打开APP

GSK拉帕替尼III期HER2阳性晚期胃癌试验EGF110656失败

  1. HER2受体
  2. lapatinib
  3. 拉帕替尼
  4. 葛兰素史克

来源:生物谷 2013-06-04 20:18

2013年6月4日讯 /生物谷BIOON/ --3日,葛兰素史克(GSK)宣布,有关拉帕替尼(lapatinib)的一项III期研究EGF110656未能达到研究的主要终点。该研究在HER2阳性晚期胃癌(gastric cancer)患者中开展,与单独化疗组相比,lapatinib联合化疗没有达到改善总存活率(OS)的主要终点。

2013年6月4日讯 /生物谷BIOON/ --3日,葛兰素史克(GSK)宣布,有关拉帕替尼(lapatinib)的一项III期研究EGF110656未能达到研究的主要终点。该研究在HER2阳性晚期胃癌(gastric cancer)患者中开展,与单独化疗组相比,lapatinib联合化疗没有达到改善总存活率(OS)的主要终点。lapatinib+化疗组OS为12.2个月,安慰剂+化疗组OS为10.5个月(HR=0.91; 95% CI: 0.73, 1.12; p=0.3492)。该项研究中未发现新的安全信号。

EGF110656研究是一项随机、双盲III期试验,在HER2阳性晚期胃癌患者中开展,将lapatinib联合化疗(奥沙利铂和卡培他滨)与安慰剂进行了比较,主要终点为总生存期,次要终点包括无进展生存期(PFS)、响应率、响应持续时间。lapatinib+化疗组PFS、响应率、响应持续时间分别为6.0个月、53%、7.3个月,安慰剂+化疗组PFS、响应率、响应持续时间分别为5.4个月、39%、5.6个月。

拉帕替尼(lapatinib)为一种新的EGFR靶向治疗药物,是一种口服的小分子表皮生长因子(EGFR:ErbB-1,ErbB-2)酪氨酸激酶抑制剂,与已批准上市的人源化单克隆抗体药物曲妥珠单抗(Herceptin)作用机制不同,Tykerb对曾经使用曲妥珠单抗治疗,而且效果不明显的部分HER2阳性乳癌患者有效。lapatinib主要用于联合卡培他滨治疗HER2受体过度表达且既往接受过包括蒽环类、紫杉醇、曲妥珠单抗(赫赛汀)治疗的晚期或转移性乳腺癌。

lapatinib目前已获批用于乳腺癌及一些实体瘤的治疗,该药在欧洲以商品名Tyverb销售,在美国以商品名Tykerb销售。

目前,lapatinib还未获批准用于HER2阳性晚期胃癌的治疗。(生物谷bioon.com)

英文原文:GSK announces Phase III data for TYKERB/TYVERB (lapatinib) in combination with chemotherapy for advanced HER2-positive gastric cancer

Issued: Monday 3 June 2013, London UKGlaxoSmithKline (GSK) plc today announced that its study of TYKERB/TYVERB? (lapatinib) in combination with chemotherapy in patients with HER2-positive advanced gastric cancer did not meet the primary endpoint of improved overall survival (OS) compared to chemotherapy alone. The median OS for patients in the lapatinib plus chemotherapy group was 12.2 months compared to 10.5 months for patients randomised to placebo plus chemotherapy (HR=0.91; 95% CI: 0.73, 1.12; p=0.3492). There were no new safety signals identified in this trial.

This was a randomised, double-blinded Phase III study of lapatinib in combination with chemotherapy (oxaliplatin and capecitabine) compared to chemotherapy plus placebo in patients with HER2-positive advanced gastric cancer in the first line treatment setting. The primary endpoint was overall survival and secondary endpoints included progression-free survival, response rate and duration of response. Median progression-free survival for patients in the lapatinib plus chemotherapy group was 6.0 months and 5.4 months for those in the chemotherapy alone group. Response rate was 53% for patients in the lapatinib plus chemotherapy group and 39% for those in the chemotherapy alone group.  In the lapatinib plus chemotherapy group, the duration of response was 7.3 months compared to 5.6 months in the placebo plus chemotherapy group. The most commonly reported (≥ 20%) adverse events (AE) in the lapatinib plus chemotherapy group were diarrhoea (58%), nausea (49%), vomiting (44%), decreased appetite (41%), fatigue (24%), rash (21%) and palmar-plantar erythrodysesthesia (20%). The most common AEs in the chemotherapy alone group were nausea (43%), vomiting (36%), decreased appetite (32%), diarrhoea (29%), fatigue (21%) and peripheral neuropathy (20%).  Serious adverse events (SAEs) reported in more than 2% of patients in the lapatinib plus chemotherapy group were diarrhoea (6%), vomiting (3%), anemia (2%), dehydration (2%), nausea (2%). Vomiting (2%) was the most common SAE reported in the chemotherapy group.TYKERB/TYVERB (lapatinib) is not approved or licensed anywhere in the world for the treatment of HER2-positive advanced gastric cancer.

About study EGF110656 (NCT00680901)This was a  global, randomised, multicentre, double-blinded, Phase III study comparing the efficacy and tolerability of lapatinib in combination with oxaliplatin and capecitabine to oxaliplatin, capecitabine and placebo in subjects with HER2-positive advanced gastric (including esophageal and gastro-esophageal junction) cancer in the first line  treatment setting.  GSK collaborated with the TRIO/IDDI (Translational Research in Oncology, TRIO; International Drug Development Institute) cooperative research group to conduct the study. The primary end point of overall survival (OS) was evaluated in the primary efficacy population which was defined as those randomised patients with HER2-positive tumours confirmed by fluorescence in situ hybridisation (FISH) testing conducted by a central laboratory. Secondary endpoints included progression-free survival, response rate, safety and quality of life.

版权声明 本网站所有注明“来源:生物谷”或“来源:bioon”的文字、图片和音视频资料,版权均属于生物谷网站所有。非经授权,任何媒体、网站或个人不得转载,否则将追究法律责任。取得书面授权转载时,须注明“来源:生物谷”。其它来源的文章系转载文章,本网所有转载文章系出于传递更多信息之目的,转载内容不代表本站立场。不希望被转载的媒体或个人可与我们联系,我们将立即进行删除处理。

87%用户都在用生物谷APP 随时阅读、评论、分享交流 请扫描二维码下载->