there is an unmet need for research for patients with anti-PD1 refractory MSI-H CRC. This study will examine the combination of niraparib and dostarlimab for a synergistic antitumor effect for patients with MSI-H CRC.

开始日期2025-01-31

申办/合作机构

University of Pittsburgh

[+1]

NCT06757244

/ Not yet recruiting临床2期IIT

DOVIPA, a Phase II Study Evaluating Efficacy and Safety of DOstarlimab and Oral VItamin D3 with Folinic Acid, 5FU, Irinotecan Plus Oxalipaltin (mFOLFIRINOX) in Non Pretreated Metastatic PAncreatic Cancer

The goal of this clinical trial is to estimate the antitumor response of mFOLFIRINOX + Dostarlimab + oral HD vitamin D3 in patients with non-pretreated histologically confirmed metastatic Stage IV adenocarcinoma of the pancreas. The patients must have an Eastern Cooperative Oncology Group (ECOG)-Performance Status (PS) 0 or 1 and adequate organ functions.
The main objective of the study will be assessed by estimating Objective response rate (ORR) according to Response Evaluation Criteria version 1.1 (RECIST 1.1) in patients with pancreatic adenocarcinoma and measurable disease.
The Secondary objectives are :
* To assess the safety and tolerability of mFOLFIRINOX + Dostarlimab + HD Vitamin D according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 by evaluating the Median Progression Free Survival (mPFS) in months, the Median Overall Survival (mOS) in months, the Median Duration of Response (mDOR) in months and Clinical benefit rate according to RECIST 1.1 (CBR)
* To further evaluate the antitumor efficacy of mFOLFIRINOX + Dostarlimab + oral HD Vitamin D by evaluating the type, frequency, and severity of treatment-emergent adverse events (TEAEs); adverse events of special interest (AESIs); safety laboratory findings There are also exploratory objectives to better understand the pancreatic adenocarcinoma.
Participants will be cared for in the digestive oncology department. A selection review will be carried out to check compliance with the study eligibility criteria. Patients included in the study will be treated with 4 cycles of induction therapy. Each cycle lasts 6weeks and includes chemotherapy such as mFolfirinox D1,D15 and D29, combined with dostarlimab 500 mg every 3 weeks and daily oral vitamin D3.
At the end of the induction treatment period, maintenance treatment will be instituted with LV5FU chemotherapy combined with dostarlimab 1000 mg every 6 weeks and daily oral vitamine D3. Treatment will be maintained until progression or unacceptable toxicity.
Throughout this period, patients will be monitored for their safety. Imaging examinations will also be carried out to monitor the progression of tumour disease.

开始日期2025-01-15

申办/合作机构

Hopital Foch

[+1]

100 项与多塔利单抗相关的临床结果

登录后查看更多信息

100 项与多塔利单抗相关的转化医学

登录后查看更多信息

100 项与多塔利单抗相关的专利（医药）

登录后查看更多信息

156

项与多塔利单抗相关的文献（医药）

2025-02-01·CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY

Cardiotoxicity associated with immune checkpoint inhibitors: Systematic review and meta-analysis

Review

作者: Carollo, Anna ; Provenzani, Alessio ; Cutaia, Sofia ; Novara, Maria Eugenia ; Piazza, Lavinia ; Rizzo, Sergio ; Di Martino, Enrica

BACKGROUND AND AIMS:

The aim of this systematic review was to assess the risk of cardiac toxicity in patients undergoing approved PD-1 (nivolumab, pembrolizumab, cemiplimab, dostarlimab), PD-L1 (atezolizumab, avelumab, durvalumab), and CTLA-4 (ipilimumab) inhibitors.

RESULTS:

Among a total of 2272 articles, 11 phase II and III clinical trials included: 5463 patients and 175 cardiac adverse events. The most common cardiac disorder was atrial fibrillation (12 %), while cardiac arrest and cardiac failure (6 %) led to death in three cases. Overall, ICI treatment increased the risk of cardiotoxicity compared with control groups (RR=1.62, 95 %-CI= 1.18-2.24, p-value=0.0033; OR=1.71, 95 %-CI= 1.20-2.42, p-value=0.0027).

CONCLUSIONS:

This study proved that the recognition of frequency and severity of all grade cardiotoxicity associated with ICIs is still underestimated. Thus, a systematic cardiological screening becomes necessary, in order to intercept the potential cardiological complications beforehand and optimize the outcomes of the respective treatment with PD-1, PD-L1 and CTLA-4 inhibitors.

