ASH 2025 | Updated Data for Ascentage Pharma‘s Olverembatinib in Second-Line CML-CP Showing Encouraging Potential for Early-Line Treatment

Core Viewpoint - Ascentage Pharma has presented promising updated data on Olverembatinib, a novel drug for second-line treatment of chronic myeloid leukemia (CML) at the 67th American Society of Hematology (ASH) Annual Meeting, indicating its potential as a safe and effective treatment option for patients resistant to prior therapies [1][3][5]. Group 1: Efficacy and Safety Data - Olverembatinib demonstrated a complete cytogenetic response (CCyR) rate of 71.8% and a major molecular response (MMR) rate of 43.6% in patients with CML resistant/intolerant to one prior line of tyrosine kinase inhibitors (TKIs) without the T315I mutation [3][12]. - In patients who failed first-line treatment with second-generation TKIs, the CCyR rate was 76.7% and the MMR rate was 43.3% [3][12]. - The safety profile of Olverembatinib was consistent with previous reports, with no new safety signals identified [3][10]. Group 2: Clinical Study Details - The study was an open-label, single-arm, multicenter clinical trial evaluating Olverembatinib at 40 mg every other day in Chinese patients with CP-CML resistant/intolerant to one prior line of TKIs [8]. - As of July 24, 2025, 47 patients were enrolled, with 39 patients receiving at least one efficacy evaluation [8][12]. - The median treatment duration was 16.0 cycles, with 89.4% of patients experiencing treatment-related adverse events [10]. Group 3: Regulatory and Commercialization Aspects - Olverembatinib is the first third-generation BCR-ABL inhibitor approved in China, currently commercialized in partnership with Innovent Biologics [4][14]. - The drug is approved for adult patients with TKI-resistant CML-CP or accelerated-phase CML harboring the T315I mutation, and is included in the China National Reimbursement Drug List [4][14]. - Ascentage Pharma is conducting three global registrational Phase III studies for Olverembatinib in multiple indications, including CML-CP and newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia [4][14].