On July 12, 2023 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported that, based on the early efficacy and momentum seen in the enrollment of 33 patients with colorectal cancer (CRC) in its DeFianCe study, it has initiated the 130 patient randomized controlled Part B of the Phase 2 study (Press release, Leap Therapeutics, JUL 12, 2023, View Source [SID1234633197]). The study evaluates Leap’s anti-Dickkopf-1 (DKK1) antibody, DKN-01, in combination with standard of care bevacizumab and chemotherapy as a second-line treatment for patients with advanced CRC.
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"Part A of the DeFianCe study enrolled an aggressive heterogenous population of second-line CRC patients representative of the second-line population that we see in the clinic who have poor outcomes on standard of care drugs and are in need of new therapies," said Zev Wainberg, MD, Professor Medicine at UCLA and co-director of the UCLA GI Oncology Program. "Exceeding a 20% overall response rate with a high disease control rate in second-line CRC patients is a clinically meaningful efficacy signal and worthy of further exploration."
"The study enrolled quickly and has already exceeded the 20% overall response rate threshold. After the planned safety review meeting with our investigators, we decided to initiate the randomized controlled study," said Cynthia Sirard, MD, Chief Medical Officer of Leap. "We continue to follow these Part A patients to assess durability of response, progression-free survival, and to determine whether additional patients with stable disease may become responders over time. We very much look forward to presenting this maturing data set at an upcoming meeting."
About the DeFiance Study
The DeFianCe study (NCT05480306) is a Phase 2, open-label, global study of DKN-01 in combination with standard of care bevacizumab and chemotherapy in patients with advanced CRC who have received one prior systemic therapy for advanced disease. The Part A cohort enrolled 33 patients, including significant numbers of patients who had early progression on first-line therapy, previous exposure to bevacizumab, tumors with Ras mutations, or liver metastases. The study has expanded into a 130-patient Part B randomized controlled trial. The primary objective of the study is progression free survival. Secondary objectives include overall response rate, duration of response, and overall survival. Leap expects to be able to enroll Part B in approximately 12 months and have initial data in late 2024.