BCR - ABL inhibitor
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ASH 2025 | Ascentage Pharma Presents First Dataset from Phase III POLARIS-1 Study of Olverembatinib in Newly Diagnosed Ph+ ALL Shows a Best MRD-Negativity CR Rate Exceeding 60%
Globenewswire· 2025-12-09 00:45
Core Insights - Ascentage Pharma presented promising data from the Phase III POLARIS-1 study of Olverembatinib for treating newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph ALL) at the ASH Annual Meeting [1][2][3] Group 1: Study Results - The POLARIS-1 study demonstrated a minimal residual disease (MRD) negativity rate of 66.0% and an MRD-negative complete response (CR) rate of 64.2% after three induction cycles in patients treated with Olverembatinib combined with low-intensity chemotherapy [3][6][12] - High-risk IKZF1 patients showed a 90% molecular response rate, indicating the drug's effectiveness in challenging cases [6][14] - The combination therapy exhibited a favorable safety profile, with common grade ≥ 3 treatment-emergent adverse events including neutropenia (63.6%) and thrombocytopenia (56.4%) [11][12] Group 2: Drug Development and Commercialization - Olverembatinib is the first third-generation BCR-ABL inhibitor approved in China, currently commercialized in partnership with Innovent Biologics [4][15] - The drug is approved for adult patients with TKI-resistant chronic-phase chronic myeloid leukemia (CML-CP) and accelerated-phase CML (CML-AP) harboring the T315I mutation, with all indications covered by the China National Reimbursement Drug List (NRDL) [4][15] - Ascentage Pharma is conducting three global registrational Phase III studies for Olverembatinib across multiple indications, including Ph ALL and gastrointestinal stromal tumors [4][15] Group 3: Conference Highlights - The ASH Annual Meeting is a significant event for the hematology community, showcasing advancements in scientific research and investigational therapies [2] - Ascentage Pharma's innovative pipeline, including Olverembatinib, Lisaftoclax, and APG-5918, received notable attention at the conference, with multiple presentations highlighting their potential [2][5]