重磅!国内最佳治疗铂敏感及铂耐药复发性卵巢癌的PARP抑制剂帕米帕利获批

2021-05-07 百济神州 百济神州

突破传统化疗局限,PARP抑制剂帕米帕利开启复发性卵巢癌治疗新时代!

202157日,百济神州第三款自主研发的抗癌新药PARP抑制剂百汇泽®(通用名:帕米帕利)正式通过国家药品监督管理局(NMPA)附条件批准,用于治疗既往经过二线及以上化疗、伴有胚系BRCAgBRCA)突变的复发性晚期卵巢癌、输卵管癌或原发性腹膜癌患者。此前帕米帕利曾获得国家重大新药创制专项支持,其新药上市许可申请还被NMPA药品审评中心(CDE)纳入优先审评。这是百济神州在新药研发上取得的又一重要里程碑,也标志着百济神州在全球热门靶点上的研发布局开始进入收获期。据悉,百济神州正在筹备商业化相关工作,预计将在本月内完成百汇泽®的商业发布。

百济神州总裁、首席运营官兼中国区总经理吴晓滨博士表示:国家药监局今天批准百汇泽®,使其成为百济神州第三款获得上市许可的自主研发创新药物,这是公司发展进程中的一项重要里程碑事件,也是对我们科学创新的极大认可。公司广泛的商业化产品组合现包含7款药物,在恶性血液瘤和实体瘤中覆盖15项适应症,帮助我们以科学为主导的中国商业化团队为有需要的患者提供服务。百济神州将继续推进公司广泛多元的产品管线,致力于实现我们的使命——为全球患者提供可及和可负担的高效药物。

百济神州肿瘤免疫学首席医学官贲勇医学博士表示:百汇泽®是中国首款获批用于治疗涵盖铂敏感以及铂耐药的复发性卵巢癌患者的PARP抑制剂,我们为此十分激动。百汇泽®的设计独特,旨在降低耐药性且提供持续抗肿瘤缓解,正如去年我们在欧洲肿瘤内科学会(ESMO)年会上公布的数据显示,这款高选择性PARP抑制剂在患者中产生了颇高的客观缓解率,且总体耐受性良好。我们十分感激参与临床试验的患者和研究者,并期待百汇泽®成为中国复发性卵巢癌患者的一款重要治疗选择。此外,我们正在其他多项试验和适应症中评估百汇泽®,包括正在开展的百汇泽®作为维持疗法用于治疗铂敏感复发性卵巢癌患者的3期临床试验。

高复发、铂耐药,卵巢癌患者渴望更好的治疗方案

卵巢癌恶性程度高、治疗难度大,是严重威胁女性健康的恶性肿瘤之一。在我国,卵巢癌年发病率居女性生殖系统肿瘤第3位且呈逐年上升趋势,死亡率则位居女性生殖道恶性肿瘤之首。由于卵巢癌早期症状较为隐匿,缺乏有效的筛查手段,且疾病进展非常迅速,70%的卵巢癌患者在确诊时已为晚期卵巢癌极易复发,在经过手术和化疗的初次治疗后,患者3年复发率达70%左右

目前医学界根据卵巢癌复发距离上次含铂化疗结束后的时间,以6个月为界,将其分为铂敏感复发和铂耐药复发。铂敏感复发的患者仍有机会采用含铂化疗的方案进行治疗。然而多次复发后,患者每次治疗结束到复发的间隔时间会越来越短,对铂类药物的敏感性也会越来越差,最终发展成为铂耐药复发。而铂耐药复发的患者,通常选用非铂类药物进行化疗,治疗方案有限,效果往往不太理想。

百汇泽,为铂敏感和铂耐药复发的卵巢癌患者带来治疗新选择

近年来,PARP抑制剂的出现为卵巢癌的治疗带来了重大变革PARP抑制剂是基于合成致死原理开发的代表性药物。所谓合成致死,是指两个非致死性突变基因单独发生时不会导致细胞死亡,而同时发生时可引起细胞死亡的现象。目前国内已有PARP抑制剂作为铂敏感复发性卵巢癌的治疗药物获批上市,而百济神州的PAPR抑制剂百汇泽®则更向前一步,着眼于铂敏感和铂耐药复发性卵巢癌的治疗研究

研究显示百汇泽®在药物作用机制上具有三点显著的与众不同之处:1. 目前已知唯一一款非药物泵(P-gp)底物的PARP抑制剂,有望克服P-gp过表达引起的耐药问题;2. 具有高透膜性的特点,更易穿透细胞膜,保持细胞膜内的有效药物浓度,从而改善临床持续缓解时间;3. PARP1PARP2酶表现出高选择性且对PARP酶具有高捕获性。

据悉,此次NMPA附条件批准百汇泽®用于治疗晚期卵巢癌、输卵管癌或原发性腹膜癌患者是基于一项 1/2 期临床试验(NCT03333915)的关键性 2 期部分临床结果。共有113 例既往接受过至少两项标准化疗、伴有gBRCA 突变的高级别上皮性卵巢癌(包括输卵管癌或原发性腹膜癌)患者在中国入组该项试验的关键性2 期部分,包括90 例晚期铂敏感卵巢癌(PSOC)患者和23 例晚期铂耐药卵巢癌(PROC)患者。

百汇泽®有效性数据是基于101例疗效可评估患者经独立审查委员会(IRC)根据RECIST v1.1进行评估,其中包括82PSOC患者和19PROC患者。PSOC患者中的中位随访时间为17.0个月,客观缓解率(ORR)为68.3%95%CI57.178.1),中位缓解持续时间(DoR)为13.8个月(95% CI10.9720.73);PROC患者中的中位随访时间为11.6个月,ORR31.6%95%CI12.656.6),中位DoR11.1个月(95%CI4.2116.59)。

复旦大学附属肿瘤医院肿瘤妇科主任吴小华教授兼该试验主要研究者称:疾病复发在晚期卵巢癌患者中十分常见,由于化疗疗效有限且毒副作用大,PARP抑制剂在后线治疗中已成为一项常用疗法。这项关键2期临床试验数据令人欣喜,展现了帕米帕利能为铂敏感或铂耐药患者带来具有临床意义且持久的缓解。我们相信帕米帕利获批能为这些患者和家属带来新的治疗希望。

据了解,百汇泽®的推荐剂量为每次60毫克、每日两次口服治疗,其将由百济神州苏州产业化基地生产。该基地质量体系建设符合中国、美国和欧盟GMP标准,制剂生产能力可达每年1亿粒,目前已用于生产首个在美获批上市的本土抗癌新药泽布替尼。

除此次获批的适应症外,目前百济神州还在就百汇泽®作为单一疗法或与其他药物联用开展多项临床研究,截至目前共有12项临床试验在全球展开,覆盖中国、日本、美国、欧洲等多个国家地区超1,100名患者,治疗领域涉及卵巢癌、前列腺癌、乳腺癌、胃癌、胶质母细胞瘤等。

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    2022-01-26 jklm09
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    2021-05-02 xxxx1054
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    2021-05-02 lishiwen

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