TEST:

VENTANA PD-L1 (SP263) Assay

P2, N=70, Recruiting, Innate Pharma | Trial completion date: Sep 2026 --> Jun 2027 | Trial primary completion date: Jun 2025 --> Jun 2027

In this retrospective, single-center study, 86 patients with metastatic NSCLC treated with ICIs (pembrolizumab or atezolizumab) between January 2020 and December 2025 were included. While these results should be interpreted cautiously given the modest sample size and the small number of progression events, they are consistent with broader real-world evidence indicating that PD-L1 expression alone may not reliably stratify clinical benefit in metastatic NSCLC. Larger prospective studies integrating PD-L1 with complementary biomarkers are needed to confirm these observations.

Using tonsillar tissue as a standardized PD-L1 reference model, we showed that selected pre-analytical variables are associated with measurable and progressive loss of PD-L1 immunoreactivity, particularly in lymphoreticular cells. These findings support increased awareness of tissue handling, archival storage, and unstained slide storage as potential sources of analytical variability in PD-L1 assessment.

P2, N=60, Recruiting, Tang-Du Hospital

P3, N=68, Active, not recruiting, Hoffmann-La Roche | Trial primary completion date: Dec 2026 --> Jun 2030

PD-L1 expression is independently associated with worse survival outcomes in patients with early-stage NSCLC treated with SBRT, indicating its potential as a prognostic biomarker for risk stratification.

AI-assisted assessment demonstrates high concordance with the expert pathologist, particularly in binary classification. However, due to discrepancies in the intermediate range, the algorithm is currently best positioned as a supportive tool for verifying borderline cases.

By evaluating PD-L1 expression in premalignant lesions and histologically negative margins, this study aims to identify molecular predictors of OSCC progression and survival. The findings may help establish PD-L1 as a prognostic biomarker and support its integration into precision oncology and immunotherapy strategies.

In this real-world cohort, adjuvant atezolizumab demonstrated favorable tolerability and clinically meaningful DFS across PD-L1 expression subgroups, including patients with PD-L1 1-49%. These findings are descriptive in nature and should be interpreted with caution, nevertheless, they provide real-world evidence supporting the potential clinical utility of adjuvant atezolizumab in appropriately selected patients with resected stage II-III NSCLC.

Our results suggest that cPD-L1 expression in most sUC occurs secondary to IL6-JAK-STAT3 and interferon α/γ signaling. This provides a biologic rationale for evaluating response to immunotherapy in this patient population.

P1, N=210, Active, not recruiting, iOnctura | Trial completion date: Mar 2025 --> Mar 2027

P1, N=24, Terminated, Imugene Limited | Active, not recruiting --> Terminated; Portfolio prioritization