不可切除III期非小细胞肺癌迎来免疫治疗新时代!PD-L1单抗在中国获批!

2020-03-04 不详 生物谷

肺癌持续占据我国恶性肿瘤发病率和死亡率的首位,严重威胁着人们的健康。疫情当前,肺癌患者群体也面对着更为严峻的挑战。肺癌发病率和死亡率居高不下,是全社会共同面对的问题。肺癌的病期决定患者的预后,而准确的临床分期是制定肺癌治疗方案的重要依据。因此,在治疗前判断患者的分期,选择不同的治疗策略是肺癌诊疗的关键。2019年12月,中国国家药品监督管理局(NMPA)正式批准度伐利尤单抗注射液(商品名:英飞

肺癌持续占据我国恶性肿瘤发病率和死亡率的首位,严重威胁着人们的健康。疫情当前,肺癌患者群体也面对着更为严峻的挑战。肺癌发病率和死亡率居高不下,是全社会共同面对的问题。肺癌的病期决定患者的预后,而准确的临床分期是制定肺癌治疗方案的重要依据。因此,在治疗前判断患者的分期,选择不同的治疗策略是肺癌诊疗的关键。


2019年12月,中国国家药品监督管理局(NMPA)正式批准度伐利尤单抗注射液(商品名:英飞凡),用于在接受铂类药物为基础的化疗同步放疗后未出现疾病进展的不可切除、III期非小细胞肺癌(NSCLC)患者的治疗。同时,多项权威诊疗指南(NCCN、ESMO、CSCO指南)均将度伐利尤单抗按1A类证据强烈推荐。放化疗后使用度伐利尤单抗注射液的PACIFIC模式成为III期不行切除NSCLC治疗的金尺度。2020年2月29日,在III期肺癌云海网络峰会上,正式宣布上市,迎来肺癌免疫治疗新时代。

PD-L1免疫治疗,III期非小细胞肺癌患者5年生存率或超50%

据2019年中国癌症中心发布的新一期全国癌症统计数据显示,肺癌患者中约85%为非小细胞肺癌(NSCLC),其中有1/3在初次确诊时为Ⅲ期非小细胞肺癌(又称局部晚期)。从肿瘤位置来看,III期非小细胞肺癌的肿瘤依然局限在胸腔内,属于局部生长,相较于已经发生远端转移的IV期(又称晚期)而言,III期非小细胞肺癌的治疗以临床治愈为目的,是一个治疗的关键窗口期。
广东省人民医院终身主任、中国胸部肿瘤协作组主席吴一龙教授表示,“对肺癌患者而言,III期是最重要的一个分水岭,也是肺癌治疗的关键窗口期。然而过去近30年,针对III期非小细胞肺癌的治疗方式几乎没有进展,标准治疗只有放化疗,没有其他针对性的药物和疗法。随着PD-L1免疫疗法在中国获批上市,III期非小细胞肺癌的治疗取得了突破性进展,给III期非小细胞肺癌患者带来了临床治愈的希望。”

从治疗手段来看,以PD-1抑制剂、PD-L1抑制剂为代表的肿瘤免疫治疗从2014年起进入肿瘤治疗领域,成为继手术、放化疗、靶向治疗后的第四大肿瘤治疗方式,其中,中国首个PD-L1免疫抑制剂度伐利尤单抗注射液的出现突破了III期非小细胞肺癌以往的治疗困境。度伐利尤单抗注射液的批准是基于III期临床试验PACIFIC对于无疾病进展生存期(PFS)的主要分析结果,并由总生存期(OS)数据支持,该试验相关结果已发表在《新英格兰医学杂志》(NEJM)上。

PACIFIC临床试验研究结果显示,同步放化疗后使用度伐利尤单抗注射液免疫治疗,降低了III期不可切非小细胞肺癌患者近32%的死亡风险;中位无疾病进展生存期(PFS)为16.8个月,延长了中位无疾病进展生存期超过11个月,3年总生存率(OS)更是高达57%3,预期5年生存率将超过50%。

值得一提的是,基于PACIFIC的临床试验数据,放化疗后使用度伐利尤单抗注射液的PACIFIC模式被美国NCCN指南列为III期不可切非小细胞肺癌的标准治疗方案。接受PACIFIC模式治疗的患者中,最常见的不良反应(发生率等于或高于20%)包括咳嗽、疲劳、肺炎或放射性肺炎、上呼吸道感染、呼吸困难和皮疹,发生严重不良反应的比例为29%,15%的患者因不良反应而终止治疗。
对此,吴一龙教授认为:“针对III期不可切除非小细胞肺癌患者,在进行以铂类为基础的同步放化疗后未出现疾病进展的患者中,无论PD-L1表达与否,对比安慰剂组,使用度伐利尤单抗注射液巩固治疗在无疾病进展生存期和总生存期方面均展现出统计学和临床意义上的显著改善,改变了以往III期非小细胞肺癌的治疗模式,给III期非小细胞肺癌患者提供了一个新的治疗选择,中国III期非小细胞肺癌迎来了免疫治疗新时代。”

患者援助项目正式启动,造福III期肺癌患者

随着度伐利尤单抗正式开始销售,其价格并不便宜,500mg售价18088元,而120mg的规格售价6066元。为了提高中国肺癌患者对于肺癌免疫治疗的可及性及规范性,减轻患者经济肩负,延长患者生命。中国低级卫生保健基金会于2月29日正式启动“因爱飞凡-肺癌免疫治疗患者援助项目”,该项目援助药品度伐利尤单抗注射液由阿斯利康投资(中国)有限公司向中国低级卫生保健基金会无偿捐赠,第一时间惠及宽大中国III期肺癌患者。

“因爱飞凡-肺癌免疫治疗患者援助项目计划分成三个阶段进行,第一阶段治疗2个周期然后赠送2个周期,第二阶段治疗4个周期赠送4个周期,第三阶段治疗6个周期赠送8个周期。预估成人全年的治疗费用大约在28万,药价降了约50%。”中国医学科学院北京协和医学院肿瘤医院内科主任李峻岭教授。

本项目援助对象为持有中华人民共和国居民身份证/军官证的大陆患者。具体援助支数依据患者疾病进展情况及临床检查结果由项目医生进行判定。度伐利尤单抗注射液使用剂量遵循说明书用法,后续援助药品剂量以不超过前期自行使用阶段用药剂量为限。项目将通过线上方式进行申请。(详情请点连接:因爱飞凡一肺癌免疫治疗患者援助项目

阿斯利康全球执行副总裁、国际业务及中国总裁王磊先生表示:“疫情当前,我们不仅第一时间将国际领先的创新免疫疗法引进到中国,为广大肺癌患者带来更多希望;同时也积极携手各界伙伴参与到抗疫第一线,大力支持‘抗击新型冠状病毒肺炎移动CT筛查公益项目’,在疫情控制的关键时期助力基层防控。一直以来,‘以患者为中心’是阿斯利康不变的承诺,未来我们将继续致力于推动国际先进创新药物进入中国市场, 同时也携手各方力量,惠及更广大肿瘤患者,助力‘健康中国2030’目标的实现。”

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    2020-12-29 juliusluan78
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    2020-03-06 smartjoy
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