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Lunit SCOPE IO

"Lunit said...that it would present one of the latest studies using its AI biomarker platform, Lunit Scope, at the Society for Immunotherapy of Cancer 2024 (SITC 2024) in Houston, Texas, from Nov. 6 to 10...Lunit will present a study on AI-enabled immuno-oncology treatment response prediction in patients with various cancer types, including rare cancers."

All participants provided informed consent before taking part in the study. View this table:View inline View popup Download powerpoint Abstract 1207 Table 1 Patients' demographicsDownload figure Open in new tab Download powerpoint Abstract 1207 Figure 1 iTIL by histology and association with PFSDownload figure Open in new tab Download powerpoint Abstract 1207 Figure 2 Association of PFS and OS with post-treatment changes in iTIL and TCDownload figure Open in new tab Download powerpoint Abstract 1207 Figure 3 Association of PFS and OS with combination of both post-treatment increase in iTIL and decrease in TC

AI-powered spatial analysis suggests that combination therapy with Pexa-vec and cemiplimab enhances the immune response, evidenced by increased TIL densities in the tumor microenvironment.Table 1: Changes in TIL Densities from Pre- to Post-TreatmentMeasureCohortPre-Treatment (mm²)(Median, IQR)Post-Treatment (mm²)(Median, IQR)p-value isTILOverall (n = 18)87.53 (179.37-114.65)214.02 (257.50-389.74)0.0040 Arm A (n = 9)41.30 (257.13-81.61)190.17 (830.30-389.34)0.0078 Arm B (n = 9)165.43 (180.52-147.69)390.17 (340.11-387.14)0.1641iTILOverall (n = 18)88.89 (129.08-116.99)161.11 (376.62-321.79)0.0237 Arm A (n = 9)56.42 (125.56-101.70)157.44 (421.03-469.55)0.0273 Arm B (n = 9)96.27 (57.33-132.29)154.92 (194.87-184.03)0.3716sTILOverall (n = 18)100.91 (291.38-193.61)219.37 (370.85-466.27)0.0599 Arm A (n = 9)35.59 (257.13-67.38)140.55 (286.46-157.15)0.0391 Arm B (n = 9)303.37 (171.24-319.84)353.58 (189.15-735.39)0.4961

P=NA | N=339 | "Lunit...announced that Lunit SCOPE IO has demonstrated significant potential in predicting immunotherapy response for patients with advanced biliary tract cancer (BTC), via AI-powered analysis of immune phenotype and tumor-infiltrating lymphocytes (TILs). The groundbreaking study, conducted in collaboration with researchers from Asan Medical Center and Severance Hospital in Seoul, Korea, was recently published in Clinical Cancer Research (CCR), an AACR journal...Key findings include...The inflamed group demonstrated both longer overall survival (12.6 vs. 5.1 months) and progression-free survival (4.5 vs. 1.9 months), as well as higher overall response rates (27.5% vs. 7.7%)....Lunit SCOPE IO provided objective and efficient assessment of the tumor microenvironment, overcoming limitations of manual evaluation demonstrating high feasibility for AI-powered analysis of immune phenotype and TIL."

Within the same immune microenvironment group, significant differences in immune metrics and T cell composition were observed according to molecular subtype. AI-based immune microenvironment groups served as prognostic markers in ECs, with the immune-active group associated with favorable outcomes.

The IIP was significantly predictive for a PFS benefit of Niv+Chemo over Chemo, more prominently in pts with a non-SRC histology.

Conclusion Relative to cases with both human and AI assessments categorized in the low-risk group (reference), cases with both categorized in the high-risk group had a significantly higher risk of recurrence, with an HR of 6.64 (95% CI 2.55–17.3). AI-MR analysis at the WSI level may serve as a valuable and unexpected complement to traditional HPF-based MR evaluations by pathologists in liposarcoma cases.

From the computational analysis, 69. 17% cases of hypothetical combinations support that Chemo-IO would be superior to IO-only in non-IIP group, whereas Chemo-IO would not be superior to IO-only in IIP group, implying a potential value of confirmatory biomarker analysis in providing evidence for regimen selection.

The AI model based on chest CT data was a strong independent biomarker to predict treatment response to ICI, which possibly reflects patients' clinical characteristics. Combining AI CT model and histopathologic biomarkers showed additive impact on the prediction of the treatment response to ICI.

AI-powered immune phenotype assessment highlights a heterogeneity of immune phenotypes across specific melanoma subtypes, as well as differential association with outcomes after immune checkpoint inhibitor treatment. While CM patients were well-stratified by immune phenotype, the predictive value of immune phenotyping was less pronounced in acral melanomas, which demonstrated poorer outcomes following immunotherapy.

