Pembrolizumab for the treatment of advanced melanoma

1. For patients with unresectable melanoma or metastatic melanoma that progressed despite treatment, pembrolizumab treatment resulted in objective response rate of 33%, 12-month progression-free survival rate of 35%, and median overall survival of 23 months.

2. Pembrolizumab administration was associated with a 14% rate of grade 3 or 4 treatment-related adverse events.

Evidence Rating Level: 1 (Excellent)

Study Rundown: Pembrolizumab is a monoclonal antibody that blocks the programmed death-1 pathway, and is used for unresectable melanoma or metastatic melanoma that has progressed after first line treatments. The purpose of this study was to determine the effects of pembrolizumab in terms of antitumor activity and overall survival in patients with advanced melanoma. In an open-label, multi-cohort study across academic medical centers in four countries, data was pooled from 655 enrolled patients and 520 patients from randomized cohorts. Objective responses were reported in 33% of patients with measurable disease and in 45% of patients who were treatment-naïve. Twelve-month progression-free survival rates were 35% in the total population and 52% in treatment-naïve patients. Median overall survival in the total population was 23 months compared to 31 months in the treatment-naïve group. About 14% of patients had 1 treatment-related grade 3 or 4 adverse event, and 9% of patients had a treatment-related serious adverse effect, with no drug-related deaths.

Overall, this study presents response rates and survival rates with pembrolizumab administration. It benefited from having patients enrolled at numerous centers around the world and having a follow-up of 21 months. Further studies are needed to compare pembrolizumab to current standard of care therapies.

Click to read the study in JAMA (Journal of the American Medical Association)

Relevant Reading: The blockade of immune checkpoints in cancer immunotherapy.

In-Depth [randomized controlled trial]: This open-label, multi-cohort clinical trial looked to determine the tumor response rates and the overall survival among patients with advanced melanoma treated with pembrolizumab. Specifically, data was pooled from 655 enrolled patients and 520 patients from randomized cohorts from academic medical centers in four countries. Patients had to have unresectable melanoma or metastatic melanoma that had progressed after first-line treatments. Objective responses were reported in 33% (95%CI 30-37%) of patients with measurable disease and in 45% (95%CI 36-54%) of patients who were treatment-naïve. Twelve-month progression-free survival rates were 35% (95%CI 31-39%) in the total population and 52% (95%CI 43-60%) in treatment-naïve patients. Median overall survival in the total population was 23 months (95%CI 20-29 months) compared to 31 months (95%CI 24-not reached) in the treatment-naïve group. Approximately 14% of patients had 1 treatment-related grade 3 or 4 adverse event, and 9% of patients had a treatment-related serious adverse effect, with no drug-related deaths.

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