Oral Presentation Eradicate Cancer 2020

Clinical performance of Immunoscore® in early colon cancer in the Asian population. (69586)

Marjane Le Bagousse 1 , Bertrand Farnault 1 , Yutaka Kawakami 2 , Toshihiko Torigoe 3 , Yili Wang 4 , Prabhu S Patel 5 , Hemangini Vora 5 , Fabienne Hermitte 1 , Bernhard Mlecnik 6 , Florence Marliot 7 8 , Carlo Bifulco 9 , Alessandro Lugli 10 , Iris D Nagtegaal 11 , Arndt Hartmann 12 , Marc Van den Eynde 13 , Michael H A Roehrl 14 15 16 , Pamela S Ohashi 17 , Eva Zavadova 18 , Francesco M Marincola 19 , Paolo A Ascierto 20 , Bernard A Fox 21 22 , Franck Pagès 7 8 , Jerome Galon 7
  1. HalioDx, Marseille, France
  2. Division of Cellular Signaling, Institute for Advanced Medical Research, Keio University School of Medicine , Tokyo, Japan
  3. Department of Pathology, Sapporo Medical University School of Medicine, Sapporo, Japan
  4. Institute of Cancer Research, Center of Translational Medicine, Health Science Center of Xi’an Jiaotong University, Xian, China
  5. The Gujarat Cancer & Research Institute, Asarwa, Ahmedabad, India
  6. Inovarion, Paris, France
  7. INSERM, Laboratory of Integrative Cancer Immunology, Paris, F-75006, France
  8. Immunomonitoring Platform, Laboratory of Immunology, AP-HP, Assistance Publique-Hopitaux de Paris, Georges Pompidou European Hospital, Paris, France
  9. Department of Pathology, Providence Portland Medical Center, Portland, OR, USA
  10. Institute of Pathology, University of Bern, Bern, Switzerland
  11. Pathology Department, Radboud University, Nijmegen, The Netherlands
  12. Department of Pathology, University Erlangen-Nürnberg, Erlangen, Germany
  13. Institut Roi Albert II, Department of Medical Oncology Cliniques Universitaires St-Luc and Institut de Recherche Clinique et Experimentale (Pole MIRO), Université Catholique de Louvain , Brussels, Belgium
  14. Department of Pathology and Laboratory Medicine, University Health Network, Toronto, Canada
  15. Department of Laboratory Medicine and Pathobiology, University of Toronto , Toronto, Canada
  16. Department of Pathology, Memorial Sloan Kettering Cancer Center, New York, USA
  17. University Health Network, Toronto, Canada
  18. Department of Oncology, First Faculty of Medicine, Charles University and General University Hospital in Prague, Prague, Czech Republic
  19. Refuge Biotechnologies, Menlo Park, CA, USA
  20. Melanoma, Cancer Immunotherapy and Innovative Therapies Unit, Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale", Napoli, Italy
  21. Department of Molecular Microbiology and Immunology, Oregon Health and Science University, Portland, OR, USA
  22. Laboratory of Molecular and Tumor Immunology, Earle A. Chiles Research Institute, Robert W. Franz Cancer Center, Providence Portland Medical Center, Portland, OR, USA

Background

Immunoscore® is an in vitro diagnostic test predicting the risk of relapse in early‐stage Colon Cancer (CC), by measuring the host immune response at the tumor site. This risk‐assessment tool provides independent and superior prognostic value than the usual risk parameters and is intended to be used as an adjunct to the TNM classification for clinical decision. In the present study, we investigated Immunoscore® clinical performance in the Asian population from the international SITC-led validation study (Pagès et al. The Lancet 2018).

Method

Out of  the 2681 eligible stage I-III patients of the international Immunoscore® study, 423 were collected from 4 expert centers in Asia including Japan (n=330), China (n=35), and India (n=58). Patients were classified by Immunoscore® based on pre-defined cutoffs, either in 5 (IS 0-4) or 2 categories: IS Low (IS 0-1) and IS High (IS 2-4). Time to recurrence (TTR) was compared between Immunoscore® categories.

Results

Immunoscore® Low and High were observed in 37% (n=158) and 63% (n=265) of the Asian cohort, respectively. Immunoscore® was positively and significantly correlated with TTR. After 5 years, 86.9% (95% CI 82.7-91.4), and 77% (95% CI 70,5-84,1) of Immunoscore -High and -Low patients respectively were event free (HR =0.52; 95% CI 0.32-0.86; p=0.0085). When adjusting the model with Immunoscore®, age, gender, T-stage, N-stage, sidedness and MSI, and when stratified by center, Immunoscore® remained a significant parameter (HR=0.45; 95% CI 0.22-0.91; p=0.027).  When stratified into 5 Immunoscore® categories, TTR rates at 5 years were 100%, 96%, 84%, 80%, and 73.5% for IS4, IS3, IS2, IS1, IS0, respectively. These results were similar to those found in European and North-American patients.

Conclusion

Immunoscore® is a strong prognostic indicator of the risk of recurrence in stage I-III CC patients who receive standard of care treatment in real-life clinical practice in Asia. This first standardized immune-based assay risk assessment tool can be used reliably to guide clinical decision according to each patient information.