2025-02-01·International Journal of Clinical Oncology

Treatment strategies for advanced and recurrent endometrial cancer using immune checkpoint inhibitors

Review

作者: Tatsuki, Shunsuke ; Chiba, Yohei ; Kaido, Yoshitaka ; Sato, Sho ; Kagabu, Masahiro ; Shoji, Tadahiro ; Nagasawa, Takayuki ; Otsuka, Haruka ; Abe, Marina ; Takatori, Eriko ; Baba, Tsukasa ; Jo, Ami

Doxorubicin + cisplatin and paclitaxel + carboplatin are standard chemotherapy regimens for endometrial cancer. The development of PD-1 and PDL-1 antibody drugs has led to the use of these agents for endometrial cancer in other countries. The KEYNOTE-775 trial for advanced or recurrent endometrial cancer demonstrated the benefits of pembrolizumab and lenvatinib combination therapy, and the results of this trial led to the approval of its coverage for recurrent cancer by the Japanese health insurance system. Currently, treatment with immune checkpoint inhibitors is transitioning from second-line to first-line therapy. In a global randomized phase III study, the drugs dostarlimab, durvalumab, and atezolizumab, which are not yet approved in Japan, showed better results in the study arms than in the control arm. Additionally, biomarkers have been developed for endometrial cancer, enabling gynecologists to pursue treatment options based on the biomarkers detected for better treatment outcomes. In this article, we review the clinical trials of immune checkpoint inhibitors for advanced or recurrent endometrial cancer.

2025-01-01·Med

If it is a solid tumor target, then it may be a hematologic cancer target: Bridging the great divide

Review

作者: Adashek, Jacob J ; Munoz, Javier L ; Kurzrock, Razelle

Tumor-agnostic US Food and Drug Administration approvals are transforming oncology. They include larotrectinib/entrectinib/repotrectinib (NTRK fusions), selpercatinib (RET fusions), dabrafenib/trametinib (BRAF^V600E mutations), pembrolizumab/dostarlimab (microsatellite instability), pembrolizumab (high tumor mutational burden), and trastuzumab deruxtecan (HER2 3+ expression) (all solid cancers). Pemigatinib is approved for FGFR1-rearranged myeloid/lymphoid neoplasms. The genomically driven tissue-agnostic approach has a strong biological rationale (cancer is a disease of the genome), yields remarkably high response rates, and provides drug access to patients with an unmet need (rare/ultra-rare malignancies). Despite the solid tumor focus, both solid and hematologic cancers can harbor identical driver molecular abnormalities and respond to cognate therapies. For example, BRAF^V600E and IDH1/2 mutations; ALK, FGFR, and NTRK fusions; PD-L1 amplification; and CD70 antigens are druggable in both solid and blood malignancies by gene-/immune-targeted therapies/chimeric antigen receptor T cells. Future biomarker-based tissue-agnostic basket studies/approvals should bridge the great divide and include both solid and hematologic cancers.

