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.
The company plans to file for accelerated approval with the FDA in the second quarter for relapsed/refractory NPM1-mutant AML, with two Phase III trials in frontline disease planned.
While positive on the menin class overall, with only topline data available an analyst questioned how differentiated ziftomenib would be from others in the class.

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

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