TEST:

PD-L1 IHC 28-8 pharmDx

Techniques are available that can optimize the automated staining of PharmDx PD-L1 assays using the Autostainer Link 48 to ensure consistent staining performance. The PD-L1 IHC PharmDx 22C3 and PD-L1 IHC PharmDx 28-8 assays show high concordance when used according to manufacturers' guidelines.

Despite low overall expression rates, PD-L1 could serve as a prognostic biomarker and a potential target for immunotherapeutic strategies in liposarcomas. Further studies are necessary to standardize PD-L1 assessment and explore effective immunotherapy approaches for these tumors.

However, both assays demonstrated a concordance rate of 61%. In the study population, the subgroup with a Combined Positive Score (CPS) ≥ 10 was the most prevalent, suggesting that high PD-L1 expression is relatively common and potentially clinically relevant in this cohort.

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.

P1, N=165, Active, not recruiting, AstraZeneca | Recruiting --> Active, not recruiting | N=371 --> 165 | Trial completion date: Jan 2026 --> Apr 2026 | Trial primary completion date: Jan 2026 --> Apr 2026

Obtaining at least five biopsy specimens enhances the detection of PD-L1 CPS ≥ 5, particularly in HER2-negative or well-circumscribed nodular AGC, potentially improving the accuracy of PD-L1 evaluation. Nevertheless, survival outcomes were unaffected, highlighting the limited predictive value of CPS.

"Agilent Technologies Inc...announced its PD-L1 IHC 28-8 pharmDx kit has received two new companion diagnostic indications approvals under EU IVDR1, expanding the eligibility of treatment to early-stage non-small cell lung cancer (NSCLC) and previously untreated advanced melanoma patients....PD-L1 IHC 28-8 pharmDx is approved for exclusive use with the Agilent Autostainer Link 48 advanced staining solution....When used in conjunction with the PD-L1 IHC 28-8 pharmDx as a companion test, in the European Union: (a) resectable NSCLC patients with PD-L1 expression ≥1% and at high risk of recurrence may be eligible for treatment with Bristol Myers Squibb’s OPDIVO (nivolumab) in combination with platinum based chemotherapy; and (b) patients 12 years of age and older with tumor cell PD-L1 expression < 1% that have previously untreated advanced (metastatic or unresectable) melanoma may be eligible for treatment with Bristol Myers Squibb’s Opdualag (nivolumab and relatlimab)."

ICIs significantly improve survival outcomes in patients with recurrent pulmonary pleomorphic carcinoma, particularly in those with high PD-L1 expression. Early postoperative recurrence and rapid progression have been observed, making therapeutic intervention challenging. Close follow-up is crucial, and ICIs become a pivotal treatment option for managing this highly aggressive cancer.

In this controlled experiment the PD-L1 assays 28-8 and SP263 concordance was high. The scoring algorithms for GEJ, GC, and EAC samples were observed as highly correlated; minor differences were likely driven by the distinct PD-L1 monoclonal antibody clones utilized in the IHC assays. These data suggest that the 2 assays are comparable for evaluating PD-L1 expression at the TAP ≥ 5% and CPS ≥ 5 cutoffs.

"Agilent’s PD-L1 IHC 28-8 pharmDx (Code SK005) provides clinically relevant information about PD-L1 expression – a critical biomarker for potential response to therapies containing anti-PD-1 antibodies such as OPDIVO (nivolumab) which has demonstrated therapeutic value across growing list of cancer types and Opdualag (nivolumab and relatimab)....PD-L1 IHC 28-8 pharmDx (Code SK005) has received European IVDR certification for nine cancer indications, including five companion diagnostic indications; non-small cell lung cancer (NSCLC), muscle invasive urothelial carcinoma (MIUC), melanoma, esophageal squamous cell carcinoma (ESCC), and gastric, gastroesophageal junction (GEJ) and esophageal adenocarcinoma."

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P2; Trial primary completion date: Aug 2024 --> Dec 2025 | Trial completion date: Feb 2027 --> Dec 2028