Glofitamab Combined With Pola-R-CHP or R-CHOP as First Therapy in Younger Patients With High-Risk Large B-Cell Lymphoma: Results From the COALITION Study.

IF 42.1 1区医学 Q1 ONCOLOGY

Journal of Clinical Oncology Pub Date : 2025-06-18 DOI:10.1200/JCO-25-00481

Adrian Minson, Emma Verner, Pratyush Giri, Jason Butler, Wojt Janowski, Chan Y Cheah, Sumita Ratnasingam, Shu Min Wong, Matthew Ku, Mark Hertzberg, Kirsten Herbert, Nada Hamad, Costas K Yannakou, Fiona Swain, Paul Neeson, Thiago M Steiner, Javad Saghebi, Piers Blombery, Sally M Hunter, Molly Robertson, Lei Shong Lau, Rory Bennett, Sean Harrop, Jing Xie, John F Seymour, Michael J Dickinson

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引用次数: 0

Abstract

Purpose: Improved outcomes are needed for patients with high-risk (HR) large B-cell lymphoma (LBCL) who have <50% chance of cure with first-line (1L) R-CHOP chemotherapy. Patients with high burden or rapid progression are often excluded from 1L trials due to screening requirements. We report the investigator-initiated, phase II COALITION trial of the CD20xCD3 bispecific antibody glofitamab combined with R-CHOP or Pola-R-CHP in younger patients with HR features, designed to minimize time between diagnosis and treatment.

Methods: Patients age ≤65 years with LBCL and at least one HR feature (international prognostic index [IPI] ≥3, National Comprehensive Cancer Network-IPI ≥4, or rearrangements of MYC and BCL2 and/or BCL6) received one cycle of R-CHOP and were randomly assigned to five cycles of Glofit-Pola-R-CHP (n = 40) or Glofit-R-CHOP (n = 40), and two cycles of glofitamab consolidation. Enrollment occurred before or after a cycle of R-CHOP. The primary objective was safety and treatment deliverability. Secondary end points included response rates and survival.

Results: Eighty evaluable patients with a median age of 58 years and total metabolic tumor volume of 842 cm³ were included and began treatment a median of 14 days from diagnosis. Over 95% of patients completed all therapy and the median relative dose intensity was >94%. Cytokine release syndrome was observed in 21% of patients, all ≤grade 2 and manageable. Overall and complete response rates were 100% and 98%, respectively. At 20.7-month median follow-up, the estimated 2-year progression-free survival and overall survival were 86% and 92%, respectively.

Conclusion: The combination of glofitamab with R-CHOP or Pola-R-CHP is deliverable and results in high rates of durable response in this population of younger patients with high-burden, HR LBCL, supporting its ongoing exploration as a 1L treatment.

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格非他单抗联合Pola-R-CHP或R-CHOP作为年轻高危大b细胞淋巴瘤患者的首选治疗：COALITION研究的结果

目的:改进的结果需要高危患者(人力资源)大型b细胞淋巴瘤(LBCL)方法:患者年龄≤65年LBCL和至少一个人力资源功能(国际预后指数(IPI)≥3,国家综合癌症Network-IPI≥4,或重组MYC和BCL2和/或BCL6)收到一个周期R-CHOP和被随机分配到5个周期的Glofit-Pola-R-CHP (n = 40)或Glofit-R-CHOP (n = 40),和两个周期glofitamab整合。入组发生在R-CHOP周期之前或之后。主要目标是安全性和治疗可交付性。次要终点包括有效率和生存率。结果：纳入80例可评估的患者，中位年龄58岁，总代谢肿瘤体积为842 cm3，在诊断后中位14天开始治疗。超过95%的患者完成了所有治疗，中位相对剂量强度为90.94%。21%的患者出现细胞因子释放综合征，均≤2级且可控。总体和完全缓解率分别为100%和98%。在中位随访20.7个月时，估计的2年无进展生存率和总生存率分别为86%和92%。结论：格非他单抗联合R-CHOP或Pola-R-CHP在高负担的年轻HR LBCL患者群体中具有高的持久缓解率，支持其作为1L治疗的持续探索。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Clinical Oncology 医学-肿瘤学

CiteScore

41.20

自引率

2.20%

发文量

8215

审稿时长

2 months

期刊介绍： The Journal of Clinical Oncology serves its readers as the single most credible, authoritative resource for disseminating significant clinical oncology research. In print and in electronic format, JCO strives to publish the highest quality articles dedicated to clinical research. Original Reports remain the focus of JCO, but this scientific communication is enhanced by appropriately selected Editorials, Commentaries, Reviews, and other work that relate to the care of patients with cancer.