FDA批准胆管癌FGFR靶向药pemigatinib获批

2020-04-20 燃石医学 燃石医学

2020年4月18日,FDA肿瘤卓越中心主任Richard Pazdur宣布Pemazyre(pemigatinib)获批上市,该药对携带FGFR2基因融合或其他重排类型的晚期经治胆管癌患者具有良好的

2020年4月18日,FDA肿瘤卓越中心主任Richard Pazdur宣布Pemazyre(pemigatinib)获批上市,该药对携带FGFR2基因融合或其他重排类型的晚期经治胆管癌患者具有良好的临床效果,成为首款获批上市的胆管癌靶向药物。

胆管癌侵袭性强、预后差,很多患者在确诊时已失去手术机会。晚期胆管癌系统治疗方案极其匮乏,一线标准化疗的客观缓解率(ORR)仅15-26%,常发生耐药,且无标准二线治疗方案。

此次pemigatinib的获批表明,对于携带FGFR2基因融合/重排的胆管癌患者来说,已经有明确有效的靶向治疗方案给患者带来临床获益,这在胆道肿瘤领域是非常重磅的个体化精准治疗突破,~9-14%胆管癌患者可能从该药物治疗中获益。

Pemigatinib二线治疗FGFR2融合/重排的胆管癌患者疾病控制率(DCR)高达82%

胆道肿瘤作为恶性程度很高的一种肿瘤,其新药开发尤为重要,而靶向药物探索的第一步是了解肿瘤的基因突变图谱。既往针对胆管癌的基因突变谱研究显示(图1)[1-3],超过50%的患者携带可靶向的基因变异,具有潜在靶向治疗机会。其中非常有潜力的靶点就是FGFR1-3基因的激活性致病变异

图1 胆道肿瘤基因组变异情况

(图片来源:Cancer Discov. 2017 Sep;7(9):943-962)

FGFR基因编码成纤维细胞生长因子受体,在肿瘤细胞增殖、存活、迁移和血管生成中发挥着重要作用。FGFR基因的融合/重排、易位和拷贝数扩增变异均可能导致多种癌症的发生。去年4月FDA批准了强生旗下杨森制药的Erdafitinib(Balversa)上市,用于治疗FGFR3或FGFR2基因改变的晚期经治膀胱癌患者,靶向FGFR的治疗方式已实现零的突破,在多个癌种中都是非常有希望的治疗靶点

在胆管癌中,~9-14%的患者携带FGFR2基因融合,是名副其实的“明星”靶点。目前获批的pemigatinib是一款针对FGFR亚型1/2/3的强效选择性口服抑制剂,在临床前研究中已发现该药物对FGFR基因突变的肿瘤细胞具有选择性的药理学活性。FIGHT-202临床试验的结果则证实了pemigatinib可作为携带FGFR2基因融合变异的晚期胆管癌患者的全新有效治疗选择。

FIGHT-202是一项开放标签、单臂、国际多中心2期临床研究,其研究成果近期已在国际著名临床研究期刊《柳叶刀·肿瘤》上在线发表[4]。这项研究发现,携带FGFR2基因融合的胆管癌患者,二线接受Pemigatinib治疗的客观缓解率(ORR)可达35.5%,疾病控制率(DCR)为88.2%,中位无进展生存期(mPFS)6.9个月,中位总生存期(mOS)21.1个月;对比既往报道中胆管癌二线FOLFOX化疗mOS 6.3个月[5],pemigatinib靶向治疗显著延长患者的总生存期,给患者带来显著获益

研究共纳入146例经过≥1线治疗的晚期胆管癌患者,分为3个队列:A组携带FGFR2融合(n=107),B组患者携带其他FGF/FGFR基因突变(n=20),C组则无FGF/FGFR基因突变(n=18),pemigatinib仅在A组呈现较好疗效,相比其他两个队列, PFS和总体生存期均大幅延长(PFS,A组6.9个月对比B组2.1个月、C组1.9个月;OS,A组21.1个月对比B组6.7个月、C组4.0个月)(图2, 3)。

