P215 | HIGH EFFICACY AND SAFETY OF ASCIMINIB IN HEAVILY PRETREATED CHRONIC PHASE CHRONIC MYELOID LEUKEMIA PATIENTS: A REAL LIFE SINGLE-CENTER EXPERIENCE

Asciminib is the first BCR-ABL inhibitor that specifically targets the ABL myristoyl pocket and it was recently approved for treatment of adult CP-CML pts treated with at least 2 prior tyrosin kinase inhibitors (TKIs). Clinical trials has demonstrated its good efficacy and safety profile after second-generation TKIs (2GTKI) and in 1st line treatment, but few data are available about the use of asciminib in real life setting. We describe our single center experience of asciminib use in heavily pretreated CP-CML pts, outside clinical trials and compassionate access program. Seven pts, 5 females and 2 males, received asciminib as 3th (3 pts), 4th (3 pts) and 5th (1 pt) line treatment, in 2 cases for resistence and in 5 pts for intolerance to previous TKI treatment. Two pts out of 7 received ponatinib before asciminib. Median age at CML diagnosis was 46 years (30-80), median time from the beginning of 1st TKI and asciminib stat was 37 months (15-112), median follow up from the asciminib beginning to last follow up was 5 months (1-18). Molecular response before asciminib was MR3 in 3 pts, MR2 in 2 pts, and the remaining 2 pts had bcr-abl transcript >1%; only 1 pt out of 7 had a deep molecular response (DMR) in the history disease before asciminib. Molecular response after asciminib start were available in 6 out 7 pts and their best results were as follow: 4 pts with intolerance and 1 pt with resistence to previous TKI obtained a DMR , 1 pts with resistence to previous TKI obtained MR2. All pts maintained their best molecular response at the last follow up. Two pts suffered grade 1 side effects (fatigue, myalgia, hypertension) and 1 pt experienced grade 2 infection (nasal mucosa infection). All 7 pts continued asciminib at the last f up, 3 out of 7 at reduced dosage. In conclusion, our experience shows asciminib as a very promising therapeutic option in heavily pretreated CP-CML pts. Molecular response improved very quickly after asciminib start, and no severe side effects occurred. These preliminary data will need to be confirmed in a larger sample and with a longer follow up.