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  • Poster presentation
  • Open Access

Correlation between immune-related adverse events and response to pembrolizumab in advanced melanoma patients

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Journal for ImmunoTherapy of Cancer20153 (Suppl 2) :P186

  • Published:


  • Melanoma
  • Overall Survival
  • Partial Response
  • Stable Disease
  • Median Duration


Immunomodulation with pembrolizumab (anti-PD-1) has been shown to reach significant objective response (RR) and extend overall survival (OS) both in ipilimumab pre-treated and naive patients with metastatic melanoma. While this immunotherapy gives OS and OR benefits, it can also result in immune-related adverse events (irAEs) which are generally of low grade and easily manageable. We retrospectively evaluated if there was a correlation between occurrence of irAEs with OR and disease control rate (DCR).


Inside the expanded access program, pembrolizumab was given in patients progressing after ipilimumab at dosage of 2 mg/kg every 3 weeks until PD or unacceptable toxicity. At our Institution 47 patients (25M, 22F) were treated. The median age was 49 years (range 28-70). All patients were stage M1c. The median duration of treatment was of 4.5 months (range 1-8).


At a median follow up of 3 months (range 1 – 8+), 11 (23.4%) pts had OR and 21 (44.7%) pts achieved DCR. In pts with grade 0/1 irAEs OR was 19.2% while in pts with grade ≥ 2 irAEs was 28.6%. OR was slightly higher among pts who experienced irAEs but the difference was not statistically significant (p = 0.45). Also DCR was slightly higher but not significant among those patients who experienced an irAEs (11/21, 52.4%) compared with those who did not (10/26, 38.5%) (p = 0.34). Among patients with grade 0/1 irAEs was observed 1 (3.8%) complete response (CR), 4 (15.4%) partial responses (PR), 5 (19.3%) stable disease (SD) and 16 (61.5%) progression of disease (PD), while in the group with irAEs was observed 1 (4.8%) CR, 5 (23.8%) PR, 5 (23.8%) SD and 10 (47.6%) PD.


OR and DCR with pembrolizumab are similarly observed among pts who develop irAEs or not. Thus, pts who do not experience an irAE have the same probability to reach clinical benefit with pembrolizumab than those who experienced irAEs

Authors’ Affiliations

Cancer Immunotherapy and Innovative Therapies Istituto Nazionale Tumori di Napoli Fondazione “G. Pascale”, O.U. Melanoma, Napoli, Italy
Cancer Immunotherapy and Innovative Therapies Istituto Nazionale Tumori di Napoli Fondazione, O.U. Melanoma, Napoli, Italy
Regina Elena National Cancer Institute, Rome, Roma, Italy
O.U. Melanoma and Sarcoma Surgery Istituto Nazionale Tumori di Napoli Fondazione “G. Pascale”, Napoli, Italy
Catholic University of Sacred Heart, Roma, Italy
Istituto Nazionale Tumori Fondazione G. Pascale, Naples, Italy


© Grimaldi et al. 2015

This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The Creative Commons Public Domain Dedication waiver ( applies to the data made available in this article, unless otherwise stated.