On October 20, 2025, Leap Therapeutics announced the final results from Part B of the DeFianCe Phase 2 study of sirexatamab (DKN‑01) in microsatellite‑stable colorectal cancer. The data were presented at the European Society for Medical Oncology (ESMO) Congress in Berlin by Dr. Zev Wainberg, a professor at UCLA, in a mini‑oral session. The study compared sirexatamab in combination with bevacizumab and chemotherapy versus bevacizumab and chemotherapy alone.
The final analysis demonstrated statistically significant improvements in progression‑free survival and overall survival in patients with high circulating DKK1 levels. In the DKK1‑high subgroup, sirexatamab also showed a greater objective response rate, and higher DKK1 concentrations correlated with even larger benefits in PFS, OS, and ORR. These findings support the drug’s potential as a targeted therapy for a biomarker‑defined patient population.
Leap stated it will continue to support development of sirexatamab in DKK1‑high colorectal cancer patients and will engage with regulatory authorities to pursue a registrational path. The company also highlighted that the data reinforce the value of optimizing the DKK1 biomarker diagnostic test to identify patients with poor prognosis. The announcement follows a recent $58.9 million private placement that provides additional capital for ongoing development.
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