en.Wedoany.com Reported - Ascentage Pharma Group (NASDAQ: AAPG; HKEX: 6855) announced 17 clinical updates on its core assets, olverembatinib and lisaftoclax, at the EHA2026 Congress, including eight poster presentations. The data come from ongoing clinical studies of olverembatinib, China's first approved third-generation BCR-ABL1 inhibitor, and lisaftoclax, the first domestically developed Bcl-2 selective inhibitor approved in China. The EHA2026 Congress took place from June 11 to 14, 2026, in Stockholm, Sweden.
Clinical data for olverembatinib were updated in two areas: chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). In CML treatment, a Phase Ib study led by Dr. Elias Jabbour of the University of Texas MD Anderson Cancer Center showed that among 22 patients with chronic-phase CML (CP-CML) resistant to ponatinib and/or asciminib, 40.9% harbored ASXL1 mutations. Following olverembatinib treatment, 44.4% of patients with ASXL1 mutations achieved clinical response, with 22.2% achieving major molecular response (MMR) and one case achieving MR4.5. A Phase II study led by Dr. Li Weiming of Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, showed that among 42 CP-CML patients without T315I mutations, the complete cytogenetic response (CCyR) rate with olverembatinib as second-line therapy was 76.2%, and the MMR rate was 47.6%, with responses deepening over treatment duration. A prospective, multicenter, controlled trial led by the team of Wen Bingbing at Shenzhen Second People's Hospital enrolled 105 CML-CP patients who had received at least two prior TKIs for more than 18 months without achieving MMR. Results showed that the 6-month MMR rate in the group switched to olverembatinib was 54.3%, significantly higher than the 10.0% in the group continuing prior TKI therapy. In the Ph+ ALL field, the global registrational Phase III study POLARIS-1 (Part 1), led by the team of Chen Suning at the First Affiliated Hospital of Soochow University, enrolled 55 newly diagnosed patients. Results showed that the CR/CRi rate at the end of induction was 94.4%, the MRD-negative CR rate was 63.0%, and the MRD negativity rate increased over time, reaching 93.1% by the end of Cycle 9. The regimen also demonstrated encouraging activity in patients with adverse prognostic genotypes, including IKZF1plus.
A Phase Ib study led by the team of Zhang Jingrao at the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences, evaluated the efficacy of olverembatinib combined with lisaftoclax in pediatric patients with relapsed/refractory (R/R) Ph+ ALL. The study enrolled 17 patients with a median age of 13 years, 40% of whom carried ABL1 mutations (including T315I). Among 9 evaluable patients, the overall response rate (ORR) was 88.9%, the MRD negativity rate was 66.7%, and 93.3% of patients achieved MMR or better by Day 28 of Cycle 2. Both drugs were detectable in cerebrospinal fluid. The same study also showed positive clinical data for olverembatinib in CML patients resistant to multiple TKIs and harboring high-risk gene mutations. Regarding clinical updates on lisaftoclax, the team of Zhou Keshu at Henan Cancer Hospital analyzed data from a pivotal Phase II study that enrolled 77 patients with BTK inhibitor-resistant R/R chronic lymphocytic leukemia/small lymphocytic lymphoma (R/R CLL/SLL), who received lisaftoclax 600 mg once daily. Among 72 evaluable patients, the median progression-free survival (PFS) was 23.9 months, and the ORR assessed by an independent review committee was 62.5%. Further analysis showed that TP53 mutation/del(17p), complex karyotype, and mutations in SF3B1, KIT, BLM, and SETD2 were associated with significantly shorter PFS, with complex karyotype and tumor size identified as independent risk factors for shorter PFS. A multicenter real-world study led by the team of Cao Chen at Qilu Hospital of Shandong University evaluated the efficacy of lisaftoclax in myeloid neoplasms, enrolling 30 patients (median age 63 years), including 25 with acute myeloid leukemia (AML), 3 with myelodysplastic syndromes (MDS), and 2 with chronic myelomonocytic leukemia (CMML). In AML patients, the CR/CRi rate was 72%, with the highest response in the ELN low-risk subgroup (87%), and an MRD negativity rate of 61% among patients achieving CR/CRi. The CR/CRi rate was 100% in patients with NPM1 mutations and 83% in those with IDH2 mutations. Among the 3 MDS patients, 2 achieved CRi. In terms of safety, Grade ≥3 treatment-emergent adverse events were primarily hematologic, including thrombocytopenia (27%), anemia (23%), and neutropenia (20%). Dr. Zhai Yifan, Chief Medical Officer of Ascentage Pharma, stated that these clinical updates validate the global therapeutic value of the core assets. Olverembatinib and lisaftoclax are investigational agents and have not been approved by the U.S. FDA.
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