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HalioDx, FFCD Collaborate for Phase II Metastatic Colorectal Cancer Trial

NEW YORK – Immuno-oncology diagnostic firm HalioDx said Thursday that it is collaborating with the Francophone Federation of Digestive Oncology (FFCD) to select patients for a Phase II trial testing immunotherapy with chemotherapy and bevacizumab in metastatic colorectal cancer.

HalioDx will use its Immunoscore in vitro diagnostic test to measure the host immune response at the tumor site by assessing lymphocytic infiltration to select patients for the multicenter POCHI trial.

The goal of the trial is to evaluate the efficacy of pembrolizumab (Merck's Keytruda) in combination with XELOX, which is capecitabine (Genentech's Xeloda) and oxaliplatin (Sanofi's Eloxatin), and bevacizumab (Genentech's Avastin) as a first line treatment for microsatellite stable metastatic colorectal cancer with proficient mismatch repair that shows high immune infiltrate. The trial aims to enroll about 400 patients and test the combination on 55 patients with high immune response, HalioDx said in a statement.  

Immunoscore is currently being used in clinical studies and cancer indications to establish "its performance as a prognostic factor as well as a predictive factor for response to drugs, notably chemotherapies and immunotherapies," HalioDx said.

Immunoscore Colon is the firm's first test in its Immunoscore portfolio that has data demonstrating clinical utility for TNM scoring in managing localized colon cancer. Its other immune-based tests are being used in clinical trials "to support translational research and clinical development," the company said.