Hansoh Pharma Announces New Clinical Evidence of Flumatinib in Newly Diagnosed Adult Ph+ ALL at ESMO 2024

The 2024 European Society for Medical Oncology (ESMO) Annual Meeting was held in Barcelona, Spain, from September 13 to 17 local time. Hansoh Pharma's innovative drug, flumatinib, was presented at this year’s conference in poster format. The study, led by the team of Professor Wang Weimin and Professor Sun Hui from the First Affiliated Hospital of Zhengzhou University, analyzed 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), providing new evidence-based medical support for the use of flumatinib in treating Ph+ ALL patients.

Flumatinib, the first domestically developed novel second-generation TKI for chronic myeloid leukemia in China, has demonstrated promising efficacy and good tolerability in multiple clinical studies targeting patients with chronic myeloid leukemia (CML). It also shows considerable potential in the treatment of Ph+ ALL.

Ph+ ALL accounts for 20%~30% of adult acute lymphoblastic leukemia (ALL). Traditional chemotherapy has shown poor efficacy, with a 5-year survival rate of less than 20% under multi-drug chemotherapy. The prognosis of Ph+ ALL patients has significantly improved after the application of tyrosine kinase inhibitors (TKI) in first-line treatment(1)(2).

This study (3) was a single-center, retrospective observational study that enrolled a total of 48 newly diagnosed adult Ph+ ALL patients who received flumatinib combined with multi-agent chemotherapy regimens between April 2020 and May 2023. Data were collected through electronic medical records and telephone follow-up until November 14, 2023.

After flumatinib combined with multi-drug chemotherapy, the induced complete remission (CR) rates at 0.5 months, 1 month, 3 months, and 6 months reached 100%, 97.9%, 100%, and 93.3%, respectively. The minimal residual disease-negative (MRD-) rates detected by flow cytometry at 0.5 months, 1 month, 3 months, and 6 months were 59.3%, 81.3%, 95.1%, and 90.0%, respectively.

With a median follow-up of 41.1 months, the 3-year overall survival (OS) rate, progression-free survival (PFS) rate, and event-free survival (EFS) rate were 70.8%, 62.5%, and 45.8%, respectively. Allogeneic hematopoietic stem cell transplantation (Allo-HSCT) was performed in 35.42% of patients, and the OS of patients who underwent Allo-HSCT was significantly better than those who did not.

Moreover, the OS of patients who achieved CR after induction therapy was significantly prolonged, and the OS of patients with MRD- was significantly better than that of MRD+ patients.

The above results show that the combination of flumatinib and multi-drug chemotherapy as an induction treatment regimen for newly diagnosed adult Ph+ ALL patients is highly effective, bringing more survival hope to Ph+ ALL patients in China.

References:
1. Lian Xiaying, Dai Haiping, Cui Qingya, et al. Clinical observation of 6 cases of newly diagnosed Ph+ acute lymphoblastic leukemia treated with flumatinib combined with induction chemotherapy followed by sequential allogeneic hematopoietic stem cell transplantation [J]. Chinese Journal of Hematology, 2023, 44(2): 169-172.

2. Mirui Hua, Chen Lin, Yang Haiping, et al. Efficacy and safety analysis of flumatinib combined with multi-drug chemotherapy in the treatment of Ph+ acute lymphoblastic leukemia: A study of 12 cases [J]. Chinese Journal of Hematology, 2021, 42(10): 858-861.
3.Wang Weimin et al. ESMO 2024 FPN：829P: Flumatinib combined with chemotherapy for newly diagnosed adult with Ph-positive acute lymphoblastic leukemia：a single-center, retrospective observational study.

Editor: Muyan

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