Dr. Hamid on the FDA Approval of Pembrolizumab in Merkel Cell Carcinoma

Omid Hamid, MD
Published: Wednesday, Dec 19, 2018



Omid Hamid, MD, director of Research and Immuno-Oncology at The Angeles Clinic, discusses the FDA approval of pembrolizumab (Keytruda) for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma.

This accelerated approval was based on findings from the phase II CITN-09/KEYNOTE-017 trial (NCT02267603). In CITN-09/KEYNOTE-017, pembrolizumab elicited an overall response rate per indedependent review of 56% (95% CI, 41%-70%), as well as a 24% complete response rate and a 32% partial response rate, in patients who did not previously receive systemic therapy for their advanced disease. 

The FDA recommends a pembrolizumab dose for MCC of 200 mg administered intravenously every 3 weeks for adults. For pediatric patients, the PD-1 inhibitor should be given at 2 mg/kg, up to a maximum of 200 mg, IV every 3 weeks for patients <18 years of age.
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Omid Hamid, MD, director of Research and Immuno-Oncology at The Angeles Clinic, discusses the FDA approval of pembrolizumab (Keytruda) for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma.

This accelerated approval was based on findings from the phase II CITN-09/KEYNOTE-017 trial (NCT02267603). In CITN-09/KEYNOTE-017, pembrolizumab elicited an overall response rate per indedependent review of 56% (95% CI, 41%-70%), as well as a 24% complete response rate and a 32% partial response rate, in patients who did not previously receive systemic therapy for their advanced disease. 

The FDA recommends a pembrolizumab dose for MCC of 200 mg administered intravenously every 3 weeks for adults. For pediatric patients, the PD-1 inhibitor should be given at 2 mg/kg, up to a maximum of 200 mg, IV every 3 weeks for patients <18 years of age.

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Medical Crossfire®: Evolving Roles for Targeted Melanoma Therapies: Assessing Rapid Progress in the Field and Looking Toward Future CombinationsFeb 28, 20191.5
Advances in™ Melanoma: Exploring BRAF/MEK in Adjuvant and Neoadjuvant SettingsSep 28, 20191.5
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