The European Society for Medical Oncology (ESMO) Congress 2024 was held in Barcelona, Spain, from September 13 to 17 (local time). Hansoh Pharma's innovative drug Flumatinib was showcased at the conference in the form of a poster presentation. Led by Professors Wang Weimin and Sun Hui from the First Affiliated Hospital of Zhengzhou University, the study evaluated the efficacy of Flumatinib combined with multi-drug chemotherapy as a first-line treatment for patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). The finding offers new evidence-based support for the use of Flumatinib in treating Ph+ ALL.
Flumatinib is China's first domestically developed second-generation TKI for chronic myeloid leukemia (CML). It has shown promising efficacy and good tolerability in multiple clinical studies on CML and has demonstrated considerable potential in treating Ph+ ALL as well.
Ph+ ALL accounts for 20% to 30% of adult acute lymphoblastic leukemia (ALL) cases, with poor outcomes using traditional chemotherapy. The five-year survival rate with multi-drug chemotherapy is less than 20%. However, the introduction of tyrosine kinase inhibitors (TKIs) in first-line treatment has significantly improved the prognosis for Ph+ ALL patients.
Background: Outcomes in patients with Philadelphia chromosome positive (Ph+) acute lympho blastic leukemia (ALL) have improved with the use of tyrosine kinase inhibitors(TKIs).
Methods: This was a single-center, retrospective observational study conducted on patients with newly diagnosed Ph+ ALL patients who received flumatinib combined with multiagent chemotherapy as treatment regimen between April 2020 to May 2023. Patients were followed up by electronic medical record system and by telephone until 14 November 2023.
Results: After the administration of flumatinib combined with multiagent chemotherapy, the induced complete remission (CR), 3 month CR, and 6 month CR rates achieved 97.9%, 100%, and 93.3%, respectively. The rate of minimal residual disease negative (MRD-) by flow cytometry was 59.3%, 81.3%, 95.1%, and 90.0% in 0.5, 1, 3, and 6 months, respectively. The rates of major molecular response (MMR) were 54.6%, 61.4%, 82.0%, and 89.3% in 0.5, 1, 3, and 6 months after treatment, respectively. While the rates of complete molecular response (CMR) were 50.0%, 43.2%, 64.1%, and 85.7%.
With a median follow-up of 41.1 months, the 3 years overall survival (OS), progression-Free Survival (PFS) and event free survival (EFS) were 70.8%, 62.5% and 45.8%, respectively. 35.42% (17/48) patients were administered allogeneic SCT. The OS of patients with SCT was significantly better than patients without SCT (94.1% vs. 54.8%, p=0.0057). The OS of patients by CR after induction therapy significantly prolonged (70.21% vs. 0, p = 0.0001). The OS of patients with MRD-negative was remarkably better than patients MRD-positive (71.79% vs. 55.56%, p＜0.0001). The OS of patients whether they had achieved MMR and CMR suggested no impact on OS. 64.1%(25/39) patients received a CMR in 3 months after treatment, the OS of patients whether had achieved CMR revealed no statistical difference(68% vs. 78.57%, p=0.4618).