391

项与多塔利单抗相关的新闻（医药）

2025-02-12

·ioncology

国际视角丨新兴生物标志物指导联合治疗，改进肺癌免疫治疗策略

点击蓝字关注我们国际视角微专辑扫描二维码可查看更多内容免疫肿瘤学（IO）彻底改变了非小细胞肺癌（NSCLC）的治疗，在各个疾病分期的患者都实现持久缓解和生存获益。免疫检查点抑制剂（ICI）的研发成功，包括PD-(L)1和CTLA-4抑制剂，为开发双重免疫检查点阻断（ICB）疗法以增强抗肿瘤免疫铺平了道路。虽然KEYNOTE-024和KEYNOTE-189等试验证明ICI单药或ICI+化疗可为晚期NSCLC患者带来显著获益，但也凸显克服耐药、提高5年总生存（OS）是未来需要解决的问题。本文作者 Marina Chiara Garassino, MD 芝加哥大学血液学和肿瘤科 Sulin Wu, MD, PhD 芝加哥大学血液学和肿瘤科 Faith Abodunrin, MD 芝加哥大学血液学和肿瘤科近期，研究人员发现了一些有前景的生物标志物，如LAG-3（淋巴细胞活化基因3）和TIGIT（具有Ig和ITIM结构域的T细胞免疫受体）。LAG-3通常与PD-L1共同表达，通过主要组织相容性复合体（MHC）II类相互作用抑制T细胞活性。相反，TIGIT在T细胞和自然杀伤细胞的表达上调，导致免疫逃避并与不良预后相关。这些生物标志物有可能改善IO治疗的患者选择问题并提高IO治疗的疗效；然而，需要进一步的证据来验证它们的临床效用。的疗效：RELATIVITY-104试验带来的启示 RELATIVITY-104试验（NCT04623775）是将LAG-3阻断抗体relatlimab（瑞拉利单抗）添加到PD-1抑制剂纳武利尤单抗和铂类双药化疗（PDCT）中作为IV期或复发性NSCLC一线治疗的第一项随机II期研究。基于RELATIVITY-047在黑色素瘤中取得成功，RELATIVITY-104试验探索了LAG-3抑制在其他肿瘤治疗中的潜力。[1]然而，试验结果需要仔细解读，尤其是疗效和亚组获益。[2,3] RELATIVITY-104研究招募了309名患者，以1:1的比例给予纳武利尤单抗+relatlimab+含铂双药化疗vs纳武利尤单抗+含铂双药化疗。主要研究终点是BICR评估的客观缓解率（ORR）。次要终点包括无进展生存期（PFS）、基于PD-L1表达分层分析的PFS和ORR等。含relatlimab方案的安全性符合预期；与对照组相比没有显著增加不良事件。RELATIVITY-104研究结果解读的挑战来自几个方面。主要终点分析显示，relatlimab组的缓解率为51.3%，而对照组为近43.7%；中位PFS分别为6.7个月和6个月（风险比[HR]=0.88；90%置信区间[CI]：0.71–1.1）。这些结果表明联合relatlimab不会使所有患者获益。亚组分析显示，基于PD-L1分析PFS和ORR，大部分获益发生在PD-L1阳性患者中。鳞状NSCLC和非鳞状NSCLC患者的PFS交互检验结果为0.023。此外，12个月时Kaplan-Meier曲线的交叉引发了人们对获益持久性的担忧。 RELATIVITY-104的探索性分析旨在确定可能从添加relatlimab中优先获益的人群。确定了两个具有潜在获益的亚组：PD-L1表达＞1%且组织学类型为非鳞状NSCLC患者；PD-L1表达在1%~49%之间且组织学类型为非鳞状NSCLC的患者。虽然这些发现很有希望，但结果受到样本量小和探索性性质的限制，因此只能产生假设，而不能确定。正在进行的III期试验对于确定relatlimab作为双重ICI疗法的一部分的疗效至关重要。Relatlimab可能通过恢复或保留效应T细胞的功能来增强抗肿瘤反应。如果得到验证，relatlimab、纳武利尤单抗和铂类双药化疗的组合可以成为晚期NSCLC的有效一线治疗。在此之前，需要明确relatlimab在推动NSCLC免疫治疗效果中的作用。 TIGIT抑制在NSCLC治疗中的新角色：GALAXIES Lung-201试验的启示尽管晚期NSCLC的免疫治疗取得了进展，但PD-L1高表达患者能否仅用免疫治疗获得持久缓解仍然难以确定。抗TIGIT疗法（例如belrestotug、tiragolumab和其他在研药物）有望成为ICI治疗的补充。 GALAXIES Lung-201试验是一项大型随机、剂量范围II期研究，评估了belrestotug（抗TIGIT贝瑞苏塔单抗）+dostarlimab（抗PD-1多塔利单抗）对肿瘤PD-L1表达≥50%、未经治疗晚期NSCLC患者的作用。中期分析显示，与dostarlimab单药治疗相比，belrestotug联合dostarlimab（三种剂量）方案的ORR均显著改善。[4]试验确定400 mg belrestotug为最佳剂量；在PD-L1高表达患者中经确认的ORR为59.4%，同时肿瘤负荷显著减少，并且循环肿瘤DNA（ctDNA）呈剂量依赖性下降。安全性分析显示毒性可控，免疫介导的不良事件主要影响皮肤和皮下组织。 PERLA试验头对头对比了dostarlimab+化疗vs帕博利珠单抗+化疗。结果显示dostarlimab与帕博利珠单抗相比并不逊色，进一步证明了dostarlimab是一种有竞争力的PD-1抑制剂，与TIGIT疗法联合使用有研发潜力。[5] 同样，CITYSCAPE试验评估了tiragolumab（抗TIGIT）与阿替利珠单抗（抗PD-L1）的联合治疗，报告称在PD-L1表达≥50%的患者中ORR为66%，而单独使用阿替利珠单抗的ORR为24%。[6] 虽然CITYSCAPE试验凸显TIGIT抑制在改善PFS方面有临床获益，但GALAXIES强调了剂量优化和ctDNA作为生物协同标志物的作用。来自III期SKYSCRAPER等试验即将获得的数据对于确定TIGIT疗法在反应率和OS方面的作用至关重要。[7]这些发现将指导生物标志物驱动的治疗策略，以优化患者选择并量身定制治疗方案。此外，随着最安全、最有效的基于TIGIT的疗法被确定，开发靶向PD-(L)1和TGIT的双特异性抗体可能为双重免疫检查点阻断提供一种变革性方法。PD-(L)1/TGIT双特异性抗体有可能克服当前疗法的局限性并改善NSCLC患者的临床结果。未来方向和研究重点 GALAXIES Lung-201和RELATIVITY-104试验通过加用TIGIT抑制剂或LAG-3抑制剂，采用双免疫检查点抑制推动NSCLC治疗进展。这些方案超越了传统的PD-1/PD-L1抑制剂治疗，为晚期NSCLC患者带来了新的希望。虽然双免疫检查点抑制的早期研究结果令人鼓舞，但在了解组织学类型、生物标志物表达和T细胞动力学之间的相互作用以改进治疗策略方面仍存在一些挑战。未来至关重要的研究内容是优化以生物标志物为主导的患者选择、改善安全管理以及提高双免疫检查点抑制的成本效益；若这些治疗方案最终取得成功，其临床应用也应谨慎细致，以提高可及性和临床效果。