ASCENTAGE-B (06855) Nelarabine first-line treatment for Ph+ ALL global registration phase III clinical study receives approval from the US FDA and European EMA.

ASCENTAGE-B (06855) announced that the company's original class 1 new drug, OCLATINIB (trade name: NALITINIB), in combination with chemotherapy for the treatment of newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) patients, has received approval to conduct a global registration Phase III clinical study (POLARIS-1, NCT06051409) from the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA). As the second global Phase III study for NALITINIB approved by regulatory agencies in Europe and the United States, the POLARIS-1 study will enroll patients in multiple countries and centers simultaneously, accelerating the market entry process for NALITINIB globally, especially in Europe and the United States. The POLARIS-1 study is an international, multicenter, randomized controlled, open-label global Phase III clinical trial designed to evaluate the efficacy and safety of NALITINIB in combination with chemotherapy in newly diagnosed Ph+ ALL patients. The POLARIS-1 study received clinical trial approval from the China CDE in 2023 and was quickly initiated. It is worth noting that the latest developments of the POLARIS-1 study will also be presented at the upcoming 2025 American Society of Hematology (ASH) annual meeting, marking the first public release of the study data. The abstract data that has been disclosed so far shows that in newly diagnosed Ph+ ALL patients treated with NALITINIB in combination with low-intensity chemotherapy, the rates of three-cycle MRD (minimal residual disease) negativity and MRD-negative complete remission (CR) can reach around 65%, significantly improving the efficacy compared to similar products overseas under the same conditions; even patients with high-risk subtypes carrying IKZF1plus gene mutations have shown good treatment outcomes. Additionally, the safety profile of this combination regimen is excellent, with a low and manageable incidence of side effects. Ph+ ALL accounts for approximately 20%-30% of adult ALL patients, with characteristics including a higher incidence in the elderly, high relapse rates, short disease-free survival, and poor prognosis. Before the emergence of small molecule targeted TKI drugs, the 5-year overall survival (OS) rate for Ph+ ALL patients treated with chemotherapy alone was less than 20%. The use of TKIs has significantly changed the treatment landscape in this area, but first and second-generation TKI treatments still have limitations for Ph+ ALL patients. NALITINIB is a class 1 new drug developed by ASCENTAGE, an oral third-generation TKI and the first third-generation BCR-ABL inhibitor to be approved for marketing in China. Its commercial promotion in China is jointly undertaken by ASCENTAGE and INNOVENT BIO. Currently, NALITINIB has been approved for multiple indications in the CML treatment-resistant field in China, with all approved indications included in the National Insurance Drug List. In addition, NALITINIB has made significant progress in the field of Ph+ ALL treatment, continuously recommended in the "CSCO Guidelines for Hematologic Malignancies" and recognized as a breakthrough therapy by the CDE. On June 14, 2024, ASCENTAGE signed an exclusive option agreement with the multinational pharmaceutical company TAKEDA for NALITINIB. If the option is exercised, TAKEDA will receive global rights and licenses for the development and commercialization of NALITINIB, excluding mainland China, Hong Kong, Macau, Taiwan, and other regions.