更新于：2024-04-26
Olverembatinib
奥雷巴替尼
更新于：2024-04-26
概要
基本信息
药物类型 小分子化药 |
别名 Oribatinib、奥瑞巴替尼、耐克替尼 + [12] |
作用机制 Bcr-Abl T315I抑制剂(bcr-abl酪氨酸激酶T315I抑制剂)、c-Kit抑制剂(干细胞生长因子受体抑制剂) |
在研适应症 |
非在研适应症 |
原研机构 |
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 中国 (2021-11-24), |
最高研发阶段(中国)批准上市 |
特殊审评快速通道 (美国)、孤儿药 (美国)、孤儿药 (欧盟)、优先审评 (中国)、突破性疗法 (中国)、附条件批准 (中国) |
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结构
分子式C31H35F3N6O7S2 |
InChIKeyLEVIGHXVOVROGW-UHFFFAOYSA-N |
CAS号1421783-64-3 |
关联
30
项与 奥雷巴替尼 相关的临床试验A Single-arm, Open-label Study of Olverembatinib, CD3/CD19 Bispecific T-cell Engager, and Chidamide in Patients With Newly Diagnosed Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia
ABC study is a phase 2, single-arm, open-label study of Olverembatinib, CD3/CD19 Bispecific T-cell Engager, and Chidamide in patients with newly diagnosed Philadelphia Chromosome-positive acute lymphoblastic leukemia (Ph+ALL). This study combined third generation TKI (Olverembatinib), histone deacetylase inhibitors (Chidamide) and CD3/CD19 bispecific T-cell engager (Blinatumomab) as first line regimen (ABC regimen) for Ph+ ALL. Investigatorsaim to explore the efficacy and safety of ABC regimen. The primary endpoint is the complete molecular remission （CMR） at 3 months, secondary endpoints are overall survival (OS), event-free survival (EFS), adverse event (AE), IKZF1del, IKZF1plus, IKZF1lpus/CD20 subgroup EFS/OS.
开始日期2024-02-01 |
申办/合作机构 |
An Open, Prospective, Single-arm Study of Olverembatinib Plus Venetoclax and Dexamethasone in Patients of Newly-diagnosed Ph+ Acute Lymphoblastic Leukemia
The purpose of this study is to explore the efficacy and safety of the OVD chemotherapy-free regimen (Olverembatinib, venetoclax and dexamethasone) in patients with newly-diagnosed Ph+ALL.
开始日期2023-11-01 |
申办/合作机构 |
A Pivotal Registrational Phase 3 Study of Olverembatinib Combined With Chemotherapy Versus Imatinib Combined With Chemotherapy in Patients With Newly Diagnosed Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia (Ph+ALL)
A global multicenter, open-label, randomized and registrational Phase 3 study to evaluate efficacy and safety of Olverembatinib combined with chemotherapy versus Imatinib combined with chemotherapy in subjects with newly diagnosed Ph+ALL.
开始日期2023-08-31 |
申办/合作机构 |
100 项与 奥雷巴替尼 相关的临床结果
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100 项与 奥雷巴替尼 相关的转化医学
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100 项与 奥雷巴替尼 相关的专利（医药）
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41
项与 奥雷巴替尼 相关的文献（医药）2024-02-01·Annals of Hematology
Olverembatinib combined with blinatumomab in treating T315I-mutated Philadelphia chromosome–positive acute lymphoblastic leukemia: two-case report
Article
作者: Wang, Lina ; Lu, Yaoyao ; Li, Zijian ; Fan, Shengxuan
ABL tyrosine kinase inhibitors (TKIs) act an irreplaceable role in the management of Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL). The treatment of these diseases has been revolutionized by the application of immunotherapeutic modalities. However, diseases with ABL kinase domain mutation T315I are resistant to the majority of TKIs, which is responsible for treatment failure. Olverembatinib is a third-generation TKI that has been approved for the treatment of T315I-mutated chronic myeloid leukemia (CML) in China; its usage in Ph+ ALL needs further exploration. Here, we present two cases with relapsed T315I mutation Ph+ ALL who received the combination regimen of blinatumomab and olverembatinib. This regimen, which has not been reported yet, was safe and effective as the patients achieved minimal residual disease (MRD) negative after 1 cycle of therapy. The management of these cases provides evidence of this new chemo-free regimen as an efficient approach for relapsed or refractory(R/R)Ph+ ALL.
2023-12-01·Science Advances
Inhibition of Parkinson’s disease–related LRRK2 by type I and type II kinase inhibitors: Activity and structures
Article
作者: Knapp, Stefan ; Alegrio Louro, Jaime ; Chatterjee, Deep ; Dederer, Verena ; Mathea, Sebastian ; Leschziner, Andres E ; Villagran Suarez, Amalia ; Sanz Murillo, Marta
Mutations in leucine-rich repeat kinase 2 (LRRK2) are a common cause of familial Parkinson’s disease (PD) and a risk factor for the sporadic form. Increased kinase activity was shown in patients with both familial and sporadic PD, making LRRK2 kinase inhibitors a major focus of drug development efforts. Although much progress has been made in understanding the structural biology of LRRK2, there are no available structures of LRRK2 inhibitor complexes. To this end, we solved cryo–electron microscopy structures of LRRK2, wild-type and PD-linked mutants, bound to the LRRK2-specific type I inhibitor MLi-2 and the broad-spectrum type II inhibitor GZD-824. Our structures revealed an active-like LRRK2 kinase in the type I inhibitor complex, and an inactive DYG-out in the type II inhibitor complex. Our structural analysis also showed how inhibitor-induced conformational changes in LRRK2 are affected by its autoinhibitory N-terminal repeats. The structures provide a template for the rational development of LRRK2 kinase inhibitors covering both canonical inhibitor binding modes.
