泰瑞沙是**一个单药一线治疗让EGFR突变晚期非小细胞肺癌中位总生存期超过3年的药物

2019-09-29 MedSci MedSci

阿斯利康今日宣布了详细的三期临床试验FLAURA的总生存期(OS)数据,该试验用于评估泰瑞沙(甲磺酸奥希替尼片)一线用于治疗EGFR突变阳性的局部晚期或转移性非小细胞肺癌(NSCLC)成人患者的疗效。 临床数据显示该试验达到了次要研究终点,相比于之前针对此类患者的标准治疗方案吉非替尼或厄洛替尼,奥希替尼显示出总生存期既有统计学的显著改善,又有临床意义上的改善(HR 0.799 [95% C

阿斯利康今日宣布了详细的三期临床试验FLAURA的总生存期(OS)数据,该试验用于评估泰瑞沙(甲磺酸奥希替尼片)一线用于治疗EGFR突变阳性的局部晚期或转移性非小细胞肺癌(NSCLC)成人患者的疗效。



临床数据显示该试验达到了次要研究终点,相比于之前针对此类患者的标准治疗方案吉非替尼或厄洛替尼,奥希替尼显示出总生存期既有统计学的显著改善,又有临床意义上的改善(HR 0.799 [95% CI, 0.641-0.997], p=0.0462)。

奥希替尼组的中位总生存期是38.6个月,而标准治疗组为31.8个月。三年后,奥希替尼组28%的患者仍在使用奥希替尼作为一线治疗,而标准疗法吉非替尼或厄洛替尼只有9%。同时,奥希替尼减少了52%的脑转移进展风险,增加了脑转移患者无脑部进展生存时间,显示出显著的统计学和临床意义上的改善 (HR 0.48 [95% CI, 0.26-0.86], p=0.014)。1

这个结果发布在在ESMO 2019(欧洲肿瘤内科学会年会)的主席研讨会上,该会议在西班牙巴塞罗那举行(Abstract #LBA5_PR)。

阿斯利康全球执行副总裁,肿瘤研发部负责人José Baselga表示:“奥希替尼为EGFR突变阳性非小细胞肺癌的治疗树立了全新的标杆,使得中位总生存期超过了3年。在此之前,任何单药疗法的所有全球三期临床试验中,我们从未见过如此明显的生存期获益。这个里程碑式的数据再次确认一线使用奥希替尼的获益,也进一步支持奥希替尼作为这类患者的标准一线疗法。”

FLAURA临床试验的负责人,来自美国亚特兰大埃默里大学Winship癌症研究所的Suresh S. Ramalingam博士表示:“针对EGFR突变阳性的非小细胞肺癌患者,FLAURA临床试验结果进一步支持将奥希替尼作为优先选择的一线治疗方案。值得注意的是,三年之后,28%的患者依然在使用奥希替尼作为一线治疗方案,而标准疗法吉非替尼或厄洛替尼只有9%。”

FLAURA临床试验总结

 

泰瑞沙组

 (n=279)

EGFR抑制剂

(吉非替尼或厄洛替尼)

(n=277)

无进展生存期PFS(主要研究终点)

 

中位值

(95% CI)

18.9

(15.2, 21.4)

10.2

(9.6, 11.1)

HR

(95% CI)

0.46

(0.37, 0.57)

p值

p < 0.0001

总生存期OS(次要研究终点)

 

HR

(95% CI)

0.799

(0.641-0.997)

p值

p = 0.0462ii

中位值

(95% CI)

38.6

(34.5-41.8)

31.8

(26.6-36.0)

12个月生存率

(95% CI)

89.1%

(84.8-92.2)

82.5%

(77.4-86.6)

24个月生存率

(95% CI)

74.2%

(68.6-79.0)

58.9%

(52.7-64.6)

36个月生存率

(95% CI)

53.7%

(47.5-59.5)

44.1%

(38.0-50.1)

脑转移无进展生存期 CNS PFS(次要研究终点)

 

HR

(95% CI)

0.48

(0.26-0.86)

p值

p = 0.014

中位值

(95% CI)

