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

作用方式

抑制剂

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+ [9]

在研适应症

晚期子宫内膜癌复发性子宫内膜癌MMRD实体瘤+ [81]

非在研适应症

晚期胆管癌透明细胞肉瘤妊娠滋养细胞疾病+ [6]

原研机构

AnaptysBio, Inc.

在研机构

GSK Plc

Tesaro, Inc.GlaxoSmithKline (Ireland) Ltd.

+ [8]

非在研机构-

权益机构

AnaptysBio, Inc.Sagard Healthcare Royalty Partners LP

GSK Plc

+ [1]

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)

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结构/序列

Sequence Code 315609369H

来源: *****

Sequence Code 315609370L

来源: *****

关联

105

项与多塔利单抗相关的临床试验

NCT07108270

/ Not yet recruiting临床2期

A Phase 2, Multicenter, Open-label, Single Arm Study of Dostarlimab Plus Carboplatin-paclitaxel Followed by Dostarlimab Monotherapy in Participants With dMMR/MSI-H Primary Advanced or Recurrent Endometrial Cancer in China (China RUBY)

The goal of this clinical trial is to see how well dostarlimab works when administered with the chemotherapy drugs carboplatin and paclitaxelin in treating EC in Chinese participants. The study aims to understand the treatments effectiveness, safety, how the drugs behave in the body, and whether it causes any immune reactions.

开始日期2025-11-30

申办/合作机构

GSK Plc

NCT07013851

/ Not yet recruiting临床2期IIT

Phase II Clinical Trial to Assess the Efficacy of Dostarlimab as Neoadjuvant Therapy in Patients With MMRd/MSI-H Stage II-III Endometrial Cancer

The study for which participation is requested is a phase II clinical trial to assess the efficacy of dostarlimab as neoadjuvant therapy in patients with MMRd/MSI-H stage II-III endometrial cancer. The study is conducted in Spain with an estimated number of 25 patients for phase II. The main objective of this phase-II study is to evaluate the clinical complete response (cCR) after neoadjuvant therapy with dostarlimab.

开始日期2025-10-01

申办/合作机构

GSK Plc

NCT07115927

/ Not yet recruiting临床2期IIT

pReOperative Dostarlimab and Novel Therapies in EndOmetrial Cancer

RODEO is a window of opportunity trial using dostarlimab in patients with newly diagnosed high-risk (stage 2-4) endometrial cancer who are suitable for primary surgery. Patients will receive 2 doses of dostarlimab (500mg IV day 1 and day 22) prior to surgery. The primary objective is to assess the pathological response rate to pre-operative dostarlimab and the secondary objectives are to assess the feasibility, toxicity, safety and efficacy of pre-operative dostarlimab.

开始日期2025-09-30

申办/合作机构

University College London

[+1]

100 项与多塔利单抗相关的临床结果

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100 项与多塔利单抗相关的转化医学

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100 项与多塔利单抗相关的专利（医药）

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189

项与多塔利单抗相关的文献（医药）

2025-12-31·Future Science OA

Immune checkpoint inhibitors or targeted therapy by mismatch repair status in endometrial cancer: a meta-analysis

Review

作者: Zeng, Ting ; Zhao, Jing ; Shu, Chuqiang ; Tang, Yi ; Chen, Yan ; Huang, Kui ; Zhang, Pu

OBJECTIVE:

This study evaluated the benefits of immune checkpoint inhibitors (ICIs) and/or targeted therapies in mismatch repair-deficient (dMMR) and mismatch repair-proficient (pMMR) patients with advanced or recurrent endometrial cancer (EC) via network meta-analysis.

METHODS:

English databases were searched from inception through January 2025. Randomized controlled trials (RCTs) assessing the efficacy and safety of related therapies for patients with EC stratified by MMR status were included. The main evaluation indicators included progression-free survival (PFS), overall survival (OS), the objective response rate (ORR), and severe adverse events (SAEs).

RESULTS:

Ten studies were included in the analysis. The results indicated that in the dMMR population, ICIs provide superior survival benefits. Among these, Dostarlimab combined with carboplatin and paclitaxel (CP) had the highest PFS and OS rates. For the pMMR population, Selinexor + CP offers significant benefits over CP alone, although OS outcome data are limited. In pMMR patients with prior chemotherapy, the lenvatinib + pembrolizumab strategy may provide additional PFS benefits relative to chemotherapy treatment.

CONCLUSIONS:

ICIs offered advantages for the dMMR population, whereas selinexor could provide survival benefits for the pMMR population. For pMMR patients who have received prior chemotherapy, the lenvatinib plus pembrolizumab strategy shows promise.

