Source – Kura Oncology
Safety problems had previously slowed down the development of Kura Oncology’s Menin inhibitor Ziftomenib for acute myeloid leukemia, but recent evidence shows the programme is back on track, and the biotech has filed a $100 million offering to assist fund its future development.
Seven of 20 patients (35%) receiving a once-daily oral 600 mg dose of the drug experienced complete remission (CR) in a Phase I/II KOMET-001 trial in patients with NPM1-mutant AML who had received extensive pretreatment, according to new findings presented by the biotech at the European Haematology Association (EHA) congress.
Given that the people in the experiment had already had treatment and had progressed after receiving an average of three medications, as well as the fact that the medication was well tolerated, the median length of response for patients was 8.2 months. At this time point, the overall response rate (ORR) is 45%.
The research also included fewer individuals with additional “gatekeeper” mutations, and here the outcomes were similar: a CR of 33% (two of six patients) with FLT-3 mutations and 50% (four of eight patients) in the group of patients with IDH mutations.
The findings place Kura in the race to offer a treatment option for NPM1-positive AML patients, who make up around a third of all instances of the disease but have no FDA-approved targeted medicines.
The mutation has been linked to a more severe type of AML, which has a 50% five-year survival rate and a significant risk of recurrence.
The Menin inhibitor may have promise for usage upstream of existing medications targeting FLT-3 and IDH 1/2, according to recent research, which includes scant indication that it promotes resistance, according to Kura’s chief medical officer, Dr. Stephen Dale.
“We believe Ziftomenib has the ideal properties to become a cornerstone of therapy across the continuum of treatment”
Kura is actively pursuing combination studies combining chemotherapies with AbbVie’s BCL-2 inhibitor Venclexta (venetoclax), as well as the Phase II pivotal study of Ziftomenib in NPM1-mutant AML.
After a patient fatality was seen in a study, the FDA placed a partial clinical hold on Kura’s development with Ziftomenib; however, the hold was shortly released, and the firm is currently one of the front-runners in attempts to bring a Menin inhibitor to market.
