20P - Extended survival analysis of ipilimumab for the treatment of advanced malignant melanoma in pretreated patients: Five-year long-term follow-up of...

Date 08 December 2017
Event ESMO Immuno-Oncology Congress 2017
Session Lunch & Poster Display session
Topics Central Nervous System Malignancies
Presenter Bernardo Rapoport
Citation Annals of Oncology (2017) 28 (suppl_11): xi6-xi29. 10.1093/annonc/mdx711
Authors B.L. Rapoport1, D. Vorobiof2, L. Dreosti3, A. Nosworthy4, G. McAdam5, A. Jordaan6, M. De Necker7, J. De Beer7, H. Duvenhage8
  • 1Medical Oncology, The Medical Oncology Centre of Rosebank, 2196 - Saxonwold/ZA
  • 2Med Onc, Sandton Oncology Centre, 2199 - Sandton/ZA
  • 3Medical Oncology, Pretoria Academic Hospital, 1 - Pretoria/ZA
  • 4Med Onc, University of Witwatersrand Medical School, 2193 - Johannesburg/ZA
  • 5Clinical Oncology, GVI Oncology, 7530 - Cape Town/ZA
  • 6Clinical Oncology, Westridge Medical Centre, 4000 - Durban/ZA
  • 7Biostatistics, TCD Outcomes Research, Pretoria/ZA
  • 8Immunoscience, Bristol Myers Squibb, 2191 - Woodmead/ZA



Ipilimumab is a human monoclonal IgG1 antibody against CTLA-4 that has been shown to prolong the overall survival of patients with advanced pretreated melanoma. In 2015, a retrospective, multi-centre, non-interventional analysis was per- formed on data collected from the ipilimumab expanded access programme in South Africa, with last follow-up date (or death) in December 2014. The current study extends this analysis by follow-up on the long-term survival of pre-treated metastatic patients up to September 2016.


Follow-up questions were sent to participating investigators, who had patients who were still alive (29) or for whom it was not known whether they were still alive (11) following the last ipilimumab infusion. Investigators had to confirm whether patients were still alive, the date of death or last contact, clinical response at last contact, and whether the patient was still responding to ipilimumab.


Of the 108 patients, 84 (78%) had cutaneous melanoma and 24 patients (22%) had non-cutaneous melanoma, including uveal, mucosal, and melanoma of unknown primary. Twenty patients previously received two or more lines of treatment for metastatic melanoma. The median age was 59 years (range 27 – 86) and there were 73 (68%) males and 35 (32%) females. Baseline ECOG PS was 0 in 33%, PS 1 in 58% and PS 2 in 6% of patients. The longest follow-up time available was 5.4 years. The median OS was 9.36 months (95% CI 7.48 – 11.84). One-year survival was 39% (95% CI 29% - 48%), 2-year survival was 22% (95% CI 15% - 30%), 3-year survival was 19% (95% CI 12% - 27%), 4- and 5-year survival was 15% (95% CI 8% - 21%). In the group of cutaneous melanoma patients, the 4- and 5-year survival was 17% (95% CI 9% - 25%) while in the non-cutaneous group the 4- and 5-year survival was 6% (95% CI 0% - 16%).


Ipilimumab at a dose of 3mg/kg is an effective treatment for patients with pre-treated advanced (unresectable or metastatic) melanoma and is associated with durable remissions and long-term survival.

Clinical trial identification

CA184-515 Ethics approval extended on protocol REC 2/21/05/14

Legal entity responsible for the study

Prof Bernardo L. Rapoport


Investigator Sponsored Research (ISR) trough Bristol-Myers Squibb South Africa


B.L. Rapoport: BMS South Africa: Advisor, Speaker Bureau, Contract Research and Funded Research; MSD: Advisor, Speaker Bureau and Contract Research; AstraZeneca: Advisor, Speaker Bureau and Contract Research; Roche South Africa: Advisor, Speaker Bureau and Contract Research. H. Duvenhage: BMS: Medical Director. All other authors have declared no conflicts of interest.