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    BIOMARKER:

    PD-L1 negative

    i
    Other names: PD-L1, CD274, HPD-L1, PD-L1, B7H1, PDL1, Programmed death ligand 1, B7-H1, B7-H, PDCD1L1, PDCD1LG1, PDCD1 Ligand 1, B7 homolog 1, CD274 Antigen, Programmed cell death 1 ligand 1, CD274 molecule
    Entrez ID:
    29126
    Related biomarkers:
    Expression
    Mutation
    CNA
    Others
    3d
    Cadonilimab (PD-1/CTLA-4 bispecific antibody) combination therapy for driver gene-negative advanced NSCLC: a single-center retrospective real-world study. (PubMed, Front Oncol)
    This study confirms the promising efficacy and acceptable safety profile of AK104 combination therapy in patients with driver gene-negative advanced NSCLC. These findings collectively support the need for further large-scale prospective studies to validate its clinical utility.
    Retrospective data • Journal • Real-world evidence
    |
    PD-L1 (Programmed death ligand 1) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    PD-L1 expression • PD-L1 negative
    |
    Kaitanni (cadonilimab)
    8d
    PIK3CA Alterations in NSCLC: Clinical Characteristics of a "Neglected" Population of Oncogene-Addicted Patients. (PubMed, Biomedicines)
    In this study, no definitive prognostic or predictive role for PIK3CA alterations could be established. Nevertheless, these findings provide a descriptive real-world characterization of this molecular subset and support the need for validation in larger, prospectively designed, molecularly stratified studies.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    PD-L1 expression • KRAS mutation • PIK3CA mutation • PD-L1 negative
    9d
    Strain-level genetic heterogeneity and colonization dynamics drive microbiome therapeutic efficacy. (PubMed, Cell Host Microbe)
    Finally, we identify 38 priority species with robust engraftment potential and significant heterogeneity as candidates for precision therapeutics. These findings establish a strain-function-efficacy paradigm, elucidating the mechanistic basis of variable outcomes and guiding next-generation microbiome drug development.
    Journal
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 negative
    10d
    1011098: An open-label randomised, phase II trial of Datopotamab deruxtecan plus Durvalumab versus Datopotamab deruxtecan in patients with PDL1-negative metastatic triple-negative breast cancer (2024-519913-76-00)
    P1/2, N=80, Recruiting, Queen Mary University Of London | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    PD-L1 negative
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Imfinzi (durvalumab) • Datroway (datopotamab deruxtecan-dlnk)
    10d
    Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma Expressing Claudin18.2 (clinicaltrials.gov)
    P3, N=2130, Recruiting, AstraZeneca
    New P3 trial
    |
    PD-L1 (Programmed death ligand 1) • CLDN18 (Claudin 18)
    |
    PD-L1 expression • CLDN18.2 expression • PD-L1 negative • CLDN18.2 positive • CLDN1 positive
    |
    Opdivo (nivolumab) • 5-fluorouracil • capecitabine • oxaliplatin • leucovorin calcium • Vyloy (zolbetuximab-clzb) • sonesitatug vedotin (AZD0901) • rilvegostomig (AZD2936)
    11d
    CheckCell-2: CISH Inactivated TILs in the Treatment of NSCLC (clinicaltrials.gov)
    P1/2, N=0, Withdrawn, Intima Bioscience, Inc. | N=70 --> 0 | Not yet recruiting --> Withdrawn
    Enrollment change • Trial withdrawal
    |
    PD-L1 negative
    |
    Keytruda (pembrolizumab) • cyclophosphamide • fludarabine IV • Proleukin (aldesleukin) • Undisclosed CISH inactivated TIL
    15d
    First-in-human phase 1/2a study of T3011, an oncolytic HSV expressing IL-12 and PD-1 antibody, administered via intratumoral (IT) injection as monotherapy in advanced solid tumors, including recurrent or metastatic HNSCC. (PubMed, BMC Med)
    T3011 shows a favorable safety profile, immune-modulating effects, and preliminary efficacy in patients with advanced solid tumors.
    P1/2 data • Journal • First-in-human
    |
    CD8 (cluster of differentiation 8)
    |
    PD-L1 expression • PD-L1 negative
    |
    T3011
    15d
    Efficacy of immune checkpoint inhibitors in the first line therapy of non-squamous non-small cell lung cancer: a systematic review and network meta-analysis. (PubMed, Crit Rev Oncol Hematol)
    For advanced nsNSCLC patients, irrespective of PD-L1 expression, prolgolimab, pembrolizumab or cemiplimab, each combined with chemotherapy, are most efficacious by OS; nivolumab or atezolizumab combined with bevacizumab and chemotherapy demonstrate the highest PFS. PD-L1 expression does not modify the effect of examined immunotherapy options on OS, though the opposite is true for PFS.
    Clinical • Retrospective data • Review • Journal • Checkpoint inhibition • PD(L)-1 Biomarker • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    PD-L1 expression • PD-L1 negative
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Avastin (bevacizumab) • Tecentriq (atezolizumab) • Libtayo (cemiplimab-rwlc) • Forteca (prolgolimab)
    17d
    1011098: An open-label randomised, phase II trial of Datopotamab deruxtecan plus Durvalumab versus Datopotamab deruxtecan in patients with PDL1-negative metastatic triple-negative breast cancer (2024-519913-76-00)
    P1/2, N=80, Not yet recruiting, Queen Mary University Of London
    New P1/2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    PD-L1 negative
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Imfinzi (durvalumab) • Datroway (datopotamab deruxtecan-dlnk)
    17d
    STK-012-101: Study of STK-012 Alone and with Other Treatments in Patients with Advanced Lung Cancer and Other Cancers (2025-522632-14-00)
    P1/2, N=56, Not yet recruiting, Synthekine Inc.
    New P1/2 trial
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    PD-L1 negative
    |
    Keytruda (pembrolizumab) • carboplatin • pemetrexed • STK-012
    18d
    A Study of Radiation Therapy With Pembrolizumab and Olaparib or Other Radiosensitizers in Women Who Have Triple-Negative or Hormone-Receptor Positive/Her2 Negative Breast Cancer (clinicaltrials.gov)
    P2, N=34, Recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Jan 2026 --> Jan 2027 | Trial primary completion date: Jan 2026 --> Jan 2027
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor)
    |
    HR positive • PD-L1 negative
    |
    Keytruda (pembrolizumab) • Lynparza (olaparib)
    23d
    Study of Durvalumab With Tremelimumab Versus SoC as 1st Line Therapy in Metastatic Non Small-Cell Lung Cancer (NSCLC) (NEPTUNE) (clinicaltrials.gov)
    P3, N=953, Active, not recruiting, AstraZeneca | Trial completion date: Dec 2025 --> Dec 2026
    Trial completion date • Tumor mutational burden • IO biomarker
    |
    PD-L1 negative
    |
    cisplatin • carboplatin • Imfinzi (durvalumab) • gemcitabine • paclitaxel • Imjudo (tremelimumab-actl) • pemetrexed