^
    2d
    Contribution of tumour and immune cells to PD-L1 expression as a predictive biomarker in metastatic triple-negative breast cancer: exploratory analysis from KEYNOTE-119. (PubMed)
    Data from this exploratory analysis suggest that, although PD-L1 expression on immune cells alone is predictive of response to programmed death 1 blockade in mTNBC, adding tumour PD-L1 expression assessment (i.e. CPS, which combines immune cell and tumour cell PD-L1 expression) may improve prediction. PD-L1 CPS thus remains an effective and broadly applicable uniform scoring system for enriching response to programmed death 1 blockade with pembrolizumab in mTNBC as well as other tumour types.
    Journal • PD(L)-1 Biomarker • IO biomarker • Metastases • Immune cell
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Keytruda (pembrolizumab)
    2d
    Tropion-Lung08: Study of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in the First-line Treatment of Subjects With Advanced or Metastatic NSCLC Without Actionable Genomic Alterations (clinicaltrials.gov)
    P3, N=740, Recruiting, Daiichi Sankyo | Trial completion date: Jun 2026 --> Apr 2028 | Trial primary completion date: Jun 2026 --> Feb 2028
    Trial completion date • Trial primary completion date • Metastases
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • RET (Ret Proto-Oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • TACSTD2 (Tumor Associated Calcium Signal Transducer 2)
    |
    PD-L1 expression
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Keytruda (pembrolizumab) • datopotamab deruxtecan (DS-1062a)
    3d
    Saci-IO TNBC: Sacituzumab Govitecan +/- Pembrolizumab in Metastatic TNBC (clinicaltrials.gov)
    P2, N=110, Recruiting, Dana-Farber Cancer Institute | Trial completion date: Apr 2027 --> Apr 2029 | Trial primary completion date: Apr 2024 --> Apr 2026
    Trial completion date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    PD-L1 expression • HER-2 negative • PD-L1 negative • PGR expression
    |
    PD-L1 IHC 22C3 pharmDx • VENTANA PD-L1 (SP142) Assay
    |
    Keytruda (pembrolizumab) • Trodelvy (sacituzumab govitecan-hziy)
    5d
    NCI-2018-01550: Pembrolizumab in Treating Participants With Recurrent Ovarian Cancer (clinicaltrials.gov)
    P2, N=5, Active, not recruiting, Jonsson Comprehensive Cancer Center | Recruiting --> Active, not recruiting | N=30 --> 5 | Trial primary completion date: Mar 2024 --> Dec 2023
    Enrollment closed • Enrollment change • Trial primary completion date
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Keytruda (pembrolizumab)
    5d
    TRIFOUR: Nadunolimab in Combination With Gemcitabine Plus Carboplatin in Patients With Advanced Triple Negative Breast Cancer. (clinicaltrials.gov)
    P1/2, N=116, Recruiting, Cantargia AB | Phase classification: P1b/2 --> P1/2
    Phase classification • Combination therapy • BRCA Companion diagnostic • PARP Companion diagnostic • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • BRCA (Breast cancer early onset)
    |
    BRCA2 mutation • BRCA1 mutation • HER-2 negative
    |
    PD-L1 IHC 22C3 pharmDx • Prosigna™ Breast Cancer Prognostic Gene Signature Assay
    |
    carboplatin • gemcitabine • nadunolimab (CAN04)
    6d
    PD-L1 Expression in High-Risk Non-Muscle-Invasive Bladder Cancer Is Influenced by Intravesical Bacillus Calmette-Guérin (BCG) Therapy. (PubMed)
    Our findings demonstrate a potential modulation of the PD-L1 status by an intravesical BCG therapy. However, its prognostic value appears limited.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 IHC 22C3 pharmDx
    7d
    Considerable interlaboratory variation in PD-L1 positivity for head and neck squamous cell carcinoma in the Netherlands- A nationwide evaluation study. (PubMed)
    In the first 3 years of PD-L1 assessment in HNSCC, the testing landscape became more uniform. However, interlaboratory variation in PD-L1 positivity rates between Dutch laboratories was substantial. This implies that there is a need for further test standardisation to reduce this variation.
