Prime Highlights:
- Ascentage Pharma receives FDA and EMA approval to start a global Phase III trial of olverembatinib combined with chemotherapy for newly diagnosed Ph+ ALL patients.
- Early trial data show promising results, with about 65% of patients achieving MRD negativity and complete response after three treatment cycles.
Key Facts:
- The POLARIS-1 study is a global, multicenter, randomized Phase III trial evaluating olverembatinib plus chemotherapy in newly diagnosed Ph+ ALL patients.
- Olverembatinib is a third-generation tyrosine kinase inhibitor (TKI) already approved in China for drug-resistant chronic myeloid leukemia and included in the National Reimbursement Drug List (NRDL).
Background:
Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855), a global biopharmaceutical company, announced that it has received approval from the U.S. FDA and the European Medicines Agency (EMA) to start a global Phase III trial of its drug olverembatinib, combined with chemotherapy, for patients newly diagnosed with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).
The POLARIS-1 study, also cleared in China in 2023, is a multicenter, randomized, open-label trial designed to evaluate the safety and effectiveness of olverembatinib in combination with chemotherapy. The trial is enrolling patients simultaneously across multiple countries to accelerate olverembatinib’s path to global registration.
Data from the upcoming 2025 American Society of Hematology (ASH) Annual Meeting show that, in newly diagnosed Ph+ ALL patients, the combination therapy achieved about 65% MRD-negative and complete response rates after three treatment cycles. The treatment also showed good results in high-risk patients, such as those with the IKZF1plus mutation, and had a manageable safety profile with mostly mild side effects.
Ph+ ALL makes up 20%–30% of adult ALL and often has a poor outlook. Older TKIs help but have limitations. Olverembatinib, a third-generation TKI, aims to address these gaps.
Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma, commented, “Clearances from the FDA and EMA for this global Phase III study mark a significant milestone for olverembatinib. We remain committed to advancing its development and bringing a new treatment option to patients worldwide.”
Olverembatinib is currently co-commercialized in China by Ascentage Pharma and Innovent Biologics. The drug has received multiple approvals for drug-resistant chronic myeloid leukemia and is recommended in Chinese clinical guidelines. In 2024, Ascentage Pharma signed an exclusive option agreement with Takeda for global commercialization rights outside China.
