Ascentage Pharma Unveils Promising Data on Alrizomadlin for Pediatric Cancers at ASCO 2026
Ascentage Pharma Presents Its First Dataset on MDM2-p53 Inhibitor Alrizomadlin (APG-115) in Pediatric Solid Tumors at ASCO 2026
Benzinga
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At the 2026 ASCO Annual Meeting, Ascentage Pharma presented initial data on alrizomadlin (APG-115), an MDM2-p53 inhibitor, showing encouraging results in treating pediatric solid tumors, particularly relapsed rhabdomyosarcoma. The drug demonstrated preliminary antitumor activity and a manageable safety profile, indicating its potential as a new treatment option.
- 01Alrizomadlin showed a complete response in one pediatric patient with relapsed rhabdomyosarcoma during monotherapy.
- 02In combination with lisaftoclax, the objective response rate was 23.5% among 17 evaluable patients, including one complete response in Ewing sarcoma.
- 03The safety profile of alrizomadlin was manageable, with no dose-limiting toxicities observed.
- 04Alrizomadlin is part of China's SPARK Plan, aimed at developing anti-tumor drugs for children.
- 05The study highlights the urgent need for new treatment options for pediatric patients with limited existing therapies.
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Ascentage Pharma Group International presented its first dataset on alrizomadlin (APG-115), an MDM2-p53 inhibitor, at the 62nd American Society of Clinical Oncology (ASCO) Annual Meeting. This presentation marks the company's ninth consecutive appearance at ASCO. The study focused on pediatric patients with relapsed or metastatic rhabdomyosarcoma (RMS) and other soft-tissue sarcomas (STSs). Results indicated that alrizomadlin monotherapy achieved a complete response in one patient with RMS. When combined with the selective Bcl-2 inhibitor lisaftoclax (APG-2575), the treatment demonstrated an objective response rate of 23.5%, including a complete response in a patient with Ewing sarcoma. The safety profile was found to be manageable, with no serious adverse events reported. Alrizomadlin has been included in the SPARK Plan by China's National Medical Products Administration, aiming to support the development of anti-tumor drugs for pediatric patients. The findings underscore the potential of alrizomadlin as a first-in-class therapy targeting critical pathways in pediatric oncology.
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The presentation of alrizomadlin data at ASCO highlights a significant advancement in treatment options for pediatric solid tumors, particularly for conditions with high unmet medical needs.
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