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PD-L1 IHC 22C3 pharmDx for Urothelial Carcinoma

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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 carcinoma1,2

  • More than a third of all global incidences of urothelial carcinoma are reported in Europe, and few advancements in treatment have been made
  • Anti-PD-1 therapies are a promising new treatment class for many cancer types—the KEYNOTE-052 and KEYNOTE-045 clinical trials studied the efficacy of KEYTRUDA, an anti-PD-1 monotherapy, at first-line and second-line respectively, in specific urothelial carcinoma patient populations
  • IHC testing for PD-L1 expression levels enables identification of patients most likely to benefit from anti-PD-1 monotherapy
Learn more about
PD-L1 IHC 22C3 pharmDx:
Trust the ONE PD-L1 test CE-IVD–marked to determine PD-L1 expression in patients with urothelial carcinoma for KEYTRUDA treatment

Proven in KEYNOTE-052 and KEYNOTE-045 for PD-L1 results in urothelial carcinoma1,2

  • PD-L1 IHC 22C3 pharmDx was the only IHC assay used to assess PD-L1 expression in the KEYNOTE-052 and KEYNOTE-045 trials
    • KEYNOTE-052 evaluated objective response rate (ORR) in locally advanced or metastatic urothelial carcinoma patients ineligible for cisplatin-containing chemotherapy
    • KEYNOTE-045 evaluated overall survival in locally advanced or metastatic urothelial carcinoma patients previously treated with platinum-based chemotherapy
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
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
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
PD-L1 testing with PD-L1 IHC 22C3 pharmDx should be an integral part of patient care from day ONE

More than half of all patients with advanced urothelial carcinoma are ineligible for first-line cisplatin-based chemotherapy treatment

  • Renal dysfunction, poor performance status, or other comorbidities can cause patients to be ineligible for treatment
  • There is no standard of care for patients who can not receive cisplatin-based chemotherapy
  • Additionally, for patients who receive cisplatin-based chemotherapy and relapse, there is no standard of care and the median overall survival is reduced to 6–7 months

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA

References: 1. PD-L1 IHC 22C3 pharmDx [package insert]. Carpinteria, CA: Dako, Agilent Pathology Solutions; 2019. 2. Keytruda [package insert]. Hoddesdon, UK: Merck Sharp & Dohme Limited; 2019. 3. Antoni S, Ferlay J, Soerjomataram I, Znaor A, Jemal A, Bray F. Bladder cancer incidence and mortality: A global overview and recent trends. Eur Urol. 2017;71(1):96-108. 4. Choueiri TK, Ross RW, Jacobus S, et al. Double-blind, randomized trial of docetaxel plus vandetanib versus docetaxel plus placebo in platinum-pretreated metastatic urothelial cancer. J Clin Oncol. 2012;30(5):507-512. 5. Bellmunt J, Mottet N, De Santis M. Urothelial carcinoma management in elderly or unfit patients. EJC Suppl. 2016;14(1):1-20. 6. 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. 7. 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. 8. Bellmunt J, de Wit R, Vaughn DJ, et al. Pembrolizumab as second-line therapy for advanced urothelial carcinoma. N Engl J Med. 2017;376(11):1015-1026.

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

Review the PD-L1 IHC 22C3 pharmDx Intended Use