Skip to main content

Volume 3 Supplement 2

30th Annual Meeting and Associated Programs of the Society for Immunotherapy of Cancer (SITC 2015)

  • Poster presentation
  • Open access
  • Published:

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


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

Author information

Authors and Affiliations


Rights and permissions

Open Access  This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made.

The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder.

To view a copy of this licence, visit

The Creative Commons Public Domain Dedication waiver ( applies to the data made available in this article, unless otherwise stated in a credit line to the data.

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Grimaldi, A.M., Simeone, E., Festino, L. et al. Correlation between immune-related adverse events and response to pembrolizumab in advanced melanoma patients. j. immunotherapy cancer 3 (Suppl 2), P186 (2015).

Download citation

  • Published:

  • DOI: