Ascentage Pharma Announces Global Registrational Phase III Study of Olverembatinib in First-Line Treatment of Ph+ ALL Cleared by US FDA and EMA

Core Viewpoint - Ascentage Pharma has received regulatory clearance from the US FDA and EMA to conduct a global Phase III study of olverembatinib for treating newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), marking a significant advancement in its clinical development efforts [1][3]. Company Overview - Ascentage Pharma Group International is a global biopharmaceutical company focused on developing novel therapies for unmet medical needs in cancer, with a strong pipeline that includes third-generation kinase inhibitors and Bcl-2 inhibitors [6][7]. Clinical Development - The POLARIS-1 trial is a global, multicenter, randomized controlled Phase III study aimed at evaluating the efficacy and safety of olverembatinib in combination with chemotherapy for newly diagnosed Ph+ ALL patients [2][3]. - The trial is designed to accelerate the registration process for olverembatinib, particularly in the US and European markets, with simultaneous patient enrollment across multiple countries [1][2]. Efficacy and Safety Data - Preliminary data from the POLARIS-1 study indicates that approximately 65% of treatment-naïve Ph+ ALL patients achieved minimal residual disease (MRD) negativity and molecular MRD-negative complete response (CR) after three treatment cycles, significantly outperforming other drugs in the same class [3]. - The combination therapy demonstrated a favorable safety profile, with a low incidence of manageable adverse events [3]. Market Context - Ph+ ALL accounts for 20%-30% of all adult acute lymphoblastic leukemia cases and is associated with high relapse rates and poor prognosis, particularly in elderly patients [3]. - Prior to the introduction of tyrosine kinase inhibitors (TKIs), the five-year overall survival rate for Ph+ ALL was less than 20%, highlighting the need for improved treatment options [3]. Strategic Partnerships - Ascentage Pharma has signed an exclusive option agreement with Takeda for olverembatinib, which could lead to Takeda licensing global rights for the drug outside of certain regions, enhancing its commercial potential [4].