Leap Therapeutics Presents DKN-01 Clinical Data at the Society of Gynecologic Oncology 2021 Annual Meeting on Women's Cancer
"DKN-01 demonstrated objective responses, including a monotherapy complete response continuing now for over 2 and a half years, and durable tumor reductions as a single agent and in combination with paclitaxel in the advanced gynecologic cancer patients treated in the study," said
"The activity of DKN-01 in this study was comparable to the monotherapy data from other widely-used immuno-oncology or targeted therapies,"
The P204 Study in Advanced Gynecologic Cancers
The P204 study was a Phase 2 basket study evaluating DKN-01 as a monotherapy or in combination with paclitaxel in groups composed of epithelial endometrial cancer (EEC), epithelial ovarian cancer (EOC), or carcinosarcoma (MMMT) patients. The primary endpoint of the P204 study was overall response rate (ORR), and secondary endpoints include disease control rate (DCR) and progression-free survival (PFS). In each group, at least fifty percent (50%) of patients were required to have specified Wnt signaling pathway alterations, a subgroup of which (Wnt activating mutations) are known to drive high tumoral
Key Findings from the P204 Study
One hundred-eleven patients were enrolled in the study, including 29 EEC patients in a DKN-01 monotherapy group, 24 EEC patients in a DKN-01 plus paclitaxel group, 14 EOC patients in a DKN-01 monotherapy group, 19 EOC patients in a DKN-01 plus paclitaxel group, 9 MMMT patients in a DKN-01 monotherapy group, and 16 MMMT patients in a DKN-01 plus paclitaxel group. The key findings from the study were:
- EEC patients and patients with Wnt activating mutations express higher levels of DKK1: EEC patients expressed higher levels of
DKK1and had a higher frequency of Wnt activating mutations than patients with EOC. Within EEC, patients with endometrioid histology had higher DKK1expression than those with non-endometrioid histology. Patients whose tumors had Wnt activating mutations expressed 14.4 times higher levels of DKK1.
- DKN-01 has enhanced activity in patients whose tumors express high levels of DKK1: In the group of 22 EEC patients treated with DKN-01 monotherapy for whom
DKK1expression data was available, patients with DKK1-high tumors (n=7) had greater ORR (14% vs. 0%), DCR (57% vs. 7%), and median PFS (3.0 months vs. 1.8 months [HR 0.39; 95% CI: 0.14, 1.1]) compared to patients with DKK1-low tumors (n=15). Additionally, seven patients did not have DKK1expression results available, of whom one had a complete response (14%) and five (72%) had a best response of stable disease, including three patients with Wnt activating mutations.
In the group of 24 EEC patients treated with DKN-01 plus paclitaxel, 72% of whom had received three or more prior systemic therapies,
- Within EEC, DKN-01 activity strongest in endometrioid histology: In the pooled group of 27 patients with endometrioid histology for whom
DKK1expression data was available, patients with DKK1-high tumors (n=14) had greater DCR (57% vs. 15%) and median PFS (4.1 months vs. 1.8 months [HR 0.34; 95% CI: 0.14, 0.81]) than patients with DKK1-low tumors (n=13). Additionally, seven patients with endometrioid histology did not have DKK1expression results available, of whom one (14%) had a complete response and five (72%) had a best response of stable disease, including two patients with Wnt activating mutations.
Conference Call Details
Leap will be hosting a conference call today at
DKN-01 is a humanized monoclonal antibody that binds to and blocks the activity of the Dickkopf-1 (
RNAscope® is a registered trademark of
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. These statements include Leap's 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, milestone, 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
President & Chief Executive Officer
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