A Pancreatic and Colorectal Cancer Trial Initiated to Address the Needs of Patients With Immune Checkpoint Inhibitor (ICI)-Resistant Disease by Combining Debiopharm's Debio 1143 IAP Antagonist With Keytruda®
LAUSANNE, Switzerland, Oct. 9, 2019 /PRNewswire/ -- Debiopharm (www.debiopharm.com) announced today the first patient enrolment in a Phase I study initiated by Dr. Phillippe Cassier, combining the oral, IAP (Inhibitor of Apoptosis Proteins) antagonist, Debio 1143, with Merck Sharpe & Dohme's (MSD) anti-PD1 Keytruda® (pembrolizumab). The CATRIPCA study focuses on two cancer patient populations with conditions that are intrinsically resistant to Immune Checkpoint Inhibitors (ICI). More specifically, the trial will recruit patients without other available therapeutic options in Non-microsatellite instability (non-MSI)-high colorectal cancer (CRC) and pancreatic ductal adenocarcinoma cancer (PDAC). Up to 46 patients will be included in the dose-escalation and expansion parts, to assess the safety and preliminary efficacy of the combination, with the primary endpoint of the study extension being the Objective Response rate.
Expected to become one of the leading causes of overall cancer mortality by 2025, pancreatic cancer is characterized by early metastasis and resistance to currently available agents including recent immunotherapies.1 In CRC, the fourth highest cause of cancer-related death, the newly developed ICIs have not demonstrated a substantial benefit as single agents.2,3 The CATRIPCA study focuses on these two cancer types to address the high unmet need by potentially enhancing ICI efficacy in these settings. As preclinical models have demonstrated synergy between Debio 1143 and immunotherapy, the compound is expected to offer an immune-sensitizing effect.
"With this combination trial, we're aiming to evaluate if the addition of Debio 1143 can stimulate the host immune system to revert primary resistance to ICIs in advanced non-MSI-high CRC or in PDAC patients."
"This study is the third of a series of Immuno-oncology studies investigating the effect of Debio 1143 in combination with ICIs. The study will evaluate a particularly difficult patient population, primarily in the immune-refractory setting with hopes that the Debio 1143-pembrolizumab combination will open up new possibilities for these patients."
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1. Bilimoria KY et al. Cancer 2007;110:1227-1234.
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