    Journal
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Keytruda (pembrolizumab)
    8d
    GALLANT-1: A Study to Investigate the Safety and Efficacy of GB1211 (a Galectin-3 Inhibitor) in Combination With Atezolizumab in Patients With Non-Small Cell Lung Cancer (NSCLC). (clinicaltrials.gov)
    P1/2, N=88, Active, not recruiting, Galecto Biotech AB | Recruiting --> Active, not recruiting | Trial completion date: Apr 2024 --> Nov 2025 | Trial primary completion date: Jul 2023 --> May 2024
    Enrollment closed • Trial completion date • Trial primary completion date • Combination therapy
    |
    PD-L1 (Programmed death ligand 1) • LGALS3 (Galectin 3)
    |
    PD-L1 expression
    |
    PD-L1 IHC 22C3 pharmDx • VENTANA PD-L1 (SP263) Assay
    |
    Tecentriq (atezolizumab) • GB1211
    9d
    Frequency of Programmed Death Receptor Ligand 1 Expression and Clinicopathological Factors Associated With Metastatic Triple-Negative Breast Cancer at a Tertiary Cancer Care Centre in South India. (PubMed, Cureus)
    Survival is associated with menopausal status and family history. No association was found between survival and PDL1 as well sidedness in our study.
    Journal • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression • PD-L1 negative
    |
    PD-L1 IHC 22C3 pharmDx
    9d
    NEPTUNE: Study of Neoadjuvant Enfortumab Vedotin and Pembrolizumab in Cisplatin-eligible Upper Tract Urothelial Cancer (clinicaltrials.gov)
    P2, N=32, Not yet recruiting, University of Michigan Rogel Cancer Center
    New P2 trial • Tumor mutational burden
    |
    TMB (Tumor Mutational Burden)
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Keytruda (pembrolizumab) • cisplatin • Padcev (enfortumab vedotin-ejfv)
    10d
    Clinical significance of inter-assay discrepancy in PD-L1 evaluation for the efficacy of pembrolizumab in advanced NSCLC with high PD-L1 expression. (PubMed, Lung Cancer)
    The inter-assay discrepancy in the PD-L1 status of tumor cells between the 22C3 and SP142 assays, reflecting an imbalance in the CD274 splice variants, could be a biomarker for primary resistance against pembrolizumab monotherapy in high PD-L1-expressing NSCLCs.
    Journal • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression • PD-L1 overexpression
    |
    PD-L1 IHC 22C3 pharmDx • VENTANA PD-L1 (SP142) Assay
    |
    Keytruda (pembrolizumab)
    10d
    Digital Pathology Applications for PD-L1 Scoring in Head and Neck Squamous Cell Carcinoma: A Challenging Series. (PubMed, J Clin Med)
    Digital pathology may help in PD-L1 scoring, serving as a second opinion consultation platform in challenging cases. Computational and artificial intelligence tools will improve clinical decision-making and patient outcomes.
    Journal • IO Companion diagnostic • PD(L)-1 companion diagnostic
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 IHC 22C3 pharmDx • VENTANA PD-L1 (SP263) Assay
    11d
    Deep learning-based assay for programmed death ligand 1 immunohistochemistry scoring in non-small cell lung carcinoma: Does it help pathologists score? (PubMed, Mod Pathol)
    For discordant cases, the OR for each AI-assisted TPS compared with the others was 0.99-1.01 and not statistically significant. This study emphasized the usefulness of the AI-assisted system for cases wherein pathologists had difficulty determining the PD-L1 TPS.
    Journal
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 IHC 22C3 pharmDx
    11d
    Safety and Efficacy of Zimberelimab (AB122) in Combination With Domvanalimab (AB154) and Etrumadenant (AB928) in Patients With Previously Treated Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=30, Active, not recruiting, Washington University School of Medicine | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Yutuo (zimberelimab) • domvanalimab (AB154) • etrumadenant (AB928)
    16d
    Frequency and Nature of Genomic Alterations in ERBB2-Altered Urothelial Bladder Cancer. (PubMed, Target Oncol)
    We noted important differences in co-occurring GA in ERBB2-altered (ECDmut+, KDmut+, amp+) versus ERBB2wt UBC, as well as higher mean TMB and higher APOBEC mutational signature in the ERBB2-altered groups. Our results can help refine future clinical trial designs and elucidate possible response and resistance mechanisms for ERBB2-altered UBC.
