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|Title:||Nivolumab for Relapsed/Refractory Diffuse Large B-Cell Lymphoma in Patients Ineligible for or Having Failed Autologous Transplantation: A Single-Arm, Phase II Study.|
|Authors:||Ansell, Stephen M;Minnema, Monique C;Johnson, Peter;Timmerman, John M;Armand, Philippe;Shipp, Margaret A;Rodig, Scott J;Ligon, Azra H;Roemer, Margaretha G M;Reddy, Nishitha;Cohen, Jonathon B;Assouline, Sarit;Poon, Michelle;Sharma, Manish;Kato, Kazunobu;Samakoglu, Selda;Sumbul, Anne;Grigg, Andrew P|
|Affiliation:||Mayo Clinic, Rochester, MN|
Austin Health, Heidelberg, Victoria, Australia
University Medical Center Utrecht Cancer Center, Utrecht, The Netherlands, on behalf of the Lunenburg Lymphoma Phase I/II Consortium-HOVON/LLPC..
University of Southampton, Southampton, United Kingdom
University of California, Los Angeles, Los Angeles, CA
Dana-Farber Cancer Institute, Boston, MA
Brigham and Women's Hospital, Boston, MA
Vanderbilt University, Nashville, TN
Emory University, Atlanta, GA
Jewish General Hospital, Montreal, Quebec, Canada
National University Cancer Institute, Singapore, Singapore
Bristol-Myers Squibb, Princeton, NJ
|Citation:||Journal of clinical oncology : official journal of the American Society of Clinical Oncology 2019: JCO1800766|
|Abstract:||Treatment options are limited for patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). Tumor cells can exploit the programmed death-1 checkpoint pathway to evade immune surveillance. In the current study, we evaluated the efficacy and safety of programmed death-1 blockade by nivolumab in patients with relapsed/refractory DLBCL. In this phase II, open-label study, patients with relapsed/refractory DLBCL who were ineligible for autologous hematopoietic cell transplantation (auto-HCT) or who had experienced failure with auto-HCT received nivolumab 3 mg/kg every 2 weeks. We assessed the efficacy and safety of nivolumab as well as genetic alterations of 9p24.1. Among 121 treated patients, patients in the auto-HCT-failed cohort (n = 87) received a median of four nivolumab doses and a median of three doses were administered to those in the auto-HCT-ineligible cohort (n = 34). At a median follow-up of 9 months in the auto-HCT-failed cohort and 6 months in the auto-HCT-ineligible cohort, independently assessed objective response rates were 10% and 3%, and median durations of response were 11 and 8 months, respectively. Median progression-free survival and overall survival were 1.9 and 12.2 months in the auto-HCT-failed cohort and 1.4 and 5.8 months in the auto-HCT-ineligible cohort respectively. All three patients with complete remission-3% of the auto-HCT-failed cohort-had durable response (11 or more, 14 or more, and 17 months). Treatment-related grade 3 and 4 adverse events were reported in 24% of patients. The most common were neutropenia (4%), thrombocytopenia (3%), and increased lipase (3%). Of all evaluable samples for 9p24.1 analysis, 16% exhibited low-level copy gain and 3% had amplification. Nivolumab monotherapy is associated with a favorable safety profile but a low overall response rate among patients with DLBCL who are ineligible for auto-HCT or who experienced failure with auto-HCT. Genetic alterations of 9p24.1 are infrequent in DLBCL.|
|Appears in Collections:||Journal articles|
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