"Lunit...today announced the presentation of seven studies at the American Association for Cancer Research (AACR) 2024 Annual Meeting...In a poster presentation, Lunit's AI-powered HER2 analyzer, Lunit SCOPE HER2's precision shines through its analysis of 194,259 pan-cancer samples, correlating different ERBB2 mutations with changes in HER2 protein expression. This AI-powered assessment successfully identified key mutation-expression correlations, particularly focusing on exon 20 insertions (ex20ins) and S310x mutations across a variety of cancers, including NSCLC, urothelial, and breast cancers...Through detailed HER2 intensity examination, the AI analysis highlighted that, among ERBB2-mutated cases with HER2 IHC images, a higher proportion of HER2 3+ tumor cells was observed in S310x and ex20ins cases compared to others....The analysis of 795 pan-cancer tissue samples revealed an important inverse correlation between CNTN4 expression and PD-L1 levels."

P2 | N=48 | NCT03737968 | "Lunit... announced the publication of a new study featuring Lunit SCOPE IO, Lunit's AI-powered analyzer for quantitative immune phenotyping from H&E...This investigation addresses the current lack of exploration into the clinical implications of neoadjuvant immunotherapy in HNSCC patients with resectable tumors, utilizing Lunit SCOPE IO to examine the changes in tumor microenvironment when treated with durvalumab and tremelimumab...In this phase II randomized clinical trial, 48 HNSCC patients were enrolled, with 24 receiving preoperative durvalumab and 24 receiving a combination of durvalumab plus tremelimumab before surgical resection....The study findings revealed that patients treated with the combination of durvalumab and tremelimumab exhibited significantly better 4-year distant recurrence-free survival (DRFS) compared to those receiving durvalumab monotherapy (91.1% vs. 53.3%)..."

Background: Programmed cell death ligand 1 (PD-L1) expression alone has limited predictive value for pembrolizumab plus 5-fluorouracil and platinum (PFP) therapy in recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). An AI-driven spatial TIL analyzer might serve as a simple and independent prognostic biomarker in HNSCC patients receiving pembrolizumab plus chemotherapy.

AI-powered multi-modal approach of using H&E image and CT image shows complimentary, and synergistic effect to predict ICI clinical outcomes in advanced NSCLC, even in the subgroup of PD-L1 high population.

In this study, we found a favorable prognosis in the group with higher TSR or higher density of CAF in CS compared to CA. This result suggests that AI-enhanced analysis of TSR and CAF can effectively predict prognosis in CRC, highlighting the potential roles of these markers in cancer prognosis.

The AI-based IIP may represent a practical, affordable, clinically actionable, and tumor-agnostic biomarker prognostic of ICI therapy response across diverse tumor types.

This study identified spatial TIL distribution relative to the TSB in CRC, and suggested that outermost sTIL and iTIL within 30 μm from the TSB, may be more important prognostic factors than overall sTIL and iTIL.

"Lunit...today announced a groundbreaking study published in the Journal for ImmunoTherapy of Cancer (JITC). The study demonstrates the ability of Lunit SCOPE IO, to enable quantitative immune phenotyping from H&E stained slides as a broadly accessible biomarker for immunotherapy...The study, conducted on a real-world multicenter cohort of 1,806 Immune Checkpoint Inhibitor (ICI)-treated patients across 27 tumor types, showcases a correlation between the Inflamed Immune Phenotype and positive ICI treatment responses....More favorable ORRs (26.3% vs 15.8%), prolonged PFS (5.3 vs. 3.1 months) and OS (25.3 vs. 13.6 months) were observed in IIP patients, irrespective of ICI regimen or programmed death-ligand 1 (PD-L1) expression."

Analysis of images of H&E-stained slides was conducted by an AI model, Lunit SCOPE IO in pre-treatment tumor samples of 163 HCC patients treated with atezolizumab plus bevacizumab as first-line (n=82), or monotherapies of nivolumab or pembrolizumab as ≥ second-line (n=81) at CHA Bundang Medical Center or Samsung Medical Center. AI-powered TME analysis shows IIP is predictive of longer PFS with ICI monotherapies, whereas intratumoral endothelial cell density is specifically associated with PFS of atezolizumab plus bevacizumab in advanced HCC. The latter finding may suggest efficacy of combined VEGFRi and ICI activity is dependent on the amount of baseline tumor vasculature.

"Lunit...published a new study in npj Precision Oncology (Nature Partner Journal), using Lunit SCOPE IO to predict prognosis in stage II–III colon cancer via AI-powered spatial analysis of tumor-infiltrating lymphocytes (TIL). This study showed that Lunit SCOPE IO and the power of AI for spatial TIL analysis can provide clinicians with a practical and efficient tool to enhance prognosis prediction."

