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Pembrolizumab for advanced melanoma: experience from the Spanish Expanded Access Program
M González-Cao1, A Arance2, J M Piulats3
1Translational Cancer Research Unit, Dr. Rosell Oncology Institute, Quiron Dexeus University Hospital, 08028, Barcelona, Spain. mgonzalezcao@oncorosell.com.
Background:
The programmed death (PD-1) inhibitor pembrolizumab has been recently approved for the treatment of advanced melanoma. We evaluated the clinical activity of pembrolizumab in melanoma patients treated under the Spanish Expanded Access Program.
Methods:
Advanced melanoma patients who failed to previous treatment lines were treated with pembrolizumab 2 mg/kg every three weeks. Patients with brain metastases were not excluded if they were asymptomatic. Data were retrospectively collected from 21 centers in the Spanish Melanoma Group.
Results:
Sixty-seven advanced melanoma patients were analyzed. Most patients were stage M1c (73.1%), had high LDH levels (55.2%) and had ECOG PS 1 or higher (59.7%). For cutaneous melanoma patients, median overall survival was 14.0 months; the 18-month overall survival rate was 47.1%. Overall response rate was 27%, including three patients with complete responses (6.5%). Median response duration was not reached, with 83.3% of responses ongoing (3.5 m+ to 20.4 m+). From ten patients included with brain metastases, four (40%) had an objective response, two (20%) of them achieved a complete response. Significant prognostic factors for overall survival were LDH level, ECOG PS and objective response. There were no serious adverse events.
Conclusion:
Although this was a heavily pretreated cohort, pembrolizumab activity at the approved dose and schedule was confirmed in the clinical setting with long-term responders, also including patients with brain metastases.
Insights
Pembrolizumab, a programmed death (PD-1) inhibitor, demonstrated clinical activity in advanced melanoma patients. This treatment showed durable responses, even in those with brain metastases, confirming its efficacy in real-world settings.
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.
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