COMMUNIQUÉ DE PRESSE

New evidence from 2 pivotal studies reinforces clinical value of Immunoscore® In Colon Cancer

  • Two large Immunoscore® studies from Phase III trials published in JNCI Cancer Spectrum & Annals of Oncology
  • Consistent prognostic performance established on 1600+ colon cancer patients strengthen Immunoscore® Level of Evidence
  • Immunoscore® unique predictive performance demonstrated for FOLFOX adjuvant chemotherapy duration

 

Marseille, France, May 26, 2020 HalioDx SAS, the immuno-oncology diagnostic company, today announced the publication of  two major Immunoscore clinical studies in Stage III colon cancer patients validating the clinical value of Immunoscore® to refine patients stratification and predict which patients benefit most from 6 months adjuvant chemotherapy.

Published in JNCI Cancer Spectrum [1], the Immunoscore-N0147 study was conducted in collaboration with clinicians and researchers from the Mayo Clinic. The Immunoscore-IDEA France study, published in Annals of Oncology [2] was conducted in collaboration with PRODIGE, a digestive oncology intergroup gathering the GERCOR, the FFCD and UNICANCER organizations. Objectives of these retrospective studies in prospectively conducted trials were to examine and validate the ability of Immunoscore® to identify patients at high-risk of relapse and investigate survival differences according to Immunoscore® in predefined subgroups, including Tumor/Node Stage and treatment duration.

The two studies were performed on independent large Phase III randomized clinical trials cohorts, and included 559 patient samples from the FOLFOX alone arm of the NCCTG N0147 trial [3], and 1062 patient samples from both arms (3 versus 6 months) of the IDEA France trial [4] (as part of the IDEA international collaboration [5]). Consistent prognostic performance were obtained, and Immunoscore® predictive performance was demonstrated for FOLFOX therapy duration.

These results strengthen Immunoscore® Level of Evidence and position Immunoscore® as an essential diagnostic tool to enable a personalized management of stage III colon cancer patients.

 

Frank A. Sinicrope, MD, Mayo clinic, Rochester, Minnesota, principal investigator of the study utilizing NCCTG N0147 tumors comments : “Those two large-scale studies confirm that use of Immunoscore® in combination with established prognostic factors allows one to more accurately assess prognosis, highlighting the clinical utility of Immunoscore®.”

Pr Franck Pagès, MD, HEGP, AP-HP, Paris: “The Immunoscore-IDEA study shows that a good quality of the immune system, particularly at the tumor site, is essential to achieve a maximum benefit from chemotherapy.”

Vincent FERT, CEO of HalioDx comments: “The results of these two studies confirm Immunoscore® as an essential diagnostic tool for GI oncologists managing localized colon cancer. HalioDx is now actively working to facilitate market access for enabling oncologists and institutions to use Immunoscore® in their routine practice.”