试验|III期临床试验结果登顶《自然》？HER2阳性胃癌的强劲对手出现了( 二 ) 自然|研究|患者|临床|帕博利

安全性数据则是“三联方案”的又一个加分项，两组的3-5级不良事件发生率、因不良事件停药的患者比例、因不良事件死亡的患者比例都基本一致，加用帕博利珠单抗还是安全可控的。

文章图片

研究安全性数据汇总
总之，基于KEYNOTE-811研究的初步疗效数据，美国FDA在2021年5月份，就已加速批准帕博利珠单抗联合曲妥珠单抗+化疗，一线治疗HER2阳性胃/胃食管连接癌的适应证。这到底是精准超前，还是有些大胆冒失，就要看未来的结果啦。
参考文献：
1.Janjigian Y Y, Kawazoe A, Ya?ez P, et al. The KEYNOTE-811 trial of dual PD-1 and HER2 blockade in HER2-positive gastric cancer[J]. Nature, 2021.
2.Mitani S, Kawakami H. Emerging targeted therapies for HER2 positive gastric cancer that can overcome trastuzumab resistance[J]. Cancers, 2020, 12(2): 400.
4.Chaganty B K R, Qiu S, Gest A, et al. Trastuzumab upregulates PD-L1 as a potential mechanism of trastuzumab resistance through engagement of immune effector cells and stimulation of IFNγ secretion[J]. Cancer Letters, 2018, 430: 47-56.
5.Janjigian Y Y, Maron S B, Chatila W K, et al. First-line pembrolizumab and trastuzumab in HER2-positive oesophageal, gastric, or gastro-oesophageal junction cancer: an open-label, single-arm, phase 2 trial[J]. The Lancet Oncology, 2020, 21(6): 821-831.
6.Rha S Y, Lee C-K, Kim H S, et al. Targeting HER2 in combination with anti-PD-1 and chemotherapy confers a significant tumor shrinkage of gastric cancer: A multi-institutional phase Ib/II trial of first-line triplet regimen (pembrolizumab, trastuzumab, chemotherapy) for HER2-positive advanced gastric cancer (AGC)[J]. Journal of Clinical Oncology, 2020, 38(15_suppl): 3081.
本文作者丨谭硕