2024 ASCO|泽璟制药将公布多纳非尼&吉卡昔替尼多项研究结果

2024-05-07

临床结果ASCO会议上市批准临床研究

5月7日，泽璟制药宣布，公司自主研发的甲苯磺酸多纳非尼片、盐酸吉卡昔替尼片（曾用名：杰克替尼）在内的合计18项临床研究结果将于2024年美国临床肿瘤学（ASCO）上公布。多纳非尼是一种口服多靶点、多激酶抑制剂类小分子抗肿瘤药物。目前，多纳非尼已经国内获批两项适应症，分别用于一线治疗晚期肝细胞癌，以及治疗局部晚期/转移性放射性碘难治性分化型甲状腺癌（RAIR-DTC）。2021年6月首次获批上市，适应症为一线治疗晚期肝细胞癌，其对标产品为德国拜耳的索拉非尼，后者也是目前肝细胞癌一线治疗的标准疗法之一。临床前药理学研究证实，多纳非尼片既可抑制VEGFR、PDGFR等多种受体酪氨酸激酶的活性，也可抑制肿瘤细胞增殖和肿瘤血管的形成，发挥多重抑制、多靶点阻断的抗肿瘤作用。盐酸吉卡昔替尼（曾用名：盐酸杰克替尼）是公司自主研发的一种新型JAK和ACVR1双抑制剂类药物，属于1类新药。吉卡昔替尼对Janus激酶包括JAK1、JAK2、JAK3和TYK2具有显著的抑制作用，且对JAK2和TYK2的抑制作用最强。目前正在开展多个免疫炎症性疾病和纤维化疾病的临床研究。此次大会多纳非尼&吉卡昔替尼的主要临床研究结果摘要信息如下：多纳非尼标题：使用综合多组学分析来确定多纳非尼与FADS2抑制剂联合治疗在肝细胞癌中的抗肿瘤效果Title:Use of integrated multi-omics analysis to determine antitumor efficacy of donafenib in combination with FADS2 inhibition in hepatocellular carcinoma摘要编号：e15083展示形式：在线发表主要研究者：朱旭教授标题：多纳非尼用于高复发风险的肝细胞癌患者根治性切除术后辅助治疗的一项多中心、回顾性研究Title: Adjuvant donafenib for patients with hepatocellular carcinoma at high risk of recurrence following radical resection: A multi-center, retrospective study in China摘要编号：e15129展示形式：在线发表主要研究者：刘连新王继洲教授标题：多纳非尼联合抗PD-1抗体治疗不可切除的肝细胞癌患者的有效性与安全性：一项回顾性真实世界研究Title: Efficacy and safety of Donafenib combined with anti-PD-1 PD-1 antibodies for initially unresectable hepatocellular carcinoma（HCC）: A retrospective real-world study摘要编号：e16131展示形式：在线发表主要研究者：刘苏来/彭创教授标题：TACE/HAIC联合多纳非尼及免疫检查点抑制剂治疗不可切除肝细胞癌的疗效和安全性：一项多中心回顾性研究Title: Efficacy and safety of transarterial therapy combined with donafenib plus immune checkpoint inhibitors for unresectable hepatocellular carcinoma: a multicenter retrospective study摘要编号：e16133展示形式：在线发表主要研究者：商昌珍教授标题：多纳非尼联合TACE治疗不可切除肝细胞癌的疗效和安全性分析：一项前瞻性、单臂、单中心、II期临床研究Title: Efficacy and safety analysis of donafenib combined with transarterial chemoembolization in the treatment of unresectable hepatocellular carcinoma a prospective，single-arm，single center，phase Ⅱ clinical study摘要编号：e16134展示形式：在线发表主要研究者：李金鹏/宋金龙教授标题：比较TACE联合多纳非尼或仑伐替尼用于治疗不可切除肝细胞癌的疗效和安全性：一项回顾性真实世界研究Title: Comparing the efficacy and safety of TACE combined with donafenib VS lenvatinib in the treatment of unresectable hepatocellular carcinoma：A retrospectine real-world study摘要编号：e16137展示形式：在线发表主要研究者：黄明声/刘欢教授标题：TACE联合多纳非尼用于不可切除肝细胞癌一线治疗：一项真实世界临床研究Title: Transarterial chemoembolization (TACE) combined with Donafenib as first-line therapy for unresectable hepatocellular carcinoma (uHCC): A real-world clinical study摘要编号：e16145展示形式：在线发表主要研究者：范文哲教授标题：比较TACE联合多纳非尼或仑伐替尼治疗不可切除肝细胞癌的疗效和安全性Title: Comparing the efficacy and safety of TACE combined with donafenib or lenvatinib in the treatment of unresectable hepatocellular carcinoma摘要编号：e16153展示形式：在线发表主要研究者：吕维富/魏宁教授标题：多纳非尼联合TACE伴或不伴免疫疗法在中晚期肝细胞癌（HCC）中的疗效和安全性Title: A retrospective study on the efficacy and safety of Donafenib combined with Transarterial chemoembolization (TACE) and with/without immunotherapy in intermediate-advanced hepatocellular carcinoma (HCC).