For Immediate Release
BioLineRx Presents New Overall Survival Data from
Phase 2a Study for BL-8040 in r/r AML Patients
Data presented at EHA shows significantly improved
overall survival compared to historical data
Potential biomarker identified for future patient selection, based on
statistically significant correlation between responders and
levels of AML blast mobilization to peripheral blood
Tel Aviv, Israel, June 18, 2018 – BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology and immunology, announced today that new data presented at the 23rd Annual Congress of the European Hematology Association (EHA), held in Stockholm, Sweden, shows that BL-8040, combined with high dose cytarabine (HiDAC), significantly enhanced overall survival in difficult-to-treat relapsed or refractory AML (r/r AML) patients in a Phase 2a clinical trial. In addition, an important new finding shows a statistically significant correlation between patient response and the mobilization of AML blasts. Responding patients demonstrated a clear and significant increase in the number of AML blasts in the peripheral blood following BL-8040 treatment,
whereas non-responding patients were largely unaffected.
“We are extremely pleased to see further significant improvement in overall survival for this very difficult-to-treat patient population, as data continues to accumulate from our Phase 2a proof-of-concept study in relapsed or refractory AML,” stated Philip A. Serlin, Chief Executive Officer of BioLineRx. “In addition, exciting new findings indicate a clear correlation between patient response and mobilization of AML blasts, thus identifying a potential biomarker for selecting patients likely to respond to BL-8040. These encouraging results strongly support the continued development of BL-8040 in relapsed or refractory AML, giving BioLineRx broad therapeutic coverage in the AML space, with potential activity at different stages of the disease and in different patient populations. We look forward to providing additional updates on overall survival from this study, and continue to execute on our other two important AML trials currently ongoing – a large, randomized, controlled Phase 2b study in consolidation AML, and a Phase 1b/2 study in maintenance of AML under our collaboration with Genentech,” added Mr. Serlin.