ROCKVILLE, Md. and SUZHOU, China, June 15, 2026 – Ascentage Pharma Group International presented multiple clinical updates from its hematology pipeline at the 31st Congress of the European Hematology Association, highlighting ongoing studies of two core assets, olverembatinib and lisaftoclax.
The company announced that 17 clinical updates were featured at EHA2026, including eight poster presentations. The meeting was held in Stockholm, Sweden, from June 11 to 14, 2026. The data focused mainly on hematologic malignancies, including chronic myeloid leukemia, Philadelphia chromosome-positive acute lymphoblastic leukemia, chronic lymphocytic leukemia, small lymphocytic lymphoma, acute myeloid leukemia, and other myeloid neoplasms.
Olverembatinib, also known as HQP1351, is described by the company as the first third-generation BCR-ABL1 inhibitor approved in China. Lisaftoclax, also known as APG-2575, is described as the first approved China-developed selective Bcl-2 inhibitor. Both therapies remain under investigation outside their approved indications, and neither olverembatinib nor lisaftoclax has been approved by the U.S. Food and Drug Administration.
Olverembatinib Data Highlight Activity In CML
Several presentations at EHA2026 focused on olverembatinib in chronic myeloid leukemia, particularly in patients whose disease had become resistant or intolerant to prior tyrosine kinase inhibitor therapy.
One Phase Ib analysis evaluated olverembatinib in 22 patients with chronic-phase CML who were resistant to ponatinib and/or asciminib. The study also examined mutational backgrounds, including ASXL1 mutations, which were present in 40.9% of patients. Among patients with ASXL1 mutations, 44.4% achieved clinical responses after treatment with olverembatinib. Two patients achieved major molecular response, including one who reached MR4.5.
The company said these findings provide early evidence that olverembatinib may remain active in difficult-to-treat patients with multi-line TKI-resistant disease.
Another Phase II study evaluated olverembatinib as second-line therapy in patients with chronic-phase CML without the T315I mutation. Among 42 evaluable patients, the complete cytogenetic response rate was 76.2%, while the major molecular response rate was 47.6%. Responses continued to deepen over time, and no treatment-related deaths were reported.
The findings support further evaluation of olverembatinib as a potential treatment option for patients with chronic-phase CML who are resistant or intolerant to first-line TKI therapy.
Trial Shows Benefit After Multiple Prior TKIs
A prospective, multicenter, controlled trial also examined whether patients with chronic-phase CML who had received at least two prior TKIs could benefit from switching to olverembatinib.
The trial enrolled 105 patients who had been treated with at least two prior TKIs for 18 months or longer and had not achieved major molecular response. Patients were assigned either to switch to olverembatinib or continue their most recent TKI therapy.
At six months, the major molecular response rate was 54.3% in the olverembatinib group, compared with 10.0% in the control group. At 12 months, the cumulative incidence of major molecular response was 57.14% among patients who switched to olverembatinib, compared with 21.43% among those who continued their previous therapy.
Common grade 3 or 4 hematologic adverse events included thrombocytopenia and anemia. Grade 3 or 4 non-hematologic adverse events were reported as rare. The company also reported that many adverse events related to prior TKI therapy improved after patients switched to olverembatinib.
POLARIS-1 Data Support Further Study In Ph+ ALL
Ascentage Pharma also presented updated results from POLARIS-1, a global registrational Phase III study evaluating olverembatinib with reduced-intensity chemotherapy in patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia.
A total of 55 patients were enrolled in Part 1 of the study. By the end of induction, the complete remission or complete remission with incomplete count recovery rate was 94.4%. The measurable residual disease-negative complete remission rate reached 63.0% by the end of induction and increased over time, reaching 93.1% by the end of cycle 9.
The company reported that the regimen showed a manageable safety profile, with no meaningful differences in efficacy or safety between the 30 mg and 40 mg dose groups. Activity was also observed in patients with adverse prognostic genotypes, including IKZF1plus.
These results add to the clinical evidence supporting continued development of olverembatinib-based regimens in newly diagnosed Ph+ ALL.
Pediatric Ph+ ALL Study Explores Chemotherapy-Free Combination
Another presentation evaluated olverembatinib in combination with lisaftoclax in pediatric patients with relapsed or refractory Ph+ ALL. The open-label Phase Ib study enrolled 17 patients with a median age of 13 years. Forty percent of patients had ABL1 mutations, including T315I.
Among nine efficacy-evaluable patients, the combination achieved an overall response rate of 88.9%. The study also reported an MRD-negativity rate of 66.7% at cycle 2 day 28. Both olverembatinib and lisaftoclax were detectable in cerebrospinal fluid, suggesting central nervous system penetration.
No treatment-related deaths were reported. The company said the findings may support further study of the chemotherapy-free oral dual-targeted regimen in pediatric patients with relapsed or refractory Ph+ ALL.
Lisaftoclax Data Presented In CLL/SLL And Myeloid Neoplasms
Updated data were also presented for lisaftoclax in chronic lymphocytic leukemia and small lymphocytic lymphoma. A correlative analysis from a pivotal Phase II study evaluated baseline characteristics and prognosis in patients with relapsed or refractory CLL/SLL who were refractory to BTK inhibitor therapy.
The study enrolled 77 patients who received lisaftoclax 600 mg once daily. Among 72 evaluable patients, the median progression-free survival was 23.9 months, while the Independent Review Committee-assessed overall response rate was 62.5%.
Further analysis found that TP53 mutation or del(17p), complex karyotype, and mutations in SF3B1, KIT, BLM, and SETD2 were associated with shorter progression-free survival. Complex karyotype and tumor size were identified as independent risk factors for shorter progression-free survival.
The company said these findings may help guide future risk stratification and support more individualized treatment strategies.
Lisaftoclax was also evaluated in a multicenter real-world retrospective study involving patients with myeloid neoplasms. The study included 30 patients, most of whom had acute myeloid leukemia. In patients with AML, the complete remission or complete remission with incomplete hematologic recovery rate reached 72%. The MRD-negativity rate among patients achieving CR or CRi was 61%.
Grade 3 or higher treatment-emergent adverse events were mainly hematologic, including thrombocytopenia, anemia, and neutropenia. Overall safety was described as manageable.
Company Emphasizes Global Development Strategy
Ascentage Pharma’s Chief Medical Officer, Yifan Zhai, MD, said the EHA2026 updates support the continued development of olverembatinib and lisaftoclax across hematologic malignancies. The company also said it plans to continue exploring combination strategies and global clinical development programs.
Ascentage Pharma is a global commercial-stage biopharmaceutical company focused on therapies for cancer and other serious diseases. Its pipeline includes inhibitors targeting the apoptotic pathway, next-generation kinase inhibitors, and protein degraders.
Olverembatinib is approved in China for certain patients with chronic myeloid leukemia, including those with T315I mutations and those resistant or intolerant to earlier-generation TKIs. Lisaftoclax is approved in China for adult patients with CLL/SLL who previously received at least one systemic therapy including BTK inhibitors.
The company is also conducting several global registrational studies, including trials in CML, Ph+ ALL, gastrointestinal stromal tumors, CLL/SLL, AML, and higher-risk myelodysplastic syndromes.
While the EHA2026 presentations add to the clinical evidence base for Ascentage Pharma’s pipeline, several findings remain from ongoing or early-stage studies. Further follow-up and regulatory review will be needed to determine how these therapies may be used in broader clinical practice.
