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2069 Amahrelis : Adcetris Maintenance after Autologous Stem Cell Transplantation in Hodgkin Lymphoma : A Real Life Study from Sfgmtc and Lysa Groups

Program: Oral and Poster Abstracts
Session: 624. Hodgkin Lymphoma and T/NK Cell Lymphoma—Clinical Studies: Poster II
Hematology Disease Topics & Pathways:
therapy sequence, Diseases, Hodgkin Lymphoma, Therapies, Combinations, Lymphoid Malignancies, Clinically relevant
Sunday, December 6, 2020, 7:00 AM-3:30 PM

Amira Marouf1,2*, Anne Ségolène Cottereau, MD3*, Guillemette Fouquet, MD4*, Salim Kanoun, MD5*, Patricia Franchi, MD6*, Romain Ricci7*, Michel Meignan, MD8*, David Sibon, MD, PhD9*, Thomas Gastinne, MD10*, Cecile Borel, MD11*, Mohammad Hammoud, MD12*, Guillaume Sicard, MD13*, Romane Gille14*, Doriane Cavalieri, MD15*, Aspasia Stamatoulas Bastard, MD16*, Lauriane Clement-Filliatre, MD17*, Julien Lazarovici, MD18*, Adrien Chauchet, MD19*, Luc Mathieu Fornecker, MD, PhD20,21*, Sandy Amorin, MD22*, Mathieu Roquet4*, Nicole Raus, Data Manager23*, Rene-Olivier Casasnovas, MD24,25*, Guillaume Cartron, MD, PhD26,27*, Hervé Ghesquieres, MD, PhD28*, Pauline Brice, MD29*, Olivier Hermine30,31, Didier Bouscary, MD, PhD4,32*, Marie Thérèse Rubio, MD, PhD33,34*, Jerome Tamburini, MD, PhD35,36,37* and Benedicte Deau Fischer4,6,38*

1CHU Cochin, Paris, France
2INSERM UMR 1163 Institut Imagine, Paris Descartes University, Faculty of medicine, Sorbonne Paris Cité, Paris, France., Paris, France
3Nuclear Medicine, APHP Cochin Hospital, PARIS, France
4Hematology Department, CHU Cochin, Paris, France
5Institut universitaire du cancer Toulouse- Oncopole, Toulouse, France
6Cochin Hospital, Hematology Department, Paris, France
7LYSARC, The Lymphoma Academic Research Organisation, Créteil, FRA
8LYSA, Paris, France
9INSERM UMR 1163 & CNRS URL 8254, Hematology Department, Necker University Hospital, APHP, Paris, France, Paris, France
10Clinical Hematology, Nantes University Hospital, Nantes, France
11Institut Universitaire du Cancer de Toulouse Oncopole, Hematology Department, Toulouse, France
12Lymphoid Malignancies, Henri Mondor Hospital, Creteil, France
13Hematology Department, Aix Marseille University, Marseille, France
14Leon Berard Hospital, Lyon, France
15Centre Hospitalier Universitaire Estaing, Hematology Department, Clermont Ferrand, France
16Henri Becquerel Center, Rouen, France
17CHRU Nancy Brabois, Vandoeuvre Les Nancy, France
18Department of hematology, Gustave Roussy Cancer Campus Grand Paris, Villejuif CEDEX, France
19Hematology Department, Besancon University Hospital, Besancon, France
20Department of Hematology, Strasbourg University Hospital, Strasbourg, France
21UMR-S1113 - IRFAC, INSERM, Faculté de Médecine, STRASBOURG, France
22Hopital Saint Vincent de Paul, Lille, France
23SFGM-TC, Lyon, France
24Hématologie Clinique and INSERM 1231, CHU Dijon, Dijon, France
25Inserm UMR 1231, Dijon, France
26Montpellier University, UMR CNRS 5235, Montpellier, France
27CHU Montpellier, Department of Clinical Hematology, Montpellier, France
28Department of Hematology, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon, Pierre Benite, France
29Hopital Saint-Louis, Paris, France
30Hematology Department, AP-HP Hôpital Necker, University Paris Descartes, Paris, France
31Imagine Institute, INSERM U1163, University of Paris, Paris, France
32Paris Descartes University, Sorbonne Paris Cité, Paris, France
33CNRS UMR 7365, Équipe 6, Biopôle de L'Université de Lorraine, Vandoeuvre Les Nancy, France
34CHRU Nancy, Hôpital Brabois, Vandœuvre-les Nancy, France
35Translational Research Centre in Onco-hematology, Faculty of Medicine, University of Geneva, Geneva, Switzerland
36Institut Cochin, Département Développement, Reproduction, Cancer, Centre National de la Recherche Scientifique (CNRS), Unité Mixte de Recherche (UMR) 8104, Institut National de la Santé et de la Recherche Médicale (INSERM) U1016, Paris, France
37Hematology department, CHU Cochin, Paris, France
38Hematolgy Department, CHU Cochin, Paris, France

Background :

AETHERA randomized controlled study (Moskowitz, Lancet 2015) showed that the administration of Brentuximab Vedotin (BV) maintenance after autologous stem cell transplantation (ASCT) improved progression free survival (PFS) in BV-naive refractory/relapsed (R/R) Hodgkin lymphoma (HL) patients. However, since BV approval for R/R HL in 2012, many patients are receiving salvage BV before ASCT, alone or combined with chemotherapy. In the AMAHRELIS retrospective nationwide French study, we investigated the real-life outcome of patients with R/R HL mostly treated with BV-based salvage therapies and who received post-ASCT BV maintenance.

