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PD-L1 IHC 28-8 pharmDx for Esophageal Carcinoma (EC)

More personalized cancer results. One test makes it possible
PD-L1 IHC 28-8 pharmDx is now MHLW-approved to identify esophageal cancer patients for the treatment with
nivolumab + chemotherapy or nivolumab + ipilimumab
Agilent Dako
Demonstrated clinical results
  • Phase 3 randomized, open-label study in chemotherapy-naive patients with unresectable advanced or recurrent esophageal cancer, to compare nivolumab + chemotherapy or nivolumab + ipilimumab versus chemotherapy alone.
  • The study results highlight overall survival (OS) and progression-free survival (PFS) benefit from nivolumab + chemotherapy, and OS benefit from nivolumab + ipilimumab in esophageal cancer patients with tumor cell PD-L1 ≥ 1%.
Clinical study results
Product information
PD-L1 IHC 28-8 pharmDx Esophageal Cancer Interpretation Manual PD-L1 IHC 28-8 pharmDx NSCLC Interpretation Manual

Refer to the Esophageal Cancer Interpretation Manual to review validated scoring guidelines that can aid in the identification of esophageal cancer patients for the treatment with
nivolumab + chemotherapy or nivolumab + ipilimumab.

Download now
PD-L1 IHC 28-8 pharmDx Esophageal Cancer Interpretation Training Program PD-L1 IHC 28-8 pharmDx NSCLC Interpretation Training Program

Get the training that may help you accurately evaluate and score   PD-L1 expression in patients with esophageal cancer.

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PD-L1 IHC 28-8 pharmDx Esophageal Cancer Brochure PD-L1 IHC 28-8 pharmDx NSCLC Brochure

PD-L1 IHC 28-8 pharmDx has been analytically validated for specificity, sensitivity, and reproducibility, and shows high clinical utility across various indications.

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Want to hear more about PD-L1 IHC 28-8 pharmDx? PD-L1 IHC 28-8 pharmDx workflow teaser image

Contact your local sales representative.

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Product information Product information​

Product details, specification sheet and safety data sheet (SDS).

PD-L1 IHC 28-8 pharmDx SDS
Robust performance

PD-L1 IHC 28-8 pharmDx is MHLW-approved and fully validated with analytical performance having met all pre-determined acceptance criteria for sensitivity, specificity and precision.

Selected analytical validation parameters Description
Specificity
  • Demonstrated specificity to clone 28-8 for PD-L1 detection.
  • Detection in normal tissues is restricted to immune cells and infrequently the cells of epithelial origin.
  • PD-L1 primary antibody displays no cross-reactivity for PD-L2.
Sensitivity
  • Analytical sensitivity of PD-L1 IHC 28-8 pharmDx was tested on 378 unique cases of human esophageal carcinoma FFPE specimens staged I to IV using a manufactured production lot. Assessment of PD-L1 expression demonstrated staining across a range of 0-95% positive tumor cells and 0-3 staining intensity
Reproducibility
  • Testing was performed at three external sites to evaluate inter-site (94.8% OA), intra-site (95.9% OA), inter-observer (98.0% OA), and intra-observer (98.8% OA) reproducibility at the ≥ 1% PD-L1 expression cutoff

OA = Overall Agreement

Order information
Product Code
PD-L1 IHC 28-8 pharmDx SK005

Required but not included in kit:

Autostainer Link 48

EnVision FLEX Wash Buffer, 20x

EnVision FLEX Hematoxylin (Link)

PT Link

PT Link Rinse Station

 

AS480

K8007

K8008

PT100 / PT200

PT109
References
  • Doki Y., Ajani. J.A., Kato K., et al. Nivolumab Combination Therapy in Advanced Esophageal Squamous-Cell Carcinoma.
    N. Engl. J. Med. 2022, 386(5), 449-462.
  • PD-L1 IHC 28-8 pharmDx Instructions for Use.
  • Ipilimumab package insert.
  • Nivolumab package insert.

Intended Use

To measure the proportion of PD-L1 expression in cancer tissue or cells

  • Indication as an aid for proper administration of nivolumab [recombinant] in non-small cell lung cancer [NSCLC] patients,
    head-and-neck cancer patients, gastric cancer patients, and esophageal cancer patients.
  • Indication as an aid for proper administration of nivolumab [recombinant] and ipilimumab [recombinant] combination in melanoma patients.

Important Basic Precautions

It is desirable to measure PD-L1 expression by PD-L1 IHC 28-8 pharmDx in determining whether or not the following drugs can be administered.

  • Nivolumab [recombinant] for the patients with non-squamous NSCLC patients or head-and-neck cancer patients who have been treated with chemotherapy previously.
  • Combination therapy of nivolumab [recombinant] and chemotherapy for NSCLC patients or gastric cancer patients who have not been treated with chemotherapy.
  • Combination therapy including nivolumab [recombinant] for esophageal cancer patients who have not been treated
    with chemotherapy.
  • Combination therapy of nivolumab [genetic recombinant] and ipilimumab [genetic recombinant] for melanoma patients and esophageal cancer patients.

If it is not possible to measure PD-L1 expression using PD-L1 IHC 28-8 pharmDx, refer to the packaging insert of the drugs, and appropriately judge the adequacy of administration.