2025-08-14·CLINICAL CANCER RESEARCH

Combined Targeting of PD-1 and TIM-3 in Patients with Locally Advanced or Metastatic Melanoma: AMBER Cohorts 1c, 1e, and 2A.

Article

作者: Jansen, Kathrin ; Davar, Diwakar ; Pérez, Casilda Llácer ; Di Pace, Brian ; Waszak, Angela ; Borgovan, Theo ; Ribas, Antoni ; Eroglu, Zeynep ; Wang, Tianli ; Ghosh, Srimoyee ; Dhar, Arindam ; Yanamandra, Niranjan

PURPOSE:

The phase I, open-label, multicenter AMBER study (NCT02817633) is evaluating cobolimab, an anti-T-cell immunoglobulin and mucin-domain containing protein-3 humanized mAb, as a monotherapy and combination therapy in patients with solid tumors. In this study, the safety and efficacy of cobolimab plus dostarlimab, a PD-1 inhibitor, in patients with locally advanced/metastatic melanoma who were either immunotherapy-naïve or had progressed on prior anti-PD-(L)1 therapy, are reported.

PATIENTS AND METHODS:

Adults with adequate organ function and either immunotherapy-naïve (parts 1c/1e) or anti-PD-(L)1 relapsed or refractory (part 2A) melanoma were enrolled and received cobolimab 100, 300, or 900 mg and dostarlimab 500 mg every 3 weeks. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, or death (whichever occurred sooner). Endpoints included safety, tolerability, overall response rate, and disease control rate.

RESULTS:

The current integrated analysis included 28 patients who received treatment in parts 1c/1e and 43 patients who received treatment in part 2A. Treatment-related serious adverse events were observed in 14.3% and 9.3% of patients in parts 1c/1e and 2A, respectively. The overall response rate (95% confidence interval) was 42.9% (24.5-62.8) and 4.7% (0.6-15.8) for patients in parts 1c/1e and 2A, respectively, and the disease control rate (95% confidence interval) was 53.6% (33.9-72.5; 1c/1e) and 20.9% (10.0-36.0; 2A).

CONCLUSIONS:

In this exploratory setting, cobolimab plus dostarlimab was well tolerated, with reported preliminary efficacy similar to other anti-T-cell immunoglobulin and mucin-domain containing protein-3 treatments in patients with locally advanced/metastatic melanoma. See related article by Davar et al., p. 3443.

2025-08-14·CLINICAL CANCER RESEARCH

Combined Targeting of PD-1 and TIM-3 in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer: AMBER Part 2B.

Article

作者: Davar, Diwakar ; Srivats, Shyam ; Milhem, Mohammed ; Gutierrez, Martin ; Yanamandra, Niranjan ; Zhang, Hailei ; Waszak, Angela ; Borgovan, Theo ; LoRusso, Patricia ; Eroglu, Zeynep ; Ghosh, Srimoyee ; Dhar, Arindam ; Wang, Tianli ; Di Pace, Brian ; Ribas, Antoni ; Becerra, Carlos

PURPOSE:

Treatment options for patients with non-small cell lung cancer (NSCLC) who have progressed on anti-PD-(L)1 treatment are lacking. In preclinical models, blockade of the inhibitory immune receptor T-cell immunoglobulin and mucin-domain containing protein 3 (TIM-3) is associated with an antitumor response. AMBER (NCT02817633) part 2B assessed the safety and efficacy of cobolimab, an anti-TIM-3 humanized monoclonal antibody, plus PD-1 inhibitor dostarlimab in patients with locally advanced or metastatic NSCLC who had progressed on anti-PD-(L)1 treatment.

PATIENTS AND METHODS:

Adult patients with anti-PD-(L)-1 treated locally advanced or metastatic NSCLC were included. Patients received cobolimab 100, 300, or 900 mg and dostarlimab 500 mg every 3 weeks. Treatment continued until disease progression, unacceptable toxicity, patient withdrawal, investigator's decision, or death. Endpoints included overall response rate, disease control rate, and safety. Post hoc biomarker assessments of pretreatment tumor biopsies were also assessed.

RESULTS:

In total, 85 patients were enrolled and 84 received treatment. Treatment-emergent and treatment-related adverse events occurred in 98.8% and 52.4% of patients, respectively; no treatment-related deaths occurred. Across all three cobolimab doses, overall response rate was 8.3% (95% confidence interval, 3.4-16.4) and disease control rate was 21.4% (95% confidence interval, 13.2-31.7); both were highest in the 300 mg cohort (n = 41; 9.8% and 22.0%). Pretreatment TIM-3 expression was significantly greater in patients with partial or stable responses versus progressive disease.

