PD-L1 IHC 22C3 pharmDx for Urothelial Carcinoma
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
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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
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IHC testing for PD-L1 expression levels enables identification of patients most likely to benefit from anti-PD-1 monotherapy
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
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
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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.