Not reached(未达到)

(16.5-NC)iii

13.9

(8.3-NC)iii

首次后续治疗或死亡时间 TFST(探索终点)

 

HR

(95% CI)

0.48

(0.39-0.58)

患者发生比例

69.5%

87.4%

中位值

(95% CI)

25.5

(22.0, 29.1)

13.7

(12.3, 15.7)

第二次后续治疗时间TSST(探索终点)

 

HR

(95% CI)

0.69

(0.56-0.84)

患者发生比例

64.5%

73.3%

中位值

(95% CI)

31.1

(28.8, 35.9)

23.4

(20.0, 25.6)

继续使用初始研究药物的患者比例

 

12个月

69.5%

47.3%

24个月

42.3%

16.2%

36个月

28.0%

9.4%


I 数据统计截止时间为2019年6月25日(OS,TFST和TSST)和2017年6月12日(PFS,CNS PFS)
ii OS最终分析p值的统计学显著性要求<0.0495(通过O’Brien- Fleming的方法计算)
iii NC=无法计算

在FLAURA临床试验中,奥希替尼的安全性数据与之前临床试验的数据保持一致。总体上奥希替尼的耐受性良好,3级及以上不良反应事件(AEs)发生率在使用奥希替尼的患者中为42%,而对照组为47%。使用奥希替尼的患者中最常发生的不良反应包括腹泻(60%)、皮疹(59%)、甲沟炎(39%)、皮肤干燥(38%)、口腔炎(29%)、疲劳(21%)和食欲下降(20%)。奥希替尼的用药时间几乎是标准疗法的两倍,但是奥希替尼组的患者经历3级或以上副作用(42% vs 47%)或由于副作用停止治疗(15% VS 18%)的患者更少。
2017年7月,FLAURA临床试验就达到了主要研究终点,显示出既有统计学意义改善,又有临床意义改善的无进展生存期(PFS),增加了患者的无疾病进展生存时间。

目前,奥希替尼在全球78个国家和地区批用于EGFR突变阳性的转移性非小细胞肺癌患者,包括美国、日本、中国和欧盟。

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  5. [GetPortalCommentsPageByObjectIdResponse(id=2059837, encodeId=9f8c205983e83, content=<a href='/topic/show?id=2cc599381bd' target=_blank style='color:#2F92EE;'>#非小细胞#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=99381, encryptionId=2cc599381bd, topicName=非小细胞)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=2e07307, createdName=lingaifan, createdTime=Sat Jul 11 23:53:00 CST 2020, time=2020-07-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1378225, encodeId=860913e82258e, content=<a href='/topic/show?id=c29b69004f9' target=_blank style='color:#2F92EE;'>#生存期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=69004, encryptionId=c29b69004f9, topicName=生存期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e68e415, createdName=juliusluan78, createdTime=Tue Oct 01 09:53:00 CST 2019, time=2019-10-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1516019, encodeId=806f15160196c, content=<a href='/topic/show?id=bd0152e64f1' target=_blank style='color:#2F92EE;'>#总生存期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=52764, encryptionId=bd0152e64f1, topicName=总生存期)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=bdf610907545, createdName=12498cb5m16暂无昵称, createdTime=Tue Oct 01 09:53:00 CST 2019, time=2019-10-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1517461, encodeId=94ab151e46172, content=<a href='/topic/show?id=43f265061a0' target=_blank style='color:#2F92EE;'>#泰瑞沙#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=65061, encryptionId=43f265061a0, topicName=泰瑞沙)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=2caa11077853, createdName=LShY0906_98743847, createdTime=Tue Oct 01 09:53:00 CST 2019, time=2019-10-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1534460, encodeId=775a15344608d, content=<a href='/topic/show?id=22b3e9887e' target=_blank style='color:#2F92EE;'>#GFR#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=21, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7988, encryptionId=22b3e9887e, topicName=GFR)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0a812532020, createdName=liuyiping, createdTime=Tue Oct 01 09:53:00 CST 2019, time=2019-10-01, status=1, ipAttribution=)]
    2019-10-01 liuyiping

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