2023-09-01·Leukemia & lymphoma
Olverembatinib for myeloid/lymphoid neoplasm associated with eosinophilia and FGFR1 rearrangement.
Letter
作者: Liu, Jinqin ; Jia, Yujiao ; Gale, Robert Peter ; Pan, Lijuan ; Li, Bing ; Qu, Shiqiang ; Qin, Tiejun ; Xiao, Zhijian ; Xu, Zefeng ; Li, Chengwen ; Yan, Xiao ; Yan, Yiru ; Jiao, Meng ; Gao, Qingyan
724
项与 奥雷巴替尼 相关的新闻（医药）2024-04-25
2024年美国临床肿瘤学会(ASCO)年会将于5月31日到6月4日在芝加哥举办，是世界上规模最大、学术水平最高、最具权威性的临床肿瘤学会议，会议汇集了全球肿瘤学医生和专业人士、患者倡导者、工业界代表和主要媒体，共同探讨当前国际最前沿的研究发现和临床试验成果。ASCO成立于1964年,是世界上最大、最具影响力的肿瘤专业学术组织,致力于癌症的预防、治疗及改善对患者的护理。ASCO在全球150多个国家和地区拥有超过45,000名成员。4月24日晚，ASCO官网公布了本次大会的研究标题，几十余名中国专家将在世界舞台上展示其研究成果，报告涵盖了多个瘤种的最新治疗策略和技术，展示了中国在全球癌症研究中的重要地位和贡献。世易编辑团队精心整理了中国专家们的研究报告，供您参考。全体大会报告Osimertinib (osi) after definitive chemoradiotherapy (CRT) in patients (pts) with unresectable stage (stg) III epidermal growth factor receptor-mutated (EGFRm) NSCLC: Primary results of the phase 3 LAURA study. Abstract: LBA4 · Suresh S. Ramalingam教授，美国埃默里大学Winship癌症研究所· 陆舜 教授，上海交通大学附属胸科医院 口头报告Lung Cancer—Non-Small Cell MetastaticSacituzumab tirumotecan (SKB264/MK-2870) in combination with KL-A167 (anti-PD-L1) as first-line treatment for patients with advanced NSCLC from the phase II OptiTROP-Lung01 study. Abstract: 8502 · 方文峰 教授，中山大学肿瘤防治中心 Ivonescimab combined with chemotherapy in patients with EGFR-mutant non-squamous non-small cell lung cancer who progressed on EGFR tyrosine-kinase inhibitor treatment (HARMONi-A): A randomized, double-blind, multi-center, phase 3 trial. Abstract: 8508 · 张力 教授，中山大学肿瘤防治中心 Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers Adjuvant icotinib of 12 months or 6 months versus observation following adjuvant chemotherapy for resected EGFR-mutated stage II–IIIA non-small-cell lung cancer (ICTAN, GASTO1002): A randomized phase 3 trial. Abstract: 8004 ·王思愚 教授，中山大学肿瘤防治中心 A phase II randomized trial evaluating consolidative nivolumab in locally advanced non-small cell lung cancer post neoadjuvant chemotherapy plus nivolumab and concurrent chemoradiotherapy (GASTO-1091). Abstract: 8008 · 刘慧 教授，中山大学肿瘤防治中心 Taiwan national lung cancer early detection program for heavy smokers and non-smokers with family history of lung cancer. Abstract: 8009 · Pan-Chyr Yang, MD, PhD，台湾大学医学院 Gastrointestinal Cancer—Colorectal and Anal Neoadjuvant treatment of IBI310 (anti-CTLA-4 antibody) plus sintilimab (anti-PD-1 antibody) in patients with microsatellite instability-high/mismatch repair-deficient colorectal cancer: Results from a randomized, open-labeled, phase Ib study. Abstract: 3505 · 徐瑞华 教授，中山大学肿瘤防治中心 Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant Phase I study of CN201, a novel CD3xCD19 IgG4 bispecific antibody, in adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia. Abstract: 6505 · 王迎 教授，中国医学科学院血液病医院 Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia CLAMP: A phase II prospective study of camrelizumab combined with pegaspargase, etoposide, and high-dose methotrexate in patients with natural killer (NK)/T-cell lymphoma. Abstract: 7002 · 刘涛 教授，华中科技大学同济医学院附属协和医院 Tucidinostat plus R-CHOP in previously untreated diffuse large B-cell lymphoma with double expression of MYC and BCL2: An interim analysis from the phase III DEB study. Abstract: LBA7003 · 赵维莅 教授，上海交通大学医学院附属瑞金医院 Hematologic Malignancies—Plasma Cell DyscrasiaPhase 3 study results of isatuximab, bortezomib, lenalidomide, and dexamethasone (Isa-VRd) versus VRd for transplant-ineligible patients with newly diagnosed multiple myeloma (IMROZ). Abstract: 7500 ·Thierry Facon, MD，University of Lille, CHU Lille·刘卓刚 教授，中国医科大学附属盛京医院Central Nervous System Tumors Efficacy and safety of the vebreltinib in patients with previously