Author of

• 20039

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  Poster Display Session (ID 63)

  • Event: ELCC 2017
  • Type: Poster Display Session
  • Track:
  • Presentations: 1
  • Moderators:
  • Coordinates: 5/07/2017, 12:30 - 13:00, Hall 1

  • 19871

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    115P - Immune related adverse events (irAE) and disease response with nivolumab in pre-treated advanced non-small cell lung cancer (NSCLC) (ID 428)

    12:30 - 12:30  |  Author(s): G. Mallesara
    • Abstract

    Background:
    IrAE with nivolumab are recognised. Incidence in practice and correlation with disease response in NSCLC has not been well characterised.
    
    Methods:
    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.
    
    Results:
    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.
    
    Conclusions:
    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
    
    Funding:
    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.
    
    Disclosure:
    All authors have declared no conflicts of interest.