Leap Therapeutics, Inc. (NASDAQ:LPTX) presented updated preliminary data on Wednesday from Part B of the DeFianCe Phase 2 trial of sirexatamab (DKN-01) in combination with bevacizumab and chemotherapy (Experimental Arm) compared to bevacizumab and chemotherapy (Control Arm).

The trial enrolled patients with advanced microsatellite stable (MSS) colorectal cancer (CRC) who have received one prior systemic therapy for advanced disease.

The updated analysis shared on Wednesday includes the overall response rate (ORR), an additional two months of patient follow-up for progression-free survival (PFS), and initial overall survival (OS) data.

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As of March 12, 2025, 34 patients remain on the study drug in the sirexatamab Experimental Arm compared to 24 patients in the Control Arm.

• In patients with high DKK1 levels, the sirexatamab Experimental Arm has a statistically significant 32% higher ORR, 3.5 months longer PFS, and OS compared to the Control Arm:
• In patients who had not received prior anti-VEGF therapy, the sirexatamab Experimental Arm has a statistically significant 22% higher ORR and 2.6 months longer PFS compared to the Control Arm, with OS not mature but favoring the sirexatamab Experimental Arm.

The combination of sirexatamab plus bevacizumab and chemotherapy is well tolerated with a safety profile.

Leap has engaged a leading financial advisor to explore business development opportunities to further the development of sirexatamab.

In January, Leap Therapeutics decided not to proceed with sirexatamab Phase 3 studies in gastric cancer.

The company released initial data from Part C of the DisTinGuish Phase 2 study of sirexatamab in combination with BeiGene Ltd's (NASDAQ:ONC) tislelizumab and chemotherapy in first-line patients with advanced gastroesophageal junction and gastric cancer.

While demonstrating activity in biomarker populations, the study did not generate a clear positive signal. It will be negative on the primary progression-free survival (PFS) endpoints when the study is completed.

Price Action: LPTX stock is up 14.7% at the last check Wednesday.

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