treated, secondary glioblastoma/IDH mutant glioblastoma with PTPRZ1-METFUsion GENe (FUGEN): A randomised, multicentre, open-label, phase II/III trial. Abstract: 2003 · Zhaoshi Bao, MD, PhD，首都医科大学附属北京天坛医院 High-dose almonertinib in treatment-naïve EGFR-mutated NSCLC with CNS metastases: Efficacy and biomarker analysis. Abstract: 2007 · 范云 教授，浙江省肿瘤医院 SarcomaUpdated efficacy results of olverembatinib (HQP1351) in patients with tyrosine kinase inhibitor (TKI)-resistant succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumors (GIST) and paraganglioma. Abstract: 11502 · 邱海波 教授，中山大学肿瘤防治中心 Sintilimab, doxorubicin and ifosfamide (AI) as first-line treatment in patients with advanced undifferentiated pleomorphic sarcoma (UPS), synovial sarcoma (SS), myxoid liposarcoma (MLPS) and de-differentiated liposarcoma (DDLPS): A single-arm phase 2 trial. Abstract: 11505 · 罗志国 教授，复旦大学附属肿瘤医院 ARTEMIS-002: Phase 2 study of HS-20093 in patients with relapsed or refractory osteosarcoma. Abstract: 11507 · 谢璐 教授，北京大学人民医院 Head and Neck Cancer Adjuvant PD-1 blockade with camrelizumab in high-risk locoregionally advanced nasopharyngeal carcinoma (DIPPER): A multicenter, open-label, phase 3, randomized controlled trial. Abstract: LBA6000 · 刘需 教授，中山大学肿瘤防治中心 Tislelizumab versus placebo combined with induction chemotherapy followed by concurrent chemoradiotherapy and adjuvant tislelizumab or placebo for locoregionally advanced nasopharyngeal carcinoma: Interim analysis of a multicenter, randomized, placebo-controlled, double-blind, phase 3 trial. Abstract: 6001 · 陈秋燕 教授，中山大学肿瘤防治中心 Endostar combined with concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone for locoregionally advanced nasopharyngeal carcinoma (LA-NPC): A phase III, prospective, randomised-controlled, multicenter clinical trial. Abstract: 6002 · 康敏 教授，广西医科大学第一附属医院 Developmental Therapeutics—ImmunotherapyClaudin18.2-targeted chimeric antigen receptor T cell-therapy for patients with gastrointestinal cancers: Final results of CT041-CG4006 phase 1 trial. Abstract: 2501 · 齐长松 教授，北京大学肿瘤医院 A potential best-in-class BCMA-CD19 bispecific CART with advanced safety by self-inhibiting IFNG signaling during CRS. Abstract: 2502 · Lei Xue Efficacy and safety of LM-108, an anti-CCR8 monoclonal antibody, in combination with an anti-PD-1 antibody in patients with gastric cancer: Results from phase 1/2 studies. Abstract: 2504 · Chang Liu, MD，北京大学肿瘤医院Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology Phase I/II first-in-human study to evaluate the safety and efficacy of tissue factor-ADC MRG004A in patients with solid tumors.Abstract: 3002· Wungki Park, MD, MS，美国纪念斯隆凯瑟琳癌症中心· 张剑 教授，复旦大学附属肿瘤医院Updated safety and efficacy data of combined KRAS G12C inhibitor (glecirasib, JAB-21822) and SHP2 inhibitor (JAB-3312) in patients with KRAS p.G12C mutated solid tumors. Abstract: 3008 · 赵军 教授，北京大学肿瘤医院 快速口头摘要报告 Lung Cancer—Non-Small Cell Metastatic A multinational pivotal study of sunvozertinib in platinum pretreated non-small cell lung cancer with EGFR exon 20 insertion mutations: Primary analysis of WU-KONG1 study. Abstract: 8513 · James Chih-Hsin Yang 教授，台大肿瘤中心 Efficacy and safety of taletrectinib in patients with advanced or metastatic ROS1+ non–small cell lung cancer: The phase 2 TRUST-I study. Abstract: 8520 · 李玮 教授，同济大学附属上海市肺科医院 Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers Overall survival of adebrelimab plus chemotherapy and sequential thoracic radiotherapy as first-line treatment for extensive-stage small cell lung cancer. Abstract: 8014 · 陈大卫 教授，山东省肿瘤医院 Breast Cancer—Metastatic ACE-Breast-02: A pivotal phase II/III trial of ARX788, a novel anti-HER2 antibody-drug