Blood. 2018 Dec 20;132(25):2639-2642. doi: 10.1182/blood-2018-07-861641. Epub 2018 Sep 28.

Five-year PFS from the AETHERA trial of brentuximab vedotin for Hodgkin lymphoma at high risk of progression or relapse.

Moskowitz CH¹, Walewski J², Nademanee A³, Masszi T⁴, Agura E⁵, Holowiecki J⁶, Abidi MH⁷, Chen AI⁸, Stiff P⁹, Viviani S¹⁰, Bachanova V¹¹, Sureda A¹², McClendon T¹³, Lee C¹⁴, Lisano J¹³, Sweetenham J¹⁵.

Author information

1: Sylvester Comprehensive Cancer Center, University of Miami Health System, Miami, FL.
2: Department of Lymphoid Malignancies, Maria Sklodowska-Curie Memorial Institute and Oncology Centre, Warsaw, Poland.
3: Department of Hematology and Hematopoietic Cell Transplantation, City of Hope National Medical Center, Duarte, CA.
4: 3rd Department of Internal Medicine, Semmelweis University, Budapest, Hungary.
5: Blood and Marrow Transplantation, Baylor University Medical Center, Dallas, TX.
6: Department of Bone Marrow Transplantation & Oncohematology, Maria Sklodowska-Curie Institute of Oncology, Gliwice, Poland.
7: Bone Marrow Transplant Program, Spectrum Health Cancer Center, Michigan State University, Grand Rapids, MI.
8: Center for Hematologic Malignancies, Oregon Health & Science University, Portland, OR.
9: Cardinal Bernardain Cancer Center, Loyola University Medical Center, Maywood, IL.
10: Department of Medical Oncology and Hematology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
11: Division of Hematology, Oncology and Transplantation, University of Minnesota, Minneapolis, MN.
12: Hematology Department and Hematopoietic Stem Cell Transplant Programme, Institut Català d'Oncologia Hospitalet, Barcelona, Spain.
13: Seattle Genetics, Inc., Bothell, WA.
14: Takeda Oncology, Cambridge, MA; and.
15: Department of Hematology and Blood and Marrow Transplant, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT.

Abstract

The phase 3 AETHERA trial established brentuximab vedotin (BV) as a consolidative treatment option for adult patients with classical Hodgkin lymphoma (cHL) at high risk of relapse or progression after autologous hematopoietic stem-cell transplantation (auto-HSCT). Results showed that BV significantly improved progression-free survival (PFS) vs placebo plus best supportive care alone. At 5-year follow-up, BV continued to provide patients with sustained PFS benefit; 5-year PFS was 59% (95% confidence interval [CI], 51-66) with BV vs 41% (95% CI, 33-49) with placebo (hazard ratio [HR], 0.521; 95% CI, 0.379-0.717). Similarly, patients with ≥2 risk factors in the BV arm experienced significantly higher PFS at 5 years than patients in the placebo arm (HR, 0.424; 95% CI, 0.302-0.596). Upfront consolidation with BV significantly delayed time to second subsequent therapy, an indicator of ongoing disease control, vs placebo. Peripheral neuropathy, the most common adverse event in patients receiving BV, continued to improve and/or resolve in 90% of patients. In summary, consolidation with BV in adult patients with cHL at high risk of relapse or progression after auto-HSCT confers a sustained PFS benefit and is safe and well tolerated. Physicians should consider each patient's HL risk factor profile when making treatment decisions. This trial was registered at www.clinicaltrials.gov as #NCT01100502.