Risk groups defined as high-risk (both iTIL and sTIL in the lowest quartile groups), low-risk (sTIL higher than the median), or intermediate-risk (not high- or low-risk) were predictive of recurrence and were independently associated with clinical outcomes after adjusting for other clinical factors. AI-powered TIL analysis can provide prognostic information in stage II/III colon cancer in a practical manner.

"Lunit...announced the presentation of six studies at the upcoming SITC (Society for Immunotherapy of Cancer) 2023 Annual Meeting, taking place from November 1 to 5, in San Diego, California...A collaborative study with the Samsung Medical Center assessed tumor-infiltrating lymphocytes (TILs) using AI-powered spatial analysis with Lunit SCOPE IO in EGFR-mutated non-small cell lung cancer (NSCLC) patients pre- and post-tyrosine kinase inhibitors (TKI) treatment."

"Lunit...today announced a research collaboration with The University of Texas MD Anderson Cancer Center to analyze the use of Merck's (known as MSD outside the US and Canada) Keytruda (pembrolizumab), a type of immunotherapy drug used in cancer treatment, in multiple cancer types. The project will use Lunit's proprietary AI solution for tissue data analysis, Lunit SCOPE IO....Lunit will collaborate with Aung Naing, M.D., professor of Investigational Cancer Therapeutics at MD Anderson, as the lead Principal Investigator (PI) for this study. The goal of the study is to evaluate AI technology with the objective of improving patient data analysis and increasing the effective use of treatment for patients with different types of cancer."

P3 | N=228 | ATTLAS (NCT03991403) | "A groundbreaking study, conducted by Samsung Medical Center and utilizing Lunit SCOPE IO, showcases the efficacy of atezolizumab plus bevacizumab and chemotherapy for NSCLC patients with EGFR or ALK mutations....By assessing patients' immune phenotype and predicting response to immunotherapy, Lunit SCOPE IO enabled the identification of individuals more likely to benefit from ABCP arm treatment. In the group with an Inflamed Score below 20%, there was no significant difference in PFS between ABCP arm and PC arm (8.28 months vs. 6.93 months). However, a substantial difference in PFS was observed in the group with an Inflamed Score of 20% or higher (12.91 months vs. 4.86 months), surpassing the overall study group. Immune phenotype as assessed by Lunit SCOPE IO showed predictive power in stratifying patients more likely to respond to ABCP treatment."

"Lunit...today announced the presentation of 9 studies at the upcoming European Society for Medical Oncology (ESMO) 2023 Congress, to be held in Madrid, Spain, from October 20-24....A collaborative study indicated that AI-based immune phenotyping can predict therapy outcomes in advanced biliary tract cancer (BTC) patients who are planning to be treated with anti-PD-1 therapy....In another study, it was found that TIL density in tumor microenvironment is highly correlated with favorable treatment response to immune checkpoint inhibitor (ICI) in head and neck squamous cell carcinoma (HNSCC)....In another study, HER2 (human epidermal growth factor receptor-2) scoring in biliary tract cancer was evaluated using Lunit SCOPE HER2. The analysis showed a substantial concordance of 75.3% between AI and human pathologists' assessments."

Cancer and stromal area TIL infiltration were generally low in R/M ACC. Higher stromal TIL infiltration was associated with a longer PFS with axitinib treatment.

"Lunit...announced the presentation of 9 studies featuring its AI pathology research at the upcoming European Society for Medical Oncology (ESMO) 2023 Congress, scheduled to be held in Madrid, Spain, from October 20 to 24, 2023...This year's collection of abstracts delves into multifaceted research, including the use of AI-powered analysis to predict treatment outcomes in different cancer types, assess HER2 expression in breast and biliary tract cancer, and streamline clinical workflows for treatment decisions in lung cancer, all utilizing the Lunit SCOPE suite."

Methods A total of 73 NPC pts treated with Nivolumab+Gemcitabine (Niv+Gem; KCSG HN17-11), Niv+Ipilimumab (Niv+Ipi, NCT03097939), Niv alone (Niv, NCT02339558), or Avelumab+Axitinib (Ave+Axi, NCT04562441) who have matched H&E slides before treatment were included in this exploratory post-hoc analysis. Drs. Bhumsuk Keam and Darren Wan-Teck Lim equally contributed to the study.

Cibersort analysis2 showed that gamma delta T cells (-52%), activated memory CD4 T cells (-50%), activated NK cells (-29%), CD8 T cells (-21%) demonstrated the most significant reductions in TFI-high. Conclusions Tumor with high fragmentation, or TFI-high is closely correlated with high fibroblast infiltration, low IFNG signature-related NK and T cells infiltration, but has minimal impact on overall densities of lymphocytes and macrophages, as well as PD-1/PD-L1 and CTLA4/CD28 axes.

