Leap Therapeutics to Present Updated Data from Part A of the DisTinGuish Study of DKN-01 Plus Tislelizumab and Chemotherapy in Gastric Cancer Patients at the 2023 ASCO Annual Meeting
- 19.5 months median OS in the overall first-line patient population, exceeding current benchmarks
- Long-term follow-up identifies additional patient with partial response, resulting in
73% ORR in overall mITT population, including86% ORR in PD-L1-low patients
"The long-term follow-up data for DKN-01 in combination with tislelizumab and chemotherapy indicates a novel and well-tolerated treatment with the potential for enhanced response rate, survival, and quality of life for advanced GEA patients," said Samuel Klempner, MD, Associate Professor at Harvard Medical School and principal investigator on the DisTinGuish study. "Median overall survival and progression-free survival for patients treated with DKN-01 plus tislelizumab and chemotherapy exceeded current PD-1 combination benchmarks, especially for those patients with low expression of PD-L1. Together with the previously reported data on the encouraging outcomes with DKN-01 for patients with high
"We are excited about the latest data from Part A of the DisTinGuish study which continues to show DKN-01 plus tislelizumab and chemotherapy as a safe and active treatment where tumor reductions can continue to deepen over time. It is extremely encouraging to see an additional patient achieve a partial response, which is ongoing, after 22 months on therapy," said Cynthia Sirard, MD, Chief Medical Officer of Leap Therapeutics. "A
Key Findings Part A DisTinGuish
- Median overall survival (OS) of 19.5 months and median progression-free survival (PFS) of 11.3 months exceeds benchmark results in the overall first-line patient population (n=25)
- Compelling OS and PFS results in all four important biomarker subgroups
- 18.7 months OS and 10.7 months PFS in PD-L1-low (vCPS < 5) patients (n=16)
- 22.0 months OS and 11.6 months PFS in PD-L1-high (vCPS > 5) patients (n=6)
- 16.9 months OS and 11.3 months PFS in
DKK1 -high patients (n=12) - 24.4 months OS and 12.0 months PFS in
DKK1 -low patients (n=9) - Additional patient with a partial response after 22 months on therapy improves objective response rate (ORR) to
73% in the overall modified intent-to-treat population (n=22), with one (5% ) complete response (CR), 15 (68% ) partial responses (PR), 5 (23% ) best responses of stable disease (SD), and 1 (5% ) non-evaluable (NE) 86% ORR in PD-L1-low patients (n=14: 12 PR, 2 SD)67% ORR in PD-L1-high patients (n-6: 1 CR, 3 PR, 1 SD, 1 NE)90% ORR in DKK1-high patients (n=10: 9 PR, 1 NE)67% ORR in DKK1-low patients (n=9: 1 CR, 5 PR, 3 SD)- Consistent with previous results, combination was well tolerated with manageable toxicity, with most adverse events related to DKN-01 being low-grade (
76% )
Leap Poster Details:
Title: A phase 2 study (DisTinGuish) of DKN-01 in combination with tislelizumab + chemotherapy as first-line (1L) therapy in patients with advanced gastric or GEJ adenocarcinoma (GEA).
Presenter: Samuel J. Klempner, Harvard Medical School
Session Type: Poster Discussion Session
Session Title: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
Date and Time: Monday, June 5, 2023, at 11:30 a.m. CT
Abstract Number: 4027
Poster Number: 335
About the DisTinGuish Study
The DisTinGuish study (NCT04363801) is a Phase 2 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 three parts in
About Leap Therapeutics
Leap Therapeutics (Nasdaq: LPTX) is focused on developing targeted and immuno-oncology therapeutics. Leap's most advanced clinical candidate, DKN-01, is a humanized monoclonal antibody targeting the Dickkopf-1 (
FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements within the meaning of the federal securities laws. Such statements are based upon current plans, estimates and expectations of the management of Leap that are subject to various risks and uncertainties that could cause actual results to differ materially from such statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Words such as "anticipate," "expect," "project," "intend," "believe," "may," "will," "should," "plan," "could," "continue," "target," "contemplate," "estimate," "forecast," "guidance," "predict," "possible," "potential," "pursue," "likely," and words and terms of similar substance used in connection with any discussion of future plans, actions or events identify forward-looking statements.
All statements, other than historical facts, including statements regarding the continuation over time of the clinical collaboration with BeiGene on the ongoing Part C of the DisTinGuish trial, with BeiGene continuing to supply tislelizumab; the expected benefits of the merger with Flame Biosciences; the cash runway into mid-2025 and the sufficiency of Leap's cash, cash equivalents and short-term investments to fund operations; stockholder approval of the conversion rights of the Series X Non-Voting Convertible Preferred Stock; the anticipated timing for initiation of or success of enrollment in clinical trials and release of clinical data, and any outcomes of such trials; the potential, safety, efficacy, and regulatory and clinical progress of Leap's product candidates; our future preclinical and clinical development plans in connection with our programs; the ability to enter into a new strategic partnership for DKN-01 or any of Leap's other programs; the ability of NovaRock Biotherapeutics to conduct the FL-301 clinical trial in
CONTACT:
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