2019 CSCO 大咖发声:国内自主研发抗肿瘤药物研发“全面开花”

2019-10-14 佚名 医谷

在今年9月结束的第二十二届全国临床肿瘤学大会暨2019年CSCO学术年会上,记者获悉在国家鼓励自主创新药物的政策推动下,国内自主研发的创新型抗肿瘤药物的研发已“多点开花”;在包括晚期肺癌、晚期肝癌、血液肿瘤等多个恶性肿瘤治疗领域,我国的创新药研发 “快马加鞭”,取得了喜人的进展,有些还有望迅速打破进口药在这些治疗领域的长期垄断,甚至孕育出比进口药更好的me-better药物,实现历史性突破,不

在今年9月结束的第二十二届全国临床肿瘤学大会暨2019年CSCO学术年会上,记者获悉在国家鼓励自主创新药物的政策推动下,国内自主研发的创新型抗肿瘤药物的研发已“多点开花”;在包括晚期肺癌、晚期肝癌、血液肿瘤等多个恶性肿瘤治疗领域,我国的创新药研发 “快马加鞭”,取得了喜人的进展,有些还有望迅速打破进口药在这些治疗领域的长期垄断,甚至孕育出比进口药更好的me-better药物,实现历史性突破,不但可以延长中国肿瘤患者的生命,还能够让创新药惠及更多中国患者。 

防控形势很严峻 自研新药求突破

恶性肿瘤(癌症)是严重威胁中国人群健康的主要公共卫生问题之一。国家癌症中心2019年1月发布的全国癌症统计数据显示,2015年全国新发恶性肿瘤病例数约为392.9万例,恶性肿瘤死亡占全部死因的23.91%,且近十几年来恶性肿瘤的发病率和死亡率均呈现上升态势,防控形势严峻。 

肺癌、消化道系统肿瘤包括肝癌、食管癌、胃癌和结直肠癌,是我国高发的恶性肿瘤,然而多数患者都在肿瘤进展到晚期才被发现,这时的肿瘤已发生转移,很多患者因此无法接受手术等根治性治疗,而只能依赖药物治疗。 

在过去几年中,随着精准靶向治疗和肿瘤免疫治疗的迅速发展,药物治疗给晚期肿瘤患者带来了显著的生存延长。然而,这些显著延长晚期肿瘤患者生存的创新抗肿瘤药物大多都是进口药。近年来,随着创新药在我国的蓬勃发展,我国创新型制药企业逐步“发力”,在2018年已先后在国内推出多个国产新型治疗肿瘤药物,打破了进口药物在这个领域的垄断,大幅度降低了这类药物的整体价格,让更多的国内晚期肿瘤患者得到生存获益。在精准靶向治疗领域,尤其是在晚期肺癌、晚期肝癌、难治性甲状腺癌和骨髓纤维化这些疾病的新药研发上,国内的创新驱动型制药企业也在奋力直追,有些有望取得历史性突破,不但打破进口药物垄断,还有望在药物疗效和安全性上超越进口药物,合理的价格也可使更多患者获得药物治疗。

剑指“癌王” 力争“破冰”

原发性肝癌是我国第四位的常见恶性肿瘤,死亡率仅次于肺癌,每年约有 38.3 万人死于肝癌,超过全球肝癌死亡病例数的一半。原发性肝癌治疗选择有限,不可切除的原发性肝癌诊断后1年生存率低于50%。

在2007年美国FDA和欧洲药品评价局批准抗肿瘤靶向治疗药物索拉非尼用于治疗肝细胞癌之后的近10年间, 全球的研究者陆续开展了数十项针对晚期肝细胞癌的一线、二线药物治疗的临床研究,但均以失败而告终;2017年4月27日,才有第二个靶向治疗药物在美国获批。 

据四川大学华西医院肿瘤科(腹部肿瘤)主任毕锋教授介绍, 肝癌被称之为“癌症之王”,每年全球患者超过75万人,是全世界癌症死亡的主要原因之一。肝部肿瘤往往是多种疾病的合并,比如,中国的肝癌患者多有乙肝感染、肝硬化等基础疾病,是三种疾病的一个合并。而且,一旦发展为肝癌,疾病进展很迅速,这是肝癌药物研发困难的一个主要原因。 

