Live from ASCO 2025 | Ascentage Pharma Releases Promising Clinical Data on Alrizomadlin Monotherapy and Combinations in Solid Tumors

Core Insights - Ascentage Pharma has presented promising clinical data for its MDM2-p53 inhibitor alrizomadlin (APG-115) at the ASCO Annual Meeting, indicating its potential as a treatment for advanced adenoid cystic carcinoma (ACC) and other solid tumors [1][2][3] Company Overview - Ascentage Pharma is a global biopharmaceutical company focused on addressing unmet medical needs in cancer treatment, with a pipeline that includes innovative drug candidates targeting apoptosis pathways [9][10] Clinical Study Highlights - The Phase II study of alrizomadlin demonstrated an objective response rate (ORR) of 16.7% and a disease control rate (DCR) of 100% in patients with advanced ACC [4][13] - In combination with PD-1 inhibitor toripalimab, alrizomadlin showed favorable antitumor activity in malignant peripheral nerve sheath tumor (MPNST), biliary-tract cancer (BTC), and liposarcoma (LPS) [3][4][13] - Notably, two patients with MPNST achieved long-term responses lasting over 60 and 96 weeks, respectively, when treated with the combination regimen [4][13] Safety and Efficacy Data - In the monotherapy arm, 33.3% of patients experienced grade 3 or higher treatment-related adverse events (TRAEs), while 12.5% experienced serious adverse events [13] - In the combination arm, 44.4% of patients reported grade 3 or higher TRAEs, with 29.6% experiencing treatment-related serious adverse events [13] Future Directions - The company aims to accelerate clinical programs to provide novel treatment options for patients globally, emphasizing the unmet clinical needs in both China and worldwide [4][12]