Ascentage details ASCO 2026 oncology data

Ascentage Pharma used the 2026 ASCO Annual Meeting to present new efficacy and safety data from two oncology programs: the BCR-ABL inhibitor olverembatinib (HQP1351) in chronic-phase chronic myeloid leukemia (CML-CP) and the MDM2–p53 inhibitor alrizomadlin (APG-115) in pediatric solid tumors.

The company highlighted maturing responses and longer follow-up for olverembatinib as a second-line treatment, alongside the first clinical dataset for alrizomadlin given alone or with the Bcl-2 inhibitor lisaftoclax (APG-2575) in children with relapsed or metastatic cancers.

In a rapid oral presentation, Ascentage reported updated results for olverembatinib in chronic-phase CML patients receiving the drug as second-line therapy. Among 42 evaluable patients, the best complete cytogenetic response (CCyR) rate at study cutoff was 76.2%, while the best major molecular response (MMR) rate was 47.6%.

Responses continued to deepen with longer treatment. By cycle 24, CCyR reached 91.3% and MMR rose to 60.9%, underscoring the durability and progression of responses over time in the evaluable group.

Safety data showed an overall incidence of treatment-related adverse events of 89.4%. These were described as predominantly manageable low-grade events, such as skin hyperpigmentation, hyperuricemia and increased creatine phosphokinase.

Grade 3 or higher hematologic toxicities were observed but were reported as recoverable with supportive care, supporting the ongoing clinical development of olverembatinib in this setting.

Ascentage stated it is running three global registrational Phase III studies of olverembatinib across multiple indications. Two of these trials have received clearance from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

The updated CML-CP dataset presented at ASCO 2026 forms part of the evidence base the company is building for potential regulatory filings and broader global development of olverembatinib.

Separately at ASCO 2026, Ascentage presented its first clinical dataset for alrizomadlin in pediatric patients with relapsed or metastatic rhabdomyosarcoma (RMS) and other solid tumors. Alrizomadlin, an orally administered MDM2–p53 inhibitor, was evaluated as monotherapy and in combination with the Bcl-2 inhibitor lisaftoclax.

In the monotherapy arm, one pediatric patient with refractory RMS achieved a complete response. This case highlighted potential single-agent activity in a heavily pretreated setting.

In the combination arm of alrizomadlin plus lisaftoclax, 17 response-evaluable pediatric patients produced an objective response rate (ORR) of 23.5% and a disease control rate (DCR) of 70.6%.

Observed responses included one complete response in a patient with Ewing sarcoma and partial responses in two RMS patients and one neuroblastoma patient, indicating activity across several tumor types.

Across both the monotherapy and combination arms, no dose-limiting toxicities were observed. Adverse events were reported as primarily gastrointestinal and hematologic, with few serious adverse events.

There were no treatment-related deaths or discontinuations in the alrizomadlin study, suggesting a manageable tolerability profile in this pediatric population.

Alrizomadlin has been included by China’s Center for Drug Evaluation (CDE) in the SPARK Plan for potential development in multiple pediatric solid tumors, providing additional regulatory support for its ongoing clinical evaluation.