多纳非尼是我国自主研发的抗肿瘤靶向小分子1类新药,目前正处于多个晚期肿瘤的注册临床试验研究中。其治疗晚期肝细胞癌的IB期临床研究结果显示,多纳非尼在客观缓解率、疾病控制率、中位总生存期等数据上,均显示优于或不逊于索拉非尼的历史数据。

据毕锋教授介绍,从多纳非尼治疗晚期肝细胞癌1B期临床研究结果看,多纳非尼治疗显示出总生存期更长的趋势,且副作用较低,病人顺应性更好等特点。

基于这些研究结果,由解放军东部战区总医院全军肿瘤中心主任秦叔逵教授和毕锋教授共同牵头领导开展了多纳非尼一线治疗晚期肝癌的II/III期临床研究,并与进口药索拉非尼头对头地进行对照研究。该研究是第一个全部在我国肝癌患者中进行的大样本(668例)、和HCC一线标准治疗药物头对头对照研究的临床试验。基于历史上治疗晚期肝癌一线治疗药物大多都没有获得阳性结果,因此,将在今年底或明年年初“出炉”的多纳非尼III期临床研究结果非常值得期待。 

毕锋教授满怀信心地认为,多纳非尼有望在肝癌治疗领域实现“零突破”,成为全球首个中国自主研发的一线治疗晚期肝癌的小分子靶向药物。 

多纳非尼 多点“开花”

多纳非尼不但在晚期肝癌上已显露与进口药“一决高低”的实力,而且在难治型甲状腺癌上也“初露锋芒”。 

据北京协和医院核医学科林岩松教授介绍,近年来甲状腺癌的发病率逐年升高,其中分化型甲状腺癌(DTC)约占95%。50%左右的甲状腺癌可在自然状态下或治疗过程中失分化而发展成为碘难治性DTC(RAIR-DTC),这部分患者病情进展快、难以控制,其治疗策略一直备受关注。

目前在国内, 索拉非尼作为快速进展型RAIR-DTC的一线靶向治疗药物已在临床上应用,但部分病人产生药物抵抗以及无法耐受的毒副反应等,获益患者的相对局限及耐药等问题均期待更适宜中国国情的本土研究及新型靶向药物的研发。

林岩松教授作为多纳非尼治疗RAIR-DTC的国内多中心III期临床研究的主要负责人,在2017年美国甲状腺年会上做了多纳非尼治疗RAIR-DTC初步疗效和安全性的研究报告,II 期临床试验结果也终不负众望,多纳非尼显示出突出的治疗效果和安全性,展现出同类最佳的治疗潜力。

此外,林岩松教授提到,多纳非尼在试验设计上针对国人有更强的普适性,在选取的临床试验对象中,纳入了病毒复制拷贝数相对较低的乙肝表面抗原阳性患者。令人欣慰的是,目前为止,这部分患者肝脏不良反应事件与同期受试的乙肝表面抗原阴性患者相近,这无疑给这类索拉非尼适应证不涵盖的中国患者的后续治疗探索了新路。

多纳非尼也为医生提供了更多治疗选择。林岩松教授表示,期待多纳非尼在RAIR-DTC患者中优异的III期临床研究结果,用数据争取药监部门的优先审评和审批,给我国广大的RAIR-DTC患者带来福音。

