Post‐transplant‐cyclophosphamide and short‐term Everolimus as graft‐versus‐host‐prophylaxis in patients with relapsed/refractory lymphoma and myeloma—Final results of the phase II OCTET‐EVER trial

Author:

Richardson Tim1,Scheid Christof1ORCID,Herling Marco2,Frenzel Lukas P.1,Herling Carmen2,Aguilar Marta Rebecca Cruz1,Theurich Sebastian3,Hallek Michael1,Holtick Udo1

Affiliation:

1. Department I of Internal Medicine, Medical Faculty and University Hospital of Cologne University of Cologne Cologne Germany

2. Department of Hematology, Cellular Therapy, and Hemostaseology University Hospital Leipzig Leipzig Germany

3. Department of Medicine III, University Hospital Ludwig Maximilian University (LMU) Munich Munich Germany

Abstract

AbstractBackgroundConditioning regimens and the choice of immunosuppression have substantial impact on immune reconstitution after allogeneic hematopoietic stem cell transplantation (aHSCT). The pivotal mechanism to maintain remission is the induction of the graft‐versus‐tumor effect. Relapse as well as graft versus host disease remain common. Classic immunosuppressive strategies implementing calcineurin inhibitors (CNI) have significant toxicities, hamper the immune recovery, and reduce the anti‐cancer immune response.MethodsWe designed a phase II clinical trial for patients with relapsed and refractory lymphoid malignancies undergoing aHSCT using a CNI‐free approach consisting of post‐transplant cyclophosphamide (PTCy) and short‐term Everolimus after reduced‐intensity conditioning and matched peripheral blood stem cell transplantation. The results of the 19 planned patients are presented. Primary endpoint is the cumulative incidence and severity of acute GvHD.ResultsOverall incidence of acute GvHD was 53% with no grade III or IV. Cumulative incidence of NRM at 1, 2, and 4 years was 11%, 11%, and 16%, respectively, with a median follow‐up of 43 months. Cumulative incidence of relapse was 32%, 32%, and 42% at 1, 2, and 4 years after transplant, respectively. Four out of six early relapses were multiple myeloma patients. Overall survival was 79%, 74%, and 62% at 1, 2, and 4 years. GvHD‐relapse‐free‐survival was 47% after 3 years.ConclusionsUsing PTCy and short‐term Everolimus is safe with low rates of aGvHD and no severe aGvHD or cGvHD translating into a low rate of non‐relapse mortality. Our results in this difficult to treat patient population are encouraging and warrant further studies.

Funder

Novartis

Publisher

Wiley

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