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Open Access 01-07-2019 | Metastasis | Original Article

Pembrolizumab as first-line treatment for metastatic uveal melanoma

Authors: Ernesto Rossi, Monica Maria Pagliara, Daniela Orteschi, Tommaso Dosa, Maria Grazia Sammarco, Carmela Grazia Caputo, Gianluigi Petrone, Guido Rindi, Marcella Zollino, Maria Antonietta Blasi, Alessandra Cassano, Emilio Bria, Giampaolo Tortora, Giovanni Schinzari

Published in: Cancer Immunology, Immunotherapy | Issue 7/2019

Abstract

Background

No standard treatment has been defined for metastatic uveal melanoma (mUM). Although clinical trials testing Nivolumab/Pembrolizumab for cutaneous melanoma did not include mUM, anti PD-1 agents are commonly used for this disease.

Patients and methods

In this prospective observational cohort single arm study, we investigated efficacy and safety of Pembrolizumab as first-line therapy for mUM. The efficacy was evaluated in terms of progression-free survival (PFS), response rate and overall survival (OS). Toxicity was also assessed.

Results

Seventeen patients were enrolled. A median of 8 cycles were administered (range 2–28). Two patients achieved partial response (11.7%), 6 a disease stabilization (35.3%), whereas 9 (53%) had a progression. No complete response was observed. PFS of the overall population was 3.8 months. PFS was 9.7 months for patients with an interval higher than 5 years from diagnosis of primary tumor to metastatic disease and 2.6 months for patients with an interval lower than 5 years [p = 0.039, HR 0.2865 (95% CI 0.0869–0.9443)]. Median OS was not reached. The two responding patients were still on treatment with Pembrolizumab at the time of data analysis. Survival was 12.8 months for patients with clinical benefit, while OS for progressive patients was 3.1 months. PD-L1 expression and genomic abnormalities predictive of relapse after diagnosis of primary tumor were not associated with PFS. Toxicity was mild, without grade 3–4 side effects.

Conclusions

The efficacy of Pembrolizumab does not seem particularly different when compared to other agents for mUM, but responding patients had a remarkable disease control.

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Title: Pembrolizumab as first-line treatment for metastatic uveal melanoma
Authors: Ernesto Rossi
Monica Maria Pagliara
Daniela Orteschi
Tommaso Dosa
Maria Grazia Sammarco
Carmela Grazia Caputo
Gianluigi Petrone
Guido Rindi
Marcella Zollino
Maria Antonietta Blasi
Alessandra Cassano
Emilio Bria
Giampaolo Tortora
Giovanni Schinzari
Publication date: 01-07-2019
Publisher: Springer Berlin Heidelberg
Keywords: Metastasis
Choroidal Melanoma
Published in: Cancer Immunology, Immunotherapy / Issue 7/2019
Print ISSN: 0340-7004
Electronic ISSN: 1432-0851
DOI: https://doi.org/10.1007/s00262-019-02352-6

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