Ascentage Pharma Group International (Ascentage Pharma, stock code: 6855) reported that it has received regulatory clearance from both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to initiate a global registrational Phase III trial (POLARIS-1; NCT06051409). The trial will evaluate olverembatinib, an investigational third-generation BCR-ABL inhibitor, in combination with chemotherapy as a first-line treatment for Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). This marks the second global registrational Phase III study of olverembatinib cleared by US and EU regulators.
The multicenter, randomized controlled, open-label Phase III POLARIS-1 trial is enrolling patients across multiple countries and was also cleared by China's Center for Drug Evaluation in 2023. Initial data from an abstract disclosed for the American Society of Hematology (ASH) 2025 Annual Meeting indicated that, among treatment-naïve patients administered olverembatinib plus low-intensity chemotherapy, the minimal residual disease (MRD) negativity rate and the molecular MRD-negative complete response rate reached approximately 65% after three treatment cycles. The regimen also demonstrated a favorable safety profile, including a low incidence of largely manageable adverse events.
Ph+ ALL, accounting for 20%-30% of adult acute lymphoblastic leukemia cases, is often characterized by an elevated incidence in older adults, a marked risk of relapse, and poorer prognosis. Olverembatinib has been developed as an orally administered third-generation tyrosine kinase inhibitor and is the first one of its kind approved in China. It has received multiple indications for drug-resistant chronic myeloid leukemia and has gained coverage by the China National Reimbursement Drug List. In June 2024, Ascentage Pharma signed an exclusive option agreement with Takeda, granting Takeda potential rights to develop and commercialize olverembatinib in territories outside mainland China, Hong Kong, Macau, and Taiwan, pending exercise of the option.
Comments