Ascentage Pharma announced on June 2, 2025, the release of the latest clinical data from its Phase II study of the MDM2-p53 inhibitor alrizomadlin (APG-115) at the 61st American Society of Clinical Oncology (ASCO) Annual Meeting. Data was presented for alrizomadlin as a single agent or in combination with PD-1 inhibitor toripalimab in patients with advanced adenoid cystic carcinoma (ACC) or other solid tumors.
Alrizomadlin monotherapy demonstrated antitumor activity in patients with advanced ACC, achieving an objective response rate (ORR) of 16.7% and a disease control rate (DCR) of 100%. Antitumor activity was also observed in malignant peripheral nerve sheath tumor (MPNST).
The combination of alrizomadlin with toripalimab was well tolerated and showed therapeutic potential in MPNST, biliary-tract cancer (BTC), and liposarcoma (LPS), with two MPNST patients achieving long-term responses lasting over 60 and 96 weeks. These results highlight alrizomadlin's potential as a global first-in-class investigational drug for various solid tumors.
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