The study we’ll be presenting is the incorporation of a novel FLT3 inhibitor gilteritinib in the standard chemotherapy for newly diagnosed acute myeloid leukaemia patients. The idea here is that FLT3 is a receptor tyrosine kinase that confers resistance to chemotherapy and the hope would be that adding this new medicine to the standard treatments would improve the outcome of patients with that condition.
What data has been collected?
Our update this year will be presenting the results of 66 patients who have been treated on the phase I study so far. What we’ve been able to establish is the recommended phase II dose, a maximum tolerated dose of gilteritinib when given in combination with standard chemotherapy. We also will be reporting the results of the FLT3 mutant group of patients who have had a greater than 90% complete remission rate with this combination. We believe that the ability to take these medicines together are reasonable and adverse events are very typical of what we see with acute leukaemia induction.
Can you tell us about the adverse events?
Acute leukaemia induction involves treatments that often will put you at risk for infections. So a lot of the adverse events that we saw as part of the study are typical – febrile neutropenia, pneumonia type complications. Specific side effects related to gilteritinib include nausea, diarrhoea but they’re typically low grade and not hard to treat with standard treatments.
The plan would be to move forward with a phase II and phase III study. We will be comparing this combination with gilteritinib to the same backbone chemotherapy with the standard drug midostaurin. Those will be done separately in an American study and a European study.
We have recently seen the drug granted approval?
Gilteritinib has been approved the past week for relapsed refractory acute leukaemia. As I mentioned, the dose we’ll be using in this chemotherapy newly diagnosed treated patients is the same dose that’s approved for the relapsed refractory setting.