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."
Dr. Philippe Cassier, Principal Investigator

"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."
Dr. Angela Zubel, Chief Development Officer, at Debiopharm

About Debio 1143
Debio 1143 is an IAP antagonist with a dual mode of action, promoting programmed cell death and fostering anti-tumor immunity. Currently in clinical development in a broad range of cancer types, the compound is being tested in combination with chemo-radiotherapy or with ICIs (PD-1/PD-L1), with reported data consistently showing a favorable and manageable safety profile. Over 200 patients have been treated so far with Debio 1143, in indications such as non-small cell lung cancer (NSCLC) and Head & Neck cancer (SCCHN).

About CATRIPCA
Initiated by Dr. Philippe Cassier at the Léon Bérard Center in France, this Phase I study was designed to test the hypothesis that combining IAP inhibition and PD1 blockade therapy could induce responses in non-MSI-high advanced/metastatic PDAC or CRC, conditions that are intrinsically resistant to ICIs alone.

Debiopharm's commitment to cancer patients
Debiopharm aims to develop innovative therapies that target high unmet medical needs in oncology. Bridging the gap between disruptive discovery products and real-world patient reach, we identify high-potential compounds for in-licensing, clinically demonstrate their safety and efficacy and then select large pharmaceutical commercialization partners to maximize patient access across the globe.

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1. Bilimoria KY et al. Cancer 2007;110:1227-1234.
2. Benson AB III et al. J Natl Compr Canc Netw 2013;11:141-152.
3. Brahmer JR et al. N Engl J Med 2012;366:2455-2465.

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