Kura and Kyowa Report Strong KOMZIFTI AML Data

Kura Oncology and Kyowa Kirin rolled out fresh data on KOMZIFTI ziftomenib paired with venetoclax and azacitidine. The numbers land well for both newly diagnosed and relapsed or refractory AML with NPM1 mutations or KMT2A rearrangements. The readout comes from the ongoing KOMET 007 Phase 1a/1b study and was presented today at ASH 2025.

In newly diagnosed NPM1 mutated AML the triplet came in strong. Among 37 evaluable patients CRc hit 86 percent and complete responses landed at 73 percent. Most striking was that 68 percent of CRc responders cleared molecular MRD by central NGS. Median duration of response and overall survival have not even been reached yet. Two thirds of patients were still alive and either on treatment or in long term follow up at data cutoff. Safety tracked with what you would normally expect from venetoclax and azacitidine. Ziftomenib did not push toxicity higher. Myelosuppression stayed low and count recovery times stayed in line. There were isolated cases of manageable differentiation syndrome and QTc prolongation with no treatment stoppage.

The relapsed or refractory setting showed the same kind of pattern. In R R NPM1 mutated AML the overall response rate reached 65 percent and CRc hit 48 percent. Venetoclax naive patients responded even better at 83 percent ORR and 70 percent CRc. Median overall survival was just under 55 weeks. Several patients went on to transplant and some continued with ziftomenib maintenance.

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For R R KMT2A rearranged AML the combo still showed meaningful activity. ORR landed at 41 percent with CRc at 28 percent. Venetoclax naive patients again saw a lift with 70 percent ORR and 60 percent CRc. Median overall survival was just over 21 weeks. Two of these patients proceeded to transplant and later received maintenance. Safety again held steady with no new issues tied to ziftomenib. One differentiation syndrome case resolved with protocol directed care and treatment resumed.

Kura’s CMO Mollie Leoni called out how consistent the safety and depth of response looked across both groups. The company continues to move its pivotal KOMET 017 trials forward targeting both front line and relapsed or refractory AML.

Kura is hosting a virtual investor event today at 12:30 p.m. ET with company leadership and clinical experts. Slides from the ASH talks are available on the company website.