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PD-L1 IHC 22C3 pharmDx for Urothelial Carcinoma

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PD-L1 Testing in Urothelial Carcinoma
Clinical Trial Results
Importance of Early PD-L1 Testing
PD-L1 IHC 22C3 pharmDx can help identify urothelial carcinoma patients for treatment with KEYTRUDA

PD-L1 is a proven biomarker for patient response to KEYTRUDA in urothelial carcinoma

  • Urothelial carcinoma is the fifth most common cancer in the United States and there is an urgent need for new effective treatments for patients
  • For patients with advanced/metastatic urothelial carcinoma, the five-year survival rate is approximately 15%, and cancer-related mortality has not improved in the past 30 years
  • Anti-PD-1 therapies are a promising new treatment class for many cancer types–the KEYNOTE-052 clinical trial studied the efficacy of KEYTRUDA, an anti-PD-1 monotherapy, at first-line in patients with locally advanced or metastatic urothelial carcinoma who were ineligible for cisplatin-containing chemotherapy
  • IHC testing for PD-L1 expression levels enables identification of patients most likely to benefit from anti-PD-1 monotherapy
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PD-L1 IHC 22C3 pharmDx:
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Trust the ONE companion diagnostic FDA-approved to determine PD-L1 expression in patients with urothelial carcinoma for treatment with KEYTRUDA

Proven in KEYNOTE-052 for PD-L1 results in urothelial carcinoma

  • PD-L1 IHC 22C3 pharmDx was the only IHC assay used to assess PD-L1 expression in the KEYNOTE-052 clinical trial
  • PD-L1 IHC 22C3 pharmDx offers the assurance of the only PD-L1 test FDA-approved as a companion diagnostic for KEYTRUDA
PD-L1 IHC 22C3 pharmDx Urothelial Carcinoma Interpretation Manual Refer to the Urothelial Carcinoma Interpretation Manual to review validated scoring guidelines that can help identify patients for treatment with KEYTRUDA
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PD-L1 IHC 22C3 pharmDx Urothelial Carcinoma Interpretation Training Program Get the training that may help you accurately evaluate and score PD‑L1 expression in patients with urothelial carcinoma
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Online Atlas of Stains for Urothelial Carcinoma: PD‑L1 IHC 22C3 pharmDx Use the Online Atlas of Stains for Urothelial Carcinoma to increase your familiarity with PD-L1 staining in urothelial carcinoma specimens
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PD-L1 testing with PD-L1 IHC 22C3 pharmDx should be an integral part of patient care from day ONE

Early PD-L1 testing can provide critical information for physicians managing urothelial carcinoma patients who are ineligible for cisplatin-containing chemotherapy

  • For patients ineligible for cisplatin-containing chemotherapy, there is a significant unmet need for treatment alternatives
  • Age- and disease-associated comorbidities of urothelial carcinoma patients, including renal dysfunction and poor performance status, affect treatment choices and eligibility for standard cisplatin-containing chemotherapy
    • In clinical practice, these comorbidities may be exacerbated by cisplatin-related toxicities
  • There is no standard of care for patients ineligible for standard cisplatin-containing chemotherapy

* 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. Gupta S, Gill D, Poole A, Agarwal N. Systemic immunotherapy for urothelial cancer: current trends and future directions. Cancers. 2017;9(15):1-14. 4. Bellmunt J, Mottet N, De Santis M. Urothelial carcinoma management in elderly or unfit patients. EJC Suppl. 2016;14(1):1-20. 5. Balar AV, Castellano D, O'Donnell PH, et al. First-line pembrolizumab in cisplatin-ineligible patients with locally advanced and unresectable or metastatic urothelial cancer (KEYNOTE-052): A multicentre, single-arm, phase 2 study. Lancet. 2017;18(11):1483-1492. 6. Galsky MD, Hahn NM, Rosenberg J, et al. Treatment of patients with metastatic urothelial cancer "unfit" for cisplatin-based chemotherapy. J Clin Oncol. 2011;29(17):2432-2438.

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

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Intended Use