Kura Oncology has claimed FDA approval for oral menin inhibitor Komzifti for a form of acute myeloid leukaemia (AML), making it the first direct competitor to Syndax’s Revuforj, which launched in the US last year.
Kyowa Kirin-partnered Komzifti (ziftomenib) has been cleared to treat relapsed/refractory AML with NPM1 mutations, the most common genetic variant in AML seen in around 30% of cases. Revuforj (revumenib) was given a green light from the FDA for a similar indication last month, around a year after its first approval for AML associated with KMT2A rearrangements.
Kura has been quick to highlight what it believes are competitive advantages of its product. Those include once-daily rather than twice-daily dosing and – potentially more importantly – a label that, unlike Syndax’s drug, does not include a boxed warning for QTc prolongation or Torsades de Pointes, two forms of cardiac rhythm disturbance.
Revuforj made $32 million in sales in the three months to end September, a 12% increase on the prior quarter, before the extension of its label to include NPM1-positive AML patients, which Syndax has said could unlock a $2 billion market opportunity in the US market alone.
The company is also working on moving Revuforj into the frontline setting as a combination with other drugs, in the phase 3 EVOLVE and REVEAL studies, and has suggested that this could expand the potential market to $5 billion.
Kura and Kyowa Kirin have won their approval for Komzifti on the strength of the KOMET-001 trial, which showed that the menin inhibitor achieved a rate of complete remission (CR) plus CR with partial hematologic recovery (CRh) of 21.4%, with a median duration of five months.
That is similar to the 23% CR/CRh rate seen in the AUGMENT-101 trial, with a median duration of 4.5 months, which supported the approval of Revuforj in NPM1-mutated AML.
“Komzifti combines compelling efficacy, a favourable safety profile, compatibility with concomitant medications, and convenient once-daily oral administration in a population with few effective treatment options,” said Kura’s chief executive, Troy Wilson.
Kura is leading the commercialisation of the new product in the US, where it will launch immediately, while Kyowa Kirin – which licensed rights to it last year for $330 million upfront – will take responsibility in other markets.
The wholesale acquisition cost in the US for a one-month supply of the drug has been set at $48,500, which is higher than the $39,500 monthly cost of Revuforj at launch.
