TY - JOUR
T1 - Interim results of brentuximab vedotin in combination with nivolumab in patients with relapsed or refractory Hodgkin lymphoma
AU - Herrera, Alex F.
AU - Moskowitz, Alison J.
AU - Bartlett, Nancy L.
AU - Vose, Julie M.
AU - Ramchandren, Radhakrishnan
AU - Feldman, Tatyana A.
AU - LaCasce, Ann S.
AU - Ansell, Stephen M.
AU - Moskowitz, Craig H.
AU - Fenton, Keenan
AU - Ogden, Carol Anne
AU - Taft, David
AU - Zhang, Qu
AU - Kato, Kazunobu
AU - Campbell, Mary
AU - Advani, Ranjana H.
N1 - Funding Information:
This work was supported by the Lymphoma Research Foundation Larry and Denise Mason Clinical Investigator Career Development Award and the National Cancer Institute, National Institutes of Health (2K12CA001727 and P50CA107399) (A.F.H.). Direct funding for this research was issued by Seattle Genetics, Inc, through the joint financial support of Seattle Genetics, Inc, and Bristol-Myers Squibb.
Funding Information:
The authors wish to acknowledge Abraham Fong and Neil Josephson for their contribution to the design of the study, and analysis and interpretation of the data, and Katrina Sebolt for assistance in manuscript preparation, as employees of Seattle Genetics, Inc. The authors also thank the patients who participated in this study, and their families and caregivers. This work was supported by the Lymphoma Research Foundation Larry and Denise Mason Clinical Investigator Career Development Award and the National Cancer Institute, National Institutes of Health (2K12CA001727 and P50CA107399) (A.F.H.). Direct funding for this research was issued by Seattle Genetics, Inc, through the joint financial support of Seattle Genetics, Inc, and Bristol-Myers Squibb.
Publisher Copyright:
© 2018 by The American Society of Hematology.
PY - 2018/3/15
Y1 - 2018/3/15
N2 - In this phase 1/2 study, brentuximab vedotin (BV) and nivolumab (Nivo) administered in combination were evaluated as initial salvage therapy in patients with relapsed or refractory (R/R) classical Hodgkin lymphoma (HL). Patients received up to 4 cycles of combination treatment, with BV administered on day 1 and Nivo on day 8 of the first cycle. For cycles 2 to 4, BV and Nivo were both administered on day 1. After study treatment, responses were evaluated by investigators per the 2014 Lugano classification, and patients could proceed to autologous stem cell transplantation (ASCT). Sixty-two patients were enrolled; the complete response rate among all treated patients (n 5 61) was 61%, with an objective response rate of 82%. Before ASCT, adverse events (AEs) occurred in 98% of patients, mostly grades 1 and 2. Infusion-related reactions (IRRs) occurred in 44% of patients overall, with 41% of patients experiencing an IRR during at least 1 infusion of BV. Five patients (8%) were treated with systemic steroids for immune-related AEs. A reduction of peripheral T-cell subsets including regulatory T cells was observed after the first dose of BV, and reduced serum levels of thymus- and activation-regulated chemokine concurrent with an increase in proinflammatory cytokines and chemokines were seen after the first BV plus Nivo infusions. The combination of BV plus Nivo was an active and well-tolerated first salvage regimen, potentially providing patients with R/R HL an alternative to traditional chemotherapy. This trial was registered at www.clinicaltrials.gov as #NCT02572167.
AB - In this phase 1/2 study, brentuximab vedotin (BV) and nivolumab (Nivo) administered in combination were evaluated as initial salvage therapy in patients with relapsed or refractory (R/R) classical Hodgkin lymphoma (HL). Patients received up to 4 cycles of combination treatment, with BV administered on day 1 and Nivo on day 8 of the first cycle. For cycles 2 to 4, BV and Nivo were both administered on day 1. After study treatment, responses were evaluated by investigators per the 2014 Lugano classification, and patients could proceed to autologous stem cell transplantation (ASCT). Sixty-two patients were enrolled; the complete response rate among all treated patients (n 5 61) was 61%, with an objective response rate of 82%. Before ASCT, adverse events (AEs) occurred in 98% of patients, mostly grades 1 and 2. Infusion-related reactions (IRRs) occurred in 44% of patients overall, with 41% of patients experiencing an IRR during at least 1 infusion of BV. Five patients (8%) were treated with systemic steroids for immune-related AEs. A reduction of peripheral T-cell subsets including regulatory T cells was observed after the first dose of BV, and reduced serum levels of thymus- and activation-regulated chemokine concurrent with an increase in proinflammatory cytokines and chemokines were seen after the first BV plus Nivo infusions. The combination of BV plus Nivo was an active and well-tolerated first salvage regimen, potentially providing patients with R/R HL an alternative to traditional chemotherapy. This trial was registered at www.clinicaltrials.gov as #NCT02572167.
UR - http://www.scopus.com/inward/record.url?scp=85046084307&partnerID=8YFLogxK
U2 - 10.1182/blood-2017-10-811224
DO - 10.1182/blood-2017-10-811224
M3 - Article
C2 - 29229594
AN - SCOPUS:85046084307
SN - 0006-4971
VL - 131
SP - 1183
EP - 1194
JO - Blood
JF - Blood
IS - 11
ER -