遏制肺癌脑转移 自研药疗效可期 

影响晚期肺癌患者生存的重要因素之一是肿瘤发生脑转移。发生脑转移的肺癌患者生存期显著低于没有发生脑转移的患者。

奥卡替尼是我国自主研发的,具有全球自主知识产权的选择性抑制ALK/ROS1基因突变的小分子靶向药物,是1类新药。 

在今年CSCO年会的创新专场上,CSCO前任理事长、同济大学附属东方医院李进教授的团队汇报了由其牵头开展的我国自主研发的、具有全球知识产权的针对ALK/ROS1基因突变的奥卡替尼的Ⅰ期临床研究结果。研究显示了令人期待的结果:在5例经由进口一代药物(克唑替尼)治疗失败和2例化疗治疗失败的ALK或ROS1阳性的NSCLC患者中,5例患者达到了肿瘤的部分缓解,另2例患者的疾病没有进展,继续稳定。其中4例合并脑转移的患者,其颅内病症最佳疗效评估均显示肿瘤缩小,且奥卡替尼也展现出对ROS1阳性NSCLC患者具有良好治疗效果。 

据同济大学医学院肿瘤研究所所长、上海肺科医院肿瘤内科主任周彩存教授介绍,基于Ⅰ期临床研究的良好数据,将继续探索奥卡替尼在一代进口药物治疗失败的晚期NSCLC患者中二线治疗的效果以及用药后发生ALK再突变的耐药机制。该临床研究将很快在全国多中心进行,期待其能在短时间内把我国自主研发、具有全球自主知识产权的药物带到临床,为我国患者带来更多获益。

MF治疗需求大 自研新药补空白

骨髓纤维化(MF)是以髓系增生为特征的造血干细胞克隆性疾病,患者常有贫血、脾肿大和髓外造血等表现,可向急性白血病转化,预后差,病死率高。MF的治疗一直缺乏有效药物,直到针对其发病机制的JAK抑制剂出现,患者的总体生存期才得以延长,症状减轻,生活质量改善。

到目前为止,全球仅有两款治疗MF的JAK抑制剂类药物,其中芦可替尼在2017年获得国家药品监督管理总局批准。然而,据浙江大学血液病研究所所长、浙江大学附属第一医院血液内科主任金洁教授介绍,虽然芦可替尼极大改进了MF的治疗选择,但是也存在贫血和血小板减少等严重副作用,因此,MF治疗领域具有巨大的未满足临床需求。

另外,价格也是影响芦可替尼临床广泛应用的一个重要因素。芦可替尼价格昂贵,患者年治疗费用接近10万,而MF患者需要较长时间持续治疗,长期用药的巨额治疗费用、为我国大多数患者不能承受。

盐酸杰克替尼片属于1类新药,具有抑制JAK激酶的作用。临床前研究和早期临床研究表明,杰克替尼片在MF治疗中显示出突出的治疗效果和改善贫血的潜力。据金洁教授介绍,临床试验中,杰克替尼片的安全性和有效性初步数据让研究者印象深刻,治疗后缩脾效果显著,且对MF患者伴有的贫血也有很好的改善。

据CSCO监事会新任监事长、哈尔滨血液病肿瘤研究所所长马军教授介绍, MF作为一个罕见病,如果杰克替尼片能够如初步临床研究结果所显示的安全性和有效性,在我国当前中高危MF治疗的巨大需求未被满足的情况下,杰克替尼片作为我国自主研发的创新药物,应该有望进入有条件批准的审批通道。

马军教授认为,自主研发的创新药物会具有非常大的价格优势,如果再进入医保,将进一步减轻患者的经济压力,那么国内的MF、血小板增多症和红细胞增多症继发MF患者都可以用上这个新药。

自研新药增话语权 助国家人民降负担

据国家癌症中心的报告显示,我国每年恶性肿瘤所导致的医疗花费超过2200亿,给国家和个人都带来巨大的负担。 

毕锋教授指出,中国的肝癌患者占到全世界的一半。针对这么大的一个患者群体,如果没有我们自己的药物,大家可以想象这些进口靶向药物,无论是一线还是二线的治疗药物,每个月都在2万到3万的治疗费用;即使经国家谈判进入医保有一定的降价,但目前还是价格偏高,病人承担了一部分费用,国家也承担了相当大的费用,无论对病人还是国家,都是一笔不小的负担。所以,如果更多我国自主研发的新药能够早日上市,对我们的国民经济和患者的疾病治疗、生存延长,都有很大意义。

