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PD-L1 IHC 22C3 pharmDx Testing for Gastric or GEJ Adenocarcinoma

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PD-L1 IHC 22C3 pharmDx can help identify gastric or GEJ adenocarcinoma patients for treatment with KEYTRUDA

PD-L1 is a proven biomarker for patient response to KEYTRUDA in certain tumors

  • Despite decreasing incidence and an increasing number of treatment options, gastric cancer continues to be a leading cause of cancer-related mortality worldwide
  • IHC testing for PD-L1 expression levels enables identification of patients most likely to benefit from anti-PD-1 monotherapy—in KEYNOTE-059, a KEYTRUDA clinical trial, 58% of patients with gastric or GEJ adenocarcinoma had tumors that exhibited PD-L1 expression
Learn more about PD-L1 IHC 22C3 pharmDx in:
PD-L1 testing should be an integral part of patient care from day ONE

Because patients with gastric or GEJ cancer have poor prognosis, it is critical to assess their PD-L1 expression status upon diagnosis

  • Most gastric cancer patients present at an advanced stage and are treated with upfront, systemic chemotherapy. Patients may initially respond to treatment, but many of them relapse over time, with durations of response being as short as a few months
  • Therefore, it is important to test for PD-L1 upon diagnosis to better inform long-term patient management and treatment
PD-L1 IHC 22C3 pharmDx Gastric or GEJ Adenocarcinoma Interpretation Training Program Get the training that may help you accurately evaluate and score PD-L1 expression in patients with gastric or GEJ adenocarcinoma
PD-L1 IHC 22C3 pharmDx Gastric or GEJ Adenocarcinoma Interpretation Manual Refer to the Gastric or GEJ Adenocarcinoma Interpretation Manual to review validated scoring guidelines that can help identify gastric or GEJ adenocarcinoma patients for treatment with KEYTRUDA
Online Atlas of Stains for Gastric or GEJ adenocarcinoma: PD-L1 IHC 22C3 pharmDx Use the Online Atlas of Stains for Gastric or GEJ Adenocarcinoma to increase your familiarity with PD-L1 staining in gastric or GEJ adenocarcinoma specimens
Trust the ONE PD-L1 test FDA-approved to determine PD-L1 expression in patients with gastric or GEJ adenocarcinoma

Proven in KEYNOTE-059, a KEYTRUDA clinical trial, for PD-L1 results in gastric or GEJ adenocarcinoma that you can rely on

  • PD-L1 IHC 22C3 pharmDx was used to assess PD-L1 expression in patients treated with KEYTRUDA in the KEYNOTE-059 trial
    • Fifty-eight percent of patients had tumors that expressed PD-L1 with a Combined Positive Score (CPS)* of greater than or equal to 1
    • After failing 2 or more prior therapies, gastric or GEJ adenocarcinoma patients with PD-L1 expression and microsatellite stable tumor status (or unknown) demonstrated an overall response rate of 13.3%

PD-L1 Prevalence in Patients with Gastric or GEJ Adenocarcinoma Enrolled in KEYNOTE-059

Intended Use

For in vitro diagnostic use.

PD-L1 IHC 22C3 pharmDx is a qualitative immunohistochemical assay using Monoclonal Mouse Anti-PD-L1, Clone 22C3 intended for use in the detection of PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC), gastric or gastroesophageal junction (GEJ) adenocarcinoma, cervical cancer and urothelial carcinoma tissues using EnVision FLEX visualization system on Autostainer Link 48.

Non-Small Cell Lung Cancer (NSCLC) PD-L1 protein expression in NSCLC is determined by using Tumor Proportion Score (TPS), which is the percentage of viable tumor cells showing partial or complete membrane staining at any intensity. The specimen should be considered to have PD-L1 expression if TPS ≥ 1% and high PD-L1 expression if TPS ≥ 50%.

PD-L1 IHC 22C3 pharmDx is indicated as an aid in identifying NSCLC patients for treatment with KEYTRUDA® (pembrolizumab). See the KEYTRUDA® product label for expression cutoff values guiding therapy in specific clinical circumstances.

Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma PD-L1 protein expression in gastric or GEJ adenocarcinoma is determined by using Combined Positive Score (CPS), which is the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100. The specimen should be considered to have PD-L1 expression if CPS ≥ 1.

PD-L1 IHC 22C3 pharmDx is indicated as an aid in identifying gastric or GEJ adenocarcinoma patients for treatment with KEYTRUDA® (pembrolizumab).

Cervical Cancer PD-L1 protein expression in cervical cancer is determined by using Combined Positive Score (CPS), which is the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100. The specimen should be considered to have PD-L1 expression if CPS ≥ 1.

PD-L1 IHC 22C3 pharmDx is indicated as an aid in identifying cervical cancer patients for treatment with KEYTRUDA® (pembrolizumab).

Urothelial Carcinoma PD-L1 protein expression in urothelial carcinoma is determined by using Combined Positive Score (CPS), which is the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100. The specimen should be considered to have PD-L1 expression if CPS ≥ 10.

PD-L1 IHC 22C3 pharmDx is indicated as an aid in identifying urothelial carcinoma patients for treatment with KEYTRUDA® (pembrolizumab). See the KEYTRUDA® product label for specific clinical circumstances guiding PD-L1 testing.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

References: 1. PD-L1 IHC 22C3 pharmDx [package insert]. Carpinteria, CA: Dako, Agilent Pathology Solutions; 2018. 2. Keytruda [package insert]. Kenilworth, NJ: Merck & Co., Inc.; 2018. 3. American Cancer Society. Global cancer facts & figures 3rd edition. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/global-cancer-facts-and-figures/global-cancer-facts-and-figures-3rd-edition.pdf. Published 2015. Accessed September 27, 2017. 4. Kanagavel D, Fedyanin M, Tryakin A, Tjulandin S. Second-line treatment of metastatic gastric cancer: Current options and future directions. World J Gastroenterol. 2015;21(41):11621-11635. 5. Ji SH, Lim DH, Yi SY, et al. A retrospective analysis of second-line chemotherapy in patients with advanced gastric cancer. BMC Cancer. 2009;9:110.

For countries outside of the United States, see the local KEYTRUDA product label for approved indications and expression cutoff values to guide therapy.