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.

Patients with high burden or rapid progression are often excluded from 1L trials due to screening requirements.

由于筛查要求，高负荷或快速进展的患者通常被排除在一线（1L）试验之外。

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.

我们报告了这项由研究者发起的II期COALITION试验，该试验评估了CD20×CD3双特异性抗体glofitamab联合R-CHOP或Pola-R-CHP在具有高危特征的年轻患者中的应用，旨在最小化诊断与治疗之间的时间间隔。

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.

年龄≤65岁的患者，如果患有LBCL并且至少具有一个高危特征（国际预后指数[IPI]≥3，国家综合癌症网络-IPI≥4，或者MYC和BCL2和/或BCL6的重排），则接受一周期的R-CHOP治疗，并随机分配接受五周期的Glofit-Pola-R-CHP（n=40）或Glofit-R-CHOP（n=40），以及两周期的glofitamab巩固治疗。

Enrollment occurred before or after a cycle of R-CHOP.

入组发生在R-CHOP治疗周期之前或之后。

The primary objective was safety and treatment deliverability.

主要目标是评估安全性和治疗的可实施性。

Secondary end points included response rates and survival.

次要终点包括反应率和生存期。

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.

纳入了80名可评估患者，中位年龄为58岁，总代谢肿瘤体积为842立方厘米，并在诊断后中位14天开始治疗。

Over 95% of patients completed all therapy and the median relative dose intensity was >94%.

超过95%的患者完成了全部治疗，中位相对剂量强度大于94%。

Cytokine release syndrome was observed in 21% of patients, all ≤grade 2 and manageable.

21%的患者观察到细胞因子释放综合征，所有病例均为≤2级且可管理。

Overall and complete response rates were 100% and 98%, respectively.

总反应率和完全反应率分别为100%和98%。

At 20.7-month median follow-up, the estimated 2-year progression-free survivaland overall survivalwere 86% and 92%, respectively.

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%。

Conclusions

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.

在这些高负担、高风险（HR）大B细胞淋巴瘤（LBCL）的年轻患者中，glofitamab与R-CHOP或Pola-R-CHP联合使用是可行的，并且能够产生高比例的持久缓解反应，这支持了将其作为一线治疗继续探索。