conjugate (ADC), versus lapatinib plus capecitabine for HER2+ advanced breast cancer (ABC). Abstract: 1020 · 胡夕春 教授，复旦大学附属肿瘤医院 Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary Efficacy and safety of cadonilimab in combination with pulocimab and paclitaxel as second-line therapy in patients with advanced gastric or gastroesophageal junction (G/GEJ) cancer who failed immunochemotherapy: A multicenter, double-blind, randomized trial. Abstract: 4012 · 张小田 教授，北京大学肿瘤医院 Phase I study of C-CAR031, a GPC3-specific TGFβRIIDN armored autologous CAR-T, in patients with advanced hepatocellular carcinoma (HCC). Abstract: 4019 · 章琦 教授，浙江大学医学院附属第一医院肝胆胰外科 Gastrointestinal Cancer—Colorectal and Anal Total neoadjuvant treatment with long-course radiotherapy versus concurrent chemoradiotherapy in local advanced rectal cancer with high risk factors (TNTCRT): A multicenter, randomized, open-label, phase 3 trial. Abstract: LBA3511 · Xin Wang, MD，四川大学华西医院 Phase I trial of hypoxia-responsive CEA CAR-T cell therapy in patients with heavily pretreated solid tumor via intraperitoneal or intravenous transfusion. Abstract: 3514 · Hangyu Zhang，浙江大学医学院第一附属医院 Three-year disease-free survival after transanal vs. laparoscopic total mesorectal excision for rectal cancer (TaLaR): A randomized clinical trial. Abstract: 3516 · 康亮 教授，中山大学附属第六医院 Genitourinary Cancer—Kidney and Bladder Camrelizumab plus apatinib for previously treated advanced adrenocortical carcinoma: A single-arm, open-label, phase 2 trial. Abstract: 4511 · Zhigong Wei，四川大学华西医院 Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant Latest results of a phase 2 study of IMM01 combined with azacitidine (AZA) as the first-line treatment in adults with higher risk myelodysplastic syndromes (MDS). Abstract: 6510 · Wei Yang，中国医科大学附属盛京医院 Safety and efficacy of CD7-CAR-T cell in patients with relapsed/refractory T-lymphoblastic leukemia/lymphoma: Phase I dose-escalation/dose-expansion study. Abstract: 6515 · Lijuan Hu, MD, 北京大学人民医院 Hematologic Malignancies—Plasma Cell Dyscrasia OriCAR-017, a novel GPRC5D-targeting CAR-T, in patients with relapsed/refractory multiple myeloma: Long term follow-up results of phase 1 study (POLARIS). Abstract: 7511 · Shan Fu，浙江大学医学院附属第一医院 Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia Timdarpacept (IMM01) in combination with tislelizumab in prior anti-PD-1 failed classical Hodgkin lymphoma: An open label, multicenter, phase II study (IMM01-04) evaluating safety as well as preliminary anti-tumor activity. Abstract: 7017 · Zhenjiu Wang, MD Gynecologic Cancer Efficacy and safety of sintilimab plus paclitaxel and cisplatin as neoadjuvant therapy for locally advanced cervical cancer: A phase II trial. Abstract: 5512 ·刘继红 教授，中山大学肿瘤防治中心 Nimotuzumab plus concurrent chemoradiotherapy for locally advanced cervical squamous cell carcinoma: The randomized, phase 3 CC3 study. Abstract: 5514 ·王俊杰 教授，北京大学第三人民医院 A phase III randomized, double-blinded, placebo-controlled study of suvemcitug combined with chemotherapy for platinum-resistant ovarian cancer (SCORES). Abstract: LBA5516 · 袁光文 教授，中国医学科学院肿瘤医院 Secondary cytoreduction followed by chemotherapy versus chemotherapy alone in platinum-sensitive relapsed ovarian cancer (SOC-1): A final overall survival analysis of a multicenter, open-label, randomized, phase 3 trial. Abstract: 5520 · 臧荣余 教授，复旦大学附属中山医院 Head and Neck Cancer Preliminary results of phase I/II study to evaluate safety and efficacy of combination pucotenlimab with epidermal growth factor receptor-ADC (EGFR-ADC) MRG003 in patients with EGFR positive solid tumors. Abstract: 6013 · 阮丹云 教授，中山大学肿瘤防治中心 Covalent FAPI PET enables accurate management