^
    3d
    Efficacy of Anti-CTLA-4 Antibody Combined With Sintilimab and Chemotherapy as Neoadjuvant Therapy for Resectable Stage II-III Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=54, Recruiting, Shanghai Pulmonary Hospital, Shanghai, China
    New P2 trial
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    PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
    |
    PD-L1 expression • ALK rearrangement
    |
    PD-L1 IHC 22C3 pharmDx
    |
    carboplatin • Tyvyt (sintilimab) • albumin-bound paclitaxel
    6d
    Agilent Receives FDA Approval for PD-L1 IHC 22C3 pharmDx in Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma (EOC) (Agilent Technologies Press Release)
    "Agilent Technologies Inc...today announced that the U.S. Food and Drug Administration (FDA) has approved PD-L1 IHC 22C3 pharmDx, as the only FDA-approved companion diagnostic indicated to aid in identifying patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma (EOC), whose tumors express PD-L1 and who may be eligible for treatment with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy."
    Approval
    |
    PD-L1 IHC 22C3 pharmDx
    6d
    Differentiation grade and combined positive score correlation in head and neck squamous cell carcinoma. (PubMed, World J Surg Oncol)
    However, in hypopharyngeal cancer, the CPS < 20 group exhibited a hazard ratio (HR) for death of 4.55 (95% CI: 1.019-20.31), suggesting a potential clinically relevant difference.This study highlights significant heterogeneity in the immune microenvironment across different subsites of head and neck squamous cell carcinoma. The relationship between CPS and tumor differentiation is site-specific, indicating that the value of CPS as a biomarker for immunotherapy response should be interpreted in the context of tumor location.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    PD-L1 IHC 22C3 pharmDx
    7d
    Choice of fixative affects programmed death-ligand 1 expression in cell blocks from pleural effusions with metastatic pulmonary adenocarcinoma. (PubMed, Cancer Cytopathol)
    PD-L1 ICC expression in CBs depends on the fixative and antibody used. Alcohol-based fixatives, particularly with low cutoffs, risk underestimating PD-L1 positivity, and may contribute to false-negative results. ICC protocol optimization is essential before diagnostic use.
    Journal • Pleural effusion • 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
    7d
    Utility of various programmed death-ligand 1 (PD-L1) assays in predicting the clinical benefit of immune checkpoint inhibitors in PD-L1-expressing non-small-cell lung cancer patients: a systematic review. (PubMed, Transl Lung Cancer Res)
    From 2,239 titles, four relevant trials (N=1,364) were included: two randomized controlled trials of atezolizumab, and two retrospective studies of nivolumab. This review was limited by different patient populations, small numbers, possible inter-pathological discordance, and study heterogeneity. Evidence for nivolumab, pembrolizumab, or durvalumab remains inconclusive.
    Review • Journal • Checkpoint inhibition • IO Companion diagnostic • PD(L)-1 Biomarker • IO biomarker • PD(L)-1 companion diagnostic
    |
    PD-L1 expression
    |
    PD-L1 IHC 22C3 pharmDx • VENTANA PD-L1 (SP263) Assay
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Tecentriq (atezolizumab) • Imfinzi (durvalumab)
    10d
    CANOPY-1: Study of Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab in Previously Untreated Locally Advanced or Metastatic Non-squamous and Squamous NSCLC Subjects (clinicaltrials.gov)
    P3, N=673, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Jun 2027 --> May 2026
    Trial completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • albumin-bound paclitaxel • pemetrexed • Ilaris (canakinumab)
    10d
    Rambro2: Ramucirumab and Pembrolizumab vs Pembrolizumab Monotherapy in PD-L1 Positive Head and Neck Squamous-Cell Carcinoma (clinicaltrials.gov)
    P2, N=37, Active, not recruiting, Washington University School of Medicine | Recruiting --> Active, not recruiting | N=72 --> 37 | Trial completion date: Apr 2031 --> Jun 2030 | Trial primary completion date: Apr 2028 --> Jun 2027
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Keytruda (pembrolizumab) • Cyramza (ramucirumab)
    10d
    Neoadjuvant Becotatug Vedotin Plus Pucotenlimab and Cisplatin for Locally Advanced Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=30, Not yet recruiting, Sir Run Run Shaw Hospital
    New P2 trial
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 IHC 22C3 pharmDx
    |
    cisplatin • Puyouheng (pucotenlimab) • Meiyouheng (becotatug vedotin) • becotarug (JMT101)
    11d
    Testing the Impact of an Anti-Cancer Drug, Atezolizumab, After Surgery to Prevent Early Stage Non-small Cell Lung Cancer From Returning, AASI-NSCLC Trial (clinicaltrials.gov)
    P3, N=336, Not yet recruiting, National Cancer Institute (NCI)
    New P3 trial
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 IHC 22C3 pharmDx • VENTANA PD-L1 (SP142) Assay
    |
    Tecentriq (atezolizumab) • Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs)
    12d
    A Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Participants With Locally Advanced, Unresectable, Stage III Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P3, N=71, Active, not recruiting, Hoffmann-La Roche | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    ALK positive • ALK fusion • ROS1 fusion • ROS1 positive
    |
    PD-L1 IHC 22C3 pharmDx • VENTANA PD-L1 (SP263) Assay
    |
    Imfinzi (durvalumab) • Rozlytrek (entrectinib) • Alecensa (alectinib)
    12d
    Evaluation of the Diagnostic Efficacy of a αvβ6/FAP-Targeting Heterodimeric Probe in Patients With Malignant Solid Tumors (clinicaltrials.gov)
    P=N/A, N=100, Not yet recruiting, Zhongnan Hospital
    New trial
    |
    PD-L1 IHC 22C3 pharmDx
    13d
    Neoadjuvant Therapy Combined With Trastuzumab Rezetecan and Toripalimab for HR+/HER2-low Breast Cancer (NEOTORCH-BREAST 08) (clinicaltrials.gov)
    P2, N=111, Recruiting, First Affiliated Hospital of Zhejiang University
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression • HER-2 positive • HR positive
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Herceptin (trastuzumab) • paclitaxel • Loqtorzi (toripalimab-tpzi) • cyclophosphamide • epirubicin • trastuzumab rezetecan (SHR-A1811)