Kura Oncology(US:KURA)2025-12-08 17:30Ziftomenib + Ven/Aza in Newly Diagnosed NPM1-m AML - In newly diagnosed NPM1-m AML patients, the combination of ziftomenib 600 mg QD with Ven/Aza resulted in a composite complete remission (CRc) rate of 86% (32/37), with a complete remission (CR) rate of 73% (27/37)[35] - Among CRc responders in newly diagnosed NPM1-m AML, 68% (17/25) achieved MRD negativity at a threshold of ≤01% and 44% (11/25) at a threshold of ≤001%[36] - In newly diagnosed NPM1-m AML, 68% (27/40) of patients remained alive and continued on study after a median follow-up of 261 weeks[40] Ziftomenib + Ven/Aza in R/R NPM1-m or KMT2A-r AML - In R/R NPM1-m AML patients, the combination of ziftomenib 600 mg with Ven/Aza resulted in an overall response rate (ORR) of 65% (31/48) and a CRc rate of 48% (23/48)[57] - In R/R KMT2A-r AML patients, the combination of ziftomenib 600 mg with Ven/Aza resulted in an ORR of 41% (13/32) and a CRc rate of 28% (9/32)[57] - Among R/R NPM1-m AML patients without prior venetoclax exposure, the CRc rate was 70% (16/23) and the ORR was 83% (19/23)[58] - Among R/R KMT2A-r AML patients without prior venetoclax exposure, the CRc rate was 60% (6/10) and the ORR was 70% (7/10)[58] - For R/R NPM1-m AML, the median duration of CRc was 399 weeks after a median follow-up of 274 weeks[61] - For R/R KMT2A-r AML, the median duration of CRc was 124 weeks after a median follow-up of 169 weeks[64]