TEST:

VENTANA PD-L1 (SP263) Assay

Tumor heterogeneity indices, particularly HI and COV derived from FDG PET/CT, demonstrated stronger predictive value for PD-L1 expression than conventional metabolic parameters. These findings suggest that metabolic heterogeneity may serve as a useful noninvasive imaging biomarker for guiding immunotherapy in NSCLC.

This study sheds light on the molecular landscape of SCP, which may be valuable to elucidate the prognostic and therapeutic implications for this uncommon disease.

Follow-up revealed metastasis in 1 patient, leading to mortality. Our findings broaden the morphologic spectrum and highlight a new point mutation in the SDHB gene, providing a genetic change spectrum for this tumor entity.

The VENTANA PD-L1 (SP263) Assay, which can guide multiple immune checkpoint inhibitor monotherapies (e.g., atezolizumab and pembrolizumab) for advanced NSCLC patients, achieved a higher percentage of successfully diagnosed and treated, and a higher quality-adjusted life-year at a lower cost compared with Dako PD-L1 IHC 22C3 assay and Dako 22C3 antibody concentrate. The robustness of the base case results was confirmed by both one-way sensitivity analysis and probabilistic sensitivity analysis. The VENTANA PD-L1 (SP263) Assay is cost-effective compared with Dako PD-L1 IHC 22C3 assay and Dako 22C3 antibody concentrate for the immunotherapy treatment for advanced NSCLC patients in China.

P2, N=60, Active, not recruiting, Hoffmann-La Roche | Trial completion date: Sep 2025 --> Dec 2025 | Trial primary completion date: Sep 2025 --> Dec 2025

P=N/A, N=62, Not yet recruiting, General Hospital of Ningxia Medical University; General Hospital of Ningxia Medical University

The Leica Biosystems CAL10 PD-L1 assay has demonstrated comparable performance to the SP263 assay. Additionally, the PD-L1 CAL10 stained glass slides and the corresponding whole side images generated by GT 450 showed comparable concordance rate.

The 3E2 antibody demonstrates high concordance with Abcam 28-8, offering a potential cost-effective alternative for PD-L1 detection with preliminary prognostic value in immunotherapy-treated LUAD patients. Further validation is required to confirm its clinical utility.

Our study establishes a robust methodology for detecting CSF PD-L1 expression using ThinPrep LBC with immunocytochemistry for LM patients. This approach suggests potential utility of CSF PD-L1 expression as a biomarker for guiding intrathecal immunotherapy for LM from solid tumors.

ALK rearrangements, detected by immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH), helps predict responses to ALK inhibitors like crizotinib...ALK IHC, with confirmatory FISH or NGS, guides tailored treatment. In this context, an integrated predictive approach enables the best clinical and therapeutic management of patients with NSCLC.

This study confirms the alignment of GEC PD-L1 expression in Italian real-world practice with clinical trials. Inter-institutional variability and the significant influence of preanalytical factors, particularly tissue aging and PD-L1 clone, highlight important challenges in routine PD-L1 testing. Addressing these issues is crucial to enhance the reliability of PD-L1 IHC assessment and ensure optimal patient selection for ICIs in GEC.

Similar efficacy (OS and PFS) was observed with the 22C3+ and SP263+ populations, demonstrating the interchangeability of these PD-L1 IHC assays for selecting patients with PD-L1 ≥50% for first-line cemiplimab monotherapy for advanced NSCLC.