Leap Therapeutics Unveils Promising Results from Colorectal Cancer Treatment Study
Leap Therapeutics Unveils Promising Results from Colorectal Cancer Treatment Study
Leap Therapeutics, Inc. (Nasdaq: LPTX), a biotechnology company dedicated to advancing targeted and immuno-oncology treatments, recently presented compelling updated data from the clinical evaluation of sirexatamab, a monoclonal antibody targeting the DKK1 protein. The study focused on colorectal cancer (CRC) patients and highlighted significant improvements in overall response rates (ORR) and progression-free survival (PFS).
Study Overview
On March 26, 2025, the company revealed the findings from Part B of the DeFianCe study, which is a Phase 2 open-label global trial assessing the efficacy of sirexatamab in collaboration with bevacizumab and chemotherapy. This combination was examined against a control cohort receiving only bevacizumab and chemotherapy. Patients involved in this study had undergo previous systemic therapy for advanced, microsatellite-stable CRC.
Key Findings
The results confirmed that patients with elevated DKK1 levels demonstrated a remarkable 32% increase in ORR as well as a 3.5-month extension in PFS when treated with the sirexatamab combination, compared to those in the control group. For the smaller cohort that hadn't previously been administered anti-VEGF therapy, the ORR was 22% higher and PFS was extended by 2.6 months.
Cynthia Sirard, MD, Chief Medical Officer at Leap Therapeutics, commented on the findings, stating that the data indicates significant potential for the combination treatment, particularly in CRC patients with high DKK1 levels.
Statistical Highlights
- - In the high DKK1 patient group (total of 44 patients):
- ORR by Blinded Independent Central Review (BICR) was 40% compared to 5.3% (p < 0.001).
- The median PFS was 9.36 months versus 5.88 months in the control (HR = 0.46, p = 0.0248).
- - For patients without prior anti-VEGF treatment (total of 95 patients):
- ORR by BICR showed 44.9% compared to 21.7% (p = 0.0066).
- Median PFS reached 10.94 months versus 8.34 months (HR = 0.59, p = 0.0386).
Next Steps
Leap Therapeutics plans to move forward with a registrational Phase 3 clinical trial. The findings also underline a significant market opportunity, with around 30,000 second-line CRC patients in the U.S. alone, and growth potential into the first-line treatment population, consisting of an estimated 45,000 patients.
The management at Leap will discuss these new findings in more depth during a conference call scheduled for March 26, 2025, at 8:00 a.m. ET. Interested parties can listen to the call through their webcast.
About Leap Therapeutics
Leap Therapeutics is engaged in the development of innovative therapies aimed at targeting and treating cancer. Their leading candidate, sirexatamab, represents a forward step in tackling colorectal cancer treatment. Trailblazing this research, they also have additional candidates in their pipeline which are dedicated to addressing significant medical need in oncology. For more information, visit Leap Therapeutics.
Conclusion
The updated data from the DeFianCe study provides a promising outlook for patients battling colorectal cancer, evidencing that the combination of sirexatamab with standard treatment regimens can yield improved outcomes. As Leap Therapeutics moves closer to initiating further studies, the potential to broaden treatment options for CRC patients remains an encouraging development in the realm of oncology.
Topics Health）
【About Using Articles】
You can freely use the title and article content by linking to the page where the article is posted.
※ Images cannot be used.
【About Links】
Links are free to use.