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2909 The Addition of Romidepsin to CHOEP and High-Dose Chemotherapy Plus Stem Cell Transplantation Did Not Ameliorate the Outcome of Untreated Angioimmunoblastic T-Cell or Follicular T-Helper Lymphoma: Subgroup Analysis of Phase II FIL-PTCL13 Study

Program: Oral and Poster Abstracts
Session: 624. Hodgkin Lymphomas and T/NK cell Lymphomas: Clinical and Epidemiological: Poster II
Hematology Disease Topics & Pathways:
Research, clinical trials, Lymphomas, non-Hodgkin lymphoma, Clinical Research, Combination therapy, T Cell lymphoma, Diseases, Therapies, Lymphoid Malignancies
Sunday, December 11, 2022, 6:00 PM-8:00 PM

Annalisa Chiappella, MD1, Anna Dodero, MD2*, Andrea Evangelista, MSc3*, Alessandro Re, MD4*, Lorella Orsucci, MD5*, Sara Veronica Usai6*, Claudia Castellino7*, Vittorio Stefoni, MD8*, Antonio Pinto9*, Manuela Zanni, MD10*, Rosanna Ciancia11*, Chiara Ghiggi12*, Francesca Gaia Rossi13*, Annalisa Arcari, MD14*, Fiorella Ilariucci15*, Vittorio Ruggero Zilioli, MD16*, Leonardo Flenghi17*, Melania Celli18*, Stefano Volpetti19*, Fabio Benedetti, MD20*, Filippo Ballerini21*, Gerardo Musuraca22*, Riccardo Bruna23*, Caterina Patti24*, Francesco Leonardi25*, Luca Arcaini, MD26*, Massimo Magagnoli, MD27*, Federica Cavallo, MD28*, Valentina Tabanelli, PhD29*, Giovannino Ciccone, MD, PhD30*, Stefano A Pileri31 and Paolo Corradini, MD32

1Division of Hematology & Stem Cell Transplant, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Milano, Italy
2Hematology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy
3Unit of Clinical Epidemiology, Città della Salute e della Scienza di Torino, Torino, Italy
4Department of Hematology, ASST Spedali Civili, Brescia, ID, Italy
5Hematology, Città della Salute Hospital and University, Torino, Italy
6Hematology, Ospedale Oncologico Armando Businco, Cagliari, Italy
7Division of Hematology, Azienda Ospedaliera S. Croce e Carle, Cuneo, Italy
8Hematology, Department of Translational and Precision Medicine, Università di Bologna, Bologna, Italy
9Hematology-Oncology and Stem-Cell Transplantation Unit, Department of Hematology and Innovative Therapies, National Cancer Institute, Fondazione 'G. Pascale', IRCCS, Naples, Italy
10Division of Hematology, Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo, Alessandria, Italy
11Onco-hematology and Stem Cell Transplantation and Cellular Therapies, Centro di Riferimento Oncologico (CRO) IRCCS, Aviano, Italy
12Hematology, IRCCS Ospedale Policlinico San Martino, Genova, Italy
13Division of Hematology, Fondazione IRCCS Cà Granda, OM Policlinico, Milano, Italy
14Hematology Unit, Ospedale Guglielmo da Saliceto, Piacenza, Italy
15Azienda Ausl IRCCS Santa Maria Nuova Reggio Emilia, Reggio Emilia, Italy
16Division of Hematology, ASST Grande Ospedale Metropolitano Niguarda, Milan, IT-MI, Italy
17Hematology, S. Maria della Misericordia Hospital, Perugia, Italy
18U.O. di Ematologia, Ospedale degli Infermi di Rimini, Rimini, Italy
19Clinic of Hematology, Presidio Ospedaliero Universitario "Santa Maria della Misericordia” di Udine, ASUFC, Udine, Italy
20Hematology and Stem Cell Transplantation, Azienda Ospedaliera Universitaria di Verona, Verona, Italy
21IRCCS Ospedale Policlinico San Martino, Clinic of Hematology, Department of Internal Medicine (DiMI), Genova, Italy
22Division of Hematology, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy
23Division of Hematology, Ospedale Maggiore Della Carità, Novara, Italy
24Division of Onco-Hematology, Azienda Villa Sofia Cervello, Palermo, Italy
25Hematology and CTMO, Azienda Ospedaliera-Universitaria di Parma, Parma, Italy
26Division of Hematology, Fondazione IRCCS Policlinico San Matteo and Department of Molecular Medicine, University of Pavia, Pavia, Italy
27Hematology, IRCCS Humanitas Research Hospital, Rozzano-Milano, Italy
28Division of Hematology , AOU Città della Salute e della Scienza di Torino, Torino, Italy
29Division of Diagnostic Haematopathology, IEO Istituto Europeo di Oncologia IRCCS, Milano, Italy
30Unit of Cancer Epidemiology, CPO Piemonte, A.O.U. Città della Salute e della Scienza di Torino, Torino, Italy
31Hematopathology Division, IEO Istituto Europeo di Oncologia IRCCS, Milano, Italy
32University of Milan, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy

Introduction: In the phase Ib/II study PTCL13 study (NCT02223208) we demonstrated feasibility of Romidepsin 14 mg/mq in addition to CHOEP followed by high-dose chemotherapy and stem cell transplantation (SCT), but no benefit was observed in term of progression free survival (PFS), and the enrollment of the trial was stopped due to inefficacy of the experimental combination. Other studies showed Romidepsin activity in relapsed or refractory PTCLs, especially in angioimmunoblastic (AITL) subtype, expecially when combined with azacytidine. On this basis, we conducted a sub-analysis of the PTCL13 trial, with the aim to evaluate the role of adding Romidepsin to CHOEP followed by high dose chemotherapy and SCT in newly diagnosis AITL and T-helper follicular lymphoma patients.

Methods: Patients aged 18-65 eligible to SCT, with advanced PTCL-NOS, AITL/T-helper follicular and ALK negative anaplastic large cell lymphoma, were eligible to PTCL13 study. Treatment plan consisted of 6 courses of Ro-CHOEP every 21 days (14 mg/ms Ro day 1 and 8), followed by cisplatin-cytarabine-dexamethasone (DHAP) with stem cell harvest and SCT. Patients in complete response (CR) after induction proceeded to autoSCT, while those in partial response (PR), with an available HLA-matched donor, proceeded to alloSCT upfront. Results: 89 patients were enrolled into the phase Ib and II part of the study; median age was 55 years (IQR 49;60); 78 (91%) had stage III-IV and 31 (36%) IPI risk >2. Pathological materials were collected at the time of diagnosis, and centrally reviewed by expert hemo-pathologist; subgroups were: 34 PTCL-NOS, 21 ALK negative and 31 AITL/THF. The clinical characteristics of the 31 AITL/THF patients were: median age 56 years (IQR 52.5-59.5), 63% male, 31% had an intermediate-high IPI score risk and 50% had a bone marrow involvement at diagnosis. The overall response (ORR) at the end of induction with 6 Romidepsin-CHOEP was achieved in 7 AITL/THF patients (22%), with 6 (19%) patients in complete remission (CR); at the end of treatment, the ORR was observed in 15 (47%) AITL/THF patients. ORR and CR results are superimposable to those of the whole population.

At a median follow-up of 28 months, the 24-months PFS for AITL/THF was 43% (95% CI: 0.22-0.61) compared to 24-months PFS for ALK-negative 37% (95% CI: 0.16-0.59) and for PTCL-nos 33% (95% CI: 0.18-0.48), p 0.136; the 24-months OS for AITL/THF was 78% (95% CI: 0.57-0.89) compared to 24-months OS for ALK-negative 63% (95% CI: 0.37-0.81) and for PTCL-nos 61% (95% CI: 0.40-0.76), p 0.556.

Conclusions: In the FIL-PTCL13 the primary endpoint was not met and the enrollment of the trial was stopped due to inefficacy of the experimental combination. With the limits of the small number and the unpowered analysis, the benefit of adding romidepsin to chemotherapy was not observed in the subgroup AITL/THF patients, even if the PFS and the OS of this subgroup seem better than the others.

Disclosures: Chiappella: Ideogen: Other: advisory board; SecuraBIO: Other: advisory board; Novartis: Other: lecture fee; Incyte: Other: lecture fee; Astrazeneca: Other: lecture fee; Takeda: Other: lecture fee, advisory board; Roche: Other: lecture fee, advisory board; Janssen-Cilag: Other: lecture fee, advisory board; Gilead Sciences: Other: lecture fee, advisory board; Clinigen: Other: lecture fee, advisory board; Celgene–Bristol Myers Squibb: Other: lecture fee, advisory board. Pinto: Incyte: Honoraria, Membership on an entity's Board of Directors or advisory committees; Merck Sharp and Dohme: Honoraria, Membership on an entity's Board of Directors or advisory committees; Servier Affaires Medicales: Honoraria, Membership on an entity's Board of Directors or advisory committees; F. Hoffmann-La Roche AG: Honoraria, Membership on an entity's Board of Directors or advisory committees. Zilioli: Roche: Consultancy; Takeda: Membership on an entity's Board of Directors or advisory committees, Other: travel expenses, Speakers Bureau; Gentili: Membership on an entity's Board of Directors or advisory committees; Servier: Membership on an entity's Board of Directors or advisory committees; MSD: Membership on an entity's Board of Directors or advisory committees; Gilead: Membership on an entity's Board of Directors or advisory committees; Janssen: Other: travel expenses, Speakers Bureau. Patti: Takeda: Consultancy; Janssen: Consultancy; Novartis: Consultancy; Abbvie: Consultancy, Other: Travel, accommodations. Arcaini: ADC Therapeutics: Membership on an entity's Board of Directors or advisory committees; Celgene/Bristol Myers Squibb: Membership on an entity's Board of Directors or advisory committees; Novartis: Speakers Bureau; Kite/Gilead: Membership on an entity's Board of Directors or advisory committees; EUSA Pharma: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Janssen-Cilag: Membership on an entity's Board of Directors or advisory committees; Verastem: Membership on an entity's Board of Directors or advisory committees; Incyte: Membership on an entity's Board of Directors or advisory committees; Roche: Membership on an entity's Board of Directors or advisory committees; Gilead Sciences: Research Funding. Cavallo: Amgen: Other: Expenses for EHA virtual meeting; Roche: Membership on an entity's Board of Directors or advisory committees, Other: Expenses for Ash meeting; Takeda: Other: Expenses for ICML virtual meeting; Servier: Speakers Bureau. Corradini: takeda: Honoraria; janssen: Honoraria; incyte: Honoraria; gilead: Honoraria; celgene: Honoraria; amgen: Honoraria; abbvie: Honoraria.

OffLabel Disclosure: Romidepsin is not registered in first line treatment of PTCL

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