FIRST INTERIM RESULTS OF THE REAL-LIFE STUDY EVALUATING THE EFFICACY AND SAFETY OF BELINOSTAT

Belinostat is a Pan-Histone Deacetylase Inhibitors (HDACi) that increases histone acetylation leading with anti-angiogenic and antitumor properties as cell cycle retardation, changes in cell microtube dynamics, apoptosis ultimately reducing cancer cell proliferation, indicated in the treatment of in refractory or relapsed (R/R) Peripheral T- Cell Lymphoma (PTCL) as monotherapy. BELBRA is the real-life observatory study initiated in Brazil with the participation of around 90 lymphoma reference centers, with 97 patients to date. Representing one of the largest real-life Belinostat studies in the world. BELBRA is the real-life observatory study to evaluate Belinostat’s option for Brazilian PTCL R&R previously submitted to multiple conventional chemotherapy regimens. Methods: to date, 97 R/R PTCL patients treated with Belinostat in Brazil have been mapped. Of these 97, we received data from 20 patients. In this interim analysis, the demographic characteristics of the 97 mapped patients were analyzed, including sex, age, and subtype. Furthermore, more detailed analyzes of the 20 patients were carried out including overall response (OR), complete and partial responses (CR and PR), assessment of disease-free progression (DFP), as well as the safety profile of Belinostat therapy. Data collection and statistical analyzes continue to be carried out. Overall, 53.9% (41) were female and 46.1% (35) male, with a median age of 60 years. Ninety-seven (97) patients diagnosed as R/R PTCL with the following classification subtype: lymphoma NOS 46.7% (35) Not Otherwise Specified (NOS), LACG 21.3% (16), MF 12 16.0% (12), ATLL 8.0% (6%), AITL 6.7% (5), LLPC 1.3% (1). Following a more detailed analysis of twenty patients (20): As first line CHOP or CHOP like therapies 16 (80.0%) and other therapies for 4 (20.0%) of patients. As for R/R PTCL Belinostate was used as monotherapy as 2nd or ≥ 3rd lines in 6 (30.0%) and 14 (70%) respectively. The overall response rate was ORR 45% (CR 10.0% and PR 35.0%) and Stable Disease SD 2 (10.0%) with a Disease Progression in 8 (45.0%) of patients. Also, in those 20 patients, Belinostate treatment with an average of 5,4 cycles (2 to 17) was well tolerated with all patients remaining in the full 1,000 mg/m2 dosage intravenously during 30 minutes on days 1 to 5 every 21 days. So far Real-world evidence from this Brazilian registry shows that Belinostat has a favorable efficacy and safety profile and supports its use in PTCL patients who are refractory or has relapsed to previous therapies.