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Mosunetuzumab 在复发/难治性惰性和侵袭性 B 细胞非霍奇金淋巴瘤中的持久应答:一项 I/II 期研究的扩展随访。

Durable Responses With Mosunetuzumab in Relapsed/Refractory Indolent and Aggressive B-Cell Non-Hodgkin Lymphomas: Extended Follow-Up of a Phase I/II Study.

机构信息

City of Hope National Medical Center, Duarte, CA.

Jewish General Hospital and McGill University, Montreal, Quebec, Canada.

出版信息

J Clin Oncol. 2024 Jul 1;42(19):2250-2256. doi: 10.1200/JCO.23.02329. Epub 2024 Mar 28.

Abstract

JCO Mosunetuzumab is a CD20xCD3 T-cell-engaging bispecific antibody administered as an off-the-shelf, fixed-duration treatment in an outpatient setting. We report an updated analysis of the durability of response, by investigator assessment, after an overall median follow-up of 3.5 years in patients with relapsed/refractory indolent or aggressive B-cell non-Hodgkin lymphoma (iNHL/aNHL) from the dose-escalation stage of a phase I/II study of mosunetuzumab (ClinicalTrials.gov identifier: NCT02500407). Across dose levels, 65.7% of patients with iNHL and 36.4% with aNHL achieved a complete or partial response to mosunetuzumab. Median duration of response (DoR) in patients with iNHL for all responders was 23.2 months (95% CI, 13.8 to not estimable [NE]), but was not reached in complete responders (95% CI, 21.0 to NE). After a median time on study of 38.9 months, no relapses were observed beyond 26 months in complete responders. In patients with aNHL, median DoR for all responders was 7.8 months (95% CI, 4.6 to 22.8). Among 12 complete responders who progressed postmosunetuzumab treatment and were retreated with mosunetuzumab, 83.3% had an objective response and 58.3% achieved a second complete response. Our study reports the longest follow-up using bispecific antibodies in patients with B-cell non-Hodgkin lymphoma and demonstrates that mosunetuzumab can mediate durable remissions with time-limited treatment.

摘要

JCO 莫努妥珠单抗是一种 CD20xCD3 T 细胞结合双特异性抗体,作为一种即用型、固定疗程的治疗药物,在门诊环境中使用。我们报告了一项来自 I/II 期莫努妥珠单抗研究剂量递增阶段的复发/难治性惰性或侵袭性 B 细胞非霍奇金淋巴瘤(iNHL/aNHL)患者的随访 3.5 年后,根据研究者评估的缓解持久性的更新分析(ClinicalTrials.gov 标识符:NCT02500407)。在各剂量水平,65.7%的 iNHL 患者和 36.4%的 aNHL 患者对莫努妥珠单抗实现完全或部分缓解。所有应答者中 iNHL 患者的中位缓解持续时间(DoR)为 23.2 个月(95%CI,13.8 至无法估计[NE]),但完全应答者未达到(95%CI,21.0 至 NE)。在中位研究时间为 38.9 个月后,完全应答者在 26 个月后没有观察到复发。在 aNHL 患者中,所有应答者的中位 DoR 为 7.8 个月(95%CI,4.6 至 22.8)。在 12 名莫努妥珠单抗治疗后进展并接受莫努妥珠单抗再治疗的完全应答者中,83.3%有客观缓解,58.3%实现了第二次完全缓解。我们的研究报告了 B 细胞非霍奇金淋巴瘤患者使用双特异性抗体的最长随访时间,并证明莫努妥珠单抗可以通过限时治疗介导持久缓解。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6306/11210942/c89afdd4641f/jco-42-2250-g002.jpg

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