of medullary thyroid carcinoma: a prospective single-arm comparative clinical trial. Abstract: LBA6018 · Ziren Kong, MD, 中国医学科学院北京协和医学院 Sarcoma A phase II study of anlotinib and an anti-PDL1 antibody in patients with alveolar soft part sarcoma: Results of expansion cohorts. Abstract: 11515 · 刘佳勇 教授，北京大学肿瘤医院 Phase 1 study of NB003, a broad-spectrum KIT/PDGFRα inhibitor, in patients with advanced gastrointestinal stromal tumors (GIST). Abstract: 11518 · 李健 教授，北京大学肿瘤医院 Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology Results of a phase 1/2 study of MHB088C: A novel B7H3 antibody-drug conjugate (ADC) incorporating a potent DNA topoisomerase I inhibitor in recurrent or metastatic solid tumors. Abstract: 3012 · 沈琳教授，北京大学肿瘤医院 9MW2821, a nectin-4 antibody-drug conjugate (ADC), in patients with advanced solid tumor: Results from a phase 1/2a study. Abstract: 3013 · 张剑 教授，复旦大学附属肿瘤医院 Developmental Therapeutics—Immunotherapy Phase I study of GUCY2C CAR-T therapy IM96 in patients with metastatic colorectal cancer. Abstract: 2518 · 齐长松 教授，北京大学肿瘤医院 Safety and preliminary efficacy results of IBI389, an anti-CLDN18.2/CD3 bispecific antibody, in patients with solid tumors and gastric or gastro-esophageal tumors: A phase 1 dose escalation and expansion study. Abstract: 2519 · 郑莉 教授，四川大学华西医院 Symptom Science and Palliative Care Effect of nurse-led multi-disciplinary treatment on patients with head and neck tumors: A randomized controlled trial. Abstract: 12013 · Jingjing Wang, MD，四川大学华西医院肿瘤中心 临床科学研讨会A phase 1/2 study of the TORC1/2 inhibitor onatasertib combined with toripalimab in patients with advanced solid tumors: Cervical cancer cohort. Abstract: 5509 · Hui Xie，德琪医药有限公司临床研发部 KRYSTAL-12: Phase 3 study of adagrasib versus docetaxel in patients with previously treated advanced/metastatic non-small cell lung cancer (NSCLC) harboring a KRASG12C mutation. Abstract: LBA8509 · Tony S. K. Mok 教授，香港大学 Sacituzumab tirumotecan (SKB264/MK-2870) in patients (pts) with previously treated locally recurrent or metastatic triple-negative breast cancer (TNBC): Results from the phase III OptiTROP-Breast01 study. Abstract: 104 · 樊英 教授，中国医学科学院肿瘤医院 Efficacy of disitamab vedotin (RC48) plus tislelizumab and S-1 as first-line therapy for HER2-overexpressing advanced stomach or gastroesophageal junction adenocarcinoma: A multicenter, single-arm, phase II trial (RCTS). Abstract: 4009 · 刘联 教授，山东大学齐鲁医院 A novel and uniquely designed bispecific antibody (LBL-024) against PD-L1 and 4-1BB in patients with advanced malignant tumors and neuroendocrine carcinoma: A report of safety and robust efficacy of LBL-024 monotherapy in phase I/II, first-in-human, open-label, multicenter, dose escalation/expansion study. Abstract: 4010 · 张盼盼 医生，北京大学肿瘤医院 Safety and efficacy of IBI389, an anti-CLDN18.2/CD3 bispecific antibody, in patients with advanced pancreatic ductal adenocarcinoma: Preliminary results from a phase 1 study. Abstract: 4011 · 郝继辉 教授，天津医科大学肿瘤医院 Neoadjuvant sintilimab and platinum-doublet chemotherapy followed by transoral robotic surgery for HPV-associated resectable oropharyngeal cancer: Single-arm, phase II trial. Abstract: 6011 · 宋明 教授，中山大学肿瘤防治中心 BiG 十周年预告 本次BiG十周年庆典，将首次分为国内和国际篇章，以原创科学和临床需求为出发点，讨论创新技术平台和创新疗法（PROTACT/分子胶、双抗/ADC、siRNA/ASO、CGT、AI制药）的重大进展和发展前景，十年一药曙光现，大浪淘沙始见金！▼报名参会 会议门票：审核制(免费)；含主论坛+分论坛，不含餐；优先biotech/Pharma、临床、院校科学家共建Biomedical创新生态圈！如何加入BiG会员？
ASCO会议临床结果
2024-04-25
·信达生物
