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6-K: Gsk's B7-H3-Targeted Antibody-Drug Conjugate, Gsk'227, Receives Ema Priority Medicines (Prime) Designation in Relapsed Extensive-Stage Small-Cell Lung Cancer

6-K: Gsk's B7-H3-Targeted Antibody-Drug Conjugate, Gsk'227, Receives Ema Priority Medicines (Prime) Designation in Relapsed Extensive-Stage Small-Cell Lung Cancer

6-K：Gsk的B7-H3靶向抗体药物偶联物Gsk'227获得Ema优先药物(Prime)称号，用于治疗复发性广泛期小细胞肺癌
美股SEC公告 ·  2024/12/16 22:08

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GSK announced on December 16, 2024, that its B7-H3-targeted antibody-drug conjugate (GSK'227) has received Priority Medicines (PRIME) Designation from the European Medicines Agency for treating relapsed extensive-stage small-cell lung cancer (ES-SCLC). This follows the FDA's Breakthrough Therapy Designation granted in August 2024, supporting medicines with potential major therapeutic advantages.The designation is based on preliminary clinical data from the ARTEMIS-001 study, an ongoing phase I trial involving over 200 patients with advanced solid tumours. GSK recently initiated a global phase I trial to support GSK'227's registrational pathway, following its acquisition of exclusive worldwide rights (excluding Greater China) from Hansoh.ES-SCLC represents 60-85% of all SCLC cases at diagnosis, with particularly poor outcomes for platinum-resistant patients showing median survival under six months. In Europe alone, 2022 saw approximately 484,554 new lung cancer cases and 375,784 deaths, with SCLC accounting for 10-15% of all lung cancer cases.
GSK announced on December 16, 2024, that its B7-H3-targeted antibody-drug conjugate (GSK'227) has received Priority Medicines (PRIME) Designation from the European Medicines Agency for treating relapsed extensive-stage small-cell lung cancer (ES-SCLC). This follows the FDA's Breakthrough Therapy Designation granted in August 2024, supporting medicines with potential major therapeutic advantages.The designation is based on preliminary clinical data from the ARTEMIS-001 study, an ongoing phase I trial involving over 200 patients with advanced solid tumours. GSK recently initiated a global phase I trial to support GSK'227's registrational pathway, following its acquisition of exclusive worldwide rights (excluding Greater China) from Hansoh.ES-SCLC represents 60-85% of all SCLC cases at diagnosis, with particularly poor outcomes for platinum-resistant patients showing median survival under six months. In Europe alone, 2022 saw approximately 484,554 new lung cancer cases and 375,784 deaths, with SCLC accounting for 10-15% of all lung cancer cases.
GSk于2024年12月16日宣布，其B7-H3靶向抗体药物偶联物（GSK'227）已获得欧洲药品管理局的优先药物（PRIME）认证，用于治疗复发性广泛期小细胞肺癌（ES-SCLC）。这项认证是在2024年8月美国FDA授予的突破性疗法认证的基础上进行的，支持具有重大治疗优势的药物。该认证基于ARTEMIS-001研究的初步临床数据，该研究是一个正在进行的I期试验，涉及200多名晚期实体肿瘤患者。GSk最近启动了一项全球I期试验，以支持GSK'227的注册路径，此前其从汉森获得了全球独家权利（不包括大中华地区）。ES-SCLC在诊断时占所有小细胞肺癌病例的60-85%，尤其是对铂金耐药患者的预后较差，中位生存期不足六个月。仅在欧洲，2022年就出现了约484,554例新肺癌病例和375,784例死亡，其中SCLC占所有肺癌病例的10-15%。
GSk于2024年12月16日宣布，其B7-H3靶向抗体药物偶联物（GSK'227）已获得欧洲药品管理局的优先药物（PRIME）认证，用于治疗复发性广泛期小细胞肺癌（ES-SCLC）。这项认证是在2024年8月美国FDA授予的突破性疗法认证的基础上进行的，支持具有重大治疗优势的药物。该认证基于ARTEMIS-001研究的初步临床数据，该研究是一个正在进行的I期试验，涉及200多名晚期实体肿瘤患者。GSk最近启动了一项全球I期试验，以支持GSK'227的注册路径，此前其从汉森获得了全球独家权利（不包括大中华地区）。ES-SCLC在诊断时占所有小细胞肺癌病例的60-85%，尤其是对铂金耐药患者的预后较差，中位生存期不足六个月。仅在欧洲，2022年就出现了约484,554例新肺癌病例和375,784例死亡，其中SCLC占所有肺癌病例的10-15%。
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