Phase 3 Trial of Olverembatinib Cleared By FDA, EMA in Ph+ALL

A recently cleared phase 3 study (NCT06051409) will evaluate olverembatinib combined with chemotherapy as a first-line treatment for patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).^1,2

Ascentage Pharma has received clearance from the FDA and the European Medicines Agency (EMA) to initiate the POLARIS-1 global registrational phase 3 study.

This marks the second global phase 3 study for olverembatinib to be cleared by US and European regulators, a key milestone intended to accelerate the drug's path to registration in these major markets. Preliminary data from the study, disclosed in an abstract for the 2025 American Society of Hematology (ASH) Annual Meeting, provide an early look at the potential of the olverembatinib combination regimen.

These data indicate high efficacy rates, with approximately 65% of treatment-naive patients achieving minimal residual disease (MRD) negativity and molecular MRD-negative complete response after 3 treatment cycles. The combination regimen also demonstrated a favorable safety profile, characterized by a low incidence of adverse events that were mostly manageable, as well as clinical benefit in difficult-to-treat, high-risk patient subtypes, including those with the IKZF1^plus mutation.

Patients received olverembatinib administered in combination with low-intensity chemotherapy.

About the POLARIS-1 Study

The POLARIS-1 study is a pivotal trial designed to establish olverembatinib as a new treatment option for a high-need patient population, with an estimated enrollment of 350 patients. The estimated completion date of the study is October 31, 2028. The study is being conducted in 14 locations across Australia and China.

The primary objective of the study is toevaluate the efficacy and safety of olverembatinib in combination with chemotherapy for newly diagnosed patients with Ph+ ALL.

The trial has received clearance from 3 major international regulatory bodies: FDA, EMA, and China Center for Drug Evaluation, which cleared the study in 2023.

"Clearances from the US FDA and the EMA for this global registrational phase 3 study mark a significant step forward in the global development of olverembatinib in Ph+ ALL,” said Yifan Zhai, MD, chief medical officer of Ascentage Pharma, in a news release. “Fulfilling our mission of addressing unmet clinical needs in China and around the world, we will press ahead with the clinical development of olverembatinib in Ph+ ALL and strive to bring a new treatment option to patients around the world as soon as possible.”

REFERENCES

1.Ascentage Pharma announces global registrational phase III study of olverembatinib in first-line treatment of Ph+ALL cleared by US FDA and EMA. News release. Ascentage Pharma. Published December 4, 2025. Accessed December 5, 2025. https://tinyurl.com/2dxufhp7

2.A study of olverembatinib in patients with newly diagnosed Ph+ALL. ClinicalTrials.gov. Updated November 7, 2024. Accessed December 5, 2025. https://www.clinicaltrials.gov/study/NCT06051409