TEST:

PD-L1 IHC 22C3 pharmDx

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

P1, N=30, Recruiting, University of Texas Southwestern Medical Center | Trial completion date: Apr 2026 --> Apr 2029 | Trial primary completion date: Apr 2026 --> Apr 2028

P3, N=740, Active, not recruiting, Daiichi Sankyo | Recruiting --> Active, not recruiting | Trial completion date: Apr 2028 --> Mar 2032 | Trial primary completion date: Feb 2028 --> Mar 2030

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.

Despite its high expression in advanced solid tumours, PD-L1 showed limited prognostic value in our cancer cohort. In contrast, systemic inflammatory markers particularly PLR, emerged as a potential indicator of clinical outcome. Our data suggest that integrating PD-L1 status with systemic inflammatory markers may improve outcome prediction and help inform therapeutic decision-making in patients with advanced malignancies.

P2, N=33, Terminated, NeoImmuneTech | N=83 --> 33 | Active, not recruiting --> Terminated; sponsor decision (not for safety)

PD-L1 expression may be associated with tumor grade in early-stage endometrioid endometrial cancer. However, its clinical significance remains unclear. These findings may be relevant in the context of fertility- preserving management and require further investigation.

Immunostaining for ALK was negative, and there was no expression of PD-L1 22C3 IHC. This case report highlights an unexpected ROS1 IHC staining associated with a rare ROS1 gene rearrangement.

P1/2, N=34, Active, not recruiting, Grupo Español de Tratamiento de Tumores de Cabeza y Cuello | Recruiting --> Active, not recruiting | Trial primary completion date: Sep 2027 --> Mar 2027

P1/2, N=264, Not yet recruiting, CSPC Megalith Biopharmaceutical Co.,Ltd.

P2, N=29, Active, not recruiting, M.D. Anderson Cancer Center | Recruiting --> Active, not recruiting

"To support expanded use of PD-L1 IHC 22C3 pharmDx on Dako Omnis, Agilent conducted a multisite external platform performance comparison study evaluating concordance of PD-L1 IHC 22C3 pharmDx results across staining platforms (Code SK006 on the ASL48 platform and Code GE006 on Dako Omnis) for the four additional indication specimens....PD-L1 IHC 22C3 pharmDx, Code SK006, was developed by Agilent in partnership with Merck...as a companion diagnostic for KEYTRUDA."