Core Insights - Ascentage Pharma has received FDA and EMA clearance for a global Phase III study of olverembatinib in combination with chemotherapy for newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) patients [1][2] - The POLARIS-1 trial aims to accelerate the registration process of olverembatinib in the US and European markets [1] - Initial data from the POLARIS-1 study indicates a 65% minimal residual disease (MRD) negativity rate and molecular MRD-negative complete response (CR) rate after three treatment cycles, showing improved efficacy compared to existing therapies [3] Company Overview - Ascentage Pharma is a global biopharmaceutical company focused on developing novel therapies for unmet medical needs in cancer [6] - The company has a diverse pipeline, including olverembatinib, a third-generation BCR-ABL inhibitor, and lisaftoclax, a Bcl-2 inhibitor [7][8] - Olverembatinib has been approved in China for multiple indications in drug-resistant chronic myeloid leukemia (CML) and is included in the National Reimbursement Drug List (NRDL) [7] Clinical Development - The POLARIS-1 study is a multicenter, randomized controlled trial designed to evaluate the safety and efficacy of olverembatinib in Ph+ ALL patients [2] - The study has also been initiated in China following clearance from the China Center for Drug Evaluation (CDE) [2] - Olverembatinib has received Breakthrough Therapy Designation from the China CDE, highlighting its potential in treating Ph+ ALL [3][4] Strategic Partnerships - Ascentage Pharma has signed an exclusive option agreement with Takeda for olverembatinib, which could lead to Takeda licensing global rights outside of certain regions [4] - The company collaborates with various leading biotechnology and pharmaceutical firms, enhancing its research and development capabilities [9]
Ascentage Pharma Announces Global Registrational Phase III Study of Olverembatinib in First-Line Treatment of Ph+ ALL Cleared by US FDA and EMA