​多款单抗临床实验最新数据发布；潘瑞鲁单抗Ⅲ期临床失败

关键词

帕博西尼 细胞毒性 奥贝利单抗 阿伐可泮 达雷妥尤单抗 阿替利珠单抗 贝伐珠单抗 替雷利珠单抗 戈利昔替尼 潘瑞鲁单抗

今日行业热点

①The Lancet Oncology：Neoadjuvant palbociclib plus either giredestrant or anastrozole in oestrogen receptor-positive, HER2-negative, early breast cancer (coopERA Breast Cancer): an open-label, randomised, controlled, phase 2 study

临床试验：帕博西尼（palbociclib）联合giredestrant或阿那曲唑（Anastrozole）辅助用于雌激素受体阳性、her2阴性早期乳腺癌(coopERA乳腺癌)的一项开放标签、随机、对照、Ⅱ期研究

DOI: 10.1016/S1470-2045(23)00268-1

②The Lancet Oncology：Combined cytotoxic and immune-stimulatory gene therapy for primary adult high-grade glioma: a phase 1, first-in-human trial

临床试验：联合细胞毒性和免疫刺激基因疗法用于原发性成人高级别胶质瘤:一项Ⅰ期、首次人体试验

DOI: 10.1016/S1470-2045(23)00347-9

③The Lancet Rheumatology：Evaluation of the safety, efficacy, and mechanism of action of obexelimab for the treatment of patients with IgG4-related disease: an open-label, single-arm, single centre, phase 2 pilot trial

临床试验：奥贝利单抗 (Obexelimab)用于IgG4相关疾病患者的安全性、有效性和作用机制:一项开放标签、单臂、单中心、Ⅱ期试点试验

DOI: 10.1016/S2665-9913(23)00157-1

④The Lancet Rheumatology：The impact of treatment with avacopan on health-related quality of life in antineutrophil cytoplasmic antibody-associated vasculitis: a post-hoc analysis of data from the ADVOCATE trial

临床分析：阿伐可泮（avacopan）用于抗中性粒细胞细胞质抗体(ANCA)相关血管炎患者健康相关生活质量的影响:对ADVOCATE试验数据的分析

DOI: 10.1016/S2665-9913(23)00092-9

⑤EClinicalMedicine：Evaluation of the safety, efficacy, and mechanism of action of obexelimab for the treatment of patients with IgG4-related disease: an open-label, single-arm, single centre, phase 2 pilot trial

临床试验：伊沙佐米（Ixazomib）、达雷妥尤单抗（Daratumumab）和低剂量地塞米松（Dexamethasone）用于新诊断多发性骨髓瘤的中等适应度患者:一项开放标签Ⅱ期试验

DOI: 10.1016/j.eclinm.2023.102167

⑥EClinicalMedicine：Effectiveness and safety of atezolizumab-bevacizumab in patients with unresectable hepatocellular carcinoma: a systematic review and meta-analysis

临床分析：阿替利珠单抗（Atezolizumab）联合贝伐珠单抗（Bevacizumab）用于不可切除肝细胞癌的有效性和安全性:一项系统评价和荟萃分析

DOI: 10.1016/j.eclinm.2023.102179

⑦PD-1抗体替雷利珠单抗的新适应症上市申请获CDE受理，推测申报的适应症为广泛期小细胞肺癌（ES-SCLC）

⑧高选择性JAK1抑制剂戈利昔替尼拟纳入优先审评，用于复发或难治的外周T细胞淋巴瘤（r/r PTCL）

⑨脂蛋白（a）-Lp（a）抑制剂莫伐倍林（Muvalaplin）首次人体Ⅰ期临床积极结果公布，24小时内显著降低胆固醇

⑩靶向CTGF的IgG1亚型全人源抗体潘瑞鲁单抗（Pamrevlumab）用于杜氏肌营养不良症(DMD)的Ⅲ期临床未达到主要终点和关键次要终点

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