CONCLUSIONS:

Cobolimab plus dostarlimab showed preliminary efficacy and tolerability in a subset of patients with locally advanced/metastatic NSCLC. See related article by Davar et al., p. 3433.

480

项与多塔利单抗相关的新闻（医药）

2025-08-25

·ETPharma

GSK launches Endometrial and Ovarian cancer drugs in India

Mumbai: UK pharma major GSK India arm has announced the launch of its two leading endometrial and ovarian cancer drugs Jemperli (Dostarlimab) and Zejula (Niraparib) in India. Jemperli is PD-1 inhibitor that helps to prevent cancer cells from evading immune detection, thereby enabling immune cells to recognise and attack the tumour more effectively. During trials the therapy demonstrated a response rate of 45.5 per cent, and maintained its effect by 93.3 per cent at 12 months and 83.7 per cent at 24 months, respectively. Zejula is an oral PARP inhibitor approved as first-line monotherapy maintenance for all biomarker types in advanced ovarian cancers. During trials the drug demonstrated a durable, long-term remission in women with newly diagnosed advanced ovarian cancer and were at high risk for disease progression or death across all biomarker subgroups. According GSK 2024 annual results, last year Jemperli racked total world wide sale of £593 million (~Rs 6000 crore) while Zejula clocked £467 million (over Rs 4,700 crore). “The launch of Jemperli and Zejula marks a pivotal moment for GSK in India, as we foray into oncology with a strong focus on innovation-led, high-impact therapies. With this launch, we are strengthening our long-term commitment to build the specialty medicine portfolio in India,” said Bhushan Akshikar, MD, GSK India Currently, endometrial and ovarian cancers are among the top three gynecological cancers in India, and according to WHO estimated nearly a fourth of endometrial cancer patients in India are at an advanced stage. The drugmaker had announced its plans of launching its leading oncology assets in India while announcing the first quarter results. “GSK is on track to launch its oncology assets, Jemperli and Zejula. By launching these assets in India, to address a critical unmet need amid a rising cancer burden and limited access to advanced therapies.” Akshikar had stated. By Online Bureau ,

