Ascentage Pharma Reports Promising Findings on Olverembatinib at EHA 2025

Rockville, Maryland, and Suzhou, China - June 15, 2025 - Ascentage Pharma (NASDAQ: AAPG; HKEX: 6855), a global biopharmaceutical company focused on addressing unmet medical needs in cancer treatment, unveiled encouraging data from 13 studies of its leading drug, olverembatinib, during the 2025 European Hematology Association (EHA) Annual Congress. Notably, olverembatinib, a third-generation tyrosine kinase inhibitor (TKI), has demonstrated broad therapeutic potential, particularly in the treatment of Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL).

The presented studies highlighted olverembatinib's impressive clinical outcomes in patients diagnosed with Ph+ ALL, showcasing elevated complete remission (CR) and complete molecular response (CMR) rates, alongside favorable tolerability in both newly diagnosed and relapsed/refractory cases.

Dr. Hongsheng Zhou of Nanfang Hospital, Southern Medical University, led a pivotal study assessing olverembatinib in combination with blinatumomab as a first-line treatment for Ph+ or Ph-like ALL. This single-center, prospective study revealed that all patients achieved CR after just one treatment cycle, with an overall survival (OS) rate of 100% and an event-free survival (EFS) rate of 91.6% over an 18-month follow-up period. "The findings suggest that this combination offers significant clinical benefits and an excellent safety profile, making it a promising chemotherapy-free treatment option for patients with Ph+ ALL," Dr. Zhou stated during the presentation.

Another study, led by Prof. Jie Jin from The First Affiliated Hospital, Zhejiang University School of Medicine, evaluated olverembatinib's efficacy in combination with the VP regimen (vindesine and prednisone) among adult patients with Ph+ ALL. Results indicated that the overall response rate (ORR) was 100%, and 97.3% of patients achieved CR. The 2-year OS and progression-free survival (PFS) rates were reported at 96.3% and 96%, respectively, underscoring the potential of this regimen in first-line therapy.

In terms of relapsed cases, a study conducted by Erlie Jiang of the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences, illustrated that olverembatinib combined with inotuzumab ozogamicin yielded a hematologic CR in all examined patients. The study reported a CMR rate of 78.6% and a 100% rate of minimal residual disease (MRD) negativity, with 64.3% of patients successfully bridging to allogeneic hematopoietic stem cell transplantation (allo-HSCT).

Additionally, Ascentage Pharma presented promising preliminary data on its investigational EED inhibitor, APG-5918, which exhibited potent antitumor activity in preclinical models of T-cell lymphoma. Dr. Eric Liang of Ascentage emphasized the drug's potential role in combination therapies, stating, "APG-5918 has shown superior efficacy compared to other EED inhibitors, making it a compelling candidate for further clinical development."

With these compelling results, Ascentage Pharma is advancing olverembatinib towards global registrational Phase III trials for Ph+ ALL, alongside other pivotal studies for its innovative drug candidates. The company aims to address significant gaps in cancer treatment, particularly for patients with limited therapeutic options.

Ascentage Pharma's commitment to innovation in oncology is reflected in its strategic partnerships with leading institutions such as the Dana-Farber Cancer Institute and the National Cancer Institute. The company continues to emphasize its goal of improving patient outcomes through the development of novel therapeutic agents.

For more detailed results from all 13 studies presented at EHA 2025, visit the official EHA website.