Ascentage Pharma presents clinical updates at EHA2026 Congress
Ascentage Pharma Group International presented 17 clinical updates at EHA2026, highlighting data on olverembatinib and lisaftoclax. Olverembatinib showed deep responses in CML and Ph+ ALL, while lisaftoclax demonstrated promise in CLL/SLL and myeloid neoplasms. The studies support the potential of these assets as treatment options for resistant or refractory hematologic malignancies.

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Ascentage Pharma Group International presented 17 clinical updates from its core assets at the 31st Congress of the European Hematology Association (EHA2026), held in Stockholm from June 11 to 14, 2026. The presentations included eight poster presentations and featured data from ongoing clinical studies of olverembatinib (HQP1351) and lisaftoclax (APG-2575). These updates highlight the company's global innovation capabilities in hematologic malignancies, including chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).
Olverembatinib Demonstrates Efficacy in CML and Ph+ ALL
Olverembatinib, the first third-generation BCR-ABL1 inhibitor approved in China, showed deep and durable responses in patients with chronic-phase CML (CML-CP) without the T315I mutation. In a Phase II study evaluating olverembatinib as a second-line treatment, the complete cytogenetic response (CCyR) rate was 76.2% and the major molecular response (MMR) rate was 47.6% among 42 evaluable patients. Responses deepened over time with longer treatment duration, and the drug exhibited manageable tolerability with no treatment-related deaths.
In a prospective, multicenter, controlled trial, patients switching to olverembatinib achieved significantly higher MMR rates compared to those continuing original TKI therapy. At 12 months, the cumulative incidence of MMR was 57.14% in the olverembatinib group versus 21.43% in the control group (P<0.0001). Common grade 3/4 hematologic treatment-emergent adverse events (TEAEs) included thrombocytopenia (42.86%) and anemia (17.14%).
Key Study Results for Olverembatinib
| Study | Population | Key Metric | Result |
|---|---|---|---|
| Phase II | CML-CP without T315I mutation | CCyR rate | 76.2% |
| Phase II | CML-CP without T315I mutation | MMR rate | 47.6% |
| Controlled Trial | CML-CP with ≥2 prior TKIs | 12-month MMR (Olverembatinib) | 57.14% |
| Controlled Trial | CML-CP with ≥2 prior TKIs | 12-month MMR (Control) | 21.43% |
In Ph+ ALL, olverembatinib demonstrated robust clinical response in the first-line global registrational Phase III study (POLARIS-1). By the end of induction, the CR/CRi rate reached 94.4% and the MRD-negative CR rate reached 63.0%. MRD-negativity rates increased to 93.1% by the end of cycle 9. The regimen showed a manageable safety profile, with no meaningful differences observed between the 30 and 40mg dose groups.
Lisaftoclax Shows Promise in Hematologic Malignancies
Updated data from the registrational Phase II study of lisaftoclax in chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) provided insights into individualized dosing regimens. Among 72 evaluable patients with R/R CLL/SLL refractory to BTKis, the median progression-free survival (PFS) was 23.9 months and the Independent Review Committee (IRC)-assessed overall response rate (ORR) was 62.5%. Mutations in TP53, complex karyotype, and other genetic markers were associated with shorter PFS.
Real-world data on lisaftoclax in myeloid neoplasms also demonstrated promising efficacy. In a study of 30 patients with acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), and chronic myelomonocytic leukemia (CMML), the CR/CRi rate for AML patients reached 72%, with the highest response observed in the ELN low-risk subgroup (87%). Grade≥3 TEAEs were primarily hematologic, including thrombocytopenia (27%), anemia (23%), and neutropenia (20%).
Key Study Results for Lisaftoclax
| Study | Population | Key Metric | Result |
|---|---|---|---|
| Phase II | R/R CLL/SLL refractory to BTKis | Median PFS | 23.9 months |
| Phase II | R/R CLL/SLL refractory to BTKis | IRC-assessed ORR | 62.5% |
| Real-world | AML patients | CR/CRi rate | 72% |
| Real-world | AML ELN low-risk subgroup | CR/CRi rate | 87% |
Yifan Zhai, MD, Chief Medical Officer of Ascentage Pharma, stated that the clinical updates further validate the therapeutic value of olverembatinib and lisaftoclax in the global hematologic malignancy field. The company plans to accelerate global clinical development and explore innovative combination treatment strategies. Olverembatinib and lisaftoclax are currently under investigation and have not yet been approved by the US FDA.
What is the anticipated timeline for the US FDA approval of olverembatinib and lisaftoclax?
How will Ascentage Pharma differentiate its assets from existing competitors in the global CML and CLL markets?
What specific combination treatment strategies does the company plan to explore for olverembatinib and lisaftoclax?

























