Long-term survival analysis of the randomised Phase III study shows a clear clinical benefit of inolimomab in SR-aGvHD
- Follow-up of INO-107 Phase III study patients up to 8.5 years is the first long term analysis of a randomized study in acute steroid-resistant graft versus host disease (SR-aGvHD)
- Investigators letter published in Blood Advances journal completes the result of the initial analysis of INO-107 study and demonstrates clinical benefit of inolimomab in SR-aGvHD
- This analysis shows a clear superiority of inolimomab against anti-thymocyte globulin
ELSALYS BIOTECH, a new player in immuno-oncology, presents the results from long-term follow-up of INO-107 Phase III study patients up to 8.5 years. These results have been published in a Letter to Blood signed by the investigators demonstrating clinical benefit of inolimomab (LEUKOTAC®) in acute steroid-resistant graft versus host disease (SR-aGvHD).
This randomized multicentre controlled parallel-group Phase 3 study (France/ Belgium) included 100 adult patients with grade II-IV SR-aGvHD treated with inolimomab versus control ATG (anti-thymocyte globulin – approved in this indication in France only) between 2009 and 2015. In this study, patients were enrolled in 15 centres and followed for one year.
For all the patients still alive at the end of the study (23 [47%] and 20 [40%] patients in the inolimomab and ATG arms, respectively) the information on death (and if yes, the main reason) and apparition of chronic GvHD has been collected in all centres involved in the INO107 study. Data were updated up to May 2018. The analysis performed with this new dataset was focusing on the primary composite criteria, the Overall Survival (OS) and the incidence of chronic GvHD.
Inolimomab reduces by 43% the relative risk of death
This long-term follow-up analysis has evidenced a positive outcome on composite primary endpoint at level of statistical significance set in the protocol (see detailed data page 2) but more importantly a very positive outcome on OS, which is the most robust endpoint of assessment in such life-threatening disease.
“The Overall Survival endpoint was reached by 30.6% (15/49) patients and 19.6% (10/51) patients in the inolimomab and ATG arms, respectively. The adjusted HR (95% CI) was 0.572 (0.346, 0.947), two-sided p= 0.030. This represents an absolute difference in survival of 11% in favour of inolimomab equivalent to relative reduction of 43% of risk of death. This analysis clearly demonstrates a clinical benefit of inolimomab and suggests that it may be a suitable therapeutic alternative in patients with grade II to IV SR-aGvHD.” comments Dr. David LIENS, Chief Medical Officer, ELSALYS BIOTECH.
“These additional data establish that the effect already noticeable at the end of the INO107 study, i.e. after a 1-year follow-up, is sustained over long-term period and show a clear clinical benefit of inolimomab in SR-aGvHD. These results are very encouraging and, together with the favourable safety profile, could ease the regulatory acceptance, at first in view of Compassionate Use, in France (ATU) and in other countries and then for market approval, both in Europe and in the USA.” Adds Dr. Jacques MIZRAHI, VP R&D, ELSALYS BIOTECH.