- The stock price of Leap Therapeutics Inc (NASDAQ: LPTX) increased over 20% pre-market. This is why it happened.
The stock price of Leap Therapeutics Inc (NASDAQ: LPTX) – a biotechnology company focused on developing targeted and immuno-oncology therapeutics – increased over 20% pre-market. Investors are responding positively to the company announcing the company will be presenting initial data from the first-line cohort of the DisTinGuish study, a Phase 2a clinical trial evaluating Leap’s anti-Dickkopf-1 (DKK1) antibody, DKN-01, in combination with tislelizumab, BeiGene Ltd.’s anti-PD-1 antibody, and chemotherapy, in patients with gastric or gastroesophageal junction cancer (G/GEJ), at the European Society for Medical Oncology (ESMO) Congress, being held virtually on September 16-21, 2021.
Leap Therapeutics will host a conference call on Friday, September 17, 2021 to discuss preliminary results from the study.
— DKN-01 in combination with tislelizumab and chemotherapy demonstrated compelling overall response rates (ORR) as a first-line treatment for advanced G/GEJ cancer
— In the primary efficacy analysis, including all patients who received a full cycle of DKN-01 therapy, the ORR was 68.2%, with 90% ORR in DKK1-high patients as compared to a 56% ORR in DKK1-low patients
— In the overall intent to treat population, including those patients who did not receive a full cycle of therapy, the ORR was 60%, with 75% ORR in DKK1-high patients as compared to a 56% ORR in DKK1-low patients
As of the date of the abstract, 13 patients had experienced a partial response (PR), 6 patients had a best response of stable disease (SD), 1 patient was non-evaluable for response (NE), 3 patients were unable to complete a full cycle of therapy (non-modified ITT (mITT)), and 2 patients were pending their first tumor assessment. Of the 18 patients that had RNAscope DKK1 expression available for the abstract, 9 were DKK1-high [6 PR, 1 NE, and 2 non-mITT] and 9 were DKK1-low [5 PR, 4 SD]. Subsequent to the date of the abstract, the 2 patients who were pending their first scan for response to therapy were determined to have had PRs, and three additional patients were determined to have had DKK1-high tumors, each of whom experienced a PR.
“Initial data from the DisTinGuish study is extremely promising as it shows DKN-01 in combination with tislelizumab and chemotherapy to have high response rates in first-line patients suffering from gastric and gastroesophageal junction cancer. Patients whose tumors have high levels of DKK1 expression, which is known to correlate with aggressive disease and poor prognosis, showed the highest response rates, suggesting how important the biomarker may be in predicting response to therapy. Additional data will be presented at ESMO and in our conference call to demonstrate the potential DKN-01 has as part of first-line therapy in this difficult-to-treat indication.”
— Cynthia Sirard, MD, Chief Medical Officer of Leap
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