Kyowa Kirin’s bet on Kura Oncology appears to have paid off, as the companies have secured approval for their jointly developed drug, Komzifti (ziftomenib).
Following the US Food and Drug Administration’s (FDA) call to greenlight the drug, Komzifti will now be available to adult patients with relapsed or refractory acute myeloid leukaemia (r/r AML).
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The targeted therapy is specifically indicated for patients with a susceptible Nucleophosmin 1 (NPM1) mutation.
Komzifti obtained the approval based on the results of the Phase III KOMET-001 study (NCT04067336), which saw the drug trigger complete remission (CR) plus CR with partial haematological recovery (CRh) in 21.4% of patients. This effect was sustained over a median duration of five months.
As Komzifti enters the market, it becomes the first once-daily oral menin inhibitor to gain FDA approval in NPM1-mutated r/r AML – an indication with limited treatment options that is commonly associated with poor patient prognoses.
It is currently estimated that just under one-third of AML cases present a NPM1 founder mutation. Within this patient population, around 70% of patients will relapse after first-line treatment within three years while 20% do not respond to first-line therapies at all.
Following Komzifti’s approval in this indication, Kura Oncology’s CEO and president Troy Wilson noted that the therapy could become the menin inhibitor of choice within its approved indication due to its “best-in-class profile”.
Wilson adds that Kura and Kyowa Kirin are “fully prepared” to launch Komzifti.
The pair will also turn their attention to exploring Komzfti’s efficacy in the front-line and combination settings, which could further bolster the drug’s positioning in the AML market.
Outside of this indication, Kura is also looking into Komzifti’s potential in treating solid tumours, with the drug having entered the Phase Ia/Ib KOMET-015 trial for gastrointestinal stromal tumours (GIST) in April 2025.
Vying for menin inhibitor glory
Kyowa Kirin joined forces with Kura in November 2024 to assist with the global development and commercialisation of the drug – setting the company back up to $1.53bn.
While Kura will take responsibility for the marketing and manufacturing of Komzifti in the US, Kyowa Kirin will deal with these tasks outside of the US.
However, Komzifti will not join the market alone, as less than one month ago, Syndax Pharmaceuticals’ Revuforj (revumenib) got the FDA go-ahead in NPM1-mutated r/r AML.
While these drugs exhibited similar efficacy in their respective studies, Revuforj did trigger CR plus CRh in 23% – sitting marginally above Komzifti’s performance in the KOMET-001 study.
However, Komzifti does hold a dosing edge over its rival, as it is administered once daily, rather than the twice-daily regimen indicated for Revuforj.
Despite this, analysts at GlobalData forecast that Revforj will come out on top sales-wise, becoming a blockbuster seller for Syndax. In 2031, the drug is estimated to pull in $1.1bn for the Massachusetts-based pharma.
Meanwhile, analysts predict that Komzifti is set to make $793m for Kura and Kyowa Kirin’s therapy in the same year.