参考文献（上下滑动可查看） 1.Tawbi HA, Schadendorf D, Lipson EJ, Ascierto PA, Matamala L, Castillo Gutiérrez E, Rutkowski P, Gogas HJ, Lao CD, De Menezes JJ, Dalle S, Arance A, Grob JJ, Srivastava S, Abaskharoun M, Hamilton M, Keidel S, Simonsen KL, Sobiesk AM, Li B, Hodi FS, Long GV; RELATIVITY-047 Investigators. Relatlimab and Nivolumab versus Nivolumab in Untreated Advanced Melanoma. N Engl J Med. 2022 Jan 6;386(1):24-34. doi: 10.1056/NEJMoa2109970. PMID: 34986285; PMCID: PMC9844513. 2.D. Morgensztern, A. Chaudhry, N. Iannotti, A. Acevedo, G. Balaburski, A. Balogh, S. Peters. 1359TiP RELATIVITY-104: First-line relatlimab (RELA) + nivolumab (NIVO) with chemotherapy vs nivo with chemotherapy in stage IV or recurrent non-small cell lung cancer (NSCLC): A phase II, randomized, double-blind study, Annals of Oncology, Vol 32, Supplement 5, 2021, Page S1030, ISSN 0923-7534, https://doi-org.libproxy1.nus.edu.sg/10.1016/j.annonc.2021.08.1960. 3.Girard N, Burotto M, Paz-Ares LG. Nivolumab (NIVO) plus relatlimab with platinum-doublet chemotherapy (PDCT) vs NIVO + PDCT as first-line (1L) treatment (tx) for stage IV or recurrent NSCLC: Results from the randomized phase II RELATIVITY-104 study. Presented at: 2024 ESMO Congress; September 13-17, 2024; Barcelona, Spain. Abstract LBA53. 4.Spigel DR, Korbenfeld E, Hayashi H, et al. Interim analysis of GALAXIES Lung-201: phase 2, randomized, open-label platform study of belrestotug plus dostarlimab in patients with previously untreated locally advanced/metastatic PD-L1 high (TPS ≥50%) non-small cell lung cancer. Presented at: 2024 ESMO Congress; September 13-17, 2024; Barcelona, Spain. Presentation LBA52. 5.Lim SM, Peters S, Ortega Granados AL, Pinto GDJ, Fuentes CS, Lo Russo G, Schenker M, Ahn JS, Reck M, Szijgyarto Z, Huseinovic N, Zografos E, Buss E, Stjepanovic N, O’Donnell S, de Marinis F. Dostarlimab or pembrolizumab plus chemotherapy in previously untreated metastatic non-squamous non-small cell lung cancer: the randomized PERLA phase II trial. Nat Commun. 2023 Nov 11;14(1):7301. doi: 10.1038/s41467-023-42900-4. PMID: 37951954; PMCID: PMC10640551. 6.Cho BC, Abreu DR, Hussein M, Cobo M, Patel AJ, Secen N, Lee KH, Massuti B, Hiret S, Yang JCH, Barlesi F, Lee DH, Ares LP, Hsieh RW, Patil NS, Twomey P, Yang X, Meng R, Johnson ML. Tiragolumab plus atezolizumab versus placebo plus atezolizumab as a first-line treatment for PD-L1-selected non-small-cell lung cancer (CITYSCAPE): primary and follow-up analyses of a randomised, double-blind, phase 2 study. Lancet Oncol. 2022 Jun;23(6):781-792. doi: 10.1016/S1470-2045(22)00226-1. Epub 2022 May 13. PMID: 35576957. 7.Dziadziuszko, R. et al. 1190TiP SKYSCRAPER-03: Phase III, open-label randomised study of atezolizumab + tiragolumab vs durvalumab in patients with locally advanced, unresectable, stage III non-small cell lung cancer (NSCLC) who have not progressed after platinum-based concurrent chemoradiation (cCRT). Annals of Oncology, Volume 32, S947 – S948 （来源：《肿瘤瞭望》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