    Journal • Tumor mutational burden • PD(L)-1 Biomarker • MSi-H Biomarker • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • TP53 (Tumor protein P53) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3) • MTAP (Methylthioadenosine Phosphorylase) • TOP2A (DNA topoisomerase 2-alpha) • APOB (Apolipoprotein B)
    |
    PD-L1 expression • MSI-H/dMMR • HER-2 overexpression • HER-2 amplification • HER-2 mutation • HER-2 amplification + PD-L1 expression
    |
    PD-L1 IHC 22C3 pharmDx
    16d
    Scoring PD-L1 Expression in Urothelial Carcinoma: An International Multi-Institutional Study on Comparison of Manual and Artificial Intelligence Measurement Model (AIM-PD-L1) Pathology Assessments. (PubMed, Virchows Arch)
    An improved understanding of sources of manual scoring variability can be applied to PD-L1 expression analysis in the clinical setting. In the future, the application of AI algorithms could serve as a valuable reference guide for pathologists while scoring PD-L1.
    Journal • Clinical • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    PD-L1 IHC 22C3 pharmDx • PD-L1 IHC 28-8 pharmDx
    17d
    Efficacy and Safety of Concurrent PD-1 Inhibitor and Radiotherapy With Immunonutrition for Esophageal Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=57, Active, not recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
    New P2 trial
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Tyvyt (sintilimab)
    18d
    Comprehensive Immunogenomic Profiling of IDH1-/2-Altered Cholangiocarcinoma. (PubMed, JCO Precis Oncol)
    Significant differences in GA and immune biomarkers are noted between IDH1/2+ and IDHwt iCCA. IDH1-/2-mutated tumors appear immunologically cold without gLOH. These immunogenomic data provide insight for precision targeting of iCCA with IDH alterations.
    Journal • Retrospective data • Tumor mutational burden • PD(L)-1 Biomarker • MSi-H Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • HRD (Homologous Recombination Deficiency) • PD-1 (Programmed cell death 1) • VTCN1 (V-Set Domain Containing T Cell Activation Inhibitor 1) • CD70 (CD70 Molecule)
    |
    PD-L1 expression • MSI-H/dMMR • IDH1 mutation • HRD • VTCN1 underexpression • IDH1 R132C • IDH wild-type • IDH1 R132 • VTCN1 expression • IDH1 R132L • IDH2 R140 • IDH2 R172
    |
    PD-L1 IHC 22C3 pharmDx
    20d
    PD-L1 expression in head and neck squamous cell carcinoma and its clinical significance: A prospective observational study from a tertiary care centre. (PubMed)
    "72% of HNSCC patients in our cohort showed PD-L1 positivity and it was not associated with any patient demographic characteristics or aggressive pathological features. Positive PD-L1 expression may have a beneficial effect on overall survival in HNSCC."
    Journal • Observational data
    |
    PD-L1 IHC 22C3 pharmDx • VENTANA PD-L1 (SP263) Assay
    29d
    Assessing the relationship between tumor-infiltrating lymphocytes and PD-L1 expression in triple negative breast cancer: Identifying optimal TILs cut-off value for pathologic reporting. (PubMed, Ann Diagn Pathol)
    This study identifies TILs cut-offs predictive of PD-L1 positivity, suggesting the need for institutions to tailor these thresholds based on the selected PD-L1 clone and treatment. Evaluating TILs solely at the tumor edge may overlook the complexity of tumor immune infiltration. While TLS presence correlates with higher PD-L1 expression, particularly with the SP142 clone, its exact predictive value for PD-L1 remains to be clarified. The SP142 clone exhibits higher positivity rates compared to 22C3.
