Kura Oncology (NASDAQ:KURA) executives said the company is focused on building momentum behind its recently approved AML therapy KOMZIFTI while advancing broader clinical development programs in leukemia and solid tumors during a fireside chat at TD Cowen’s Oncology Innovation Summit.
Troy Wilson, president and CEO of Kura Oncology, said KOMZIFTI is approved for adult patients with relapsed or refractory NPM1-mutant acute myeloid leukemia, and that the company has seen “robust new patient starts” and early launch momentum. He said Kura is pursuing development that could ultimately address up to 50% of AML patients and expects multiple data readouts this year to support ziftomenib as a broadly combinable AML backbone.
Solid Tumor Data Highlighted Ahead of ASCO
The discussion also covered data for darlifarnib in combination with adagrasib across KRAS-driven solid tumors. A company speaker identified in the transcript as Operator said the data came from a dose-escalation study and should be viewed in aggregate, with signs of a dose response.
The speaker said nearly all patients experienced some tumor regression, including patients who were previously treated and some who had received a RAS inhibitor. In non-small cell lung cancer, the company reported a 50% response rate in later-line patients, compared with an expected 30% to 40% objective response rate for adagrasib monotherapy in earlier-line settings. In pancreatic ductal adenocarcinoma, the company reported a 67% response rate, compared with an expected roughly 30% in second-line patients. In colorectal cancer, the cumulative response rate was 14%, but 29% among KRAS inhibitor-naive patients, compared with 19% expected with adagrasib alone.
On safety, the speaker said the adverse events reflected the known profiles of the individual drugs, including cytopenias associated with farnesyltransferase inhibitors and gastrointestinal toxicity associated with adagrasib. The speaker said there was no evidence of overlapping toxicity and that dose interruptions or adjustments appeared similar to expectations for adagrasib alone.
Kura plans to present a slightly updated data cut at ASCO, including about 30 patients across two doses the company plans to advance: 3 mg and 5 mg of darlifarnib plus 400 mg of adagrasib. The 8 mg dose will not be advanced because, according to the speaker, it did not have the appropriate benefit-risk profile.
KOMET-007 Data to Be Updated at EHA
Kura is also expected to present updated data from KOMET-007 at the European Hematology Association meeting. The company said the study evaluated combinations in frontline AML, including 7+3 chemotherapy in NPM1- and KMT2A-mutant patients.
According to the transcript, 99 patients were treated at the dose level the company has taken forward into a pivotal trial. At an earlier cutoff, complete response rates were 82% for KMT2A and 94% for NPM1. Complete response with incomplete count recovery reached 90% to 96%, and the company said patients achieved high levels of MRD negativity.
The company also said it expects to show a slightly updated data cut and more sensitive MRD data at EHA. The speaker said the data should support the design of the frontline KOMET-017 trial and encourage enrollment.
KOMZIFTI Launch and Commercial Strategy
Wilson said Kura is pleased with the KOMZIFTI launch after reporting $5.8 million in first-quarter revenue, 85 new patient starts and 157 total prescriptions during the quarter. He said the launch is ahead of internal expectations on early dynamics, market access, new patient starts and prescriptions.
Wilson said Kura is promoting KOMZIFTI only as monotherapy in relapsed/refractory NPM1-mutant AML, but is aware of physician-initiated combination use with venetoclax and azacitidine, as well as gilteritinib in FLT3-mutant patients. About 40% of patients are receiving combination therapy, according to the discussion.
Kura continues to estimate the relapsed/refractory NPM1-mutant AML market at $350 million to $400 million. Wilson said the company’s goal is to capture a majority share of that market while enrolling frontline studies, which he said represent a much larger opportunity.
Frontline AML Opportunity
Wilson said the frontline AML setting includes approximately 11,000 incident patients per year. Based on expected treatment duration and current pricing assumptions, he estimated the opportunity at $7 billion to $10 billion for the incident patient population. Assuming Kura captures about one-third of that market, Wilson said the company estimates peak U.S. sales of about $3 billion per year, with additional potential outside the United States.
On Europe, Wilson said Kura does not currently expect to file for approval and reimbursement based on the relapsed/refractory setting because regulators and payers typically want randomized data with survival endpoints. He said Kura’s two parallel Phase 3 trials in fit and unfit frontline AML patients are intended to support global registration, with accelerated endpoints in the U.S. and survival-based endpoints for both the U.S. and rest of world.
The company said enrollment in the frontline trials is proceeding according to plan, with sites opening in the U.S., Europe and Asia.
About Kura Oncology (NASDAQ:KURA)
Kura Oncology, Inc (NASDAQ: KURA) is a clinical-stage biopharmaceutical company focused on the discovery and development of targeted oncology therapies. Headquartered in La Jolla, California, the company leverages expertise in molecular biology and precision medicine to identify key drivers of cancer growth and design small-molecule inhibitors that block those pathways. Kura’s research platform integrates genomic insights with medicinal chemistry to advance candidates against well-validated targets in solid tumors and hematologic malignancies.
The company’s lead clinical candidate, tipifarnib, is a farnesyltransferase inhibitor being evaluated for the treatment of HRAS-mutant head and neck squamous cell carcinoma and various non-small cell lung cancers.