临床结果免疫疗法临床3期临床2期

2025-02-12

·ioncology

SKYSCRAPER-06研究：Tiragolumab联合阿替利珠单抗未能改善晚期非鳞状NSCLC患者的OS

点击蓝字关注我们根据2024年ESMO免疫肿瘤学大会（摘要号LBA2）上公布的SKYSCRAPER-06研究结果，Tiragolumab（一种阻断TIGIT与其配体结合的单克隆抗体）联合PD-1抑制剂阿替利珠单抗和化疗的一线组合未能改善局部晚期不可切除或转移性非鳞状非小细胞肺癌（NSCLC）患者的无进展生存期（PFS）和总生存期（OS）。对于肿瘤不具有EGFR或ALK变异的晚期NSCLC患者，无论PD-L1表达情况如何，帕博利珠单抗联合化疗都是一线治疗的标准方案。TIGIT（含免疫球蛋白和免疫受体酪氨酸抑制基序结构域的T细胞免疫受体）在调节T细胞和NK细胞免疫突触的免疫反应中起着重要作用，是免疫肿瘤学中一个有前景的新靶点。 SKYSCRAPER-06是一项全球性II/III期随机双盲安慰剂对照试验，纳入542名未接受过治疗的局部晚期不可切除/转移性非鳞状NSCLC患者。各组基线特征相似，但在Tiragolumab+阿替利珠单抗+化疗组中，男性患者更多（68% vs 62%），PD-L1肿瘤比例评分（TPS）<1%的患者更少（34% vs 42%），且基线肝转移患者更多（14% vs 9%）。SKYSCRAPER-06研究组方案为Tiragolumab 600mg联合阿替利珠单抗1200mg联合卡铂/顺铂+培美曲塞，对照组为安慰剂联合帕博利珠单抗200mg联合卡铂/顺铂+培美曲塞，每三周进行一次，共四个周期，随后进行维持治疗，直至病情进展、临床获益丧失、毒性不可接受或撤回知情同意。在数据截止时，Tiragolumab+阿替利珠单抗+化疗组的疗效低于标准疗法，中位PFS分别为8.3个月vs 9.9个月（风险比[HR]=1.27；95%置信区间[CI]: 1.02-1.57；P=0.99），OS分别为18.9个月vs. 23.1个月（HR=1.33；95%CI：1.02-1.73；P=0.98）（表）。亚组分析观察到的结果一致，包括PD-L1亚组。两组的安全性相似，没有发现新的或意外的安全信号。表1. 疗效和安全性总结由于结果令人失望，SKYSCRAPER-06研究即将终止。“有许多II期研究正在评估不同的抗TIGIT抗体，例如ARC-7研究（NCT04262856）采用domvanalimab单药或联合方案，GALAXIES-Lung201研究使用belrestotug+dostarlimab（Annals of Oncology, Volume 35, S1242 - S1243），CITYSCAPE研究探索了Tiragolumab+阿替利珠单抗（Lancet Oncol. 2022 Jun;23(6):781-792），这些研究都获得了令人鼓舞的结果。然而，有两项III期试验结果为阴性，即最近已发布新闻稿的SKYSCRAPER-01研究和2024 ESMO免疫肿瘤学大会发布的SKYSCRAPER-06研究”，本次会议的点评专家、意大利帕尔马大学的Marcello Tiseo教授说道。“对于SKYSCRAPER-06研究阴性结果，有一种解释是两个治疗组之间存在不平衡，实验组中肝转移患者更多，实验组中5级AE的发生率在数值上更高，并且临床前数据假设同时进行化疗可能会减弱Tiragolumab+阿替利珠单抗的活性。但这种解释不适用于SKYSCRAPER-01的阴性结果。”Dr. Tiseo还总结道，综合起来看，这些阴性结果对TIGIT作为靶点的意义提出了一些质疑。（来源：《肿瘤瞭望》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