    Journal • Tumor-infiltrating lymphocyte • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression • HER-2 expression
    |
    PD-L1 IHC 22C3 pharmDx • VENTANA PD-L1 (SP142) Assay
    29d
    Personalized Vaccine Immunotherapy in Combination With Checkpoint Inhibitor for Treatment of Triple Negative Breast Cancer (clinicaltrials.gov)
    P1, N=18, Not yet recruiting, Emory University
    New P1 trial • Combination therapy • Checkpoint inhibition • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • BRCA (Breast cancer early onset)
    |
    PD-L1 expression • BRCA2 mutation • BRCA1 mutation • BRCA mutation
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Keytruda (pembrolizumab) • Yervoy (ipilimumab)
    1m
    Evaluation of alternative prognostic thresholds for SP142 and 22C3 immunohistochemical PD-L1 expression in triple-negative breast cancer: results from a population-based cohort (ESMO-BC 2024)
    No abstract available
    Clinical • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    PD-L1 IHC 22C3 pharmDx • VENTANA PD-L1 (SP142) Assay
    1m
    PD-L1 mRNA derived from tumor-educated platelets as a potential immunotherapy biomarker in non-small cell lung cancer. (PubMed, Transl Lung Cancer Res)
    The patients were enrolled in clinical trials for immune checkpoint inhibitors (ICIs), including nivolumab, pembrolizumab, atezolizumab, durvalumab, tremelimumab, and camrelizumab. For the patients who were treated with immunotherapy alone (n=64), a similar PFS advantage was observed in the high PD-L1 group (2.8 vs. 8.0 months, P=0.002). This article presented the first data on TEP-derived PD-L1 mRNA in advanced NSCLC patients following immunotherapy and showed the potential advantage of using it as the surrogate biomarker for predicting the PFS and overall survival of patients following immunotherapy.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
    |
    PD-L1 expression • EGFR wild-type • PD-L1-L
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Tecentriq (atezolizumab) • Imfinzi (durvalumab) • AiRuiKa (camrelizumab) • Imjudo (tremelimumab)
    1m
    Comparison of PD-L1 (22C3) Expression in Paired Primary and Metastatic Breast Carcinoma. (PubMed, Clin Breast Cancer)
    Our study showed a decrease in PD-L1 expression and disconnected molecular features during breast cancer progression. Repeating PD-L1 IHC testing could be considered in some specific metastatic sites if primary tumors were negative. Further studies are needed to identify other predictive factors for immune checkpoint inhibitor (ICI) therapy in patients with breast carcinoma.
    Journal • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    PD-L1 IHC 22C3 pharmDx
    1m
    KEYNOTE-E59: A Study of ASP1570 Taken by Itself or With Pembrolizumab in Adults With Solid Tumors (clinicaltrials.gov)
    P1/2, N=330, Recruiting, Astellas Pharma Global Development, Inc. | Trial completion date: Apr 2027 --> Dec 2027 | Trial primary completion date: Apr 2027 --> Dec 2027
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    EGFR (Epidermal growth factor receptor) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    PD-L1 expression • EGFR mutation • ALK positive • ALK mutation • NTRK fusion
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Keytruda (pembrolizumab) • ASP1570
    1m
    NCI-2018-00192: Pembrolizumab and Sunitinib Malate in Treating Participants With Refractory Metastatic or Unresectable Thymic Cancer (clinicaltrials.gov)
    P2, N=30, Suspended, Dwight Owen | Recruiting --> Suspended
    Trial suspension • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Keytruda (pembrolizumab) • Sutent (sunitinib)
    1m
    Responder-derived FMT (R-FMT) and Pembrolizumab in Relapsed/Refractory PD-L1 Positive NSCLC (clinicaltrials.gov)
    P2, N=26, Not yet recruiting, Diwakar Davar | Trial completion date: Nov 2028 --> Jun 2029 | Trial primary completion date: Nov 2028 --> Jun 2029
    Trial completion date • Trial primary completion date
    |
    ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab)
    1m
    An artificial intelligence-powered PD-L1 combined positive score (CPS) analyser in urothelial carcinoma alleviating interobserver and intersite variability. (PubMed)
    This study suggests that AI models can help pathologists to reduce discrepancies between pathologists in quantifying immunohistochemistry including PD-L1 22C3 CPS, especially when evaluating data from different institutions, such as in a telepathology setting.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 IHC 22C3 pharmDx
    1m
    Programmed death-ligand (PD-L1) expression and lymph node involvement in Penile Squamous Cell Carcinoma (AUA 2024)
    PDL-1 immunoexpression in PSC appears to be associated with high-risk features and worse clinical outcomes. It is noteworthy the clinical significance of lymph node involvement in PD-L1+ cases and the considerable difference in the overall survival between the two groups. This is in line with the current literature, although we didn’t find any studies with this string correlation with lymph node involvement.
    PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 IHC 22C3 pharmDx
    1m
    Clinical implications of PD-L1 expression and pathway-related molecular subtypes in advanced Asian colorectal cancer patients. (PubMed)
    Major subtypes showing a significantly higher proportion of TMB-H or MSI-H were irrespective of PD-L1 status. These findings demonstrate pathological pathways associated with high PD-L1 expression, suggesting that pathway-induced oncogenic constructive PD-L1 upregulation may be the reason for the corresponding patients' primary resistance to immune checkpoint inhibitors (ICIs), rather than a lack of pre-existing immune responses.
    Journal • PD(L)-1 Biomarker • MSi-H Biomarker • IO biomarker • Metastases
    |
    PD-L1 IHC 22C3 pharmDx
    1m
    Comparing Three Different Anti-Programmed Death-Ligand 1 Antibodies in Immunohistochemical Evaluation of Combined Chemoimmunotherapy Response in Patients With NSCLC: A Prospective Study. (PubMed, JTO Clin Res Rep)
    "Therefore, the 22C3 assay may be useful for clinical decision-making for patients with NSCLC treated with combined chemoimmunotherapy. Trial registration number: UMIN 000043958."
    Journal
    |
    PD-L1 expression
    |
    PD-L1 IHC 22C3 pharmDx • VENTANA PD-L1 (SP142) Assay • PD-L1 IHC 28-8 pharmDx
    1m
    Comprehensive molecular and immune profiling of triple negative invasive lobular carcinoma (AACR 2024)
    These data suggest that TN-ILC had higher frequency of CDH1, ERBB2, AKT1, ARID1A mutations, higher M2 macrophages and neutrophils and lower M1 macrophages and CD8 T cells infiltration and, lower T cell inflamed signature. High TMB and AR expression can translate into use of immunotherapy (ICI) and AR antagonists in these patients. Additonal analysis to determine the optimal biomarker for ICI response in TN-ILC is needed.
    Tumor mutational burden • PD(L)-1 Biomarker • MSi-H Biomarker • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • TP53 (Tumor protein P53) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • BCL2 (B-cell CLL/lymphoma 2) • ARID1A (AT-rich interaction domain 1A) • CD8 (cluster of differentiation 8) • AKT1 (V-akt murine thymoma viral oncogene homolog 1) • MCL1 (Myeloid cell leukemia 1) • LAG3 (Lymphocyte Activating 3) • KMT2C (Lysine Methyltransferase 2C) • CDH1 (Cadherin 1) • BCL2A1 (BCL2 Related Protein A1) • FOXP3 (Forkhead Box P3) • PMAIP1 (Phorbol-12-Myristate-13-Acetate-Induced Protein 1) • BCL2L10 (BCL2 like 10) • BAK1 (BCL2 Antagonist/Killer 1)
    |
    PD-L1 expression • ER positive • TMB-H • MSI-H/dMMR • HER-2 mutation • ARID1A mutation • BCL2 expression • AKT1 mutation • AR expression
    |
    PD-L1 IHC 22C3 pharmDx • VENTANA PD-L1 (SP142) Assay
    1m
    Genomic profiling of KRAS and EGFR-altered non-squamous non-small cell lung cancer reveal ancestry-specific co-alterations with therapeutic implications (AACR 2024)
    Our study provides a comprehensive landscape of ancestry-specific patterns in KRAS and EGFR-altered non-Sq NSCLC. These findings can help better understand cancer disparities, aid in the development of new therapeutic strategies and inform more inclusive clinical trials and treatment decisions.
    Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • TMB (Tumor Mutational Burden) • STK11 (Serine/threonine kinase 11) • ARID1A (AT-rich interaction domain 1A) • NF1 (Neurofibromin 1) • KEAP1 (Kelch Like ECH Associated Protein 1) • GNAS (GNAS Complex Locus)
    |
    PD-L1 expression • TMB-H • KRAS amplification
    |
    FoundationOne® CDx • PD-L1 IHC 22C3 pharmDx
    1m
    Phase 3 MK-2870-007 study: MK-2870 (SKB264) plus pembrolizumab vs pembrolizumab alone as first-line treatment for metastatic non-small-cell lung cancer with PD-L1 tumor proportion score (TPS) ≥50% (AACR 2024)
    AEs will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0. Enrollment began in December 2023 and is currently ongoing.
    Clinical • PD(L)-1 Biomarker • IO biomarker • Tumor proportion score • Metastases
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • TACSTD2 (Tumor Associated Calcium Signal Transducer 2)
    |
    TROP2 expression • TROP2 overexpression
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Keytruda (pembrolizumab) • sacituzumab tirumotecan (MK-2870)
    1m
    Artificial intelligence (AI)-powered quantification of glypican-3 (GPC3) expression facilitates patient selection for GPC3-targeted therapy in solid tumors (AACR 2024)
    FFPE slides were stained for GPC3+ (GC33, Ventana), PD-L1+ (22C3, Dako) cells and then scanned at 20x using the Aperio Versa8 scanner... Here we profiled GPC3 expression across tumor types and showed high level of expression in HCC followed by SQ-NSCLC. We have established an AI-powered digital pathology platform that can provide a standardized, scalable, and reproducible method of characterizing GPC3 positivity to support further patient selection in clinical study.
    Clinical • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • GPC3 (Glypican 3)
    |
    PD-L1 expression • GPC3 expression
    |
    PD-L1 IHC 22C3 pharmDx
    |
    codrituzumab (RG7686)
    1m
    Accurate PD-L1 IHC assessment in urothelial carcinoma by an AI algorithm robust across multiple sites, antibody clones, and scanners (AACR 2024)
    For the threshold of TPS≥1% (cut-off established for adjuvant therapy with Nivolumab), agreement rates of AI scores with human GT scores were 92.5% for cohort 1 (22C3) and 96.4% for cohort 2 (SP263)... Across 136 UC samples stained with two PD-L1 antibody clones, and derived from a total of four institutions and three scanner models, the fully automatic AI system showed excellent agreement with human pathologist scores. These results on challenging validation data show the potential of AI applications to standardize and optimize PD-L1 scoring and demonstrate consistency and safety of suitable AI-based systems for application in clinical routine.
    PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    PD-L1 IHC 22C3 pharmDx • VENTANA PD-L1 (SP263) Assay
    |
    Opdivo (nivolumab)
    1m
    Comparison the results from PD-L1 IHC and PD-L1 multiplex immunofluorescence for the prediction of anti-PD-1 immunotherapeutic response (AACR 2024)
    Current results indicate that pTPS exhibited correlation to mIF PD-L1 positive rate instead of mIF PD-L1 TPS. CD3/PD-1 copositive rate but not pTPS nor mIF PD-L1 positive rate, shows its potential to predict anti PD-1 IMT response through the pathology controlled mIF detection system and AI based analysis system.
    PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • CD68 (CD68 Molecule)
    |
    PD-L1 expression
    |
    PD-L1 IHC 22C3 pharmDx
    1m
    PD-L1 antigen stability using PD-L1 IHC pharmDx on human cancer tissues (AACR 2024)
    Diagnostic evaluation and selection of potential pembrolizumab-responsive patients is achieved by determining the programmed cell death ligand-1 (PD-L1) expression using the companion diagnostic PD-L1 IHC 22C3 pharmDx assay, for several indications...These data provide high confidence in determining PD-L1 expression on properly stored aged cut sections. Commercial claims may be shorter based on region, as specified in the local instructions for use.
    PD(L)-1 Biomarker • IO biomarker • PD(L)-1 companion diagnostic • IO Companion diagnostic
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Keytruda (pembrolizumab)
    1m
    Multi-omic analysis of serial biopsies to inform biomarkers of sensitivity to olaparib and durvalumab in patients with metastatic BRCA-wildtype triple negative breast cancer (mTNBC) (AACR 2024)
    Findings highlight the value of paired Bxs to identify predictive biomarkers of PARPi + immune checkpoint inhibitor sensitivity. The striking predictive value of the BLIA/BLIS signature warrants evaluation in a larger trial. Emerging resistance mechanisms justify AMTEC trial expansion to include PARPi + MEKi or PARPi + AKTi in biomarker selected patients, which is now in progress.
