Kura Oncology, Inc.KURA

Kura Oncology, Inc. (KURA) is an oncology-focused research site. Their drug KOMZIFTI (ziftomenib) has been associated with a 79% incidence of serious adverse reactions, with 4 fatal adverse reactions reported. Differentiation syndrome incidence for KOMZIFTI (ziftomenib) was 13%, with 4 fatal cases in KMT2A-rearranged AML patients and 2 fatal patients overall. The median time to onset of differentiation syndrome was 15 days. QTc interval prolongation incidence for KOMZIFTI (ziftomenib) was 12%, with 8% experiencing Grade 3 QTc interval prolongation. QTc prolongation incidence was 14% for patients <65 years and 10% for patients >=65 years. A 9% incidence of QTcF > 500 msec and a 12% incidence of increase from baseline QTcF > 60 msec were observed. Dosage interruption due to adverse reaction occurred in 54% of patients, dose reduction due to adverse reaction in 4%, and permanent discontinuation due to adverse reaction in 21%. Net product revenue for KOMZIFTI (ziftomenib) was $9.1 million, with 115 new patient starts.

In combination trials, KOMET-007 (ziftomenib + venetoclax + azacitidine) showed an 87% ORR and a 70% CRc rate, with 75% MRD negativity and a median duration of CRc of 9.2 months. The median OS was not reached. For KOMET-007 (ziftomenib + 7+3), 12-month OS rates were 94% and 71%, with CRc rates of 96% and 90%. FIT-001 (darlifarnib + cabozantinib) demonstrated ORRs of 50% and 44%, a disease control rate (DCR) of 94%, and a median PFS of 13 months. Tumor shrinkage was observed in 75% of patients. FIT-001 (darlifarnib + adagrasib) showed confirmed ORRs of 67%, 50%, and 29%, with 77% tumor shrinkage.