^
    2d
    A Study Comparing Two Immunotherapy Options for Human Papillomavirus Positive HPV-Positive Head and Neck Cancer After Treatment (clinicaltrials.gov)
    P2, N=68, Not yet recruiting, University of Chicago | Initiation date: Jan 2026 --> Dec 2026
    Trial initiation date • Minimal residual disease
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 IHC 22C3 pharmDx • NavDx®
    |
    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    2d
    MINA: Microbiome Immunotherapy Neoadjuvant Assessment (clinicaltrials.gov)
    P=N/A, N=30, Recruiting, University College Cork | Trial completion date: Feb 2027 --> Nov 2027
    Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative
    |
    PD-L1 IHC 22C3 pharmDx
    2d
    Perioperative Cemiplimab for Resectable Non-Small Cell Lung Cancer With High PD-L1 (clinicaltrials.gov)
    P2, N=33, Not yet recruiting, Henry Ford Health System
    New P2 trial
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Libtayo (cemiplimab-rwlc)
    5d
    PD-L1 expression across urothelial carcinoma subtypes: A multicenter comparison of 22C3 and SP142 for clinical decision-making in the immunotherapy era. (PubMed, Pathol Res Pract)
    The 22C3 and SP142 assays show analytical concordance for overall PD-L1 status but significant variability in IC scoring. Given the variability in PD-L1 expression across UC-s, precise characterization of both TC and IC staining per assay is crucial. These findings support incorporating UC-s subtype and assay-specific PD-L1 profiles into routine diagnostics to optimize immunotherapy decisions.
    Journal • 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
    9d
    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, Terminated, Novartis Pharmaceuticals | Trial completion date: May 2026 --> Jan 2026 | Active, not recruiting --> Terminated; Results of primary analysis showed addition of canakinumab to combination treatment did not improve tumor response or overall survival; the decision to stop the trial was not due to safety concerns
    Trial completion date • Trial termination
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • albumin-bound paclitaxel • pemetrexed • Ilaris (canakinumab)
    9d
    MERIDIAN: Molecular Residual Disease Interception in Locoregionally-Advanced High Risk HPV+ and HPV- HNSCC (clinicaltrials.gov)
    P2, N=102, Recruiting, University Health Network, Toronto | N=200 --> 102 | Trial completion date: Jul 2026 --> Jul 2028 | Trial primary completion date: Jul 2026 --> Sep 2027
    Enrollment change • Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2)
    |
    PD-L1 expression
    |
    PD-L1 IHC 22C3 pharmDx
    |
    rilvegostomig (AZD2936)
    9d
    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)
    15d
    Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in 1L Non-Small Cell Lung Cancer (TROPION-Lung07) (clinicaltrials.gov)
    P3, N=1170, Active, not recruiting, Daiichi Sankyo | Trial completion date: Aug 2027 --> May 2029 | Trial primary completion date: Aug 2027 --> May 2029
    Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1) • TACSTD2 (Tumor Associated Calcium Signal Transducer 2)
    |
    PD-L1 expression
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • pemetrexed • Datroway (datopotamab deruxtecan-dlnk)
    17d
    Evaluating the Relationship Between Programmed Death Ligand-1 (Clone: 22C3), Anaplastic Lymphoma Kinase (D5F3), and C-ros Oncogene 1 (OT11A1) Expression in Lung Adenocarcinoma. (PubMed, Cureus)
    Only three cases exhibited copositivity for both ALK and ROS1, with an odds ratio of about 1.17 (95% CI: 0.20-6.58) and a p-value of approximately 0.95, indicating no significant association. Conclusion The expression of PD-L1 is independent of ALK and ROS1 alterations in lung adenocarcinoma, suggesting that these biomarkers do not significantly correlate with one another.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    PD-L1 expression • ALK positive
    |
    PD-L1 IHC 22C3 pharmDx
    17d
    BCA101X301: A trial to see if ficerafusp alfa given with pembrolizumab can treat participants with head and neck cancer. (2024-519654-37-00)
    P2/3, N=191, Recruiting, Bicara Therapeutics Inc.
    New P2/3 trial
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Keytruda (pembrolizumab) • ficerafusp alfa (BCA101)
    17d
    DS3201-330: A Study of Valemetostat Tosylate Plus Pembrolizumab versus Pembrolizumab Alone in First-Line NSCLC Without Actionable Genomic Alterations (2024-519671-26-00)
    P1/2, N=21, Completed, Daiichi Sankyo Inc.
    New P1/2 trial
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    PD-L1 expression • KRAS mutation
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Keytruda (pembrolizumab) • Ezharmia (valemetostat)
    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)