1077P - A meta-analysis of immune-related adverse events (irAE) of immune checkpoint inhibitors (ICI) from cancer clinical trials

Date 09 October 2016
Event ESMO 2016 Congress
Session Poster display
Topics Immunotherapy
Presenter Badi El Osta
Citation Annals of Oncology (2016) 27 (6): 359-378. 10.1093/annonc/mdw378
Authors B. El Osta1, F. Hu2, R. Sadek2, R. Chintalapally1, S. Tang1
  • 1Hematology / Oncology, Georgia Cancer Center at Augusta University, 30912 - Augusta/US
  • 2Biostatistics, Georgia Cancer Center at Augusta University, 30912 - Augusta/US



Targeting immune checkpoints is a novel and growing strategic approach in cancer therapy. This strategy may trigger irAE. We hypothesize that more patients (pts) will develop irAE with ICI targeting only immune cells compared to ICI targeting tumor cells as well (PD-L1). In addition, we want to determine specific irAE profile and overall response rate (ORR) for each of the ICI by target(s).


We reviewed all ICI cancer clinical trials (103; 201 arms) that reported irAE and were published on PubMed or presented at an ASCO meeting (only if not published on PubMed) during 2005-2015. 127 arms from 81 trials were eligible for this meta-analysis (11400 pts). We collected and compared arm-specific data including ICI target, number of pts with irAE any grade, grade 3+ and grade 5, specific irAE, and ORR. R package “meta” was used for the meta-analysis to calculate and compare % of pts with irAE and ORR.


23 studies with 2392 pts from 34 arms treated with ICI reported the incidence (%) of patients with any grade irAE per immune checkpoint target inhibition. The majority of arms (91%) and pts (88%) studied were on phase 1/2 clinical trials. Pts were treated for solid malignancy on 33 arms (97%), mainly melanoma (44.1%). No arms included ICI combinations. Incidence (%) of pts with irAE any grade was higher with ICI targeting CTLA-4 (54%) than PD-1 (26%) and PD-L1 ICI (13.7%) (P


Our meta-analysis supported our mechanistic-driven hypothesis that ICI targeting only immune cells caused more pts to develop irAE. Most specific irAE % and ORR were highest with PD-1/CTLA-4 ICI combination. Our observation is important to guide designing future ICI combination clinical trials. We encourage investigators to report % pts with global irAE in ICI trials.

Clinical trial identification


Legal entity responsible for the study

Georgia Cancer Center at Augusta University


Georgia Cancer Center at Augusta University


All authors have declared no conflicts of interest.