PMID- 29229594 OWN - NLM STAT- MEDLINE DCOM- 20190319 LR - 20240207 IS - 1528-0020 (Electronic) IS - 0006-4971 (Print) IS - 0006-4971 (Linking) VI - 131 IP - 11 DP - 2018 Mar 15 TI - Interim results of brentuximab vedotin in combination with nivolumab in patients with relapsed or refractory Hodgkin lymphoma. PG - 1183-1194 LID - 10.1182/blood-2017-10-811224 [doi] 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 = 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. CI - (c) 2018 by The American Society of Hematology. FAU - Herrera, Alex F AU - Herrera AF AD - City of Hope National Medical Center, Duarte, CA. FAU - Moskowitz, Alison J AU - Moskowitz AJ AD - Memorial Sloan Kettering Cancer Center, New York, NY. FAU - Bartlett, Nancy L AU - Bartlett NL AD - Division of Hematology and Oncology, Washington University School of Medicine, St. Louis, MO. FAU - Vose, Julie M AU - Vose JM AD - University of Nebraska Medical Center, Omaha, NE. FAU - Ramchandren, Radhakrishnan AU - Ramchandren R AD - Karmanos Cancer Institute, Detroit, MI. FAU - Feldman, Tatyana A AU - Feldman TA AD - Hackensack University Medical Center, Hackensack, NJ. FAU - LaCasce, Ann S AU - LaCasce AS AD - Dana-Farber Cancer Institute, Boston, MA. FAU - Ansell, Stephen M AU - Ansell SM AD - Mayo Clinic, Rochester, MN. FAU - Moskowitz, Craig H AU - Moskowitz CH AD - Memorial Sloan Kettering Cancer Center, New York, NY. FAU - Fenton, Keenan AU - Fenton K AD - Seattle Genetics, Inc, Bothell, WA. FAU - Ogden, Carol Anne AU - Ogden CA AD - Seattle Genetics, Inc, Bothell, WA. FAU - Taft, David AU - Taft D AD - Seattle Genetics, Inc, Bothell, WA. FAU - Zhang, Qu AU - Zhang Q AD - Seattle Genetics, Inc, Bothell, WA. FAU - Kato, Kazunobu AU - Kato K AD - Bristol-Myers Squibb, Princeton, NJ; and. FAU - Campbell, Mary AU - Campbell M AD - Seattle Genetics, Inc, Bothell, WA. FAU - Advani, Ranjana H AU - Advani RH AD - Stanford University Medical Center, Palo Alto, CA. LA - eng SI - ClinicalTrials.gov/NCT02572167 GR - K12 CA001727/CA/NCI NIH HHS/United States GR - P30 CA008748/CA/NCI NIH HHS/United States GR - P50 CA107399/CA/NCI NIH HHS/United States PT - Clinical Trial, Phase I PT - Clinical Trial, Phase II PT - Journal Article PT - Multicenter Study PT - Research Support, N.I.H., Extramural PT - Research Support, Non-U.S. Gov't DEP - 20171211 PL - United States TA - Blood JT - Blood JID - 7603509 RN - 0 (Chemokines) RN - 0 (Immunoconjugates) RN - 31YO63LBSN (Nivolumab) RN - 7XL5ISS668 (Brentuximab Vedotin) SB - IM CIN - Blood. 2018 Mar 15;131(11):1156-1157. PMID: 29545402 MH - Adolescent MH - Adult MH - Aged MH - Antineoplastic Combined Chemotherapy Protocols/*administration & dosage/adverse effects MH - Brentuximab Vedotin MH - Chemokines/blood MH - Female MH - Hodgkin Disease/blood/*drug therapy/pathology MH - Humans MH - Immunoconjugates/administration & dosage/adverse effects MH - Male MH - Middle Aged MH - Nivolumab/administration & dosage/adverse effects MH - Recurrence MH - T-Lymphocytes, Regulatory/metabolism/pathology PMC - PMC5855021 COIS- Conflict-of-interest disclosure: K.F., C.A.O., D.T., Q.Z., and M.C. are employees of and receive equity ownership in Seattle Genetics, Inc. A.F.H. received research funding from Seattle Genetics, Bristol-Myers Squibb, MedImmune, Merck, Immune Design, Genentech, and Pharmacyclics. A.J.M. received research funding from Seattle Genetics. N.L.B. received research funding from Seattle Genetics, Janssen, Affimed, ImaginAb, KITE, Forty Seven, Pharmacyclics, Celgene, Bristol-Myers Squibb, AstraZeneca, Genentech, Merck, Millennium, Pfizer, Immune Design, and Novartis. J.M.V. received research funding from Seattle Genetics, Bristol-Myers Squibb, Onyx, Merck, KITE, Janssen, Celgene, Allos Therapeutics, Acerta, Incyte, and US Biotest. R.R., T.A.F., and A.S.L. received research funding from Seattle Genetics. S.M.A. received research funding from Seattle Genetics and Merck. C.H.M. received research funding from Seattle Genetics, Pharmacyclics, and Merck. R.H.A. received research funding from Seattle Genetics, Agensys, Bristol-Myers Squibb, Celgene, Genentech, Infinity, Kura, Merck, Millennium, Regeneron, Janssen, and Pharmacyclics. A.F.H. has consulted for Merck, Genentech, Bristol-Myers Squibb, and Pharmacyclics. N.L.B. has consulted for Seattle Genetics, Gilead, and KITE. R.R. has consulted for Seattle Genetics. C.H.M. has consulted for Seattle Genetics, Celgene, Genentech, and Merck. R.H.A. has consulted for Gilead, Spectrum, Bristol-Myers Squibb, Pharmacyclics, NanoString, Forty Seven, Sutro, and Juno Therapeutics. T.A.F. is a member of a speakers bureau for Seattle Genetics, Pharmacyclics, Johnson & Johnson, AbbVie, and Celgene. The remaining author declares no competing financial interests. EDAT- 2017/12/13 06:00 MHDA- 2019/03/20 06:00 PMCR- 2018/03/15 CRDT- 2017/12/13 06:00 PHST- 2017/10/13 00:00 [received] PHST- 2017/11/30 00:00 [accepted] PHST- 2017/12/13 06:00 [pubmed] PHST- 2019/03/20 06:00 [medline] PHST- 2017/12/13 06:00 [entrez] PHST- 2018/03/15 00:00 [pmc-release] AID - S0006-4971(20)32398-3 [pii] AID - 2017/811224 [pii] AID - 10.1182/blood-2017-10-811224 [doi] PST - ppublish SO - Blood. 2018 Mar 15;131(11):1183-1194. doi: 10.1182/blood-2017-10-811224. Epub 2017 Dec 11.