ISH news • September 2021

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September 2021

Each month the members of the Scientific and Education Committee of the International Society of Hematology (ISH) write this newsletter for our subscribers featuring relevant news in Global Hematology.
 
In this issue we highlight the results of a randomized clinical trial in newly diagnosed immune thrombocytopenia and the outcomes of two new and exciting bi-specific antibodies for the treatment of myeloma and B-cell lymphoma.

Our hearts go out to all patients and families that have been affected by COVID19, a disease which knows no borders. Our most sincere gratitude to all healthcare personnel involved in any way in the management and care of the COVID19 pandemic for their tireless efforts. We hope widespread access to effective vaccination is available worldwide very soon.

Follow the latest updates of the World Health Organization here. Visit our website www.ishworld.org for special written communications on COVID19 and hematology developed by expert clinicians from around the world.

Mycophenolic Acid in First line ITP: a Phase 3 Randomized Trial

 
Improvements on the current glucocorticoid standard in ITP are warranted. The FLIGHT trial by Bradbury and colleagues was recently published in the New England Journal of Medicine, a randomized clinical trial in persosn with newly diagnosed ITP 

What were the results of the study?

  • The study randomized 120 patients the median age was 54 years (range, 17-87) with a pre-treatment platelet count of 7x109/L with a variation of prednisolone or dexamethasone.
  • Treatment failures were higher in the glucocorticoid/placebo group (44 vs 22%)
  • MMF achieved a higher platelet response (≥100x109/L) with 91.5% vs. 63.9% in the glucocorticoid group
  • Treatment refractoriness was 6.8% in MMF and 24.6% in the glucocorticoid plus placebo.
  • Remarkably in the secondary outcome of physical function and fatigue were worse for the MMF treated group.
  • There were no differences in the occurrence of bleeding, rescue treatments or side effects.
 

New Antibodies in Lymphoma and Myeloma

 
Epcoritamab a novel bispecific CD3/CD20 antibody was studied in a phase 1/2 study recently published in Lancet, where adults with relapsed or refractory non-Hodgkin lymphoma in Europe were enrolled. The antibody was administered subcutaneously in 73 patients in escalating doses up to 60 mg without dose-limiting effects and without reaching a maximum tolerated dose. Common events were fever and non-severe cytokine release syndrome (69 and 59%, respectively). Overall response rate was 68% and complete response 45% in diffuse large B-cell lymphoma patients, patients with relapsed/refractory follicular lymphoma had an overall response rate of 90% with 50% complete responses.
 
Teclistamab, a B-cell maturation antigen (BCMA) and CD3 directed bispecific antibody also showed promise in a phase I/II study in 157 patients with relapse/refractory multiple myeloma with a median of six prior treatment lines. The recommended phase II starting dose was 300 µg/kg subcutaneous with step up to 1,500 µg/kg weekly. Frequent adverse events were cytokine release syndrome, neutropenia, anemia, and thrombocytopenia. The overall response rate in the phase 2 cohort (n=40) was 65%, with a 58% very good partial response or better and a not-reached median duration of response.
 
 

WORDS FROM THE ISH CHAIR OF COUNCIL

is a matter of concern. There are new drugs for several diseases, some of them very effective, but out of reach for most patients. One example is the treatment of thrombotic thrombocytopenic purpura (TTP). Plasma exchange is routinely employed, this procedure is effective but expensive and the addition of rituximab, which may also increase responses, also increases cost. Recently, caplacizumab has been proposed as a new therapeutic option and even hailed as a new standard by some. This drug is an antibody fragment that reduces von Willebrand factor-mediated platelet adhesion and platelet consumption and blocks the formation of blood clots. However, it is interesting that a recent study by Goshua, et al. published in Blood reported a Markov model analysis with an incremental cost effectiveness ratio (ICER) of $1,482,260 USD for adding caplacizumab to standard TTP management. They concluded that is not cost effective. Nevertheless, it is interesting to note that the antibody has been conditionally recommended by the International Society of Thrombosis and Hemostasis (TTP guidelines). The average cost of therapy is around USD $270,000. There are many new drugs and antibodies in hematology, but are we ready, in the real world, to afford these new therapeutic options?
 
Keep safe,
David Gómez-Almaguer MD
ISH Chair of Council

 

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HEMATOLOGY

Journal ISH

Hematology is the official journal of the ISH published online by Taylor Francis.  It is an international open access journal publishing original research and reviews in the field of general hematology, including oncology, pathology, biology, clinical research, and epidemiology.

Hematology aims to bridge the interests and practice of both those carrying out laboratory work and those whose main inclination is patient care.  ISH members have a reduced author publishing fee to Hematology.
 

 
Universidad Autonoma de Nuevo Leon, Hematology Service, Hospital Universitario Monterrey, México
E-Mail : dgomezalmaguer@gmail.com

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