TEST:

Immunoscore®

P=N/A; N=100; Recruiting; Sponsor:Institut Sainte Catherine

This study found that CD8IM TILs might be a marker as good as the more complex IS for predicting CRC prognosis in non-metastatic CRC patients CD8IM should be further explored as a simple predictive biomarker of adjuvant therapy benefits to advance personalized medicine in early-stage CRC.

Preliminary results of the POCHI trial demonstrate a good safety profile and a high efficacy of Pembrolizumab combined to a standard regimen (CAPOX+bevacizumab). To our opinion the impressive ORR and DCR observed justify further evaluation in a randomized phase III trial dedicated to pMMR/MSS mCRC pts with a high immune infiltrate.

In this combined analysis of 2 adjuvant trials dedicated to stage III colon cancer patients, post-surgery ctDNA was found in 19.7% of them and was confirmed as a major independent prognostic marker. Immunoscore® was also confirmed as an independent prognostic marker in the 80.3% of patients that are ctDNA-.

Conclusions These preliminary results of the POCHI trial demonstrate a good safety profile and a high efficacy of Pembrolizumab combined to a standard therapeutic regimen. The impressive CR rate and DCR observed justify further evaluation of the quadruplet treatment combination in a randomized phase III trial dedicated pMMR/MSS mCRC pts with a high immune infiltrate.

This study found no association between immune cell score and survival. These results indicate that immune cell score may not serve as a prognostic tool in ccRCC.

CAF-PD-1+CD8+ T cell interactions were absent from low IS tumors. Thus, CAF-PD-1+CD8+ T cell interactions are important in CRC patients with high IS, and these cellular interactions require further investigation.

We achieved increasingly precise and biologically relevant biomarkers by using data-driven CD3/CD8 density cutoffs and ratios, while controlling for important clinicopathologic and molecular variables in CRC. Independent validation and inclusion of other immune or stromal cell types will bring these findings closer to clinical utility in CRC.

Methods Patients with MSS mCRC who have progressed on 2-3 lines of prior chemotherapy regimen received PolyPEPI1018 (1.2 mg, sc) and atezolizumab (1,200 mg, iv) Q3W. PolyPEPI1018 induced immunological responses at both peripheral and tumor level, converted "cold" tumor into "hot", although to date no responses per RECIST have been noted. The study is on-going.

Total 29 patients had validated results from Immunoscore® and were included in this analysis.There is difference in Immunoscore® results in left- versus right-sided tumors.Total there are 16 patients with left colon cancer with median Immunoscore® -1.94(1,44-2,43).There are 13 patients with right colon cancer with median Immunoscore® -2.23(1,79-2,67).ConclusionThere is association of Immunoscore® and primary tumor sidedness, even in small patients number. We can hypothesize that this could be one of reasons for different prognosis and survival of left and right sided tumors.

This is an open-label, single-arm multicenter stage-2 phase II study investigating the efficacy and safety of 5 fractions of short course radiotherapy, followed by 6 cycles of mFOLFOX-6 plus avelumab, followed by Total Mesorectal Excision (TME), in patients with LARC... Combining both IS and mrTRG achieved a promising predictive value for pCR in LARC and therefore upon further validation may be potentially used for patient selection in non-operative management strategies. Clinical trial information: NCT03503630.

Additionally, this study showed that it is possible to implement an analogous immune cell score approach and validate the Immunoscore® using open source software in an academic setting. Thus, the Immunoscore® could be useful to improve the traditional staging system in colon and rectal cancer used in clinical practice.

mIS could be utilized to predict prognosis more accurately in high-risk patients with NMIBC by identifying those with higher or lower risk of progression. Therefore, mIS could be used to allocate these highrisk patients to more streamlined follow-up or more aggressive treatment strategies.

Conclusions This study confirms the prognostic value of IS in patients with stage III CRC treated with CAPOX or FOLFOX and suggests that IS low cases may gain greater benefit from receiving CAPOX than FOLFOX. Validation of this result is merited.

P2; N=76; Recruiting; Sponsor:Yanhong Deng

P=N/A; N=100; Recruiting; Sponsor:D'Or Institute for Research and Education

These results revealed a significant prognostic role for the spatial distributions of the CD3, and CD8 lymphocytes, as well as the ISCR in relation to pCR following NACT.

"Veracyte...announced today new data from a clinical research study demonstrating the ability of its Immunoscore Immune Checkpoint (IC) assay to predict which patients with metastatic non-small cell lung cancer (NSCLC) may benefit from immune checkpoint inhibitors (ICIs). The findings will be shared in an oral presentation at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago on June 6 at 1:15 p.m. CDT."

"Veracyte, Inc....will be shared at the upcoming 2022 American Society of Clinical Oncology (ASCO) Annual Meeting. The meeting will take place in person and virtually from June 3-7, in Chicago."

