Author(s): Lihua E. Budde, MD1; Sarit Assouline, MD, MSc2; Laurie H. Sehn, MD3; Stephen J. Schuster, MD4; Sung-Soo Yoon, MD, PhD5; Dok Hyun Yoon, MD, PhD6; Matthew J. Matasar, MD7; Francesc Bosch, MD, PhD8; Won Seog Kim, MD, PhD9; Loretta J. Nastoupil, MD10; Ian W. Flinn, MD, PhD11; Mazyar Shadman, MD, MPH12; Catherine Diefenbach, MD13; Chan Yoon Cheah, MBBS, DMedSc14; Connie Y. Ma, MSc15; Huang Huang, MSc16; Antonia Kwan, MBBS, PhD15; Michael C. Wei, MD, PhD15; Shen Yin, PhD15; Nancy L. Bartlett, MD17
ABSTRACT
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 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.
Author Affiliations
1City of Hope National Medical Center, Duarte, CA; 2Jewish General Hospital and McGill University, Montreal, Quebec, Canada; 3BC Cancer Centre for Lymphoid Cancer and the University of British Columbia, Vancouver, British Columbia, Canada; 4Lymphoma Program, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA; 5Seoul National University Hospital, Seoul, South Korea; 6Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea; 7Rutgers University, New York, NY; 8University Hospital Vall d’Hebron and Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain; 9Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, South Korea; 10MD Anderson Cancer Center, Houston, TX; 11Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN; 12Fred Hutchinson Cancer Research Center, Seattle, WA; 13Perlmutter Cancer Center at NYU Langone Health, New York, NY; 14Linear Clinical Research Limited, Nedlands, Australia; 15Genentech, Inc, South San Francisco, CA; 16Hoffmann-La Roche Limited, Mississauga, Ontario, Canada; 17Siteman Cancer Center, Washington University School of Medicine, St Louis, MO