Moreover, high PD-L1 expression of each respective cell type of tumor, lymphocyte, and macrophage was observed in the IIP. Consistent with previous knowledge of the IP, our PD-L1 results support use of immune-oncology approaches in this phenotype.

001). Conclusions The degree of methylation aberrancy in cancer is inversely correlated with TIL infiltration in the tumor microenvironment assessed by AI-based H& E analysis.

Conclusions Our findings reveal an enriched TIL distribution in the IM subtype compared to the others, while enrichment of total TIL was also associated with genomic alterations including BRCA mutations. The differential distribution of TIL highlights its potential as a valuable biomarker guiding optimal immuno-oncology treatment strategies.

Y-biologics Inc would like to thank all the participating patients, dedicated clinical trial investigators and their team members who have helped to bring this novel therapy to the clinic. This research was supported by Korea Drug Development Fund funded by Ministry of Science and ICT, Ministry of Trade, Industry, and Energy, and Ministry of Health and Welfare (HN21C1391, Republic of Korea).

4%) patients were administered cisplatin after TKI and prior to sample acquisition...Conclusions Our findings suggest that EGFR-TKI affects immune landscape of EGFR-mutated NSCLC as higher PD-L1 expression and differential IPs. Inflamed IP after EGFR-TKI was significantly associated with favorable response to ICI as subsequent treatment.

"Lunit...announced the presentation of 6 abstracts featuring its Lunit SCOPE suite at the upcoming SITC 2023 (Society for Immunotherapy of Cancer 2023) Annual Meeting, scheduled to take place from November 1 to November 5, in San Diego, California. This year's posters span a spectrum of research, from predicting treatment outcomes in non-small cell lung cancer (NSCLC) to examining immune responses in breast cancer subtypes, utilizing the Lunit SCOPE suite."

P=NA | N=85 | "A total of 85 patients with non-small cell lung cancer (NSCLC) who received immune checkpoint inhibitors (ICI) were analyzed for the study. According to the study, the utilization of Lunit SCOPE IO for TLS evaluation yielded clinically significant correlations with patients' overall survival (OS). 25 patients with detected TLS had notably prolonged overall survival compared to 60 patients without TLS. This correlation remained consistent irrespective of PD-L1 expression, a known biomarker for treatment response in NSCLC patients."

Conclusions Among morphological tumor features quantified by AI, tumor immature desmoplastic stroma and TILs, particularly epithelial TIL densities, were best able to distinguish MMR-D from MMR-P tumors. These findings have implications for prognosis and subtype-based interventions and can guide spatial molecular interrogation.

Background Adding atezolizumab (atezo) to FOLFOXIRI/bev prolongs PFS of mCRC patients (pts) in AtezoTRIBE trial...Conclusions IPs and IS by Lunit SCOPE IO provide a characterization of tumor microenvironment, being associated with Immunoscore, Immunoscore IC and TILs. Further development of AI-powered TILs analyses taking into account their densities may help identifying biomarkers of immunogenicity in mCRC.

Overall survival was not significantly different by TIL densities. Conclusions AI-powered assessment of TIL density in tumor microenvironment, especially intratumoral TIL density, is associated with favorable treatment outcomes to ICI in R/M HNSCC.

Background Recently, anti-PD-1/L1 plus gemcitabine and cisplatin (GemCis) has demonstrated significant survival benefits in randomized phase 3 trials for advanced BTC. Conclusions Immune phenotype classified by AI-powered spatial TIL analysis was effective to predict the efficacy outcomes of advanced BTC pts treated with anti-PD-1 therapy. Further evaluation is required in the setting of anti-PD-1/L1 plus GemCis.

All patients (n=154) were treated with anti-PD-1 (pembrolizumab or nivolumab) monotherapy, and 72 of 154 patients (46.8%) were treated as 2nd line. Gemcitabine plus cisplatin (GemCis) was used prior to anti-PD-1 as first-line therapy in all patients... Immune phenotype classified by AI-powered spatial TIL analysis was effective to predict the clinical outcomes of patients with advanced BTC treated with anti-PD-1 therapy.

"Lunit...announced collaboration with the National Cancer Center Hospital East (NCCHE) to evaluate and validate its AI pathology solution for tissue data analysis...This partnership aims to leverage the capabilities of Lunit SCOPE, an AI-biomarker platform, in analyzing Immunohistochemistry and H&E tissue slide data from various clinical trials, including NCCHE's molecular profiling projects such as SCRUM-Japan MONSTAR-SCREEN."