Flumatinib versus imatinib in newly diagnosed patients with chronic myeloid leukemia

This study aimed to investigate the safety and effectiveness of flumatinib (HHGV678) compared to imatinib (Gleevec) in patients with chronic-phase chronic myeloid leukemia. 

This study concluded that flumatinib was a safe and more effective than imatinib in these patients. 

Imatinib is the standard treatment for chronic myeloid leukemia (CML). It is a targeted therapy called a tyrosine kinase inhibitor (TKI). Flumatinib is another TKI that is being investigated in clinical trials. It has been shown that flumatinib is a more potent TKI than imatinib.

However, more data about the safety and effectiveness of flumatinib compared to imatinib in patients with newly diagnosed chronic phase (CP) CML are needed. 

This study involved 394 patients with Philadelphia chromosome-positive CP-CML who had not received prior treatment. 196 patients received flumatinib treatment and 198 patients received imatinib treatment. Patients were followed up for 12 months.

At 6 months, the rate of major molecular response (MMR) was 33.7% for the flumatinib group compared to 18.3% for the imatinib group. MMR is when the level of the BCR-ABL gene (found in cancer cells) is very low. At 12 months, the rate of MMR was 52.6% for the flumatinib group compared to 39.6% for the imatinib group.

At 3 months, the rate of early molecular response was 82.1% for the flumatinib group compared to 53.3% for the imatinib group.  

At 6 months, 8.7% of the flumatinib group had a deep molecular response (DMR – a sign of remission) compared to 3.6% of the imatinib group. At 9 months, 16.8% of the flumatinib group had DMR compared to 5.1% of the imatinib group. At 12 months, 23% of the flumatinib group had DMR compared to 11.7% of the imatinib group.  

At 12 months, no patients from the flumatinib group progressed to an accelerated phase or blast crisis (a more severe form of CML) compared to 4 patients in the imatinib group.  

Side effects like edema (swelling), rash, neutropenia (low-level white blood cells that fight off infections), anemia (low-level red blood cells), and low-level blood phosphate were more frequent in the imatinib group. Side effects such as diarrhea and elevated liver enzymes (liver damage) were more frequent in the flumatinib group. 

This study concluded that flumatinib was safe and allowed better responses than imatinib in patients with newly diagnosed CP-CML.  

This study was funded by Hansoh Pharmaceuticals, the manufacturer of flumatinib. This trial was done in China, so the results may not translate to other populations.