Objectives :

As primary objective, we assessed 2 years-PFS of patients treated with post-ASCT BV maintenance from 2012 to 2017 in France. As secondary objectives, we correlated variables (such as use of salvage BV before ASCT, centrally reviewed TEP-assessed response) with survival, and evaluated reported tolerance of BV using the CTCAE v4.0 criteria.

Methods :

We conducted this observational retrospective study in 58 national centers. Inclusion criteria were R/R HL patients who received at least two infusions of BV after ASCT, at the exclusion of patients in progression after transplant. Among 1134 patients who underwent ASCT for R/R HL between 2012 and 2017 in France based on the French society of bone marrow transplantation database, 835 (74%) patients were screened and data were available for 794 (70%) patients. FDG-PET scan at relapse and before transplantation were recorded and centrally reviewed (still ongoing). FDG-PET scan were reported using the Deauville score (DS), and complete remission was defined by a DS < 4. Post-transplant status was evaluated based on CT-scan or on FDG-PET scan results. This study was approved by the SFGMTC and the LYSA.

Results : Fifteen percent (115/794) of patients met eligibility criteria, and were enrolled in this study. Among them, 95% met inclusion criteria for BV maintenance according to the AETHERA study as primary refractory disease (43%), early relapse (27%) or extranodal disease (49%). The mean number of BV injections after ASCT was 11 (3-18). Patients characteristics were : mean age was 34 y (range between 16-70y), 54% were male, and 57% of patients were stage III or IV at relapse. Notably, 70% of patients received BV as salvage therapy and 81% achieved a complete remission before ASCT. The median follow-up period was 35 months. The 2 years survival for the whole cohort was 75,3% for PFS (95% CI : 68,4-84,3) and 96,4% for overall survival (95% CI : 94,2-100) (Figure 1). The use of BV as part of salvage therapy before transplant had no impact on PFS. We observed a trend to an increased occurrence of neuropathy in patients receiving BV before transplant without impact on early treatment discontinuation. We tested several variables for correlation with survival using a univariate Cox model including high risk patients defined as primary refractory disease or early relapse and disseminated disease, extranodal relapse, use of BV before transplant, number of salvage lines, remission status before and after transplant (complete response versus partial response or stable disease), time between ASCT and BV onset and number of BV cycles after transplant. Among these variables, high risk status, less than 10 post transplant BV cycles and absence of post transplant complete remission significantly correlated with a reduced survival probability, and remained significant after analysis using a multivariate Cox model (Table 1).

Conclusion :

From the real-life AMAHRELIS study, we confirmed the very good outcome of R/R HL patients in the era of post-transplant BV maintenance, with a 2y-PFS of 75% similar to the results of the AETHERA landmark study (2y-PFS of 63%). The results of current strategies with pre- and post-transplant BV outperformed historical series based on high dose therapies, including those of tandem transplant for high risk patients. Future studies incorporating BV strategies with immune checkpoint inhibitors might improve outcome in R/R HL patients.

Disclosures: Meignan: ROCHE: Consultancy, Honoraria, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company). Sibon: takeda france: Consultancy. Stamatoulas Bastard: Pfizer: Other: TRAVEL, ACCOMMODATIONS, EXPENSES; Celgene: Honoraria; Takeda: Consultancy. Fornecker: Takeda: Consultancy; Roche: Consultancy. Casasnovas: Takeda: Consultancy, Honoraria, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company), Research Funding; Roche: Consultancy, Honoraria, Other: travel, accomodations, expenses, Research Funding; Gilead: Consultancy, Honoraria, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company), Research Funding; Abbvie: Consultancy, Honoraria; MSD: Consultancy, Honoraria; Amgen: Consultancy, Honoraria. Cartron: Gilead: Honoraria; Jansen: Honoraria; Abbvie: Honoraria; Celgene: Consultancy, Honoraria; Sanofi: Honoraria; F. Hoffmann-La Roche: Consultancy, Honoraria. Ghesquieres: Gilead: Consultancy, Honoraria, Other: TRAVEL, ACCOMMODATIONS, EXPENSES; CELGENE: Consultancy, Other: TRAVEL, ACCOMMODATIONS, EXPENSES; Roche: Consultancy, Other: TRAVEL, ACCOMMODATIONS, EXPENSES; Janssen: Honoraria. Brice: Takeda: Consultancy; Roche: Consultancy. Hermine: AB Science: Consultancy, Current equity holder in publicly-traded company, Honoraria, Patents & Royalties, Research Funding; Celgene BMS: Consultancy, Research Funding; Roche: Consultancy; Novartis: Research Funding; Alexion: Research Funding. Rubio: Medac: Consultancy; Gilead: Honoraria; MSD: Honoraria; Novartis: Honoraria; Neovii: Research Funding. Deau Fischer: Takeda: Consultancy; Roche: Consultancy.

*signifies non-member of ASH