Leap Therapeutics Presents DKN-01 Monotherapy Data at AACR Virtual Special Endometrial Cancer Conference
DKN-01 demonstrated single agent activity in the EEC patients treated in the study, particularly in biomarker-selected subgroups relating to
"Pathways modulated by
"These DKN-01 monotherapy efficacy results are achieved with a favorable safety profile and warrant further study of DKN-01 either as a monotherapy or in combination in endometrial cancer patients with Wnt activating mutations or high levels of tumor
The P204 Study in Gynecologic Cancers
The P204 study is a Phase 2 basket study evaluating DKN-01 as a monotherapy or in combination with paclitaxel in patients with advanced gynecologic malignancies, including EEC, epithelial ovarian cancer (EOC), and carcinosarcoma. Data being presented at the
Key Findings from the P204 Study
Twenty-nine EEC patients were enrolled in the DKN-01 monotherapy group, over 75% of whom had experienced three or more prior lines of therapy. Of those patients, 26 were evaluable for response. Three important biomarker-selected subgroups were the focus of the data presentation:
- Patients with Wnt Signaling Alterations: In the group of 20 patients with a Wnt signaling alteration, one patient (5%) has an ongoing complete response, one patient (5%) had a partial response (PR), eight patients (40%) had a best response of stable disease (SD), and 10 patients (50%) had progressive disease (PD), representing an ORR of 10% and a ODCR of 50%. In the group of six patients without any Wnt signaling alterations, one patient (16.7%) had a best response of SD and five patients (83.3%) had PD. The patients with a Wnt signaling alteration experienced PFS of 1.9 months and OS of 15.1 months, compared to the patients without a Wnt signaling alteration who experienced PFS of 1.8 months and OS of 8.4 months.
- Patients with Wnt Activating Mutations: The nine patients with a Wnt activating mutation experienced PFS of 5.5 months and had not reached a median OS, compared to the 20 patients without a Wnt activating mutation who experienced PFS of 1.8 months and OS of 12.2 months.
- Patients expressing high tumor levels of
DKK1: Tumoral DKK1expression data was available for 19 EEC patients treated with DKN-01 monotherapy. In the group of seven patients with DKK1-high tumors, one patient (14.3%) had a PR, three patients (42.9%) had SD, and 3 patients (42.9%) had PD, representing an ORR of 14.3% and a ODCR of 57.1%. In the group of 12 patients with DKK1-low tumors, one patient (8.3%) had SD and 11 patients (91.7%) had PD. The DKK1-high patients experienced PFS of 3.0 months, compared to the DKK1-low patients who experienced PFS of 1.8 months.
DKN-01 is a humanized monoclonal antibody that binds to and blocks the activity of the Dickkopf-1 (
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. These statements include statements regarding expectations with respect to the development and advancement of DKN-01, including the initiation, timing and design of future studies, enrollment in future studies, potential for the receipt of future option exercise, milestones or royalty payments from BeiGene, and other future expectations, plans and prospects. Although Leap believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, forward-looking statements are subject to known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from our expectations. Such risks and uncertainties include, but are not limited to: that the initiation, conduct, and completion of clinical trials, laboratory operations, manufacturing campaigns, and other studies may be delayed, adversely affected, or impacted by COVID-19 related issues, the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for financing; the outcome, cost, and timing of our product development activities and clinical trials; the uncertain clinical development process, including the risk that clinical trials may not have an effective design or generate positive results; our ability to obtain and maintain regulatory approval of our drug product candidates; the size and growth potential of the markets for our drug product candidates; our ability to continue obtaining and maintaining intellectual property protection for our drug product candidates; and other risks. Detailed information regarding factors that may cause actual results to differ materially will be included in
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