Margetuximab retifanlimab作为一线治疗HER2 + / PD-L1 +不可切除的或转移性胃食管腺癌:桃花心木队列。

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Catenacci DVT Kang YK Yoon HH,垫片,Kim圣哦,DY, Spira AI, Ulahannan SV,艾弗里EJ,博兰点,曹国伟J,钟HC,加德纳F,球员SJ,李千瓦,哦,SC, Peguero J, Sonbol MB,沈L, moehle M,太阳J,李D,罗萨莱斯可,公园H

Margetuximab retifanlimab作为一线治疗HER2 + / PD-L1 +不可切除的或转移性胃食管腺癌:桃花心木队列。

ESMO开放。2022年10月,7 (5):100563。doi: 10.1016 / j.esmoop.2022.100563。Epub 2022年8月24日。

PubMed ID
36029651 (在PubMed
]
文摘

背景:人类表皮生长因子受体2 (HER2)阳性转移性胃癌和胃食管腺癌(GEA)是全球接受化疗+曲妥珠单抗。小说不仅治疗策略努力优化效果,但也会限制毒性。在桃花心木群,margetuximab Fc-engineered, anti-HER2单克隆抗体(mAb)加上retifanlimab anti-programmed细胞死亡蛋白1马伯,一线her2阳性/编程death-ligand 1 (PD-L1)阳性赫亚。患者和方法:桃花心木群单组试验第1部分是评估患者margetuximab + retifanlimab HER2免疫组织化学3 +,PD-L1-positive(结合积极的分数> / = 1%),和non-microsatellite instability-high肿瘤。主要目标人群是安全/耐受性和证实客观缓解率(ORR)。结果:截至2021年8月3日,43岁的患者登记和接收margetuximab / retifanlimab。九年级3治疗相关的不良事件(tra)报告了8例(18.6%)患者和8 7例(16.3%)患者的严重的交易。没有等级4/5的交易。三个病人停止margetuximab / retifanlimab因为免疫相关的不良事件。或者由独立评估是53%(21/40(95%可信区间(CI) 36.1 - -68.5)),平均响应时间为10.3个月(95% CI 4.6——可评价的); disease control rate was 73% [29/40 (95% CI 56.1-85.4)]. The study sponsor discontinued the study in advance of the planned enrollment when it became apparent that the study design would no longer meet the requirements for drug approval because of recent advances in the treatment of GEA. CONCLUSIONS: The chemotherapy-free regimen of combined margetuximab/retifanlimab as first-line treatment in double biomarker-selected patients demonstrated a favorable toxicity profile compared with historical outcomes using chemotherapy plus trastuzumab. The ORR observed in this study compares favorably versus ORR observed with other chemotherapy-free approaches.

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药物
药物靶点
药物 目标 类 生物 药理作用 行动
Retifanlimab 程序性细胞死亡蛋白1 蛋白质 人类
是的
抗体
拦截器
 细节