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

作者：Lihua Elizabeth Budde, Sarit E. Assouline, Laurie Helen Sehn, Stephen J. Schuster, Sung‐Soo Yoon, Dok Hyun Yoon, Matthew J. Matasar, Francesc Bosch, Won Seog Kim, Loretta J. Nastoupil, Ian W. Flinn, Mazyar S. Shadman, Catherine Diefenbach, Chan Yoon Cheah, Connie Y. Ma, Huang Huang, Antonia Kwan, Michael C. Wei, Shen Yin, Nancy L. Bartlett · 发表于：Journal of Clinical Oncology · 年份：2024 · DOI：10.1200/jco.23.02329 · 被引用次数：61 · 研究领域：CAR-T cell therapy research、Lymphoma Diagnosis and Treatment、Monoclonal and Polyclonal Antibodies Research

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported. 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 postmosu...