摘要编号：e16171展示形式：在线发表主要研究者：赵辉教授标题：TACE-HAIC联合多纳非尼及免疫疗法治疗伴有门静脉肿瘤血栓的肝细胞癌的有效性及安全性Title: TACE-HAIC combined with Donafenib and immunotherapy for hepatocellular carcinoma (HCC) with portal vein tumour thrombus (PVTT): A retrospective analysis.摘要编号：e16174展示形式：在线发表主要研究者：刘瑞宝尹立楠教授标题：多纳非尼联合TACE及抗PD-1抗体作为肝细胞癌一线治疗的疗效与安全性Title: The Efficacy and Safety of Donafenib Combined with Transcatheter Arterial Chemoembolization and Anti PD-1 Antibodies as First-line Therapy for Hepatocellular Carcinoma: A Retrospective Study摘要编号：e16178展示形式：在线发表主要研究者：郑家平教授标题：不同一线肝癌治疗药物（多纳非尼、索拉非尼或仑伐替尼）联合TACE治疗失败后序贯瑞戈非尼的疗效比较Title: Comparative effificacy of systemic sequential regorafenib after TACE combined with First-line targeted drugs(donafenib, sorafenib or lenvatinib) treatment failure for advanced hepatocellular carcinoma: A retrospective, single-center, real world study.摘要编号：e16190展示形式：在线发表主要研究者：吕维富/魏宁教授标题：术后辅助性肝动脉灌注化疗联合多纳非尼治疗单发大肿瘤伴微血管侵犯的肝细胞癌Title: Postoperative adjuvant hepatic arterial infusion chemotherapy combined with donafenib in hepatocellular carcinoma with solitary large tumor and microvascular invasion: a multicenter, prospective, single-arm, phase II trial摘要编号：e16227展示形式：在线发表主要研究者：张磊教授标题：多纳非尼联合抗PD-1抗体用于有高复发风险肝细胞癌患者切除后的辅助治疗（PATH研究）Title: Adjuvant theraPy with DonAfenib plus anTi-PD-1 antibody PD-1 antibody for patients (pts) at high risk of Hepatocellular carcinoma (HCC) recurrence after resection (PATH study)摘要编号：e16228展示形式：在线发表主要研究者：梁廷波/白雪莉教授标题：多纳非尼作为肝切除后肝细胞癌（HCC）患者的辅助治疗的疗效和安全性Title: Efficacy and safety of donafenib as adjuvant therapy for patients with hepatocellular carcinoma (HCC) after hepatectomy: A Retrospective, Multicenter Cohort Study摘要编号：e16234展示形式：在线发表主要研究者：杨欣荣教授标题：以多纳非尼为基础的系统性治疗方案用于肝细胞癌一线治疗的疗效和安全性Title: The efficacy and safety of donafenib-containing regimens as first-line therapy for hepatocellular carcinoma (HCC): A multicenter retrospective study.摘要编号：e16243展示形式：在线发表主要研究者：尹国文/张庆桥教授泛TKI标题：立体定向放疗（SBRT）联合TACE及酪氨酸激酶抑制剂（TKIs）与单独TACE联用TKIs治疗伴有门静脉肿瘤血栓（PVTT）的不可切除肝细胞癌（uHCC）的一项随机对照试验Title: Stereotactic body radiotherapy (SBRT) combined with transcatheter arterialchemoembolization (TACE) and tyrosine kinase inhibitors (TKIs) versus TACE and TKISalone for unresectable hepatocellular carcinoma (uHCC) with portal vein tumor thrombus(PVTT):A randomized controlled trial摘要编号：4102展现形式：壁报展示分会场标题：Gastrointestinal Cancer-Gastroesophageal, Pancreatic, and Hepatobiliary展示时间：2024.06.01 1:30 PM-4:30 PM主要研究者：王辛教授吉卡昔替尼标题：接受吉卡昔替尼治疗的骨髓纤维化患者中铁蛋白、血红蛋白与贫血反应之间的关联：ZGJAK006研究的事后分析Title: Association between ferritin, hemoglobin and anemia response in jaktinib-treated myelofibrosis (MF) patients (pts): A post-hoc analysis of the ZGJAK006 study摘要编号：e18527展示形式：在线发表主要研究者：金洁教授往期推荐视角 | 纸面之外的药明康德2023年报Claudin18.2ADC赛道群雄逐鹿：3家率先进入III期临床下一个10亿美元重磅炸弹选手"裁员潮”仍在加剧：2月多家药企裁员点击下方“药研网”，关注更多精彩内容