Global Registrational Phase III Study of Olverembatinib (HQP1351) Cleared by FDA

Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancer, age-related diseases, and chronic hepatitis B (CHB), announced today that it has received clearance from the US Food and Drug Administration (FDA) to initiate a global registrational Phase III trial of olverembatinib (HQP1351) in previously treated adult patients with chronic-phase chronic myeloid leukemia (CML-CP).

Under protocol HQP1351CG301, titled “A Global Multicenter, Open-Label, Randomized, Phase III Registrational Study of Olverembatinib (HQP1351) in Patients with Chronic-Phase Chronic Myeloid Leukemia (POLARIS-2),” the study is designed to assess the efficacy and safety of olverembatinib in the treatment of patients with CML-CP with or without the T315I mutation. The US FDA’s clearance of the trial marks the first global registrational Phase III trial for olverembatinib in patients with CP-CML to be conducted. The trial is scheduled to commence during the first half of 2024. 

Olverembatinib is a global best-in-class novel drug developed by Ascentage Pharma. As the first and only China-approved third-generation BCR-ABL inhibitor, olverembatinib can effectively target BCR-ABL and a spectrum of BCR-ABL mutants, including the T315I mutation. In November 2021, olverembatinib was approved in China for the treatment of adult patients with TKI-resistant CML-CP or accelerated-phase CML (CML-AP) harboring the T315I mutation. In November 2023, olverembatinib was approved for a new indication in adult patients with CML-CP resistant and/or intolerant of first-and second-generation TKIs. And in early 2024, the drug was included in the latest guidelines from the National Comprehensive Cancer Network (NCCN) for the management of CML.

Dr. Dajun Yang, Chairman and CEO of Ascentage Pharma, remarked that, “FDA’s clearance of POLARIS-2 marks another major milestone for olverembatinib and our company at large, as we conduct a range of global registrational trials of our major assets to combat challenging hematologic malignancies. We are most encouraged that our cutting-edge, patient-centric innovation, which has culminated in a safe and effective treatment in China even in patients with relapsed, refractory, and/or difficult-to-treat cases of CML, will bring meaningful improvement to patients’ lives. Recent inclusion of olverembatinib in the prestigious NCCN CML management guidelines also marks another major milestone for olverembatinib, signalling its widespread acceptance by the oncology community. Fulfilling our mission of addressing unmet clinical needs in China and around the world, we will continue to investigate olverembatinib and accelerate our clinical development programs to benefit more patients.”