Core Insights - Ascentage Pharma's novel drug, olverembatinib, has been selected for presentations at the 67th American Society of Hematology (ASH) Annual Meeting, marking the eighth consecutive year for this recognition, highlighting its significance in the hematology community [1][4] - The company will present data from multiple clinical studies, including the global Phase III study (POLARIS-1) of olverembatinib combined with low-intensity chemotherapy for newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (ALL) [2][6] - Ascentage Pharma is actively advancing its clinical development programs to provide more treatment options for patients [4][18] Company Overview - Ascentage Pharma Group International is a global, commercial stage biopharmaceutical company focused on discovering, developing, and commercializing novel therapies for unmet medical needs in cancer [19] - The company has a robust pipeline that includes olverembatinib, the first third-generation BCR-ABL inhibitor approved in China, and other investigational drug candidates like lisaftoclax and APG-5918 [20][22] Clinical Study Highlights - The POLARIS-1 study aims to evaluate the efficacy and safety of olverembatinib combined with low-intensity chemotherapy in patients with newly diagnosed Philadelphia chromosome-positive ALL, with a primary endpoint of minimal residual disease negativity rate [7][9] - In the study, olverembatinib demonstrated a 64.2% MRD-negative complete response rate by the end of induction therapy, indicating its potential effectiveness [9] - Safety results showed that olverembatinib combined with chemotherapy was well tolerated, with common grade ≥3 treatment-emergent adverse events including neutropenia (63.6%) and thrombocytopenia (56.4%) [8] Additional Clinical Findings - In a registrational Phase II trial, olverembatinib showed a significant therapeutic advantage over the best available therapy in patients with TKI-resistant chronic-phase chronic myeloid leukemia (CML-CP), with a median event-free survival of 21.22 months compared to 2.86 months for the control group [14] - The study also reported high complete hematologic response rates (85% for olverembatinib vs. 34.8% for BAT) and complete cytogenetic response rates (37.5% vs. 18.9%) [14] Future Directions - Ascentage Pharma is conducting global registrational Phase III trials for olverembatinib in various indications, including newly diagnosed Ph+ ALL and SDH-deficient gastrointestinal stromal tumors (GIST) [20] - The company aims to continue accelerating its clinical development programs to expand treatment options for patients [4][18]
Ascentage Pharma to Present Data from Multiple Studies of Olverembatinib, Including the First Dataset from POLARIS-1 Study, at ASH 2025