Leap Therapeutics Presents Updated Positive Data from the DisTinGuish Study of DKN-01 Plus Tislelizumab at the ESMO Congress
The Company announced positive initial data from the DisTinGuish study on
"Initial data from this trial have shown that patients with high levels of
About the DisTinGuish Study
The DisTinGuish study (NCT04363801) is a Phase 2a study of DKN-01 in combination with tislelizumab, an anti-PD-1 antibody, with or without chemotherapy as first-line or second-line therapy in patients with inoperable, locally advanced, G/GEJ adenocarcinoma. The study is being conducted in two parts in
- Among patients who received a full cycle of DKN-01 therapy, the ORR was 68.2%, with 90% ORR in
DKK1-high patients and 56% in DKK1-low patients
- Response was independent of PD-L1 expression, and particularly strong in the less favorable to checkpoint inhibitor therapy, PD-L1 low (vCPS < 5), population
- Among those patients with PD-L1-low expression (vCPS < 5), the ORR was 79%, with 100% in
DKK1-high patients and 57% in DKK1-low patients
- Among those patients with PD-L1-high expression (vCPS ≥ 5), the ORR was 67%, with 75% ORR in
DKK1-high patients and 50% in DKK1-low patients DKK1levels could not be determined in one patient who had PD-L1 expression data; however, the patient's PD-L1 expression level was determined to be low (vCPS score 0) and the patient achieved a partial response DKK1expression and PD-L1 expression are not correlated
- Median duration of response and progression-free survival data are not yet mature, and patient follow-up continues
Twenty-five first-line patients were enrolled, and as of the cut-off date of the presentation, 15 patients had experienced a partial response (PR), six patients had a best response of stable disease (SD), one patient was non-evaluable for response (NE), and three patients were unable to complete a full cycle of DKN-01 therapy (non-modified ITT (mITT)).
Among the 21 patients that had RNAscope®
Among the 20 patients that had PD-L1 expression available, 14 were PD-L1 low vCPS < 5 [11 PR, 3 SD] and 6 were PD-L1 high vCPS > 5 [4 PR, 1 SD, 1 NE].
A copy of the poster presentation is available on the Company's website at https://www.leaptx.com/our-pipeline.
Leap will host a conference call on
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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