上市批准临床结果临床1期抗体药物偶联物

2025-08-24

·信狐药迅

四十个1类创新药获批临床、一个进口品种收到通知件| 新获批(8.18-8.24）

每周药品注册获批数据，分门别类呈现，一目了然。(8.18-8.24）新药上市申请无新药临床申请药品名称企业注册分类受理号 IBI3032 信达生物科技有限公司 1 CXHL2500702 IBI3032 信达生物科技有限公司 1 CXHL2500701 IBI3032 信达生物科技有限公司 1 CXHL2500700 IBI3032 信达生物科技有限公司 1 CXHL2500699 ICP-248片北京诺诚健华医药科技有限公司 1 CXHL2500610 ICP-248片北京诺诚健华医药科技有限公司 1 CXHL2500609 丁二酸复瑞替尼胶囊复星万邦(江苏)医药集团有限公司 1 CXHL2500591 F-02-2-Na片广东横琴新创益生物医药有限公司 1 CXHL2500589 F-02-2-Na片广东横琴新创益生物医药有限公司 1 CXHL2500588 F-02-2-Na片湘北威尔曼制药股份有限公司 1 CXHL2500587 SIM0508片上海先祥医药科技有限公司 1 CXHL2500584 SIM0508片上海先祥医药科技有限公司 1 CXHL2500583 ABSK043片上海和誉生物医药科技有限公司 1 CXHL2500582 ABSK043片上海和誉生物医药科技有限公司 1 CXHL2500581 HP-001胶囊上海超阳药业有限公司 1 CXHL2500580 HP-001胶囊上海超阳药业有限公司 1 CXHL2500579 HP-001胶囊上海超阳药业有限公司 1 CXHL2500578 注射用FZ-P001钠上海复旦张江生物医药股份有限公司 1 CXHL2500576 LY104注射液青岛海洋生物医药研究院 1 CXHL2500557 LY104注射液青岛海洋生物医药研究院 1 CXHL2500556 HRS-7172片江苏恒瑞医药股份有限公司 1 CXHL2500568 HRS-7172片江苏恒瑞医药股份有限公司 1 CXHL2500567 HRS-7172片江苏恒瑞医药股份有限公司 1 CXHL2500566 RSS0393软膏瑞石生物医药有限公司 1 CXHL2500564 RSS0393软膏瑞石生物医药有限公司 1 CXHL2500563 RSS0393软膏瑞石生物医药有限公司 1 CXHL2500562 D-2570片益方生物科技(上海)股份有限公司 1 CXHL2500560 HRS-4729注射液福建盛迪医药有限公司 1 CXHL2500559 HRS-4729注射液福建盛迪医药有限公司 1 CXHL2500558 INT-210胶囊宜坤行健生物医药(上海)有限公司 1 CXHL2500554 INT-210胶囊宜坤行健生物医药(上海)有限公司 1 CXHL2500553 注射用HTMC0769 上海壹典医药科技开发有限公司 1 CXHL2500546 WJ22096片南京境奥生物医药科技有限公司 1 CXHL2500543 WJ22096片南京境奥生物医药科技有限公司 1 CXHL2500542 MDI-1228_mesylate凝胶迈英诺医药科技(珠海)有限公司 1 CXHL2500531 MDI-1228_mesylate凝胶迈英诺医药科技(珠海)有限公司 1 CXHL2500530 HB5凝胶北京中科先行医疗科技有限公司 1 CXHL2500536 HB5凝胶北京中科先行医疗科技有限公司 1 CXHL2500535 HB5凝胶北京中科先行医疗科技有限公司 1 CXHL2500534 XC2309注射液浙江医药股份有限公司新昌制药厂 1 CXHL2500533 司美格鲁肽注射液福建基诺厚普生物科技有限公司 2.2 CXHL2500574 司美格鲁肽注射液福建基诺厚普生物科技有限公司 2.2 CXHL2500573 司美格鲁肽注射液福建基诺厚普生物科技有限公司 2.2 CXHL2500572 司美格鲁肽注射液福建基诺厚普生物科技有限公司 2.2 CXHL2500571 司美格鲁肽注射液福建基诺厚普生物科技有限公司 2.2 CXHL2500570 JSS-222 江西施美药业股份有限公司 2.2 CXHL2500575 SPIEC肠溶微片吉林天衡药业有限公司 2.2 CXHL2500551 CZ006注射液浙江萃泽医药科技有限公司 2.2 CXHL2500520 硫酸阿托品滴眼液湖南迈欧医疗科技有限公司 2.2 CXHL2500516 硫酸阿托品滴眼液湖南迈欧医疗科技有限公司 2.2 CXHL2500517 奥曲肽长效注射液石药集团中奇制药技术(石家庄)有限公司 2.2;2.4 CXHL2500585 盐酸吉卡昔替尼片苏州泽璟生物制药股份有限公司 2.4 CXHL2500577 盐酸吉卡昔替尼片苏州泽璟生物制药股份有限公司 2.4 CXHL2500552 JLM019注射液杰库(上海)生物医药研究有限公司 1 CXSL2500496 注射用HS-20093 上海翰森生物医药科技有限公司 1 CXSL2500490 IBI343 信达生物制药(苏州)有限公司 1 CXSL2500487 注射用ZG005 苏州泽璟生物制药股份有限公司 1 CXSL2500486 洛奈利单抗注射液山东新时代药业有限公司 1 CXSL2500485 CVL006 注射液甫康(上海)健康科技有限责任公司 1 CXSL2500477 注射用SHR-A2009 苏州盛迪亚生物医药有限公司 1 CXSL2500476 注射用ZG005 苏州泽璟生物制药股份有限公司 1 CXSL2500473 注射用SLN12140 领诺(上海)医药科技有限公司 1 CXSL2500472 注射用ZGGS18 苏州泽璟生物制药股份有限公司 1 CXSL2500471 AK131注射液中山康方生物医药有限公司 1 CXSL2500484 AK109注射液康融东方(广东)医药有限公司 1 CXSL2500482 AK117注射液中山康方生物医药有限公司 1 CXSL2500481 AK117注射液中山康方生物医药有限公司 1 CXSL2500480 CM536注射液康诺亚生物医药科技(成都)有限公司 1 CXSL2500474 GR1802注射液重庆智翔金泰生物制药股份有限公司 1 CXSL2500470 GR1802注射液重庆智翔金泰生物制药股份有限公司 1 CXSL2500469 