TEST:

PD-L1 IHC 22C3 pharmDx

P2, N=30, Not yet recruiting, West China Hospital , Sichuan University; West China Hospital , Sichuan University

Both the primary lung and metastatic liver lesion showed a tendency to shrink. This regimen may be considered a promising treatment for non-small cell lung carcinoma resembling hepatoid carcinoma as it achieved survival beyond the previously reported median.

CD73 expression in EGFRm LUAD is heterogeneous and associated with diverse TME profiles. These findings support the potential of CD73 as a predictive biomarker and therapeutic target, highlighting its clinical relevance in EGFRm LUAD.

P1/2, N=117, Active, not recruiting, Cantargia AB | Recruiting --> Active, not recruiting

These observations may help reconcile the discordant performance of the two PD-L1 assays in ICB-treated urothelial carcinoma while underscoring the role of dendritic cells in orchestrating ICB response. See related article by Galsky et al., p. XX .

P2, N=32, Not yet recruiting, University of Michigan Rogel Cancer Center | Trial completion date: Nov 2027 --> Mar 2028 | Initiation date: Feb 2025 --> Jun 2025 | Trial primary completion date: Nov 2027 --> Mar 2028

The inclusion of PD-L1 expressing AMs leads to differences in CPS positivity, especially in large TNBC subtype tumors.

P2, N=30, Recruiting, Dwight Owen | Trial completion date: Dec 2025 --> Apr 2025 | Trial primary completion date: Dec 2024 --> Apr 2025

P2, N=120, Recruiting, Hunan Province Tumor Hospital | Phase classification: P1 --> P2

P1, N=15, Completed, The Netherlands Cancer Institute | Active, not recruiting --> Completed | Phase classification: P1b --> P1 | Trial completion date: Jun 2026 --> Dec 2024

P2, N=171, Active, not recruiting, Immutep S.A.S. | Trial completion date: Mar 2025 --> Oct 2025

PD-L1 scoring by SP263 and 22C3 are interchangeable but not SP142 regardless of EGFR status. PD-L1 ITH was more common in EGFR-wildtype versus EGFR-mutant tumours. Extra care should be taken to select the most representative tumour core for tumours with high histological grade or TPS 1-49% as this may influence peri-operative treatment decisions.

Mixed and collisional small cell-squamous cell carcinomas are essentially distinct tumors. In the clinical diagnostic of MCSSC, the tumor should be clearly identified as mixed or collisional carcinoma to guide the clinical treatment and prognosis more accurately.

While PD-L1 status was an imperfect overall biomarker for BCG unresponsiveness, there was an association between initial PD-L1 expression and BCG response. Additionally, there was an upregulation of PD-L1 expression in BCG unresponsive specimens. These findings generate a hypothesis-generating discussion regarding the tumor immune-microenvironment and its response to BCG. Further investigation is necessary to better understand this interaction and its impact on tumor biomarker profiling and patient selection for combination therapy.

The real-world 5-year survival rate of NSCLC cases with PD-L1 ≥ 50 % treated with first-line pembrolizumab was comparable to that in a clinical trial. Histological type and number of metastatic sites influenced long-term and 5-year survival.

The patient was started on atezolizumab+nab-paclitaxel(PTX)therapy, but progression disease(PD)was observed without obvious effect. Pembrolizumab+carboplatin+gemcitabine was started as second-line therapy, and the tumor achieved partial response(PR)but developed PD within 6 months. After that, she was administrated olaparib, but PD was observed, and after the therapy with PTX+bevacizumab, she is now treated with eribulin.

PD-L1 expression may differ between preoperative biopsy specimens and surgical specimens. PD-L1 expression evaluated using small biopsy specimens may be largely influenced by chance due to intra-tumoral heterogeneity.

P2, N=44, Recruiting, Instituto Nacional de Cancer, Brazil | Not yet recruiting --> Recruiting

He received a combination of cisplatin, etoposide, paclitaxel, and sintilimab. Four months after the treatment began, chest computed tomography (CT) showed significant mass reduction. Therefore, ICIs may be a promising therapy option for patients with PPC.

Immunohistochemical detection of PD-L1 expression in malignant pleural fluid of advanced NSCLC provides a basis for clinical tumor immunotherapy. Immunohistochemical detection of PD-L1 expression in malignant pleural fluid of advanced NSCLC is minimally invasive, simple, and fast, particularly for metastatic NSCLC where malignant pleural fluid is the first symptom, offering significant clinical application value.

Overall, this work highlights the continuing challenge of consistency in PD-L1 testing. Although the underlying prevalence of PD-L1 expression varies in the lung cancer population based on tumour-related factors, controllable differences in testing parameters also account for variations in PD-L1 prevalence.

