Division of Hematology, Department of Internal Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.
Division of Hematology, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.
Cancer. 2024 Jun 1;130(11):1972-1981. doi: 10.1002/cncr.35217. Epub 2024 Feb 2.
Glofitamab is a bispecific antibody with promise for treating relapsed/refractory B-cell lymphoma according to a phase 1/2 clinical trial. This study examined its real-world effectiveness.
This was an investigator-initiated, multicenter retrospective study including 34 patients who had relapsed/refractory B-cell lymphomas after at least three prior lines of therapy and received glofitamab monotherapy in a compassionate use program in Taiwan between January 2021 and October 2022.
At a median follow-up of 15.9 months, 56% of patients responded to glofitamab and 23% achieved complete remission. Response to the previous line of therapy significantly correlated with response to glofitamab (p = .020). Most responses were durable; only five out of the 19 responders had documented disease recurrence at the data cutoff date. The estimated progression-free survival (PFS) was 3.2 months, and the estimated 1-year PFS was 33% for the entire cohort. PFS was better for responders than nonresponders (median PFS, 16.9 vs. 1.8 months; 1-year PFS, 60% vs. 0%). Forty-three cytokine release syndrome (CRS) events were observed, three of which were grade 3; all were manageable without glofitamab discontinuation. No immune effector cell-associated neurotoxicity was reported. Among seven hepatitis B virus (HBV) carriers (six had antiviral prophylaxis) and 14 patients with remote HBV (four had antiviral prophylaxis), no HBV reactivation was observed.
In this real-world cohort, glofitamab exhibited effectiveness comparable to trial results without excessive CRS or new safety issues. With appropriate prophylaxis, glofitamab-treated patients with chronic or remote HBV infection are unlikely to experience virus reactivation.
根据一项 1/2 期临床试验,Glofitamab 是一种双特异性抗体,有望治疗复发/难治性 B 细胞淋巴瘤。本研究评估了其真实世界的疗效。
这是一项由研究者发起的、多中心回顾性研究,纳入了 34 例在至少三线治疗后复发/难治性 B 细胞淋巴瘤且在 2021 年 1 月至 2022 年 10 月期间在台湾参加同情用药计划中接受 glofitamab 单药治疗的患者。
在中位随访 15.9 个月时,56%的患者对 glofitamab 有反应,23%的患者达到完全缓解。先前治疗线的反应与 glofitamab 的反应显著相关(p = 0.020)。大多数反应是持久的;在截止日期时,19 名应答者中只有 5 名记录到疾病复发。估计无进展生存期(PFS)为 3.2 个月,整个队列的 1 年 PFS 估计为 33%。应答者的 PFS 优于无应答者(中位 PFS,16.9 与 1.8 个月;1 年 PFS,60%与 0%)。观察到 43 例细胞因子释放综合征(CRS)事件,其中 3 例为 3 级;均无需停用 glofitamab 即可控制。未报告免疫效应细胞相关神经毒性。在 7 例乙型肝炎病毒(HBV)携带者(6 例有抗病毒预防)和 14 例有远程 HBV 的患者(4 例有抗病毒预防)中,未观察到 HBV 再激活。
在本真实世界队列中,glofitamab 的疗效与试验结果相当,无过度 CRS 或新的安全性问题。在适当的预防措施下,接受 glofitamab 治疗且有慢性或远程 HBV 感染的患者不太可能发生病毒再激活。