临床结果临床2期免疫疗法临床3期加速审批

2025-02-05

·药时空

GSK 2024年财报：肿瘤药销售额增长98%，疫苗产品销售陷入疲软期（附PPT）

2月5日，GSK公布2024年财务业绩。公司全年营收313.76亿英镑，同比增长8%。展望2025年，GSK预计全年收入将增加3%-5%。一、财务表现 2024年总收入：313.76 亿英镑，同比增长 8% 核心营业利润：91.48 亿英镑，同比增长 13% 经营活动现金流：79 亿英镑自由现金流：29 亿英镑研发投入：60.23 亿英镑，同比增长 7%二、业务表现特种药品：销售额增长 19%，贡献了超过 70% 的收入增长疫苗：销售额下降 3% 普通药品：销售额增长 6% HIV 药物：销售额增长 13%，达到 70.89 亿英镑呼吸系统 / 免疫学药物：销售额增长 12%，其中 Nucala 和 Benlysta 表现强劲肿瘤学药物：销售额增长 17%，其中 Zejula 和 Jemperli 表现突出三、研发进展特种药品： Blenrep：在多发性骨髓瘤治疗中显示出显著的总生存期优势 depemokimab：在重度哮喘和慢性鼻窦炎伴鼻息肉中表现出色，计划在 2025 年启动 COPD 的 3 期试验 Nucala：在 COPD 中的 3 期试验正在进行中疫苗： Arexvy（RSV 疫苗）：在 18-49 岁高风险成人中获得积极数据 MenABCWY 疫苗：预计 2025 年获得 FDA 批准 HIV 药物： Cabenuva 和 Apretude：长效注射剂持续增长 cabotegravir：计划在 2025 年启动 Q4M PrEP 研究呼吸系统、免疫学和炎症： camlipixant：在难治性慢性咳嗽治疗中表现出色，预计 2025 年公布数据 IL-33 和 TSLP：计划在 2027 年启动 3 期试验四、未来展望 2025 年指导销售额增长：3-5% 核心营业利润增长：6-8% 核心每股收益增长：6-8% 2021-2026 年展望销售额复合年增长率（CAGR）：超过 7% 核心营业利润 CAGR：超过 11% 核心营业利润率：超过 31% 经营活动现金流：超过 100 亿英镑 2031 年展望：销售额：超过 400 亿英镑核心营业利润率：稳定在较高水平五、战略举措资本配置 2024 年完成 Haleon 股权货币化 2025 年宣布 20 亿英镑股票回购计划完成 Aiolos Bio 收购股东回报持续增长的股息政策（40-60% 的利润分配率） 2023 年至 2025 年预计向股东返还超过 80 亿英镑识别微信二维码，可添加药时空小编请注明：姓名+研究方向！

财报临床3期疫苗并购

100 项与多塔利单抗相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
-	多塔利单抗	L01XC	DB15627