    Clinical • Tumor mutational burden • PD(L)-1 Biomarker • PARP Biomarker • BRCA Biomarker • IO biomarker • Metastases • Biopsy • Omic analysis
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    TMB (Tumor Mutational Burden) • AR (Androgen receptor) • BRCA (Breast cancer early onset) • RAD51 (RAD51 Homolog A)
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    BRCA wild-type • RAD51 mutation
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    PD-L1 IHC 22C3 pharmDx
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    Lynparza (olaparib) • Imfinzi (durvalumab)
    1m
    Clinical significance of inter-assay discrepancy in PD-L1 expression evaluation for the efficacy of pembrolizumab in advanced NSCLC patients with high PD-L1 expression (AACR 2024)
    The inter-assay discrepancy in the PD-L1 expression status on tumor cells between the 22C3 and SP142 assays, reflecting an imbalance of the CD274 splicing variants, could be a primary-resistance mechanism to the pembrolizumab monotherapy in highly PD-L1-expressing NSCLCs.
    Clinical • PD(L)-1 Biomarker • IO biomarker • Metastases
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    PD-L1 (Programmed death ligand 1)
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    PD-L1 expression • PD-L1 overexpression
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    PD-L1 IHC 22C3 pharmDx • VENTANA PD-L1 (SP142) Assay
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    Keytruda (pembrolizumab)
    1m
    Characterization of PDLIM2 in non-small cell lung cancer (AACR 2024)
    PDLIM2-AH was associated with improved overall survival (OS) (median 21.7 vs L: 15.6 months; p < 0.001; Hazard ratio [HR] = 0.825, 95% Confidence Interval [CI] 0.765 - 0.889) and time on pembrolizumab treatment (median 6.2 vs L: 5.6 months; p = 0.009; HR = 0.825 95% CI 0.714 - 0.953). NSCLC-A with high PDLIM2 expression have a unique mutational profile, increased immune cell infiltration and favorable OS. Therapeutic strategies for targeting PDLIM2 to modulate NF-κB and STAT3 signaling should be further explored.
    Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker
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    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • TP53 (Tumor protein P53) • TMB (Tumor Mutational Burden) • STK11 (Serine/threonine kinase 11) • RB1 (RB Transcriptional Corepressor 1) • KEAP1 (Kelch Like ECH Associated Protein 1) • SMARCA4 (SWI/SNF related, matrix associated, actin dependent regulator of chromatin, subfamily A, member 4) • PDLIM4 (PDZ and LIM domain 4)
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    PD-L1 expression • EGFR mutation • TMB-H
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    PD-L1 IHC 22C3 pharmDx
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    Keytruda (pembrolizumab)
    1m
    Prevalence of fibroblast growth factor receptor (FGFR) alterations (alts) and programmed death-ligand 1 (PD-L1) expression (exp) in Chinese solid tumor patients (pts) (AACR 2024)
    BALVERSA (erdafitinib), a selective pan-FGFR kinase inhibitor, has shown clinical activity against FGFR altered solid tumors in pts who exhausted standard treatment options... The large Chinese solid tumor cohort analysis showed comparable FGFR alts prevalence between Chinese and Western population. Differences in relationship between FGFR alts and PD-L1 expression across tumor types reflect the differential role of predominant FGFR types in each tumor type.
    Clinical • PD(L)-1 Biomarker • IO biomarker
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    PD-L1 (Programmed death ligand 1) • FGFR3 (Fibroblast growth factor receptor 3) • FGFR1 (Fibroblast growth factor receptor 1) • FGFR (Fibroblast Growth Factor Receptor)
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    PD-L1 expression • PD-L1 overexpression • FGFR1 amplification • FGFR1 expression
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    PD-L1 IHC 22C3 pharmDx • MSK-IMPACT
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    Balversa (erdafitinib)