Ascentage Pharma Group International (AAPG,6855.HK) announced that it received clearance from both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to launch a global registrational Phase III study, known as POLARIS-1 (NCT06051409). The trial will evaluate its investigational compound, olverembatinib, in combination with chemotherapy for patients newly diagnosed with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).
This marks the second global Phase III registrational study of olverembatinib to be approved by regulators in the US and Europe. POLARIS-1 is enrolling patients across multiple countries simultaneously, aiming to accelerate the drug's pathway to registration, particularly in the US and European markets.
The study is designed as a global, multicenter, randomized, controlled, open-label Phase III trial to assess the efficacy and safety of olverembatinib combined with chemotherapy in newly diagnosed Ph+ ALL patients. In addition, the trial was initiated in China following clearance by the China Center for Drug Evaluation (CDE) in 2023.
On June 14, 2024, Ascentage signed an exclusive option agreement to enter into an exclusive license agreement with Takeda for olverembatinib. In the event that Takeda exercises the option, Takeda would license the global rights to develop and commercialize olverembatinib in all territories outside of, among others, mainland China, Hong Kong, Macau, and Taiwan, China.
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