已入深夜,您辛苦了!由于当前在线用户较少,发布求助请尽量完整的填写文献信息,科研通机器人24小时在线,伴您度过漫漫科研夜!祝你早点完成任务,早点休息,好梦!

Glofitamab Monotherapy in Patients with Non-Hodgkin B-Cell Lymphoma after Failing CAR T-Cell Infusion: Primary Analysis of the Bicar Study, a Phase II Lysa Study

医学 临床终点 内科学 队列 危险系数 弥漫性大B细胞淋巴瘤 淋巴瘤 奥比努图库单抗 肿瘤科 胃肠病学 美罗华 临床试验 置信区间
作者
Pierre Sesques,Roch Houot,Yassine Al Tabaa,Fabien Le Bras,Loïc Ysebaert,Fabrice Jardin,Sylvain Choquet,Jacques‐Olivier Bay,François Gros,Franck Morschhauser,Olivier Casasnovas,Thomas Gastinne,Catherine Thiéblemont,Magalie Joris,Laure Ricard,Caroline Régny,Laurianne Drieu La Rochelle,Pierre Feugier,Ambroise Marçais,Karin Tarte,Camille Laurent,Guillaume Cartron
出处
期刊:Blood [Elsevier BV]
卷期号:142 (Supplement 1): 893-893 被引量:4
标识
DOI:10.1182/blood-2023-177703
摘要

