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Blood. 2016 Sep 22;128(12):1562-6. doi: 10.1182/blood-2016-02-699850. Epub 2016 Jul 18.

Five-year survival and durability results of brentuximab vedotin in patients with relapsed or refractory Hodgkin lymphoma.

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City of Hope National Medical Center, Duarte, CA;
Division of Medical Oncology, Department of Medicine, University of Washington/Fred Hutchinson Cancer Research Center, Seattle, WA;
Division of Hematology and Medical Oncology, Department of Medicine, Loyola University Medical Center, Maywood, IL;
Mayo Clinic, Rochester, MN;
Division of Hematology and Oncology, Department of Medicine, University of Miami Sylvester Comprehensive Cancer Center, Miami, FL;
British Columbia Cancer Agency Centre for Lymphoid Cancer, Vancouver, BC, Canada;
German Hodgkin Study Group, Department of Internal Medicine I, University Hospital of Cologne, Cologne, Germany;
Seattle Genetics, Inc., Bothell, WA;
Millenium Pharmaceuticals, Inc., Cambridge, MA; and.
Memorial Sloan Kettering Cancer Center, New York, NY.


Presented here are the 5-year end-of-study results from the pivotal phase 2 trial of brentuximab vedotin in patients with relapsed/refractory (R/R) Hodgkin lymphoma (HL) after failed hematopoietic autologous stem cell transplantation. At 5 years, the overall patient population (N = 102) had an estimated overall survival (OS) rate of 41% (95% confidence interval [CI]: 31-51) and progression-free survival (PFS) rate of 22% (95% CI: 13-31). Patients who achieved a complete response (CR) to brentuximab vedotin (N = 34) had estimated OS and PFS rates of 64% (95% CI: 48-80%) and 52% (95% CI: 34-69%), respectively. The median OS and PFS were not reached in CR patients, with 13 patients (38% of all CR patients) remaining in follow-up and in remission at study closure. Of the 13 patients, 4 received consolidative hematopoietic allogeneic stem cell transplant, and 9 (9% of all enrolled patients) remain in sustained CR without receiving any further anticancer therapy after treatment with brentuximab vedotin. Of the patients who experienced treatment-emergent peripheral neuropathy, 88% experienced either resolution (73%) or improvement (14%) in symptoms. These 5-year follow-up data demonstrate that a subset of patients with R/R HL who obtained CR with single-agent brentuximab vedotin achieved long-term disease control and may potentially be cured. The trial was registered at as #NCT00848926.

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