Yesterday I got the opportunity to present the work that has been done in the last four years as the GIMEMA clinical trial called 1811. It was the first report of the clinical trial enrolling patients unfit or unable to get conventional chemotherapy affected by acute lymphoblastic leukaemia Ph-positive. In this programme we enrolled the patients in a ponatinib and steroid as first line therapy. This was a quite exciting programme because, for the first time, we will be able to demonstrate that the no chemo, no transplant programme will be able to get 100% complete haematological response, in three months’ time getting complete cytogenetic response and 50% of this population after twelve weeks of treatment getting also complete molecular response, deeply assessed by conventional RT-PCR. That’s why it was quite impressive data.
What could be the impact of this data?
The impact for this population was associated with 17.5 months of observation. We were able to demonstrate that we get a prolonged overall survival in the majority of patients, 82% of this population are still alive within this kind of observational time. So it’s quite amazing to get a population that usually gets less than five or six, seven months getting more than one year of survival. The other point is also that the event free survival was completely improved. This population get a better quality of life; most of these patients get no hospitalisation, just the first cycle, the first twenty days, and transfusion dependency in the majority of the cases. That’s the main impact of our programme.