2024年4月25日，美国旧金山和中国苏州——信达生物制药集团（香港联交所股票代码：01801），一家致力于研发、生产和销售肿瘤、自身免疫、代谢及心血管、眼科等重大疾病领域创新药物的生物制药公司，今日宣布，将在 2024 年美国临床肿瘤学会（ASCO）年会上公布约20项最新临床研究数据，包括公司旗下一系列单抗、双抗及抗体偶联药物（ADC）在研管线，及达伯舒®（信迪利单抗注射液）、耐立克®（奥雷巴替尼）、他雷替尼（ROS1抑制剂）等创新肿瘤药物。本届 ASCO 年会将于当地时间2024年5月31日-6月4日在美国芝加哥举办。信达生物制药集团高级副总裁周辉博士表示：“很高兴在本次ASCO大会上首次公布了信达生物多个下一代创新肿瘤双抗及ADC分子的临床数据，早期探索取得的成果令我们欣喜，也使我们对于进一步开发充满信心。作为少数拥有“IO+ADC”技术平台和充沛管线储备的生物制药企业，信达生物将在癌症治疗领域持续取得突破，致力于为医生和患者提供更创新、有效和安全的治疗手段及方案。”重要临床研究结果摘要信息如下：IBI363 (PD-1/IL-2 双特异性抗体融合蛋白)(共三项，滑动查看更多）摘要标题：全球首创（First-in-class） PD-1/IL-2双特异性抗体融合蛋白IBI363在晚期结直肠癌患者中的I期研究：安全性和有效性初步结果摘要编号：3593会议类型及展现形式：壁报分会场-消化道肿瘤-结直肠和肛门癌展示时间：2024年6月1日 下午1:30-4:30 (美国中部时间)演讲者：浙江大学医学院附属第一医院 陈怡文教授摘要标题：全球首创（First-in-class） PD-1/IL-2双特异性抗体融合蛋白IBI363治疗晚期黑色素瘤：I期研究的安全性和有效性初步结果摘要编号：9562 会议类型及展现形式：壁报分会场-黑色素瘤/皮肤癌 展示时间：2024年6月1日 下午1:30 -4:30 (美国中部时间)演讲者：福建省肿瘤医院 陈誉教授摘要标题：PD-1/IL-2双特异性抗体融合蛋白IBI363治疗其他实体瘤患者：I期研究的安全性和有效性初步结果摘要编号：e14593 会议类型及展现形式：在线发表 展示时间：2024年5月23日 下午5:00 （*美国东部时间）演讲者：浙江大学医学院附属第一医院 白雪莉教授IBI389 (抗CLDN18.2/CD3 双特异性抗体)(共两项，滑动查看更多）摘要标题：抗CLDN18.2/CD3双特异性抗体IBI389在实体瘤和胃或胃食管肿瘤患者中的安全性和初步疗效结果：I期剂量递增和扩展研究 摘要编号：2519会议类型及展现形式：快速口头报告-开发性治疗药物-免疫疗法展示时间：2024年6月2日 上午11:30-下午1:00 (美国中部时间)演讲者：四川大学华西医院 郑莉教授摘要标题：抗CLDN18.2/CD3双特异性抗体IBI389在晚期胰腺导管腺癌患者中的安全性和疗效：I期研究的初步结果摘要编号：4011 会议类型及展现形式：口头报告（临床科学研讨会）-消化道肿瘤的新型抗体疗法 展示时间：2024年6月2日 下午4:30 -6:00 (美国中部时间)演讲者：天津市肿瘤医院 郝继辉教授 IBI343 (抗CLDN18.2 ADC)摘要标题：IBI343（抗Claudin18.2 ADC）在晚期胰腺导管腺癌或胆道癌患者的安全性和疗效：I期研究的初步结果摘要编号：3037会议类型及展现形式：壁报分会场-开发治疗-分子靶向药物和肿瘤生物学 展示时间：2024年6月1日 上午9:00-12:00 (美国中部时间)演讲者：复旦大学附属肿瘤医院 虞先濬教授IBI310 (抗CTLA-4抗体)摘要标题：IBI310（抗CTLA-4抗体）联合信迪利单抗（抗PD-1抗体）对微卫星高度不稳定性（MSI-H）/错配修复缺陷(dMMR)结直肠癌患者的新辅助治疗：一项随机、开放标签的 Ib 期研究结果摘要编号：3505会议类型及展现形式：口头报告-消化道肿瘤-结直肠和肛门癌 展示时间：2024年6月2日 上午8:00-11:00 (美国中部时间)演讲者：中山大学肿瘤防治中心 徐瑞华教授他雷替尼（ROS1抑制剂）摘要标题：他雷替尼在晚期或转移性 ROS1阳性非小细胞肺癌患者的疗效和安全性：II期TRUST-I研究摘要编号：8520会议类型及展现形式：快速口头报告-肺癌-晚期非小细胞肺癌 展示时间：2024年6月1日 下午4:30-6:00 (美国中部时间)演讲者：同济大学附属上海市肺科医院 李玮教授IBI110 (抗LAG-3抗体)摘要标题：IBI110（抗LAG-3抗体）联合信迪利单抗（抗PD-1抗体）治疗晚期肺泡软组织肉瘤患者的有效性和安全性：II期研究结果摘要编号：11559会议类型及展现形式：壁报分会场-肉瘤 展示时间：2024年6月1日 下午1:30-4:30 (美国中部时间)演讲者：北京大学肿瘤医院 刘佳勇教授达伯舒®(信迪利单抗)1 (共九项，滑动查看更多）摘要标题：信迪利单抗联合紫杉醇和顺铂新辅助治疗局晚期宫颈癌的疗效和安全性：一项II期研究摘要编号：5512会议类型及展现形式：快速口头报告-妇科肿瘤展示时间：2024年6月1日 上午8:00-9:30 (美国中部时间)演讲者：中山大学肿瘤防治中心 刘继红教授摘要标题：新辅助信迪利单抗联合含铂双药化疗后进行经口机器人手术治疗 HPV 相关可切除口咽癌：单臂，II期临床研究摘要编号：6011 会议类型及展现形式：口头报告（临床科学研讨会）-精准切除：可手术切除的HPV阳性口咽癌的治疗决策 展示时间：2024年6月3日 下午3:00-4:00 (美国中部时间)演讲者：中山大学肿瘤防治中心 宋明教授摘要标题：单臂2期研究：信迪利单抗联合阿霉素和异环磷酰胺 (AI) 作为晚期未分化多形性肉瘤 (UPS)、滑膜肉瘤 (SS)、粘液样脂肪肉瘤 (MLPS) 和去分化脂肪肉瘤 (DDLPS) 患者的一线治疗疗效和安全性摘要编号：11505 会议类型及展现形式：口头报告-肉瘤 展示时间：2024年6月3日 下午3:00-6:00 (美国中部时间)演讲者：复旦大学附属肿瘤医院 罗志国教授摘要标题：BBCAPX-II研究生存结果更新：信迪利单抗联合贝伐珠单抗和CapeOx一线治疗RAS突变、MSS、不可切除的转移性结直肠癌摘要编号：3563 会议类型及展现形式：壁报分会场-消化道肿瘤-结直肠和肛门癌 展示时间：2024年6月1日 下午1:30-4:30 (美国中部时间)演讲者：浙江大学医学院附属第二医院 袁瑛教授摘要标题：信迪利单抗联合白蛋白紫杉醇二线治疗局晚期或转移性胃/胃食管结合部腺癌（G/GEJA）的疗效及生物标志物分析更新结果摘要编号：4037 会议类型及展现形式：壁报分会场-消化道肿瘤-胃食管、胰腺及肝胆肿瘤 展示时间：2024年6月1日 下午1:30-4:30 (美国中部时间)演讲者：中国医学科学院肿瘤医院 姜志超教授摘要标题：信迪利单抗联合阿昔替尼治疗晚期FH缺陷肾细胞癌：一项多中心、开放标签、单臂、II期研究（SAFH）摘要编号：4523 会议类型及展现形式：壁报分会场-泌尿生殖系统肿瘤-肾和膀胱肿瘤 展示时间：2024年6月2日 上午9:00-12:00 (美国中部时间)演讲者：四川大学华西医院 曾浩教授摘要标题：信迪利单抗联合安罗替尼一线治疗晚期非透明细胞肾癌（nccRR）：一项探索性、前瞻性、多中心临床研究的初步结果摘要编号：4544 会议类型及展现形式：壁报分会场-泌尿生殖系统肿瘤-肾和膀胱肿瘤展示时间：2024年6月2日 上午9:00-12:00（美国中部时间）演讲者：中山大学肿瘤防治中心 董培教授摘要标题：信迪利单抗联合呋喹替尼治疗晚期pMMR状态子宫内膜癌：一项多中心、单臂II期临床研究摘要编号：5619 会议类型及展现形式：壁报分会场-妇科肿瘤 展示时间：2024年6月3日 上午9:00-12:00（美国中部时间）演讲者：复旦大学附属肿瘤医院 吴小华教授摘要标题：信迪利单抗联合化疗新辅助(2个周期vs.3个周期)治疗可切非小细胞肺癌（neoSCORE）：一项随机、II期临床研究的最终生存及探索性生物标志物分析结果摘要编号：8048会议类型及展现形式：壁报分会场-肺部肿瘤-非小细胞/小细胞/其他胸腺肿瘤展示时间：2024年6月3日 下午1:30-4:30(美国中部时间)演讲者：浙江大学医学院附属第二医院 邱福铭教授耐立克®(奥雷巴替尼) 摘要标题：奥雷巴替尼（HQP1351）治疗酪氨酸激酶抑制剂（TKI）耐药的琥珀酸脱氢酶缺陷型（SDH-）胃肠道间质瘤（GIST）和副神经节瘤患者的最新疗效数据摘要编号：11502会议类型及展现形式：口头报告-肉瘤展示时间：2024年6月3日 下午3:00-6:00 (美国中部时间)演讲者： 中山大学肿瘤防治中心 邱海波教授关于信达生物- 滑动查看更多介绍 -“始于信，达于行”，开发出老百姓用得起的高质量生物药，是信达生物的使命和目标。信达生物成立于2011年，致力于研发、生产和销售肿瘤、自身免疫、代谢、眼科等重大疾病领域的创新药物，让我们的工作惠及更多的生命。公司已有10个产品获得批准上市，它们分别是信迪利单抗注射液（达伯舒®），贝伐珠单抗注射液（达攸同®），阿达木单抗注射液（苏立信®），利妥昔单抗注射液（达伯华®），佩米替尼片（达伯坦®），奥雷巴替尼片（耐立克®）， 雷莫西尤单抗注射液（希冉择®）2，塞普替尼胶囊（睿妥®）2，伊基奥仑赛注射液（福可苏®）和托莱西单抗注射液（信必乐®）。