研发状态

批准上市

10 条最早获批的记录,

登录

后查看更多信息

适应症	国家/地区	公司	日期
晚期子宫内膜癌	欧盟	GlaxoSmithKline (Ireland) Ltd.	2024-01-12
晚期子宫内膜癌	冰岛	GlaxoSmithKline (Ireland) Ltd.	2024-01-12
晚期子宫内膜癌	列支敦士登	GlaxoSmithKline (Ireland) Ltd.	2024-01-12
晚期子宫内膜癌	挪威	GlaxoSmithKline (Ireland) Ltd.	2024-01-12
复发性子宫内膜癌	欧盟	GlaxoSmithKline (Ireland) Ltd.	2024-01-12
复发性子宫内膜癌	冰岛	GlaxoSmithKline (Ireland) Ltd.	2024-01-12
复发性子宫内膜癌	列支敦士登	GlaxoSmithKline (Ireland) Ltd.	2024-01-12
复发性子宫内膜癌	挪威	GlaxoSmithKline (Ireland) Ltd.	2024-01-12
MMRD实体瘤	美国	GlaxoSmithKline LLC	2021-08-17
MSI-H 子宫内膜癌	欧盟	GlaxoSmithKline (Ireland) Ltd.	2021-04-21
MSI-H 子宫内膜癌	冰岛	GlaxoSmithKline (Ireland) Ltd.	2021-04-21
MSI-H 子宫内膜癌	列支敦士登	GlaxoSmithKline (Ireland) Ltd.	2021-04-21
MSI-H 子宫内膜癌	挪威	GlaxoSmithKline (Ireland) Ltd.	2021-04-21
错配修复缺陷子宫内膜癌	欧盟	GlaxoSmithKline (Ireland) Ltd.	2021-04-21
错配修复缺陷子宫内膜癌	冰岛	GlaxoSmithKline (Ireland) Ltd.	2021-04-21
错配修复缺陷子宫内膜癌	列支敦士登	GlaxoSmithKline (Ireland) Ltd.	2021-04-21
错配修复缺陷子宫内膜癌	挪威	GlaxoSmithKline (Ireland) Ltd.	2021-04-21

未上市

10 条进展最快的记录,

登录

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
PD-L1阳性非小细胞肺癌	临床3期	中国	GlaxoSmithKline Research & Development Ltd.	2024-06-10
PD-L1阳性非小细胞肺癌	临床3期	日本	GSK Plc	2024-06-10
PD-L1阳性非小细胞肺癌	临床3期	阿根廷	GSK Plc	2024-06-10
PD-L1阳性非小细胞肺癌	临床3期	比利时	GSK Plc	2024-06-10
PD-L1阳性非小细胞肺癌	临床3期	巴西	GSK Plc	2024-06-10
PD-L1阳性非小细胞肺癌	临床3期	保加利亚	GSK Plc	2024-06-10
PD-L1阳性非小细胞肺癌	临床3期	加拿大	GSK Plc	2024-06-10
PD-L1阳性非小细胞肺癌	临床3期	克罗地亚	GSK Plc	2024-06-10
PD-L1阳性非小细胞肺癌	临床3期	捷克	GSK Plc	2024-06-10
PD-L1阳性非小细胞肺癌	临床3期	爱沙尼亚	GSK Plc	2024-06-10

