LEUKOTAC® at the 44th congress of the European Society for Blood and Marrow Transplantation (EBMT)
A poster summarising the safety profile results of the randomised Phase 3 testing LEUKOTAC® in patients with steroid-resistant acute graft-versus-host disease (SR-aGvHD) to be presented at the EBMT 2018
ELSALYS BIOTECH to organise a dedicated workshop on LEUKOTAC® with French transplant physicians to discuss the next steps towards making the treatment available again
Lyon, FRANCE, 15 March 2018, ELSALYS BIOTECH, a new player in immuno-oncology, will present at the 44th EBMT congress which will take place in Lisbon, Portugal, from 18 to 21 March, the progress made on LEUKOTAC® (inolimomab), its monoclonal antibody that recently demonstrated promising clinical results in the treatment of SR-aGvHD.
The company will present a poster on additional analysis of safety data of the Phase 3 study testing LEUKOTAC® vs ATG* (control arm) in 100 patients with SR-aGvHD. The data demonstrate that LEUKOTAC® represents a relevant alternative treatment, notably because of its significantly more favourable safety profile as compared to ATG. There are 3 times fewer related adverse events (AE) for all stages with LEUKOTAC® (14%) than with ATG (41%), p=0.004, as well as 2.5 times less related AE of grade 3 or higher (LEUKOTAC® 12% vs ATG 29%, p = 0.04). It is shown as well a clear decrease in potentialy life-threatening infectious episodes such as sepsis and septic shock (14% vs 24% and 4% vs 16% for the LEUKOTAC® and ATG groups, respectively). Other major data concern the increase in overall survival at one year (+ 37%) with LEUKOTAC®, at the limit of statistical significance (HR=0.628, p=0,055 unilateral).
Based on these results, the ELSALYS BIOTECH team will organise, on the sidelines of the EBMT congress, a workshop with French transplant physicians to discuss these results, as well as retrospective data on the administration of LEUKOTAC® collected from more than 120 children in the context of the nominative TUA**. The company will present its clinical development plan in this pediatric population and more broadly the next steps towards making treatment available again.
«To date, the French clinicians know LEUKOTAC® best as they have administered it to more than 2,000 patients in compassionate use or in clinical trials. So, logically, we share first and foremost with them about our product’s latest data and the next steps we plan in order to better assess how LEUKOTAC® could be integrated into the current management of aGvHD when the product is available,» says Dr. David LIENS, Medical Director, ELSALYS BIOTECH.
«The 44th EBMT congress is an important step for ELSALYS since it is the first European medical congress where we present additional analysis of Phase 3 data on LEUKOTAC®. We are moving towards ensuring that this product is made available to the community of transplant physicians and patients at the earliest opportunity,» concludes Dr. Christine GUILLEN, CEO and Co-founder, ELSALYS BIOTECH.
*ATG: anti-thymocyte globulin.
** Temporary Use Authorisation.