KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Clinical Trial Results
Advanced Merkel Cell Carcinoma
KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Clinical Findings for KEYNOTE-017
Objective Response Rate and Duration of Response in KEYNOTE-017
Objective Response Rate (ORR)
In 50 patients with advanced MCCResponse(95% CI, 13–38)
Response(95% CI, 20–47)
Duration of Response (DOR)
KEYTRUDA 2 mg/kg Q3W (n=28) |
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Median DORNot Reached |
Patients with responses lasting ≥6 months96%(n=27/28) |
Patients with responses lasting ≥12 months54%(n=15/28) |
Study Design for KEYNOTE-017
Study Overview
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Study Arms
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Patient Characteristics
- Median age was 71 years (range: 46–91 years)
- 80% were aged ≥65 years
- 68% male
- 90% white
- 48% had an ECOG PS of 0
- 52% had an ECOG PS of 1
- 14% had stage IIIB disease and 86% had stage IV
- 84% had prior surgery and 70% had prior radiation therapy
Dosing With KEYTRUDA in Advanced MCC
For adult patients:
The recommended dose of KEYTRUDA in adults is 200 mg Q3W or 400 mg Q6W administered after dilution as an intravenous infusion over 30 minutes until disease progression, unacceptable toxicity, or up to 24 months.
For pediatric patients:
The recommended dose of KEYTRUDA in pediatric patients is 2 mg/kg (up to a maximum of 200 mg), administered after dilution as an intravenous infusion over 30 minutes Q3W until disease progression, unacceptable toxicity, or up to 24 months.
No premedication is necessary with KEYTRUDA for adult or pediatric patients.
See full Prescribing Information for preparation and administration instructions and dosage modifications for adverse reactions.
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)
Category 2A = Based upon lower-level evidence, there is uniform National Comprehensive Cancer Network® (NCCN®) consensus that the intervention is appropriate.1
Preferred intervention = Intervention that is based on superior efficacy, safety, and evidence; and, when appropriate, affordability.1
NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.