A phase II study of monalizumab in patients with recurrent/metastatic squamous cell carcinoma of the head and neck: The I1 cohort of the EORTC-HNCG-1559 UPSTREAM trial

医学 免疫疗法 内科学 肿瘤科 头颈部鳞状细胞癌 不利影响 队列 头颈部癌 实体瘤疗效评价标准 临床研究阶段 临床终点 胃肠病学 癌症 临床试验
作者
Rachel Galot,Christophe Le Tourneau,Esma Saada‐Bouzid,Amaury Daste,Caroline Even,Philip R. Debruyne,Stéphanie Henry,Sylvie Zanetta,Anemie Rutten,Lisa Licitra,Jean Luc Canon,Marie Christine Kaminsky,Pol Specenier,Sylvie Rottey,J. Guigay,Anthony Kong,Inge Tinhofer,Édith Borcoman,L. Dirix,Tiana Raveloarivahy,Catherine Fortpied,Maureen Vanlancker,Marie Morfouace,André Govaerts,Jean Pascal Machiels
出处
期刊:European Journal of Cancer [Elsevier BV]
卷期号:158: 17-26 被引量:36
标识
DOI:10.1016/j.ejca.2021.09.003
摘要

Monalizumab is a monoclonal antibody targeting the inhibitory natural killer group 2A (NKG2A) receptor localised on natural killer (NK) and T cells. Its ligand, the human leukocyte antigen E (HLA-E), is overexpressed in squamous cell carcinoma of the head and neck (SCCHN). By targeting the HLA-E-NKG2A pathway, monalizumab may enhance NK and T cell activity.The UPSTREAM trial is a biomarker-driven umbrella trial studying targeted therapies and immunotherapies in patients with recurrent/metastatic (R/M) SCCHN progressing after platinum therapy. The immunotherapy 1 (I1) cohort was a phase II, single-arm substudy evaluating monalizumab (10 mg/kg intravenously on day 1 of a 14-day cycle). The primary end-point was the objective response (OR) rate (Response Evaluation Criteria in Solid Tumours 1.1) over the first 16 weeks. A two-stage Simon design was used (H1 15%, H0 3%, α 8%, power 90%) with pre-planned interruption of accrual if no OR was observed after the first 25 patients.Twenty-six eligible patients were enrolled. Seventeen (65%) patients had received ≥2 previous lines of systemic treatment, and 15 (58%) patients were PD(-L)1 inhibitor pretreated. No OR was observed. Stable disease was observed in 6 patients (23%) with a median duration of 3.8 months (95% confidence interval [CI]: 2.7-NE). The median progression-free survival and overall survival were 1.7 months (95% CI: 1.5-1.8) and 6.7 months (95% CI: 3.0-9.6), respectively. The most frequent treatment-related adverse event was grade I/II fatigue (19%).Monalizumab monotherapy has limited activity in R/M SCCHN. The I1 cohort did not meet its primary objective. Monalizumab combined with durvalumab is under investigation within UPSTREAM.
最长约 10秒,即可获得该文献文件

科研通智能强力驱动
Strongly Powered by AbleSci AI
科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
PPP完成签到,获得积分10
刚刚
凶狠的盼柳完成签到,获得积分10
刚刚
Autin完成签到,获得积分0
刚刚
刚刚
tyran完成签到,获得积分10
1秒前
1秒前
2秒前
单纯代萱发布了新的文献求助10
3秒前
3秒前
嗯嗯发布了新的文献求助10
4秒前
5秒前
邋遢大王不邋遢完成签到,获得积分10
6秒前
6秒前
Peter_Zhu完成签到,获得积分10
7秒前
8秒前
夏青荷发布了新的文献求助10
8秒前
林家小弟完成签到,获得积分10
8秒前
希柚完成签到 ,获得积分10
9秒前
9秒前
ttxpx发布了新的文献求助10
10秒前
顾矜应助甜欣028采纳,获得10
10秒前
彩虹猫完成签到 ,获得积分10
10秒前
单纯代萱完成签到,获得积分10
11秒前
素浅关注了科研通微信公众号
11秒前
优雅梦曼完成签到,获得积分10
11秒前
Hello应助Ariel采纳,获得10
11秒前
CC完成签到,获得积分10
12秒前
中岛悠斗完成签到,获得积分10
12秒前
谷粱紫槐完成签到,获得积分10
12秒前
小蘑菇应助原野小年采纳,获得10
13秒前
RR发布了新的文献求助10
13秒前
林夕完成签到,获得积分10
13秒前
记录者完成签到 ,获得积分10
14秒前
CC发布了新的文献求助10
15秒前
科研鑫完成签到,获得积分10
16秒前
科研通AI5应助yn采纳,获得10
16秒前
柴胡完成签到,获得积分10
16秒前
天真的不尤完成签到 ,获得积分10
17秒前
Soir完成签到 ,获得积分10
19秒前
研友_VZG7GZ应助小张采纳,获得10
20秒前
高分求助中
All the Birds of the World 4000
Production Logging: Theoretical and Interpretive Elements 3000
Animal Physiology 2000
Les Mantodea de Guyane Insecta, Polyneoptera 2000
Am Rande der Geschichte : mein Leben in China / Ruth Weiss 1500
CENTRAL BOOKS: A BRIEF HISTORY 1939 TO 1999 by Dave Cope 1000
Machine Learning Methods in Geoscience 1000
热门求助领域 (近24小时)
化学 材料科学 医学 生物 工程类 有机化学 物理 生物化学 纳米技术 计算机科学 化学工程 内科学 复合材料 物理化学 电极 遗传学 量子力学 基因 冶金 催化作用
热门帖子
关注 科研通微信公众号,转发送积分 3736925
求助须知:如何正确求助?哪些是违规求助? 3280839
关于积分的说明 10021396
捐赠科研通 2997494
什么是DOI,文献DOI怎么找? 1644637
邀请新用户注册赠送积分活动 782085
科研通“疑难数据库(出版商)”最低求助积分说明 749707