Leap Therapeutics(LPTX) Prnewswire·2025-03-26 11:00Core Insights - Leap Therapeutics has presented updated data from the DeFianCe study, indicating that sirexatamab in combination with bevacizumab and chemotherapy shows statistically significant improvements in overall response rate (ORR) and progression-free survival (PFS) for colorectal cancer (CRC) patients with high DKK1 levels and those who have not received prior anti-VEGF therapy [1][2][3] Study Results - In patients with high DKK1 levels (n=44), the sirexatamab Experimental Arm demonstrated a 32% higher ORR (48.0% vs. 15.8%) and a median PFS of 9.36 months compared to 5.88 months in the Control Arm [3][4] - For patients without prior anti-VEGF therapy (n=95), the sirexatamab Experimental Arm showed a 22% higher ORR (55.1% vs. 32.6%) and a median PFS of 10.94 months compared to 8.34 months in the Control Arm [4][3] - Across the intent-to-treat population (n=188), the sirexatamab Experimental Arm had an ORR of 36.2% compared to 25.5% in the Control Arm, with median PFS still maturing [4][3] Market Opportunity - The combination therapy has a significant market opportunity, targeting approximately 30,000 second-line treated CRC patients in the US and 160,000 in the next seven largest markets, particularly among the 25-50% of patients with high DKK1 levels and the 50% who have not received prior anti-VEGF therapy [7] - There is potential to expand into first-line CRC treatment, with an estimated 45,000 patients in the US and 265,000 in the next seven largest markets [7] Future Plans - Leap Therapeutics is considering a registrational Phase 3 clinical trial to further evaluate the efficacy of sirexatamab in the identified patient populations [7][2] - The company has engaged a leading financial advisor to explore business development opportunities to advance the development of sirexatamab [7]