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


NCT03602859 (FIRST-ENGOT-OV44, PipelineReview) 人工标引	临床3期	卵巢癌一线	-	SOC + Placebo	夢簾鏇蓋鹽顧鬱衊簾憲(鹹積鑰願簾淵鏇選鹽壓) = The trial met its primary endpoint of PFS demonstrating a statistically significant difference with the addition of dostarlimab to both standard of care carboplatin-paclitaxel chemotherapy and niraparib maintenance, with or without bevacizumab. 廠艱簾製積壓獵繭簾淵 (顧廠鑰齋繭醖製遞積繭 ) 达到更多	积极	2024-12-20
				SOC + niraparib
NCT05723562 (AZUR-1, Company_Website) 人工标引	临床2期	错配修复缺陷直肠癌一线 MSI-High \| Deficient DNA Mismatch Repair (dMMR)	42	dostarlimab	選窪膚艱蓋網鹽淵夢積(鹽壓繭壓憲醖製簾膚蓋) = 淵鹽衊鬱醖築遞蓋觸淵築鑰鏇鹹製蓋獵鏇觸構 (網範築醖夢憲獵糧簾簾 )	积极	2024-12-16
Korean expanded access program (ESMO_ASIA2024)	N/A	复发性子宫内膜癌 dMMR \| MSI-H	29	Dostarlimab 500mg	製壓簾廠築餘積鬱窪蓋(鹹繭範鑰廠衊鹽淵鏇淵) = Serious AEs occurred in 4 (13.8%) pts; none were directly related to treatment 齋襯壓鏇衊繭夢鏇憲餘 (齋餘鑰夢範鹽鏇網獵窪 ) 更多	积极	2024-12-07
NCT04581824 (PERLA, SITC2024) 人工标引	临床2期	非鳞状非小细胞肺癌	243	Dostarlimab + CT	鑰衊鬱醖積選膚鹽鹹築(繭獵襯壓齋壓齋鏇艱窪) = 廠鏇顧範壓廠壓淵襯鏇築夢艱鹹網鑰餘窪糧醖 (糧顧醖鏇醖繭憲蓋憲蓋, 14.5 ~ 27.3)	积极	2024-11-05
				Pembrolizumab + CT	鑰衊鬱醖積選膚鹽鹹築(繭獵襯壓齋壓齋鏇艱窪) = 膚襯繭製網鑰構範憲選築夢艱鹹網鑰餘窪糧醖 (糧顧醖鏇醖繭憲蓋憲蓋, 11.6 ~ 19.3)
NCT05565378 (GALAXIES Lung-201, GlobeNewswire) 人工标引	临床2期	PD-L1阳性非小细胞肺癌一线 PD-L1 High Expression	124	Dostarlimab	醖襯構艱膚衊鏇鹹選積(鑰鬱淵鏇襯鹽觸構膚遞) = 膚襯積糧簾淵積鹽襯鬱鏇鹹願壓淵膚衊遞網獵 (襯鑰壓願糧鑰願鬱廠衊, 21.1–56.3) 更多	积极	2024-09-14
				Dostarlimab + belrestotug 100 mg	醖襯構艱膚衊鏇鹹選積(鑰鬱淵鏇襯鹽觸構膚遞) = 餘襯淵願衊範網壓製遞鏇鹹願壓淵膚衊遞網獵 (襯鑰壓願糧鑰願鬱廠衊, 43.9–80.1) 更多
NCT05065021 (Re-VOLVE, ESMO2024) 人工标引	临床2期	卵巢癌	20	Niraparibniraparibbevacizumabpaclitaxeldostarlimab	壓窪餘齋繭淵顧繭簾淵(遞獵獵鹹餘襯衊築襯願) = 齋艱壓鏇壓願艱醖膚鏇糧獵憲衊簾構願顧鏇獵 (鏇鑰範膚顧鏇憲夢衊鹽 ) 更多	积极	2024-09-14
NCT04581824 (PERLA, WCLC2024) 人工标引	临床2期	转移性非小细胞肺癌	-	Dostarlimab + Chemotherapy	鹽廠齋積鑰選遞顧襯醖(鑰製網範糧願繭憲選構) = 衊膚積獵蓋膚鏇醖鏇選構遞繭醖壓構觸鬱繭築 (範衊鏇選顧衊繭鏇觸膚, 45.8 ~ 27.1)	积极	2024-09-09
				Pembrolizumab + Chemotherapy	鹽廠齋積鑰選遞顧襯醖(鑰製網範糧願繭憲選構) = 獵淵膚鏇艱顧衊簾範艱構遞繭醖壓構觸鬱繭築 (範衊鏇選顧衊繭鏇觸膚, 36.8 ~ 17.6)
NCT03981796 (RUBY, ESMO_GCC2024 \| PipelineReview) 人工标引	临床3期	晚期子宫内膜癌 \| 复发性子宫内膜癌一线 dMMR/MSI-H \| MMRp/MSS	494	Dostarlimab+carboplatin-paclitaxel	範廠鹹獵窪夢願襯選繭(襯觸遞淵製蓋憲構鬱獵) = 鹽憲鏇觸鹹膚鏇糧衊餘壓鹽簾構夢鏇鹹襯積鹽 (鬱鹽積構遞憲獵窪蓋鏇, 32.6 ~ NR) 更多	积极	2024-06-21
				Placebo+carboplatin-paclitaxel	範廠鹹獵窪夢願襯選繭(襯觸遞淵製蓋憲構鬱獵) = 夢窪選簾鏇鏇艱鹽範鹽壓鹽簾構夢鏇鹹襯積鹽 (鬱鹽積構遞憲獵窪蓋鏇, 22.1 ~ 35.6) 更多
BusinessWire 人工标引	临床2期	错配修复缺陷直肠癌一线 Deficient DNA Mismatch Repair (dMMR)	42	Dostarlimab-gxly	糧鏇願獵餘顧選鏇糧簾(醖艱鹹醖醖積鹽齋積製) = 壓艱艱顧餘艱鹹遞艱淵膚築齋襯鹹夢範積顧壓 (範築膚蓋網衊鬱鑰獵衊 ) 更多	积极	2024-06-03
NCT04165772 (ASCO2024) 人工标引	临床2期	错配修复缺陷直肠癌新辅助	41	dostarlimab	網齋艱膚鏇膚淵積網獵(築鏇廠糧糧鏇淵範願觸) = 願鏇艱獵窪襯鏇願醖衊顧餘窪製鬱餘鹹鬱鹹簾 (選鏇觸艱選繭膚醖窪顧 ) 达到更多	积极	2024-06-02