智通财经APP讯,中国生物制药(01177)发布公告,集团研发的1类创新药库莫西利胶囊已在2024年全国临床肿瘤学大会(2024 CSCO)以口头报告的形式公布了III期临床(TQB3616-III-01)最新研究成果,用于联合氟维司群注射液治疗内分泌经治的激素受体阳性╱人表皮生长因子受体2阴性(HR+/HER2-)晚期乳腺癌:中位无进展生存期(PFS)为16.62个月,客观缓解率(ORR)为40.21%,总生存期(OS)呈获益趋势。
TQB3616-III-01是全球首个口服CDK2/4/6抑制剂联合内分泌治疗用于HR+/HER2-晚期乳腺癌取得阳性结果的III期试验。这是一项随机、双盲、平行对照、多中心临床研究,旨在评估库莫西利联合氟维司群(实验组)对比安慰剂联合氟维司群(对照组)在内分泌经治的HR+/HER2-晚期乳腺癌患者中的有效性和安全性。
研究结果显示,库莫西利联合氟维司群组对比安慰剂联合氟维司群组的中位PFS为16.62个月vs. 7.46 个月。与对照组相比,库莫西利联合治疗的中位PFS延长9.16个月,疾病进展╱死亡风险降低64% (HR=0.36, P<0.0001)。主要研究结果中位PFS、风险比(HR)和PFS绝对获益程度均高于现有标准治疗的数据。
集团在2024 CSCO公布了20余项最新研究成果,全面展示了集团在多个肿瘤治疗领域取得的突破性进展。未来,集团将继续聚焦创新,深入探索创新药物与治疗方案,以期为患者带来更多获益,让健康科技,温暖更多生命。
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