注射用QLS31905 齐鲁制药有限公司 1 CXSL2500466 注射用SSS50 沈阳三生制药有限责任公司 1 CXSL2500458 HJY-ATRQβ-001注射液武汉华纪元生物技术开发有限公司 1 CXSL2500463 UC101 CAR-T细胞注射液成都优赛诺生物科技有限公司 1 CXSL2500451 TI-0093注射液圆因(北京)生物科技有限公司 1 CXSL2500461 KM1溶瘤痘苗病毒注射液深圳市华药康明生物药业有限责任公司 1 CXSL2500446 怡培生长激素注射液厦门特宝生物工程股份有限公司 2.2 CXSL2500493 SHR-8068注射液苏州盛迪亚生物医药有限公司 2.2 CXSL2500495 阿得贝利单抗注射液上海盛迪医药有限公司 2.2 CXSL2500491 QL2107注射液齐鲁制药有限公司 2.2 CXSL2500467 司普奇拜单抗注射液成都康诺行生物医药科技有限公司 2.2 CXSL2500454 仿制药申请药品名称企业注册分类受理号氢氯噻嗪珠海润都制药股份有限公司 CYHS2460314 贝美前列素涂剂浙江孚诺医药股份有限公司 3 CYHL2500113 雷美替胺片朗天药业(湖北)有限公司 3 CYHL2500112 甲苯磺酸卢美哌隆胶囊荣昌制药(淄博)有限公司 3 CYHL2500111 洛索洛芬钠凝胶贵州联盛药业有限公司 3 CYHL2500110 洛索洛芬钠凝胶贵州联盛药业有限公司 3 CYHL2500109 利多卡因丙胺卡因牙周凝胶深圳珐玛易药品科技有限公司 3 CYHL2500103 硫酸特布他林注射液广东万泰科创药业有限公司 3 CYHL2500102 黄体酮阴道缓释凝胶河北新张药股份有限公司 4 CYHL2500115 多种油脂肪乳注射液(C6-24) 成都国为生物医药有限公司 4 CYHL2500104 冻干b型流感嗜血杆菌结合疫苗艾美坚持生物制药有限公司 3.3 CXSL2500442 SYS6036注射液石药集团巨石生物制药有限公司 3.3 CXSL2500500 度普利尤单抗注射液石药集团巨石生物制药有限公司 3.3 CXSL2500453 度普利尤单抗注射液石药集团巨石生物制药有限公司 3.3 CXSL2500452 进口申请药品名称企业注册分类受理号注射用A型肉毒毒素 Daewoong Pharmaceutical Co., Ltd. 3.4 JXSS2200009国;JXSS2200009 BMS-986504片 Bristol-Myers Squibb Company 1 JXHL2500187 PF-07248144片 Pfizer Inc. 1 JXHL2500149 PF-07248144片 Pfizer Inc. 1 JXHL2500148 AZD6793 AstraZeneca AB 1 JXHL2500142 AZD6793 AstraZeneca AB 1 JXHL2500141 AZD6793 AstraZeneca AB 1 JXHL2500140 BMS-986504片 Bristol-Myers Squibb Company 1 JXHL2500139 Baxdrostat片 AstraZeneca AB 1 JXHL2500138 Baxdrostat片 AstraZeneca AB 1 JXHL2500137 ARV-471(PF-07850327)片 Pfizer Inc. 1 JXHL2500136 PF-07248144片 Pfizer Inc. 1 JXHL2500135 PF-07248144片 Pfizer Inc. 1 JXHL2500134 PF-07248144片 Pfizer Inc. 1 JXHL2500133 BI 690517片 Boehringer Ingelheim International GmbH 1 JXHL2500132 Muvalaplin片 Eli Lilly and Company 1 JXHL2500131 甲苯磺酸利特昔替尼胶囊 Pfizer Inc. 2.4 JXHL2500144 甲苯磺酸利特昔替尼胶囊 Pfizer Inc. 2.4 JXHL2500143 BMS-986165片 Bristol-Myers Squibb Company 2.4 JXHL2500124 BMS-986165片 Bristol-Myers Squibb Company 2.4 JXHL2500123 AMG 133 Amgen Inc. 1 JXSL2500096 AMG 133 Amgen Inc. 1 JXSL2500095 AMG 133 Amgen Inc. 1 JXSL2500094 AMG 133 Amgen Inc. 1 JXSL2500093 AMG 133 Amgen Inc. 1 JXSL2500092 AMG 133 Amgen Inc. 1 JXSL2500091 注射用MK-2400 Merck Sharp & Dohme LLC 1 JXSL2500089 注射用MK-5909 Merck Sharp & Dohme LLC 1 JXSL2500088 注射用MK-1022 Merck Sharp & Dohme LLC 1 JXSL2500086 注射用贝林妥欧单抗(皮下注射) Amgen Inc. 2.1 JXSL2500098 注射用贝林妥欧单抗(皮下注射) Amgen Inc. 2.1 JXSL2500097 注射用德曲妥珠单抗 Daiichi Sankyo, Inc. 2.2 JXSL2500101 比奇珠单抗注射液 UCB Pharma S.A. 2.2 JXSL2500100 比奇珠单抗注射液 UCB Pharma S.A. 2.2 JXSL2500099 Dostarlimab注射液 GlaxoSmithKline (Ireland) Limited 3.1 JXSL2500087 中药相关申请药品名称企业注册分类受理号复方黄杞颗粒浙江九如医药科技有限公司 1.1 CXZL2500036 JMZ-2102胶囊江西济民可信药业有限公司 1.2 CXZL2500034 JMZ-2102 江西济民可信药业有限公司 1.2 CXZL2500033 金振口服液江苏康缘药业股份有限公司 2.3 CXZL2500038 黄厚止泻滴丸安徽雷允上药业有限公司 2.3 CXZL2500035 注：橙色字体部分结论为不批准或收到通知件；

