Syndax and Kura go head to head again

Syndax and Kura have been vying in menin inhibition for some time, and now the FDA has set up a new clash between the companies, with the PDUFA dates for their assets only around a month apart. The big day for Syndax’s contender, Revuforj, will come before that of Kura’s Kyowa Kirin-partnered project, ziftomenib, despite the fact that Syndax only made its announcement on Tuesday, while Kura’s splash came over three weeks ago. Both groups are gunning for approval in NPM1-mutant relapsed/refractory AML. Syndax, which already has US approval for Revuforj in KMT2A-rerranged relapsed acute leukaemia, could therefore steal Kura’s thunder again; Kura dropped out of the KMT2Ar space, at least with monotherapy, although combo work in first-line AML continues. KMT2Ar only accounts for around 10% of AML, compared with 30% for NPM1m, so more is riding on these decisions and subsequent launches. And the rivals will need whatever edge they can get, given the similar efficacy results from the registrational Augment-101 and Komet-001 trials. Kura has claimed a better safety profile with ziftomenib, with a lower rate of QTc prolongation in particular, so any toxicity warnings will also be closely watched.

The menin inhibitor race in r/r NPM1m AML

Source: company releases.