Leap Therapeutics' LPTX Shows Promise with Sirexatamab in Colorectal Cancer Treatment
- Leap Therapeutics reports promising efficacy of sirexatamab in treating microsatellite stable colorectal cancer in the DeFianCe study.
- Patients with high DKK1 levels showed a 38.0% objective response rate with sirexatamab, outperforming standard treatments.
- The company aims to advance biomarker-driven trials, enhancing treatment options for colorectal cancer patients.
Leap Therapeutics Advances Immuno-Oncology with Promising Results for Sirexatamab in Colorectal Cancer
Leap Therapeutics, Inc. (Nasdaq: LPTX), a biotechnology firm specializing in targeted and immuno-oncology therapeutics, recently showcases significant progress in its development of sirexatamab (DKN-01), an anti-DKK1 monoclonal antibody. The latest findings from Part B of the DeFianCe study (NCT05480306) reveal promising efficacy of sirexatamab when combined with bevacizumab and chemotherapy in patients suffering from microsatellite stable (MSS) colorectal cancer (CRC). This Phase 2 study specifically targets patients who have already undergone systemic therapy, marking an important step in the ongoing battle against this challenging cancer subtype.
The study's results, presented at the European Society for Medical Oncology (ESMO) Congress 2025 by Dr. Zev Wainberg from UCLA, highlight a significant disparity in treatment outcomes for patients classified with elevated levels of DKK1, a negative prognostic factor. Among the 88 participants with high DKK1 levels treated with sirexatamab, the objective response rate (ORR) reached 38.0%, compared to 23.7% for the control group receiving standard treatment. This stark difference emphasizes the drug's potential efficacy in a patient population that typically faces poor prognoses.
In addition to ORR, the study also reports enhanced median progression-free survival (mPFS) figures, with the sirexatamab group achieving 9.03 months versus 7.06 months for the control group (Hazard Ratio [HR] 0.61, p-value = 0.0255). While overall survival (OS) data remains incomplete for the sirexatamab arm, it is noteworthy that the control group's median overall survival stands at 14.39 months (HR 0.42, p-value = 0.0118). These outcomes provide a compelling case for Leap Therapeutics to pursue further development of sirexatamab in biomarker-driven registrational trials, potentially revolutionizing treatment options for CRC patients with high DKK1 levels.
Beyond these groundbreaking findings, Leap Therapeutics emphasizes the importance of targeted therapies in the evolving landscape of cancer treatment. The promising results from the DeFianCe study not only strengthen the case for sirexatamab but also align with the company's broader mission to develop innovative therapies that can significantly improve patient outcomes. As the company moves forward, it positions itself at the forefront of the immuno-oncology sector, advocating for advancements that could transform treatment paradigms in colorectal cancer.
Overall, the latest study results underscore the importance of biomarker identification in tailoring cancer therapies. Leap Therapeutics continues to pioneer its research, aiming to offer new hope to patients who have limited treatment options and face challenging prognoses in the fight against colorectal cancer.