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PD-L1 IHC 22C3 pharmDx testing for Cervical Cancer

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PD-L1 IHC 22C3 pharmDx can help identify cervical cancer patients for treatment with KEYTRUDA

PD-L1 is a proven biomarker for patient response to KEYTRUDA in cervical cancer

  • Cervical cancer is the third most common gynecologic cancer in the United States
  • Patients with metastatic cervical cancer have poor prognosis—the median overall survival is only one year, with short-lived responses to treatment and rapid deterioration of quality of life
  • Anti-PD-1 therapies are a promising new treatment class for many cancer types—the KEYNOTE-158 clinical trial studied the efficacy of KEYTRUDA, an anti-PD-1 monotherapy, in patients with recurrent or metastatic cervical cancer
  • IHC testing for PD-L1 expression levels enables identification of patients most likely to benefit from anti-PD-1 monotherapy
Trust the ONE PD-L1 test FDA-approved to determine PD-L1 expression in patients with cervical cancer

Proven in KEYNOTE-158 for PD-L1 results in cervical cancer that you can rely on

PD-L1 IHC 22C3 pharmDx was the only IHC assay used to assess patients for PD-L1 expression in the KEYNOTE-158 trial

* Prevalence calculation based on patients with known PD-L1 expression (Cohort E, n=97)—1 patient (1% of the cohort) had unknown PD-L1 expression status; Efficacy results based on patients in KEYNOTE-158 Cohort E with tumors that expressed PD-L1 with a CPS ≥ 1 and who received at least one line of chemotherapy in the metastatic setting (n=77)

PD-L1 IHC 22C3 pharmDx Cervical Cancer Interpretation Training Program Get the training that may help you accurately evaluate and score PD-L1 expression in patients with cervical cancer
PD-L1 IHC 22C3 pharmDx Cervical Cancer Interpretation Manual Refer to the Cervical Cancer Interpretation Manual to review validated scoring guidelines that can help identify patients for treatment with KEYTRUDA
PD-L1 testing with PD-L1 IHC 22C3 pharmDx should be an integral part of patient care from day ONE

Because durations of response are short at first line and there is no standard of care at second line, it is critical to assess PD-L1 expression status upon diagnosis

  • Platinum-based chemotherapy regimens are the most common first-line treatment for metastatic cervical cancer
  • However, treatment efficacy is variable, with patients experiencing progression-free survival (PFS) of less than one year
  • Additionally, following first-line treatment, there is no universally accepted standard of care, and PFS is even shorter, typically less than six months

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. Reddy OL, Shintaku PI, Moatamed NA. Programmed death-ligand 1 (PD-L1) is expressed in a significant number of the uterine cervical carcinomas. Diagn Pathol. 2017;12(1):45. 4. Siegel RL, Miller KD, Jemal A. Cancer statistics, 2016. CA Cancer J Clin. 2016;66(1):7-30. 5. Borcoman E, Tourneau CL. Pembrolizumab in cervical cancer: latest evidence and clinical usefulness. Ther Adv Med Oncol. 2017;9(6):431-439. 6. Marth C, Landoni F, Mahner S, McCormack M, Gonzalez-Martin A, Colombo N, for ESMO Guidelines Committee. Cervical cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2017;28(suppl 4):iv72-iv83. 7. Boussios S, Seraj E, Zarkavelis G, et al. Management of patients with recurrent/advanced cervical cancer beyond first line platinum regimens: Where do we stand? A literature review. Crit Rev Oncol Hematol. 2016;108:164-174.

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