P2, N=57, Recruiting, Breast Cancer Trials, Australia and New Zealand | Trial completion date: Sep 2025 --> Sep 2026 | Trial primary completion date: Sep 2024 --> Sep 2025

P2, N=73, Active, not recruiting, Incyte Corporation | Trial completion date: Jan 2027 --> Jul 2026 | Trial primary completion date: Jan 2027 --> Jul 2026

Multiplex IHC in an independent ICB-treated cohort confirmed that tumor cell-dominant PD-L1 expression was associated with shorter survival. Using different PD-L1 assays, we uncovered that SP142 may preferentially stain PD-L1-expressing DCs, key to orchestrating antitumor immunity, while tumor cell-dominant PD-L1 expression, which underlies a subset of "PD-L1 positive" specimens, is associated with poor ICB outcomes.

The short-term efficacy of APA monotherapy in R/M-HNSCC patients tended to be better when CPS was positive. TPS helps predict the population that does not benefit from APA monotherapy.

P3, N=1210, Recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Dec 2025

Our data indicated that basaloid ESCC had less benefits from immunotherapy than conventional ESCC, and manifested as immune "cold" with immature-type desmoplastic reaction, lower TILs, lower peritumoral TLSs, and lower PD-L1 expression than conventional ESCC.

Nivolumab demonstrated efficacy and safety in clinical practice, supporting its use in patients with good PS, even in later lines.

P1/2; Trial completion date: Dec 2027 --> May 2028 | Trial primary completion date: Dec 2027 --> May 2028

P1; Recruiting --> Active, not recruiting | Trial completion date: Jun 2025 --> Nov 2025 | Trial primary completion date: Jun 2025 --> Nov 2025

P2; Not yet recruiting --> Recruiting

P2; Trial completion date: Sep 2025 --> Sep 2026 | Trial primary completion date: Dec 2024 --> Dec 2025

The patient subsequently received chemotherapy with pemetrexed and carboplatin. This case offers a long-term follow-up of the effectiveness and safety of combining pembrolizumab and anlotinib in advanced SMARCA4-UT, and substantiates the role of long-term immunotherapy in preventing radiographic/clinical recurrence following surgery. This case illustrates new potential efficacy of immunotherapy in combination with surgery as a treatment approach of SMARCA4-UT.

Multivariate analysis identified that PD-L1 expression ≥10 and ≥1 were associated with favorable outcomes regarding OS (hazard ratio [HR] 0.283, P = .027 and HR 0.303, P = .006, respectively). Combined analysis of PD-L1 expression in malignant and tumor-infiltrating cells can be a promising biomarker for the prognosis of HCC patients treated with AB.

P2; Active, not recruiting --> Completed | Trial completion date: Oct 2025 --> Sep 2024

P=N/A; Recruiting --> Completed | Phase classification: P2 --> PN/A | N=30 --> 15 | Trial completion date: Jun 2024 --> Nov 2024 | Trial primary completion date: Jun 2023 --> Oct 2024

P1; Suspended --> Active, not recruiting

P1; N=37 --> 7 | Trial completion date: Nov 2024 --> Dec 2025

P2; Recruiting --> Completed | N=50 --> 13 | Trial completion date: Feb 2026 --> Dec 2024 | Trial primary completion date: Sep 2025 --> Jun 2024

P; With both SP142 and 22C3, we identified an intermediate IHC PD-L1 group within TNBCs that was supported on the molecular level. Any PD-L1 IHC expression, even though it is < 1, tended to have positive prognostic impact. We suggest that the generally accepted threshold of PD-L1 IHC positivity in TNBC should be investigated further. The Swedish Cancerome Analysis Network - Breast (SCAN-B) study was retrospectively registered 2nd Dec 2014 at ClinicalTrials.gov; ID NCT02306096.

P2; N=55 --> 11 | Trial completion date: Dec 2025 --> Aug 2024 | Recruiting --> Terminated | Trial primary completion date: Aug 2022 --> Aug 2024; This is because Medpacto decided to modify its development strategy as the business and development environment changed.

Treatment included R-CHOP (n=26), R-DA EPOCH (n=2), MTR (n=1), and R-MPV (n=1).26.66% had PD-L1 <1% while 73.33% had PD-L1 ≥1%; 33.33% had PD-L1 <5%, while 66.67% had PD-L1 ≥5%...Limitations include small number of patients, short follow up and inclusion of 2 patients of primary CNS lymphoma, that might have affected the analysis minimally. Further research is essential to standardize the cutoff value and scoring method.