Final Results from DeFianCe Study on Deck for ESMO 2025: What This Means for MSS Colorectal Cancer Treatment
Leap Therapeutics (NASDAQ: LPTX) will be in the clinical spotlight at the European Society for Medical Oncology (ESMO) Congress 2025, set to present final clinical data from Part B of the DeFianCe study on Sunday, October 19, 2025, in Berlin. This pivotal phase 2 trial explores the efficacy of combining sirexatamab (DKN-01), Leap’s leading anti-DKK1 monoclonal antibody, with bevacizumab and chemotherapy versus the current standard regimen in patients with advanced microsatellite stable (MSS) colorectal cancer who have already undergone one round of systemic treatment.
Key Study Details to Be Presented by Dr. Zev A. Wainberg at ESMO
The session, led by Professor Zev A. Wainberg from UCLA’s GI Oncology Program, will discuss findings that may help shape the evolving landscape for MSS colorectal cancer—one of the more challenging tumor subtypes to treat effectively. The trial specifically investigates whether targeting DKK1 with sirexatamab adds benefit beyond bevacizumab and chemotherapy in a second-line setting. This outcome could have ripple effects on treatment sequencing and research direction.
| Study Arm | Therapies | Patient Population | Study Endpoint | Presenter |
|---|---|---|---|---|
| Sirexatamab Arm | DKN-01 + Bevacizumab + Chemotherapy | MSS CRC (2nd-line, n=undisclosed) | Final efficacy/safety data | Zev A. Wainberg, M.D. |
| Control Arm | Bevacizumab + Chemotherapy | MSS CRC (2nd-line, n=undisclosed) | Final efficacy/safety data | Zev A. Wainberg, M.D. |
Upcoming Data Has Potential to Shape Targeted Immunotherapy Strategies
The anticipation around this presentation highlights the interest in novel approaches for MSS colorectal cancer, a group that typically responds less favorably to existing immuno-oncology agents. The results could inform whether the addition of DKN-01 to the backbone regimen can enhance response or progression-free survival. While detailed patient numbers and data specifics remain under wraps until the Congress, the announcement alone signals clinical momentum for Leap’s pipeline in an area of high unmet need.
Pipeline and Forward-Looking Considerations for Leap Therapeutics
Leap’s broader portfolio also includes FL-501, an antibody targeting GDF-15, underscoring a focus on difficult-to-treat cancers via targeted pathways. While today’s press release centers on clinical science, investors are also mindful of forward-looking risks as outlined in the company’s filings—particularly regarding the pursuit of strategic partnerships, future cash conservation efforts, and the path to commercialization.
Takeaway: Keep an Eye on ESMO 2025 for Pivotal CRC Updates
The October ESMO session will offer much-anticipated clinical clarity for LPTX and the broader GI oncology field. For clinicians, investors, and patients alike, these final results from the DeFianCe trial could signal a potential inflection point in MSS colorectal cancer management. Those tracking innovative immuno-oncology approaches should circle this event on their calendar—and watch for detailed data disclosures from Leap’s pipeline later this year.
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