目前，同时还有3个品种在NMPA审评中，5个新药分子进入III期或关键性临床研究，另外还有18个新药品种已进入临床研究。公司已与礼来、罗氏、赛诺菲、Adimab、Incyte和MD Anderson 癌症中心等国际合作方达成30多项战略合作。信达生物在不断自研创新药物、谋求自身发展的同时，秉承经济建设以人民为中心的发展思想。多年来，始终心怀科学善念，坚守“以患者为中心”，心系患者并关注患者家庭，积极履行社会责任。公司陆续发起、参与了多项药品公益援助项目，让越来越多的患者能够得益于生命科学的进步，买得到、用得起高质量的生物药。至2023年底，信达生物患者援助项目已惠及17余万普通患者，药物捐赠总价值34亿元人民币。信达生物希望和大家一起努力，提高中国生物制药产业的发展水平，以满足百姓用药可及性和人民对生命健康美好愿望的追求。详情请访问公司网站：www.innoventbio.com或公司领英账号Innovent Biologics。声明：信达生物不推荐未获批的药物/适应症的使用。1.除摘要5619外，信迪利单抗部分均为基于研究者申请发起的临床研究（IIT）。2.雷莫西尤单抗注射液（希冉择®）和塞普替尼胶囊（睿妥®）由礼来公司研发。前瞻性声明本新闻稿所发布的信息中可能会包含某些前瞻性表述。这些表述本质上具有相当风险和不确定性。在使用“预期”、“相信”、“预测”、“期望”、“打算”及其他类似词语进行表述时，凡与本公司有关的，目的均是要指明其属前瞻性表述。本公司并无义务不断地更新这些预测性陈述。这些前瞻性表述乃基于本公司管理层在做出表述时对未来事务的现有看法、假设、期望、估计、预测和理解。这些表述并非对未来发展的保证，会受到风险、不确性及其他因素的影响，有些乃超出本公司的控制范围，难以预计。因此，受我们的业务、竞争环境、政治、经济、法律和社会情况的未来变化及发展的影响，实际结果可能会与前瞻性表述所含资料有较大差别。
临床1期ASCO会议抗体药物偶联物临床结果
2024-04-25
SAN FRANCISCO and SUZHOU, China, April 24, 2024 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces that about 20 accepted abstracts of clinical data from multiple trials in relation to multiple novel mono-/bi-specific antibodies and antibody-drug-conjugates (ADCs) as well as innovative drugs including TYVYT® (sintilimab injection), olverembatinib, taletrectinib (ROS1 TKI) from its oncology pipeline will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting 2024 from May 31 to June 4, 2024, in Chicago, IL, U.S..
Dr. Hui Zhou, Senior Vice President of Innovent, stated: "We are very pleased to present a robust set of clinical data for our next-generation innovative bispecific antibodies and ADC molecules for the first time at the 2024 ASCO Annual Meeting. We observed the preliminary efficacy and safety signals for those innovative candidates, underscoring their potential for further development and clinical value. As one of the few biopharmaceutical companies with both the technology platforms and robust pipeline in "IO+ADC" areas, Innovent will continue to make breakthroughs in the field of cancer treatment, and is committed to providing doctors and patients with more innovative, effective and safe treatment options."
Details on the abstracts are listed below:
About Innovent
Innovent is a leading biopharmaceutical company founded in 2011 with the mission to provide high-quality biologics that are affordable to all. The company discovers, develops, manufactures and commercializes innovative medicines that treat some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has 10 products in the market, 3 new drug applications under the NMPA review, 5 assets in Phase III or pivotal clinical trials and 18 more molecules in early clinical stage. Innovent partners with over 30 global healthcare leaders, including Eli Lilly, Roche, Sanofi, Adimab, Incyte and MD Anderson Cancer Center.
Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn.
Statement: Innovent does not recommend the use of any unapproved drug (s)/indication (s).
Forward-looking statement
This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent Biologics ("Innovent"), are intended to identify certain of such forward-looking statements. The Company does not intend to update these forward-looking statements regularly.
These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of the Company with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond the Company's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, the Company's competitive environment and political, economic, legal and social conditions.
The Company, the Directors and the employees of the Company assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialise or turn out to be incorrect.