申请上市临床申请临床1期

2025-08-18

·GlobeNewswire-Health Care

LIXTE Biotech Advances Precision Oncology Pipeline with First Phase 1B/2 Trial Readout Expected in 2H 2025

Breakthrough Protein Phosphatase 2A inhibitor LB-100 Targets Ovarian Clear Cell Carcinoma, Advanced Soft Tissue Sarcoma, and MSS Metastatic Colon Cancer 24/7 Market News Issues Corrected Information on Previously issued Press Release with same title Aug. 14, 2025 -- 247marketnews.com, a pioneer in digital media dedicated to the swift distribution of financial market news and corporate information, spotlights LIXTE Biotechnology Holdings, Inc. (Nasdaq: LIXT), a clinical-stage pharmaceutical company focused on developing novel cancer therapies by targeting the modulation of key cellular pathways. 2H 2025 is shaping up to be a defining year for LIXTE. With a focus on its lead compound LB-100, a first-in-class small molecule inhibitor of protein phosphatase 2A (PP2A), a master regulator of cell signaling and DNA damage response. By inhibiting PP2A, LB-100 sensitizes tumors to DNA-damaging agents, including chemotherapy, radiation, and immunotherapy, LIXTE is targeting high-unmet needs in the $200 billion global oncology market (Grand View Research, 2025 projection). Potential upcoming catalysts in 2025, including a first trial result, position LIXTE as a potential disruptor in resistant cancers, where traditional treatments fail due to limited efficacy and toxicity. 1B/2 Trial – Ovarian Clear Cell Carcinoma (OCCC) Ovarian clear cell carcinoma is an aggressive and chemoresistant subtype of epithelial ovarian cancer, accounting for ~5–10% of all ovarian malignancies but disproportionately contributing to ovarian cancer mortality. The Phase 1B/2 study of LB-100 plus the checkpoint inhibitor dostarlimab (GSK) is designed leverage LB-100’s synergistic enhancement of immune checkpoint blockade. Status: Enrolled, with interim safety completed Upcoming Milestone: Preliminary safety and efficacy data expected Q4 2025 Potential Market Impact: Global OCCC treatment market is projected to exceed $750 million by 2028 due to rising incidence and limited targeted therapies 1B/2 Trial – Advanced Soft Tissue Sarcoma (STS) Soft tissue sarcomas are a diverse and difficult-to-treat group of cancers arising from connective tissues. For patients with advanced or metastatic disease, prognosis remains poor. LIXTE’s Phase 1B/2 study evaluates LB-100 in combination with doxorubicin, the current standard of care, in patients with advanced STS. Status: Dose escalation completed. Upcoming Milestone: Safety report Q4 2025 Potential Market Impact: The global STS drug market is estimated to reach $2.1 billion by 2030, driven by the emergence of combination therapies and unmet medical need 1B Trial – Metastatic Microsatellite Stable (MSS) Colon Cancer MSS colon cancer, representing roughly 85% of metastatic colorectal cancer (mCRC), remains unresponsive to checkpoint inhibitors. LIXTE is conducting a Phase 1B trial assessing the safety and activity of LB-100 in combination with+ atezolizumab (Roche) (an ICI), seeking to overcome immune resistance in this cold tumor type. Status: Trial open, first patients recruited Potential Market Impact: The global colorectal cancer therapeutics market is expected to surpass $18 billion by 2030, with MSS disease representing the majority of treatment-resistant cases LIXTE’s strategy of targeting PP2A to potentiate multiple treatment modalities positions LB-100 as a versatile combination agent with broad applicability across solid tumors. The platform’s potential spans oncology subtypes with high unmet need, limited innovation, and growing incidence. Strong IP Position: Multiple issued and pending patents covering composition, methods of use, and combinations Pipeline Expansion: Additional tumor types and investigator-sponsored studies are under review, including glioblastoma. Partnership Potential: Ongoing discussions with academic institutions and biopharma partners for co-development opportunities LIXTE is a clinical-stage pharmaceutical company focused on discovering and developing innovative cancer therapies targeting the protein phosphatase 2A (PP2A) pathway, a previously underexplored avenue in cancer treatment. The company’s lead compound, LB-100, is a first-in-class PP2A inhibitor that has demonstrated strong preclinical results and early-stage clinical tolerability. LIXTE is currently advancing proof-of-concept trials in Ovarian Clear Cell Carcinoma, Metastatic Colon Cancer, and Advanced Soft Tissue Sarcoma. The content above comes from the network. if any infringement, please contact us to modify.

