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Kura/Kyowa Kirin’s Ziftomenib Scores In NPM1m AML, But Differentiation Is Key

 
• By Alaric DeArment

The company plans to file for accelerated approval with the US FDA next quarter, but there are concerns about how differentiated ziftomenib would be from Syndax’s first in class menin inhibitor.

Myeloma multiplex leukemia cancer 3d color render illustration isometric view
• Source: Shutterstock

Kura Oncology and Kyowa Kirin plan to pursue US Food and Drug Administration approval based on positive Phase II topline results for ziftomenib in relapsed/refractory NPM1-mutant acute myeloid leukemia (AML), but there are still questions that remain as to how they can differentiate it from other menin inhibitors like Syndax Pharmaceuticals’ first-in-class Revuforj (revumenib), which recently hit the market.

The companies announced 5 February positive topline results from the Phase II KOMET-001 trial of ziftomenib, a once-daily oral menin inhibitor. Kura management stated in a same-day call with analysts...

Key Takeaways
  • Kura/Kyowa Kirin said the KOMET-001 trial of ziftomenib hit the primary endpoint of CR/CRh, and Kura suggested it also reached the targeted 20%-30% response rate.

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