410P - Ipilimumab efficacy and safety profile in metastatic melanoma in Saskatchewan

Date 18 December 2016
Event ESMO Asia 2016 Congress
Session Poster lunch
Topics Cancer Immunology and Immunotherapy
Melanoma and other Skin Tumours
Presenter Neha Papneja
Citation Annals of Oncology (2016) 27 (suppl_9): ix126-ix129. 10.1093/annonc/mdw589
Authors N. Papneja1, C. Olson2, C.H. Lee3, H. Lim4, R. Bryce3, K. Gesy2, N. Iqbal5, T. Abbas5
  • 1Department Of Medicine, Saskatoon Cancer Centre University of Saskatchewan, S7N 0W8 - Saskatoon/CA
  • 2Department Of Pharmacy, Saskatoon Cancer Centre University of Saskatchewan, S7N 0W8 - Saskatoon/CA
  • 3Clinical Research Support Unit, Saskatoon Cancer Centre University of Saskatchewan, S7N 0W8 - Saskatoon/CA
  • 4Department Of Community Health And Epidemiology, Saskatoon Cancer Centre University of Saskatchewan, S7N 0W8 - Saskatoon/CA
  • 5Saskatchewan Cancer Agency, Saskatoon Cancer Centre University of Saskatchewan, S7N 0W8 - Saskatoon/CA

Abstract

Background

Ipilimumab is a recombinant, human monoclonal antibody that inhibits cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), and thus, potentiates anti-tumor T-cell response. This study objective was to assess overall efficacy and safety profile of Ipilimumab in metastatic melanoma patients in community settings.

Methods

This is a retrospective observational study that examined all metastatic melanoma patients who received greater than one dose of Ipilimumab 3mg/kg in Saskatchewan from September 2012 – April 2016 as first or second line therapy. Clinical data obtained from patients’ records include the following: patient’s and disease characteristics, previous treatments, next line of treatment, TTF, median OS and side effects profile.

Results

There were 42 patients who received Ipilimumab. We excluded 1 patient, as an age criterion was not met. The median overall survival time for the 41 patients was 7.5 months (95% confidence interval [CI], 4.3 to 11.5). There were 27 patients who deceased secondary to their metastatic melanoma. There are 14 patients who are still alive, of which 7 patients have noteworthy survival times ranging from 13.0 to 28.5 months to date. The one-year survival rate is 28.4%. The TTF instead of progression free survival (PFS) was assessed in this study as with Ipilimumab pseudo-progression is initially observed. The median TTF was 5.8 months (95% CI, 3.9 to 7.5). There are 4 patients who required no further treatment and are still alive. The longest ongoing time without treatment failure to date is 15.0 months. The toxicity profile was similar to that identified in published literature and most commonly included: diarrhea, rash, fatigue and abnormal liver function tests.

Conclusions

Saskatchewan patients who received Ipilimumab have median overall survival and time to treatment failure results that are comparable to the original clinical trial. This supports the utilization of Ipilimumab as it has similar efficacy and safety profile in community settings. This demonstrates the clinical benefit of immunotherapy achieved in a tightly controlled clinical trial setting can be replicated in a real world clinical practice.

Clinical trial indentification

Legal entity responsible for the study

Neha Papneja

Funding

Saskatchewan Cancer Agency - University of Saskatchewan

Disclosure

All authors have declared no conflicts of interest.