HalioDx SAS, the immuno-oncology diagnostic company, today announced that it has entered into a Collaboration Agreement with the FFCD, the French Cooperative Group dedicated exclusively to digestive oncology, on the Phase II multicenter POCHI trial (FFCD1703 - NCT04262687) in which immune response at the tumor site will be used to inform patient eligibility to participate in the POCHI trial. The objective of the trial is to evaluate the efficacy of pembrolizumab in combination with XELOX (capecitabine plus oxaliplatin) and bevacizumab as first line treatment of microsatellite stable (MSS) / proficient mismatch repair system (pMMR) metastatic colorectal cancer (mCRC) with high immune infiltrate.
Immune Checkpoint Inhibitors (ICIs) have demonstrated high efficacy in mCRC with microsatellite instability (MSI) / deficient mismatch repair system (dMMR) but remain ineffective alone in MSS/ pMMR tumors. MSS/pMMR tumors presenting a high immune infiltrate as assessed by Immunoscore® could be sensitive to ICI therapy. The POCHI trial will prospectively enroll about 400 patients with the goal of testing the combination on 55 patients with an MSS/pMMR mCRC with high immune response (≈15%).
David Tougeron, MD, PhD at Poitiers University Hospital, Principal Investigator of the POCHI trial comments: “The POCHI study is crucial to determine whether tumor immune response assessment can help identifying MSS/pMMR mCRC patients eligible for ICI in combination with chemotherapy plus anti-angiogenic. We believe that this study will lead to a phase III trial to evaluate ICI combination in patients with an MSS/pMMR mCRC with a high immune score.”
Vincent FERT, CEO of HalioDx comments: “Immunoscore® offers a unique opportunity to extend the number of patients with mCRC potentially candidates to immunotherapy, and we are delighted to take part in this effort. Aside the now well demonstrated performances and clinical utility of Immunoscore® in localized colon cancer and notably its predictive performance for the duration of adjuvant chemotherapy, we believe that Immunoscore®, holds a significant potential for predicting immunotherapy response by gauging the immune response to tumor”, he added.