No abstracts available

No abstracts available

These data underline that Immunoscore IC is a potent tool to predict the efficacy of ICIs in patients with NSCLC. Immunoscore IC characterized patients who are resistant to ICIs.

No abstracts available

P3; Trial completion date: Jun 2024 --> Jun 2026 | Trial primary completion date: Dec 2023 --> Dec 2025

P=N/A; Not yet recruiting --> Recruiting | Trial completion date: Jul 2027 --> Mar 2028 | Initiation date: Jul 2021 --> Mar 2022 | Trial primary completion date: Jul 2027 --> Mar 2028

Bd demonstrated its independent prognostic value for DFS and OS. Given these findings, Bd per the ITBCC 2016 should be mandatory in every pathology report in stage III CC patients. Bd and Immunoscore® could play a complementary role in personalized healthcare in this setting.

Agreement among pathologists was minimal with a Kappa of 0.34 and 0.57 before and after training, respectively. The standardized IS assay outperformed expert pathologist assessment in the clinical setting.

Markers with the highest clinical relevance were summarized as the consensus immunoscore. This immune evaluation refines the prognosis of the patients and the chemotherapy decision-making process and was introduced as essential and desirable diagnostic criteria into three major international guidelines.

Numerous clinical studies in an adjuvant setting have been conducted and the combination therapy of 5-fluorouracil and oxaliplatin has been established as the standard treatment for Stage III and as an option for high-risk Stage II patients. Biologics such as bevacizumab and antiepidermal growth factor receptor antibodies have failed to show additional survival benefits...The ultimate goal is to accurately predict the risk of recurrence and to prevent recurrence in colon cancer patients. In this review we focus on the clinical development of adjuvant chemotherapy and stratification of patients according to risk of recurrence and the future direction of adjuvant chemotherapy.

Immunoscore improves the prognostic definition of patients with colon cancer, the identification of those patients at high risk of tumor recurrence, and the ability to predict which patients will derive most benefit from the use of adjuvant chemotherapy. Immunoscore has robust analytical performance characteristics which include good interlaboratory reproducibility and overall assay precision.

"Veracyte, Inc...announced that its Immunoscore Colon Cancer test has been included in the Pan-Asian adapted ESMO1 Clinical Practice Guidelines for the diagnosis, treatment and follow-up of patients with localized colon cancer. The new guidelines appear online in Annals of Oncology and will be highlighted at the ESMO Asia Virtual Oncology Week 2021 meeting, being held November 17-23, 2021...The Immunoscore Colon Cancer test was included in the 2020 ESMO Clinical Practice Guidelines for Diagnosis, Treatment, and Follow-up of Colon Cancer. The new Pan-Asian guidelines take into account ethnic differences associated with the treatment of localized colon cancer in Asian patients."

P3 | "These data will be validated on larger number of patients treated with Tedopi® after the step 2 analysis. EudraCT number 2015-003183-36; NCT number: NCT02654587"

P2; N=48; Not yet recruiting; Sponsor:Sun Yat-sen University

Finally, depending on the patient's characteristics and tumor risk stage, the strategy may be surveillance, adjuvant FP alone or oxaliplatin-based adjuvant CT. In the near future, new tools such as Immunoscore® (HalioDx; Luminy Biotech Enterprises, Marseille Cedex, France) and circulating tumor DNA may help to identify more precisely patients with minimal residual disease for more personalized adjuvant treatment approaches.

No abstracts available

No abstracts available

"In addition, both oxaliplatin and bevacizumab have been shown to have immunomodulatory properties that may increase the efficacy of an ICI. Patients must have been resected of their primary tumour so as to evaluate two different immune scores (Immunoscore® and TuLIS) and are eligible if one score is "high". The first patient was included on April 20, 2021."

P=N/A; N=100; Not yet recruiting; Sponsor:Hospital St. Joseph, Marseille, France

P2; Not yet recruiting --> Recruiting | Trial completion date: Dec 2023 --> Sep 2023 | Trial primary completion date: Dec 2022 --> Sep 2023

Based on these results, we are currently setting up an international cohort for confirmation. The potential role of IS with immunotherapies must be anticipated.

In patients with metastatic CRC, analysis of IS was shown to predict tumor metastatic burden which had prognostic value.Data also suggest that potential for IS to provide predictive information for chemotherapy (fluoropyrimidine + oxaliplatin) response in CRC, yet further studies are needed...We aim to develop a MV model, and to validate it in an independent dataset. Important and relevant issues include the fact that only a fraction of mutations result in neoantigens recognized by T-cells, the potential for poor presentation of neoantigens by MHC1, as well as activating or suppressive cytokines.

Immunoscore is also predicting response to neoadjuvant chemotherapy-based treatment in several indications. This paves the way for the use of Immunoscore in clinical practice not only in gastrointestinal tumors but also in bladder cancer, and beyond.