Pembrolizumab for advanced melanoma: experience from the Spanish Expanded Access Program

Area of Science:

• Oncology
• Immunotherapy
• Melanoma Research

Background:

• Pembrolizumab, a programmed death (PD-1) inhibitor, is approved for advanced melanoma.
• The Spanish Expanded Access Program provided access to this treatment for eligible patients.

Purpose of the Study:

• To evaluate the clinical activity and outcomes of pembrolizumab in advanced melanoma patients.
• To assess the efficacy of pembrolizumab in a real-world clinical setting.

Main Methods:

• Retrospective analysis of 67 advanced melanoma patients treated with pembrolizumab (2 mg/kg every three weeks).
• Inclusion of patients with asymptomatic brain metastases.
• Data collected from 21 centers within the Spanish Melanoma Group.

Main Results:

• Median overall survival of 14.0 months and an 18-month survival rate of 47.1% for cutaneous melanoma.
• Overall response rate of 27%, with 6.5% complete responses; responses were durable.
• Objective response in 40% of patients with brain metastases, including complete responses.

Conclusions:

• Pembrolizumab demonstrated confirmed clinical activity in a heavily pretreated advanced melanoma cohort.
• The treatment showed potential for long-term responses, including in patients with brain metastases.
• Efficacy was observed in a real-world clinical setting at the approved dose and schedule.