Leap Therapeutics (NASDAQ:LPTX) announced positive updated data from its Phase 2 study of sirexatamab (DKN-01), an anti-DKK1 monoclonal antibody, in combination with bevacizumab and chemotherapy, compared to bevacizumab and chemotherapy, in patients with advanced microsatellite stable (MSS) colorectal cancer (CRC) who have received one prior systemic therapy for advanced disease.
According to Leap, the updated analysis includes overall response rate (ORR) by investigator-assessment and blinded independent central review, an additional two months of patient follow-up for progression-free survival (PFS)—that demonstrates a favorable maturation of the data, and initial overall survival data.
In a statement, Cynthia Sirard, MD, CMO of Leap, commented, “The updated data from Part B of the DeFianCe study presented today confirms that sirexatamab can generate significantly higher ORR and longer PFS in CRC patients who have high levels of DKK1 or who have not had prior anti-VEGF therapy, two exploratory populations with strong scientific rationale. In the full intent-to-treat population, sirexatamab demonstrated a higher ORR and a tail population with longer PFS that continues to mature. With more sirexatamab-treated patients currently continuing on study drug than control arm patients, there is potential for the dataset to continue to strengthen over the coming months.”
Dr. Sirard concluded, “We believe that there is a compelling opportunity to move forward with a registrational study for sirexatamab to confirm these results and bring a new therapy to patients with CRC.”
