Clinical activity and safety of Pembrolizumab in Ipilimumab pre-treated patients with uveal melanoma

Abstract

Background: Untreated metastatic uveal melanoma (“UM”) carries a grave prognosis. Unlike cutaneous melanoma (“CM”) there are no established treatments known to significantly improve outcomes for a meaningful proportion of patients. Inhibition of the PD1-PDL1 axis has shown promise in the management of cutaneous melanoma and we here report a two centre experience of UM patients receiving pembrolizumab.

Methods: To assess the efficacy and safety of pembrolizumab we retrospectively analysed outcome data of 25 consecutive UM patients participating in the MK3475 expanded access programme who received pembrolizumab at 2mg/kg 3 weekly. Tumour assessment was evaluated using RECIST 1.1 and immune-related Response Criteria (“irRC”) by CT scanning. Toxicity was recorded utilising Common Terminology Criteria for Adverse Events (“CTCAE”) v4.03.

Results: 25 patients were identified receiving a median of 6 cycles of treatment. Two patients achieved a partial response and 6 patients stable disease. After a median follow-up of 225 days median progression free survival was 91 days and overall survival was not reached. There was a significant trend for improved outcomes in patients with extrahepatic disease progression as opposed to liver only progression at the outset. 5 patients experienced grade 3 or 4 adverse events; there were no treatment related deaths.

Conclusions: Pembrolizumab 2mg/kg q3w is a safe option in UM patients. Disease control rates, particularly in the subgroup of patients without progressive liver disease at the outset are promising; these results merit further investigation in clinical trials possibly incorporating liver targeted treatment modalities.

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