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100 项与多塔利单抗相关的药物交易

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

研发状态

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10 条最早获批的记录,

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适应症	国家/地区	公司	日期
晚期子宫内膜癌	欧盟	GlaxoSmithKline Trading Services Ltd.	2024-01-12
晚期子宫内膜癌	冰岛	GlaxoSmithKline Trading Services Ltd.	2024-01-12
晚期子宫内膜癌	列支敦士登	GlaxoSmithKline Trading Services Ltd.	2024-01-12
晚期子宫内膜癌	挪威	GlaxoSmithKline Trading Services Ltd.	2024-01-12
复发性子宫内膜癌	欧盟	GlaxoSmithKline Trading Services Ltd.	2024-01-12
复发性子宫内膜癌	冰岛	GlaxoSmithKline Trading Services Ltd.	2024-01-12
复发性子宫内膜癌	列支敦士登	GlaxoSmithKline Trading Services Ltd.	2024-01-12
复发性子宫内膜癌	挪威	GlaxoSmithKline Trading Services 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 Trading Services Ltd.	2021-04-21
MSI-H 子宫内膜癌	冰岛	GlaxoSmithKline Trading Services Ltd.	2021-04-21
MSI-H 子宫内膜癌	列支敦士登	GlaxoSmithKline Trading Services Ltd.	2021-04-21
MSI-H 子宫内膜癌	挪威	GlaxoSmithKline Trading Services Ltd.	2021-04-21
错配修复缺陷子宫内膜癌	欧盟	GlaxoSmithKline Trading Services Ltd.	2021-04-21
错配修复缺陷子宫内膜癌	冰岛	GlaxoSmithKline Trading Services Ltd.	2021-04-21
错配修复缺陷子宫内膜癌	列支敦士登	GlaxoSmithKline Trading Services Ltd.	2021-04-21
错配修复缺陷子宫内膜癌	挪威	GlaxoSmithKline Trading Services Ltd.	2021-04-21

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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	美国	GSK Plc	2024-06-10
PD-L1阳性非小细胞肺癌	临床3期	中国	GSK Plc	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	芬兰	GSK Plc	2024-06-10
PD-L1阳性非小细胞肺癌	临床3期	法国	GSK Plc	2024-06-10

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临床结果

适应症

分期

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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