SOURCE Innovent Biologics
ASCO会议
100 项与 奥雷巴替尼 相关的药物交易
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研发状态
| 适应症 | 最高研发状态 | 国家/地区 | 公司 |
|---|---|---|---|
| 慢性期慢性髓性白血病 | 批准上市 | 中国 更多 | |
| 费城染色体阳性急性淋巴细胞白血病 | 临床3期 | 中国 更多 | |
| 费城染色体阳性慢性粒细胞白血病 | 临床2期 | 中国 更多 | |
| 急性淋巴细胞白血病 | 临床1期 | 加拿大 更多 | |
| 胃肠道间质瘤 | 临床1期 | 中国 更多 |
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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 |
|---|
临床2期 | 144 | 膚襯觸獵構鑰膚窪蓋夢(網遞憲製構鏇壓淵簾製) = 範窪膚鏇願繭製齋鬱顧 壓餘範遞積繭襯壓範窪 (蓋簾襯蓋廠窪醖範繭淵, 10.15 ~ NR) 更多 | 积极 | 2023-12-11 | |||
Best Available Therapy (BAT) | 膚襯觸獵構鑰膚窪蓋夢(網遞憲製構鏇壓淵簾製) = 築構餘獵積範顧遞鹽構 壓餘範遞積繭襯壓範窪 (蓋簾襯蓋廠窪醖範繭淵, 2.53 ~ 4.73) 更多 | ||||||
ASH2023 人工标引  | 临床2期 | 29 | Olverembatinib + VP regimen | 壓鹽糧繭鬱積鹹簾窪夢(餘觸繭鏇膚鹽鹽鏇淵膚) = 襯願淵觸鹹選選築範壓 範範壓鹹築鏇製衊餘醖 (餘膚願鹽鏇繭衊艱網觸 ) 更多 | 积极 | 2023-12-11 | |
临床2期 | 45 | 鬱齋窪繭鹹製窪網築遞(憲鹽壓築選襯襯鏇製網) = 膚艱構構淵鏇醖構鹹醖 範選憲鑰醖壓鬱鏇壓選 (觸簾構廠窪廠製鏇餘窪 ) 更多 | 积极 | 2023-12-11 | |||
N/A | 56 | 膚艱範構鏇網顧膚築廠(壓構膚醖鑰鬱鬱醖襯蓋) = 構選憲鹹積蓋鑰顧顧獵 鏇網憲壓選鹹獵鏇積顧 (壓廠鬱鑰繭選膚製壓夢 ) 更多 | - | 2023-12-11 | |||
ASH2023 人工标引 | N/A | 急性髓性白血病 一线 | 18 | 窪鬱齋鏇遞糧窪蓋餘繭(膚蓋餘膚鹹膚壓餘獵齋) = 製顧遞襯鹹簾積觸夢醖 築鏇鬱糧淵衊蓋鹹糧選 (鏇簾遞願窪鹽鹽窪膚鏇 ) 更多 | 积极 | 2023-12-10 | |
ASH2023 人工标引 | N/A | 13 | 窪構繭願夢壓憲積夢鑰(網憲顧膚鑰網齋壓積憲) = 鬱鑰鑰襯範觸遞鹹窪鹹 繭鑰襯積餘顧願夢餘醖 (鹽齋構鹽餘衊鹹餘餘齋 ) 更多 | 积极 | 2023-12-09 | ||
临床1期 | 76 | (pts with CML-CP) | 網醖鏇構糧繭鬱夢淵壓(製鏇選糧鑰鑰鹽襯糧齋) = 選範繭壓廠積壓衊膚築 憲鹹襯築鏇鑰構繭醖鏇 (範壓獵築觸顧糧繭網艱 ) 更多 | 积极 | 2023-12-09 | ||
(pts with CML-CP; failed ≥ 4 prior TKIs) | 網醖鏇構糧繭鬱夢淵壓(製鏇選糧鑰鑰鹽襯糧齋) = 積積簾鬱糧淵憲構餘簾 憲鹹襯築鏇鑰構繭醖鏇 (範壓獵築觸顧糧繭網艱 ) 更多 | ||||||
EHA2023 人工标引 | N/A | 13 | 獵觸簾艱繭製鑰築廠壓(鏇鑰簾鹽鏇鏇積壓簾網) = 糧顧淵艱範窪簾淵膚網 窪窪夢鹽餘鏇構鏇鹽鹹 (鑰網淵鹽築積遞衊餘憲 ) 更多 | - | 2023-06-08 | ||
临床1期 | 琥珀酸脱氢酶缺陷型胃肠道间质瘤 SDH Deficient Expression | 20 | 蓋壓構製齋鬱夢蓋簾鏇(廠窪觸願憲齋膚鹽艱顧) = All pts experienced treatment-emergent adverse events (AEs) (most, grade 1 or 2); 2 pts experienced grade 3 AEs; the only hematologic AE with an incidence rate ≥ 20% was anemia (55%). 廠選願簾選襯醖選選蓋 (鑰構夢糧窪襯鏇夢顧膚 ) 更多 | 积极 | 2023-05-31 | ||
临床1期 | 101 | (CML-CP) | 壓窪簾願願遞構膚遞糧(顧築醖積鬱鏇膚顧襯窪) = 獵顧繭築壓衊蓋壓膚窪 糧廠壓顧範製積獵觸衊 (顧膚顧壓顧觸選齋糧積, 44 ~ 65) 更多 | 积极 | 2022-11-15 | ||
(T315I mutations + CML-CP) | 壓窪簾願願遞構膚遞糧(顧築醖積鬱鏇膚顧襯窪) = 糧選遞繭繭獵壓膚積鹹 糧廠壓顧範製積獵觸衊 (顧膚顧壓顧觸選齋糧積 ) 更多 |
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