40年重大突破!FDA批准礼来抗癌药Lartruvo联合阿霉素用于软组织肉瘤(STS)一线治疗

  • 礼来,Lartruvo,FDA
  • 生物谷

2016年10月25日美国医药巨头礼来(Eli Lilly)抗癌管线近日在美国监管方面传来喜讯,美国食品和药物管理局(FDA)已加速批准抗癌新药Lartruvo(olaratumab注射液,10mg/mL)联合阿霉素(doxorubicin)用于组织学亚型为适合含蒽环类方案并且不适合采用放疗或手术根治的软组织肉瘤(STS)成人患者。

此次批准,使Lartruvo+阿霉素方案成为过去40年以来FDA批准用于软组织肉瘤(STS)的首个一线疗法,标志着晚期STS在临床治疗迈出的重要一步。在临床试验中,与阿霉素单药治疗相比,Lartruvo联合阿霉素使STS总生存期提高11.8个月之多。

软组织肉瘤(STS)是对发生于全身软组织(脂肪、肌肉、神经、纤维组织、血管)的一大类恶性肿瘤的统称,非常复杂并具有多种亚型,使得难以诊断和治疗。近几十年来,能够延长晚期STS总生存期(OS)的一线治疗方面始终无进展。根据美国癌症研究协会,在2015年,仅在美国确诊1.2万STS新病例,约5000例死亡病例。因此,该领域存在着远未满足的巨大医疗需求。

Lartruvo是一种人血小板衍生生长因子受体α(platelet-derived growth factor recepter α,PDGFRα)拮抗剂,该药是FDA批准治疗STS的首个单克隆抗体药物。之前,FDA已授予该药快车道地位、孤儿药地位、突破性药物资格、优先审查资格。在欧盟方面,上月中旬olaratumab获得了欧洲药品管理局(EMA)人用医药产品委员会(CHMP)支持批准的积极意见,这也意味着olaratumab极有可能在今年年底获批在欧洲上市。

Lartruvo的获批,是基于一项关键性II期JGDG研究的数据。该研究是一项开放标签、随机研究,在133例组织学亚型为适合含蒽环类方案并且不适合采用放疗或手术根治的软组织肉瘤(STS)成人患者中开展,将Lartruvo+阿霉素化疗联合疗法与阿霉素化疗单药疗法进行了对比。数据显示,与阿霉素单药治疗组相比,Lartruvo+阿霉素联合治疗组中位总生存期提高11.8个月,数据具有统计学显著差异(中位OS:26.5个月 vs 14.7个月,p<0.05)。此外,Lartruvo+阿霉素联合治疗组中位无进展生存期也显著提高4.4个月(中位PFS:8.2个月 vs 4.4个月)。在数据分析时,Lartruvo+阿霉素联合治疗组总缓解率(ORR)为18.2%、死亡39例(59%),阿霉素单药治疗组ORR为7.5%、死亡52例(78%)。

olaratumab是一种人IgG1单克隆抗体,旨在扰乱肿瘤细胞和肿瘤微环境中的细胞上的PDGFRα信号通路。该药通过直接靶向肿瘤细胞以及围绕在肿瘤周围支持肿瘤生长的细胞,发挥抗肿瘤活性。目前,olaratumab联合阿霉素化疗治疗晚期软组织肉瘤的一项III期临床已完成患者招募。礼来将根据该项III期研究的数据,将加速批准转变为完全批准。

值得一提的是,今年1月,FDA批准日本药企卫材(Eisai)内部研发的新型抗癌药Halaven(甲磺酸艾瑞布林)治疗晚期或转移性脂肪肉瘤。今年5月,Halaven再获欧盟批准治疗不可切除性脂肪肉瘤,这是软组织肉瘤的一种亚型。

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