这些数据说明对于携带FGFR2融合的患者,pemigatinib的效果可能远好于化疗,是患者生存获益的最佳选择。基于此,FDA批准了该药的临床应用,成为胆管癌精准治疗的里程碑事件。

图2 晚期胆管癌患者二线服用pemigatinib的缓解率

(A组携带FGFR2融合/其他重排,B组携带其他FGF/FGFR基因突变,C组不携带FGF/FGFR基因突变)

图3 晚期胆管癌患者二线使用pemigatinib的PFS

Pemigatinib国内上市指日可待

这一药物获批对于中国胆管癌患者同样有着重要的意义。2018年12月,信达生物与pemigatinib的研发公司达成战略合作,获得该药物在中国大陆、中国香港、中国澳门和中国台湾地区的开发和商业化的权利。2020年3月4日,pemigatinib的 II 期关键性注册临床研究完成了中国首例患者给药*,我们期待这样的好药可以早日在国内上市,以便惠及越来越多的胆管癌患者。

分析胆道肿瘤突变谱发现,超过50%的患者携带可靶向的基因变异,其中突变频率较高的基因变异包括FGFR1-3基因融合/扩增变异,ERBB2基因扩增,IDH1/2基因变异等。

针对FGFR1-3基因变异,除pemigatinib以外,还有两款FGFR抑制剂也极具潜力,晚期胆管癌患者今后或将有更多选择。其中Infigratinib(BGJ398)是另一种口服FGFR抑制剂,目前的研究数据表明其对FGFR融合的晚期胆管癌患者疗效较好, 在61例携带FGFR2变异的晚期胆管癌经治(二线治疗以上)患者中,ORR为14.8%(其中携带FGFR2融合的患者ORR为18.8%),DCR为75.4%(FGFR2融合患者中为83.3%),mPFS为5.8个月[6]。

另一个药物是TAS-120,一种高选择性不可逆的三代泛FGFR抑制剂。TAS-120的I期实体瘤篮子试验结果显示,在28例携带FGFR2融合的经治肝内胆管癌患者中,ORR为25%、DCR为78.6%;值得期待的是,该药可用于Infigratinib或 Debio1347耐药的FGFR2融合肝内胆管癌患者,4例耐药患者服用TAS-120后均达PR,PFS>7个月[7]。

原始出处:

1. Valle JW, et al. New Horizons for Precision Medicine in Biliary Tract Cancers. Cancer Discov. 2017 Sep;7(9):943-962.

2. Javle M, et al. Utility of next-generation sequencing for clinical management. Cancer. 2016 Dec 15;122(24):3838-3847.

3. Lowery MA, et al. Comprehensive Molecular Profiling of Intrahepatic and Extrahepatic Cholangiocarcinomas: Potential Targets for Intervention. Clin Cancer Res. 2018Sep 1;24(17):4154-4161.

4. Abou-Alfa GK, et al. Pemigatinib for previously treated, locally advanced or metastatic cholangiocarcinoma: a multicentre, open-label, phase 2 study. Lancet Oncol. 2020 Mar 20. pii: S1470-2045(20)301091.

5. Lamarca A, Palmer DH, Wasan HS, et al. ABC-06 | A randomised phase III, multi-centre, open-label study of active symptom control (ASC) alone or ASC with oxaliplatin / 5-FU chemotherapy (ASC+mFOLFOX) for patients (pts) with locally advanced / metastatic biliary tract cancers (ABC) previously-treated with cisplatin/gemcitabine (CisGem) chemotherapy. J Clin Oncol 2019 37:15_suppl, 4003-4003.

6. Javle M, et al. Phase II Study of BGJ398 in Patients With FGFR-Altered Advanced Cholangiocarcinoma. J Clin Oncol. 2018 Jan 20;36(3):276-282.

7. Goyal L, et al. TAS-120 Overcomes Resistance to ATP-Competitive FGFR Inhibitors in Patients with FGFR2 Fusion-Positive Intrahepatic Cholangiocarcinoma. Cancer Discov. 2019 Aug;9(8):1064-1079.

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    2020-09-11 bugit
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    2020-06-19 feather89
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    2020-04-22 yibei
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    2020-04-22 liuyiping
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