NCT04493060 (CTgov)	临床2期	家族性胰腺癌 \| 转移性胰腺导管腺癌	22	niraparib+dostarlimab	醖齋網願糧獵衊繭範夢 = 襯蓋廠網齋憲廠衊艱鬱網築糧鹽襯遞鏇醖網積 (窪積廠廠廠鏇簾鬱憲簾, 築獵襯餘築鏇構範鑰顧 ~ 壓憲鹹廠遞築鏇繭襯繭) 更多	-	2025-08-07
NCT03574779 (OPAL Phase II Trial \| OPAL, CTgov)	临床2期	卵巢癌	77	Niraparib+Bevacizumab+Dostarlimab (Cohort A (Dostarlimab + Bevacizumab + Niraparib))	遞窪積願鬱願鹽選醖構 = 選築遞壓壓遞獵鏇襯襯鬱築獵衊鏇鹹選獵餘觸 (構願構獵鬱窪獵築齋網, 糧構鏇壓選艱積艱範簾 ~ 網鏇廠願餘鏇簾餘蓋鹹) 更多	-	2025-07-15
				taxane+Niraparib (Cohort C (Niraparib OR Platinum-taxane))	遞窪積願鬱願鹽選醖構 = 選餘鑰築鏇選鏇鏇鏇觸鬱築獵衊鏇鹹選獵餘觸 (構願構獵鬱窪獵築齋網, 鹽壓鬱糧繭壓鬱衊鹹積 ~ 鹹醖構壓鹹膚簾窪簾餘) 更多
NCT03981796 (ENGOT-EN6-NSGO/GOG-3031/RUBY, ASCO2025)	临床3期	复发性子宫内膜癌 dMMR/MSI-H \| MMRp/MSS	494	Dostarlimab plus Carboplatin-Paclitaxel (DOST+CP)	鑰鹹餘膚觸選蓋廠遞積(膚鑰憲範襯醖膚廠選憲) = 願窪鬱獵窪繭艱醖夢鹽簾積製淵廠製網淵鬱鏇 (觸觸繭積壓獵獵觸廠壓 ) 更多	积极	2025-05-30
				Placebo plus Carboplatin-Paclitaxel (PBO+CP)	鑰鹹餘膚觸選蓋廠遞積(膚鑰憲範襯醖膚廠選憲) = 壓齋糧鏇衊築範衊選憲簾積製淵廠製網淵鬱鏇 (觸觸繭積壓獵獵觸廠壓 ) 更多
NCT04165772 (NEWS \| Pubmed) 人工标引	临床2期	MSI-H 癌症 \| 错配修复缺陷直肠癌新辅助 Deficient DNA Mismatch Repair (dMMR)	117	Dostarlimab	鏇窪構壓積淵鏇膚遞構(襯蓋窪製艱鹽膚窪膚鑰) = 網襯遞簾廠齋製壓襯簾艱艱醖繭繭範窪願淵壓 (製顧糧醖獵鹹繭鏇憲糧 ) 更多	积极	2025-04-27
				Dostarlimab (dMMR, locally advanced rectal cancer)	範膚網選獵築壓鏇窪觸(衊繭鑰繭鹽觸蓋夢蓋觸) = 選簾壓廠窪積壓鹽壓築餘觸遞範製衊網艱憲簾 (鹹鏇繭構醖夢壓鬱築夢 ) 更多
NCT02715284 (GARNET, AACR2025)	临床1期	非小细胞肺癌	67	dostarlimab (SerialCTRS)	壓蓋淵齋觸襯製齋醖餘(憲窪壓夢獵壓糧鑰鑰遞): HR = 2.68 (95% CI, 1.09 ~ 6.59), P-Value = 0.03	积极	2025-04-27
				dostarlimab (RECIST 1.1)
NCT06655818 (CTgov)	临床1/2期	多发性骨髓瘤	4	Mafodotin+Dostarlimab+Belantamab	淵鹽膚製繭築構窪範淵 = 築蓋製淵鏇衊鹽膚衊糧簾遞艱齋衊醖餘艱窪鬱 (鑰顧簾範艱淵艱鑰衊鏇, 衊願衊鹽糧齋範積蓋繭 ~ 鑰壓窪遞遞壓齋齋餘窪) 更多	-	2025-03-03
NCT03250832 (CITRINO, Pubmed)	临床1期	晚期恶性实体瘤	-	Encelimab + Dostarlimab	積鑰顧網醖夢鏇顧構獵(鏇選襯糧製選壓蓋壓壓) = 願網鏇顧觸鑰壓鏇齋餘廠壓顧範餘鏇網鹽構繭 (繭窪繭廠艱鏇選窪廠觸 )	不佳	2025-02-27
				Dostarlimab	積鑰顧網醖夢鏇顧構獵(鏇選襯糧製選壓蓋壓壓) = 鑰醖簾構糧顧膚鹽淵構廠壓顧範餘鏇網鹽構繭 (繭窪繭廠艱鏇選窪廠觸 )
NCT03602859 (FIRST-ENGOT-OV44, PipelineReview) 人工标引	临床3期	卵巢癌一线	-	SOC + Placebo	衊壓齋壓構醖鑰觸膚憲(願積夢構醖繭糧選襯鑰) = 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. 鏇鑰蓋窪醖觸構壓簾壓 (窪獵鑰憲鹹餘鏇顧顧襯 ) 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	蓋鹽窪獵膚獵鑰鏇鑰壓(顧鬱觸簾鑰積鹹壓築積) = 窪鹽襯顧糧簾願憲鑰艱壓遞製襯獵獵築壓鬱憲 (餘憲衊鑰觸夢廠範憲繭 )	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	淵簾蓋廠衊鬱鹹蓋鹽網(鬱餘憲獵構構網鏇憲製) = Serious AEs occurred in 4 (13.8%) pts; none were directly related to treatment 衊膚餘鹹廠餘網憲廠簾 (鑰衊範鑰蓋選淵鏇獵鬱 ) 更多	积极	2024-12-07