79O - Clinical performance of Immunoscore® in early colon cancer in the Asian population

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).

Methods

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.

Conclusions

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.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

INSERM.

Funding

French National Institute of Health and Medical Research, the LabEx Immuno-oncology, the Transcan ERAnet Immunoscore European project, Association pour la Recherche contre le Cancer, CARPEM, AP-HP, Institut National du Cancer, Italian Association for Cancer Research, national grants and the Society for Immunotherapy of Cancer.

Disclosure

J. Galon: Shareholder/Stockholder/Stock options: HalioDx; Advisory/Consultancy: Amgen; BMS; CatalYm GmbH; Gilead; GSK; Licensing/Royalties: INSERM; Research grant/Funding (institution): AstraZeneca; Research grant/Funding (institution): Imcheck Therapeutics; Research grant/Funding (institution): IObiotech; Research grant/Funding (institution): Janssen; Research grant/Funding (institution): MedImmune; Research grant/Funding (institution): Perkin-Elmer; Advisory/Consultancy: Northwest Biotherapeutics; Advisory/Consultancy: Roche; Advisory/Consultancy: Sanofi. Y. Kawakami: Honoraria (self): AstraZeneca; Bristol-Myers Squibb; Chugai Pharma; MSD; Ono Pharmaceutical; Sumitomo Dainippon Pharma; Taiho Pharmaceutical; Research grant/Funding (institution): Bristol-Myers Squibb; Research grant/Funding (institution): Ono Pharmaceutical. B. Mlecnik: Licensing/Royalties: INSERM. F. Marliot: Travel/Accommodation/Expenses: HalioDx. C.B. Bifulco: Shareholder/Stockholder/Stock options: PrimeVax; Advisory/Consultancy: Bristol-Myers Squibb; Advisory/Consultancy: PrimeVax; Licensing/Royalties: Providence Health & Services. A. Lugli: Honoraria (self): 3DHISTECH; Sakura; Sysmex; Advisory/Consultancy: Amgen. A. Hartmann: Honoraria (self): AbbVie; Honoraria (self): AstraZeneca; Honoraria (self): BMS; Honoraria (self): Boehringer Ingelheim; Honoraria (self): Ipsen; Honoraria (self): Janssen-Cilag; Honoraria (self): MSD; Honoraria (self): Roche; Advisory/Consultancy: 3DHISTECH; Advisory/Consultancy: AstraZeneca, Bristol-Myers Squibb, Cepheid, Diaceutics, Illumina, Ipsen, Janssen-Cilag, MSD, NanoString Technologies, Qiagen, Roche; Research grant/Funding (institution): AstraZeneca; BioNTech AG; Cepheid; Janssen-Cilag; NanoString Technologies; Roche; Advisory/Consultancy: NanoString Technologies. M. van den Eynde: Honoraria (self): HalioDx. M.H.A. Roehrl: Honoraria (self): Gerson Lehrman Group; Advisory/Consultancy: Proscia; Advisory/Consultancy: Trans-Hit; Advisory/Consultancy: UDX. F. Marincola: Leadership role, Full/Part-time employment, Investigator in AbbVie sponsored cl. trials: AbbVie. P.A. Ascierto: Shareholder/Stockholder/Stock options: PrimeVax; Advisory/Consultancy: 4SC; Alkermes; Amgen; Array BioPharma; AstraZeneca; Bristol-Myers Squibb; Genmab; Idera; Immunocore; Incyte; Italfarmaco; MedImmune; Merck Serono; Merck Sharp & Dohme; Nektar; Newlink Genetics; Novartis; Pierre Fabre; Roche/Genentech; Sandoz; Sanofi; Sun; Research grant/Funding (institution): Array BioPharma; Research grant/Funding (institution): Bristol-Myers Squibb; Research grant/Funding (institution): Roche/Genentech; Travel/Accommodation/Expenses: Merck Sharp & Dohme. B.A. Fox: Leadership role, Shareholder/Stockholder/Stock options, Full/Part-time employment: UbiVac; Shareholder/Stockholder/Stock options: PrimeVax; Honoraria (self): Janssen Biotech; Honoraria (self): Nodality; Advisory/Consultancy: AstraZeneca; Bayer; Bristol-Myers Squibb; Celldex; Definiens; Incyte; Macrogenics; MedImmune; OncoSec; Turnstone Bio; Ultivue; Research grant/Funding (institution): Akoya Biosciences; Bristol-Myers Squibb; DEfiniens; Janssen Biotech; Macrogenics (Inst); MedImmune (Inst); Merck; NanoString Technologies; OncoSec; Perkin Elmer; Shimadzu; Viralytics; Licensing/Royalties, patent licensed to UbiVac: Providence Health System; Travel/Accommodation/Expenses: Bristol-Myers Squibb; Definiens; NanoString Technologies. F. Pagès: Advisory/Consultancy, Research grant/Funding (institution): Bristol-Myers Squibb; Advisory/Consultancy: Gilead Sciences; Advisory/Consultancy: Janssen; Advisory/Consultancy: Merck; Advisory/Consultancy: Roche; Research grant/Funding (institution), Travel/Accommodation/Expenses: HalioDx; Licensing/Royalties: INSERM. All other authors have declared no conflicts of interest.