Daiichi broadens its Vanflyta net

Acute myeloid leukaemia has increasingly become the domain of targeted therapies, so it’s notable that Daiichi is casting a broader net with its latest phase 3 trial of Vanflyta. The Flt3 inhibitor is approved for first-line AML patients with Flt3-ITD mutations, but the Quantum-Wild trial, recently listed on clinicaltrials.gov, will recruit newly diagnosed Flt3-ITD-negative subjects. This could open up a larger patient pool: Daiichi estimates that 70-80% of fit AML patients are Flt3 wildtype. There is reason for caution, however: an investigator-sponsored phase 2 trial in Flt3 wildtypes, Quiwi, didn’t meet its primary PFS endpoint, although Daiichi claimed a win on overall survival – the primary outcome of Quantum-Wild. A question, if the study is successful and leads to a broader Vanflyta label, is whether biomarker testing will remain commonplace for AML patients. Novartis’s kinase inhibitor Rydapt is marketed for first-line Flt3-mutated AML, while another targeted approach is IDH inhibition, with Servier’s Tibsovo an example of an approved therapy. Meanwhile, menin inhibitors are taking aim at NPM1 mutant and KMT2A rearranged AML, although for now these remain investigational. Interestingly, Kura is combining its contender, ziftomenib, with Astellas’s Flt3 inhibitor Xospata, in the Komet-008 study.

The history of Vanflyta

Source: OncologyPipeline.