周彩存教授认为, 与进口药物相比,国内自主研发/知识产权的新型肺癌治疗药物会更有价格竞争力,治疗可及性更高,可覆盖更多患者,这对属于发展中国家的中国的患者来说是至关重要的。

中国工程院院士,国家癌症中心国家新药(抗肿瘤)临床研究中心主任孙燕院士曾把拥有自主研发药物的民生意义与我国的“两弹一星”相提并论。上海交通大学附属胸科医院的韩宝惠教授表示认同,“这就好比说中国一定要研发并掌握制造原子弹的技术,因为谁掌握了技术、谁就有话语权。在医药市场,如果我们只有进口药,那就无法打破价格和技术垄断,就会永远受制。所以,有了自主研发的新药,就代表拥有自主定价权,因为可以通过竞价把价格降下来,最终把这些贵重的药变成平民老百姓切实可及的药物。对中国这样一个发展中国家来讲,意义是非常重大的。”

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  3. [GetPortalCommentsPageByObjectIdResponse(id=1672177, encodeId=8de016e2177cd, content=<a href='/topic/show?id=177c85966dc' target=_blank style='color:#2F92EE;'>#自主研发#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=90, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=85966, encryptionId=177c85966dc, topicName=自主研发)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6d2c26890289, createdName=xlwang2700, createdTime=Sun Nov 24 23:44:00 CST 2019, time=2019-11-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1809221, encodeId=a45f180922175, content=<a href='/topic/show?id=262d8309110' target=_blank style='color:#2F92EE;'>#肿瘤药物研发#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=97, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=83091, encryptionId=262d8309110, topicName=肿瘤药物研发)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTI5PdY90y5Jib8FnPhCXTR2d9v3K17epNSwB2eb0vmXUldNJl2e72S4unZTAHLAojicdVSialTDFHAxA/132, createdBy=78d82500042, createdName=ms7514935887898259, createdTime=Fri Jun 12 16:44:00 CST 2020, time=2020-06-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1300312, encodeId=8f881300312dd, content=<a href='/topic/show?id=ed5ee332423' target=_blank style='color:#2F92EE;'>#研发#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=87, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=73324, encryptionId=ed5ee332423, topicName=研发)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=aea0290, createdName=lqvr, createdTime=Wed Oct 16 10:44:00 CST 2019, time=2019-10-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1301476, encodeId=6dcc13014e6d9, content=<a href='/topic/show?id=aa308e8307e' target=_blank style='color:#2F92EE;'>#药物研发#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=74, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=87830, encryptionId=aa308e8307e, topicName=药物研发)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a435298, createdName=huirong, createdTime=Wed Oct 16 10:44:00 CST 2019, time=2019-10-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1446791, encodeId=a85e1446e9166, content=<a href='/topic/show?id=94bd830865e' target=_blank style='color:#2F92EE;'>#肿瘤药物#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=84, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=83086, encryptionId=94bd830865e, topicName=肿瘤药物)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/PiajxSqBRaEKneTxOtx0KRAPibib3sfmib4P2269UG6op6ZN5ZKddPvUibR7RfFob8X6FicRugoeY8Dicy4cibArjj168Q/132, createdBy=c17d5287383, createdName=smartjoy, createdTime=Wed Oct 16 10:44:00 CST 2019, time=2019-10-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1537727, encodeId=aef7153e72752, content=<a href='/topic/show?id=1f9983082fa' target=_blank style='color:#2F92EE;'>#肿瘤药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=87, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=83082, encryptionId=1f9983082fa, topicName=肿瘤药)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ed1012894470, createdName=30397608, createdTime=Wed Oct 16 10:44:00 CST 2019, time=2019-10-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1593706, encodeId=1fa91593e06e3, content=<a href='/topic/show?id=ff895565586' target=_blank style='color:#2F92EE;'>#抗肿瘤药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=87, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=55655, encryptionId=ff895565586, topicName=抗肿瘤药)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=aa5e18156549, createdName=zhu_jun9843, createdTime=Wed Oct 16 10:44:00 CST 2019, time=2019-10-16, status=1, ipAttribution=)]
    2019-10-16 lqvr
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