115P - Immune related adverse events (irAE) and disease response with nivolumab in pre-treated advanced non-small cell lung cancer (NSCLC)

Date 07 May 2017
Event ELCC 2017
Session Poster Display Session
Topics Immunotherapy
Thoracic Malignancies
Non-Small Cell Lung Cancer
Presenter Elizabeth Connolly
Citation Annals of Oncology (2017) 28 (suppl_2): ii28-ii51. 10.1093/annonc/mdx091
Authors E. Connolly, G. Mallesara, I. Nordman
  • Medical Oncology, Calvary Mater Hospital Newcastle, 2298 - Newcastle/AU



IrAE with nivolumab are recognised. Incidence in practice and correlation with disease response in NSCLC has not been well characterised.


A retrospective, descriptive analysis was carried out on 40 patients who received nivolumab on a compassionate access program from July 2015 to November 2016. Disease response was assessed by RECIST criteria.


The median age of patients was 63 years (range 28-80). 24 patients were female (60%). 17 received nivolumab as second line therapy, 12 as third line, 9 as fourth line, and 2 as fifth line. Best response included partial response (PR) in 15% (n = 6), stable disease (SD) in 40% (n = 16), progressive disease (PD) in 38% (n = 15) and unknown in 8% (n = 3). Treatment is ongoing in 30% (n = 12) (mean 6 months, range 2-18 months). 70% (n = 28) had irAE of any grade. Development of rash (n = 11; 28%) and pruritis (n = 10; 25%) were the most frequent irAE experienced. Grade 3 pruritus, pneumonitis, hepatitis, rash, arthralgia, and fatigue were seen. 2 patients developed grade 3 biopsy proven immune related colitis. Treatment requiring endocrinopathies occurred; hypothyroid (13%; n = 5), hyperthyroid (5%; n = 2) and hypoadrenal (5%; n = 2). Therapy was ceased due to grade 4 rash (n = 1), grade 3 hepatitis (n = 1), progressive neurological symptoms (n = 1) and psychiatric symptoms requiring hospital admission with no prior history of psychiatric illness (n = 1). The psychiatric and neurological symptoms resolved with treatment cessation and both patients have ongoing disease control on observation. A death occurred from suspected immune related hepatitis. Importantly, 5 of 6 patients who had PR developed grade 3 and above irAE. Of 13 patients who received treatment for greater than 3 months with SD, 11 developed irAE (85%). Of 10 patients on treatment for greater than 6 months with disease control (PR or SD); 7 developed grade 3 irAE or treatment requiring endocrinopathies. Of 10 non responders (PD within 3 months) 40% (n = 4) developed irAE; all grade 1. Clinically there appears to be a trend between response and development of irAE.


The irAE are in line with published data however are of higher incidence and severity in this case series. There may be a trend of response and development of irAE.

Clinical trial identification

not applicable

Legal entity responsible for the study

Calvary Mater Newcastle


Study conducted by Calvary Mater Newcastle. Nivolumab received on compassionate access programme from Bristol-Myers Squibb (BMS) however BMS have not been involved in data collection or interpretation.


All authors have declared no conflicts of interest.