Introduction. Chimeric antigen receptor (CAR) T-cells have improved outcomes of patients (pts) with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL). However, 40% to 60% of those pts will experience relapse or progression with a median overall survival (mOS) shorter than 6 months (mo) according to the French DESCAR-T registry study. Glofitamab is a 2:1 CD20xCD3 bispecific antibody that demonstrated efficacy in pts with R/R DLBCL. We report the results of the primary analysis of a phase II multicenter study using glofitamab in pts with R/R non-Hodgkin B-cell lymphoma after CAR T-cell infusion. Patients and Methods Pts with a biopsy-proven DLBCL (cohort 1) or non-DLBCL (cohort 2), with no metabolic response, progression or in relapse at least one month after CAR T-cell infusion, received obinutuzumab (1000 mg) 3 days before (Day -3, D-3) the first glofitamab dose. Intravenous glofitamab was administered with step-up dosing on D1 (2.5mg), D3 (10mg) and D8 (30mg) of Cycle (C) 1 and at 30mg on D1 of C2-11 (21-day cycles). The primary endpoint was defined for cohort 1 with a null hypothesis of 6.3 mo of mOS and a hypothesis of improvement to 12.6 mo (hazard ratio [HR]: 0.5). No hypothesis testing was planned for cohort 2. On Dec 22nd, 2022, enough events had been observed allowing the analysis of the primary endpoint based on data exported on June 2nd, 2023. Results. As of June 2 nd, 2023, 67 pts were enrolled, and 63 pts (44 pts in cohort 1, 19 pts in cohort 2) received ≥1 dose of study treatment. All pts in cohort 1 had a biopsy proven DLBCL whereas pts in cohort 2 had follicular lymphoma (n=6), mantle cell lymphoma (n=5), transformed follicular lymphoma (n=4), transformed marginal zone lymphoma (n=2), primary mediastinal B-lymphoma (n=1), or t-Waldenström macroglobulinemia(n=1). In combined cohort 1 and cohort 2, median age was 65 years (range: 33-77) and 84.1% of pts had Ann Arbor stage III/IV. Median number of prior therapies received was 3 (range: 2-6; ≥3 prior therapies: 87.3%; IPI ≥3: 58.7%). Prior CAR T-cell therapy was axi-cel (n=29, 46%), tisa-cel (n= 25, 39.7%), brexu-cel (n=5, 7.9%) or investigational CAR T-cell (n= 4, 6.3%). Thirteen pts (20.6%) were refractory (no response to CAR T-cells), 50 pts (79.4%) were in relapse/progression, among these, 15 (30%) relapsed/progressed between 1-3 mo, 18 (36%) between 3-6 mo and 17 (34%) >6mo after CAR T-cell infusion. The median number of glofitamab cycles administered was 5 (range: 1-12). Nine pts (14.3%) experienced cytokine release syndrome (CRS) (grade [G]1: 3 pts, G2: 6pts) and 2 pts experienced neurologic events (NE) G2. Neutropenia G ≥3 was observed in 22 pts (33.3%), thrombocytopenia G ≥3 in 9 pts (11.1%) and anemia G ≥3 in 7 pts (11.1%). Eighteen pts (28.6%) experienced serious adverse events (SAE) G ≥3, mainly infection (17 pts, among them 9 pts related to COVID-19). Thirty-five pts (55.5%) permanently discontinued glofitamab: 28 pts (44.4%) for progression, 4 pts for death and 3 pts for toxicity (musculoskeletal pain, hepatitis, genital infection). With a median follow-up of 9.7 mo (95% CI: 8.1-11.8), for cohort 1 the mOS was 17.6 mo (90% CI: 8.3-19.7), the lower limit of the 90% CI was ≥6.3 and so the null hypothesis could be rejected, and the primary endpoint was met. The mOS for cohort 2 was not reached (NR) (90% CI: 6.4-NR). According to central review, overall best metabolic response was 65.9% (CMR: 36.4%) and 57.9% (CMR 52.6%) in cohort 1 and 2, respectively. The median duration of CMR was 19.7 mo (95% CI: 4.9-19.7) and NR (95% CI: 2.8-NR) for cohort 1 and 2, respectively. Median progression-free survival was 4.9 mo (95% CI: 2.6-19.7) and 4.1 months (95% CI:1.4-NR for cohort 1 and 2, respectively). Conclusion. Glofitamab demonstrated a significant increase in OS when used in pts in first relapse/progression after CAR T-cells. In this context, glofitamab resulted in deep and durable responses and manageable safety.
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
1秒前
总之完成签到 ,获得积分10
2秒前
ASZXDW发布了新的文献求助10
5秒前
李健应助嘴巴张大一点采纳,获得10
5秒前
5秒前
酷波er应助zht采纳,获得10
7秒前
9秒前
liujianzhuo发布了新的文献求助10
9秒前
EineK发布了新的文献求助30
10秒前
FashionBoy应助风云鱼采纳,获得10
12秒前
12秒前
13秒前
kk发布了新的文献求助30
14秒前
15秒前
15秒前
番茄煮糖发布了新的文献求助10
18秒前
白之玉发布了新的文献求助10
18秒前
zht发布了新的文献求助10
22秒前
22秒前
传奇3应助陶醉的代丝采纳,获得10
22秒前
23秒前
23秒前
Lv完成签到,获得积分10
25秒前
罢黜百家发布了新的文献求助10
25秒前
李爱国应助科研通管家采纳,获得10
28秒前
ywd完成签到,获得积分10
28秒前
彭于晏应助科研通管家采纳,获得10
28秒前
潇潇雨歇发布了新的文献求助10
28秒前
共享精神应助科研通管家采纳,获得10
28秒前
Orange应助科研通管家采纳,获得10
28秒前
完美世界应助科研通管家采纳,获得10
28秒前
Orange应助科研通管家采纳,获得10
28秒前
上官若男应助科研通管家采纳,获得10
29秒前
传奇3应助科研通管家采纳,获得10
29秒前
思源应助科研通管家采纳,获得10
29秒前
科研通AI5应助科研通管家采纳,获得10
29秒前
ceeray23应助科研通管家采纳,获得10
29秒前
29秒前
zjmm发布了新的文献求助10
29秒前
30秒前
高分求助中
【此为提示信息,请勿应助】请按要求发布求助,避免被关 20000
All the Birds of the World 4000
Production Logging: Theoretical and Interpretive Elements 3000
Musculoskeletal Pain - Market Insight, Epidemiology And Market Forecast - 2034 2000
Am Rande der Geschichte : mein Leben in China / Ruth Weiss 1500
CENTRAL BOOKS: A BRIEF HISTORY 1939 TO 1999 by Dave Cope 1000
Density Functional Theory: A Practical Introduction, 2nd Edition 840
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 3749768
求助须知:如何正确求助?哪些是违规求助? 3292981
关于积分的说明 10079202
捐赠科研通 3008280
什么是DOI,文献DOI怎么找? 1652178
邀请新用户注册赠送积分活动 787229
科研通“疑难数据库(出版商)”最低求助积分说明 752013