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Lunit SCOPE IO

"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.

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).

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.

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."

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 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.

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 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."

Lunit...is set to make a significant impact at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois. This year, Lunit will present 16 abstracts at the conference, showcasing the groundbreaking capabilities of its AI-biomarker platform, Lunit SCOPE. This comprehensive collection of studies includes 10 poster presentations and 6 online publications, covering a wide spectrum of topics. From predicting clinical outcomes to exploring the complex dynamics of tumor microenvironments, these advancements highlight Lunit's unwavering commitment to advancing AI pathology research and personalized cancer care."

"Lunit...announced the presentation of 16 abstracts featuring its AI-biomarker platform at the American Society of Clinical Oncology (ASCO) Annual Meeting, to be held in Chicago, Illinois, on June 2-6."

Immune Phenotype based on AI-powered spatial TIL analysis may provide complementary information for clinical decision-making between IO-only and Chemo-IO in advanced NSCLC patients with TPS ≥ 50%.

An AI-based ensemble model combining H&E images with semantic contents extracted from pre-developed AI models significantly improved the accuracy and robustness of MET pathogenic mutation prediction using an H&E sample in NSCLC. These findings allow for cost-effective screening for MET alterations.

Change of TIL density in TME during CRT was significantly correlated with favorable clinical outcome of preoperative CRT and consolidation nivolumab, resulting in high pCR rate in MSS LARC.

Neoadjuvant durvalumab +/- tremelimumab promotes dynamic change toward inflamed immune phenotype, resulting in favorable clinical outcomes. Resistance mechanism of stand-still-non-inflamed patients even on D+/-T should be further investigated. Clinical trial information: NCT03737968.

TGFBs is closely correlated with fibroblast density within the TME and may confer resistance to immunotherapy. Unique morphologic features of the TGFBs can be captured by AI, enabling scalable application to various datasets for clinical and translational research.

IIP, IFNG signature, and CSF1R expression are more strongly correlated with intratumoral macrophage density versus stromal macrophage density, suggesting a relationship between macrophage location and function in the TME warranting further investigation.

While most cases of resectable PDAC were found to have TIL infiltration mainly in stroma, relatively higher iTIL infiltration was associated with better prognosis. An increase in iTIL after chemo(radio)therapies may be associated with better outcomes.

"One of the studies to be presented evaluates a deep learning-based ensemble model to predict the KRAS G12C mutation...According to the research, the prediction model showed improved accuracy compared to previously reported KRAS mutation prediction studies. The Lunit SCOPE based KRAS G12C mutation prediction model showed a high predictive power with an AUC (Area Under the Curve) of 0.787, indicating the accuracy of the AI algorithm. It also showed AUC of 0.745 in validation with independent external data....Other studies to be presented further demonstrate the effectiveness of Lunit SCOPE IO as a diagnostic aid in the treatment of various cancer types."