强生宣布中国首个且目前唯一治疗BRCA突变转移性去势抵抗性前列腺癌的复方制剂泽倍珂®在华获批[1]
2024-10-21 19:00:51
百姓健康网
泽倍珂®是每日一次的口服复方制剂,用于联合泼尼松或泼尼松龙一线治疗携带BRCA1/2突变的转移性去势抵抗性前列腺癌成人患者,临床证实其相较标准治疗可显著延长影像学无进展生存期[2]。
北京2024年10月21日 /美通社/ -- 强生公司今日宣布,旗下创新治疗药物泽倍珂®(尼拉帕利阿比特龙片)正式获得国家药品监督管理局批准。作为目前国内首个且唯一获批的双效复方制剂[1],泽倍珂®联合泼尼松或泼尼松龙用于治疗携带胚系和/或体系BRCA基因突变的转移性去势抵抗性前列腺癌成人患者(mCRPC)[3]。
泽倍珂®是BRCA1/2突变mCRPC成人患者的一线靶向治疗方案[4]。作为一种高选择性聚腺苷二磷酸核糖聚合酶(PARP)抑制剂[5],尼拉帕利和醋酸阿比特龙的组合联合泼尼松或泼尼松龙,能够靶向mCRPC患者的两种致癌驱动因素——雄激素受体轴和BRCA1/2突变[3],[6],[7]。经临床验证,泽倍珂®联合泼尼松或泼尼松龙可显著延长BRCA1/2突变mCRPC患者的影像学无进展生存期(rPFS)。此外,与安慰剂相比,尼拉帕利还显示出总体生存 (OS)改善的趋势,可显著延长至症状进展时间(TSP)和至细胞毒性化疗起始时间(TCC),同时并维持了患者的生活质量[8]。
近年来,中国前列腺癌的发病率显著上升。据国家癌症中心最新发布的2022年度中国恶性肿瘤疾病负担报告显示,我国前列腺癌的发病率为每10万人中18.61例,已成为男性泌尿生殖系统中最常见的肿瘤[9]。尽管随着我国医疗水平的提高,前列腺癌的治疗已经取得一定进展,但是mCRPC仍然是一种致命的疾病[10],[11]。据统计,大约10-15%的mCRPC患者携带BRCA1/2基因突变[12],[13],而携带BRCA1/2基因突变的前列腺癌往往恶性程度更高,可能具有更强的侵袭性和更高的转移性疾病比例,患者的生存结局更差[14],[15],[16],[17],[18]。因此,NCCN和EAU等国内外权威指南均推荐对mCRPC患者进行基因检测,以提供更加精准的治疗决策,改善患者临床获益[19],[20]。
强生创新制药中国区总裁Cherry Huang女士表示:"泽倍珂®的获批再次印证了前列腺癌精准治疗时代的到来,突显了基因检测在前列腺癌诊疗中的重要意义。长期以来,强生始终关注不同疾病阶段前列腺癌患者的切实需求,持续引入创新疗法及产品组合,从前列腺癌的晚期治疗,进一步覆盖到更早期阶段。同时,我们也希望让更多患者实现前列腺癌全程管理,在早期、规范化、足疗程的诊疗中获得更长生存。"
此次泽倍珂®的获批是基于一项随机、双盲、安慰剂对照的多中心III期MAGNITUDE研究。结果显示,在BRCA突变亚组中,尼拉帕利联合醋酸阿比特龙加泼尼松或泼尼松龙(AAP)显著降低影像学进展或死亡风险达47%(rPFS, HR=0.53;95%CI 0.36,0.79;p=0.0014)[3]。在第二次期中分析时,中位随访时间为24.8个月,与安慰剂联合AAP的10.9个月相比,尼拉帕利联合AAP治疗BRCA突变亚组的中位rPFS为19.5个月(HR,0.55[95%(CI),0.39-0.78])[21]。此外,尼拉帕利在至症状进展时间(TSP)上有统计学意义上的获益,与对照组相比,症状进展风险显著降低了46%(未达到中位数与23.6个月相比;HR=0.54,95% CI:0.35-0.85;P=0.0071)[3]。值得注意的是,试验还观察到,接受尼拉帕利联合APP治疗的BRCA1/2 基因突变 mCRPC 患者与接受安慰剂联合AAP治疗的患者相比,尼拉帕利在至细胞毒性化疗起始时间(TCC)上达到统计学意义和临床意义的改善(中位时间未达到 vs. 27.3 个月;HR:0.56,95% CI:0.35-0.90; p=0.0152)[3]。
在安全性方面,研究显示尼拉帕利和AAP联合用药与单药的已知安全性一致。该联合疗法最常见的不良反应(>10%)包括肌肉骨骼疼痛、疲乏、便秘、高血压、恶心、水肿、呼吸困难等[3]。
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