1149 - Ipilimumab for advanced melanoma in an Expanded Access Programme (EAP): ocular, mucosal and acral subtype UK experience

Date 28 September 2012
Event ESMO Congress 2012
Session Publication Only
Topics Cytotoxic agents
Skin cancers
Melanoma
Therapy
Biological therapy
Presenter Heather Shaw
Authors H. Shaw1, J. Larkin2, P. Corrie3, S. Ellis4, J. Nobes5, E. Marshall6, S. Kumar7, S. Danson8, R. Plummer9, P. Nathan10
  • 1Mount Vernon Cancer Centre, HA6 2RN - Northwood/UK
  • 2Department Of Medicine, Royal Marsden Hospital, London/UK
  • 3Oncology Centre, Cambridge University Hospitals NHS Foundation Trust, Cambridge/UK
  • 4Department Of Oncology, Southampton General Hospital, Southampton/UK
  • 5Department Of Medicine, Norfolk and Norwich University Hospital, Norwich/UK
  • 6Oncology, Clatterbridge Centre for Oncology, Liverpool/UK
  • 7Department Of Oncology, Velindre Cancer Centre, CARDIFF/UK
  • 8Department Of Oncology, Weston Park Hospital, SHEFFIELD/UK
  • 9Medical Oncology, Northern Institute for Cancer Research, University of Newcastle upon Tyne, Newcastle/UK
  • 10Cancer Services, Mount Vernon Cancer Centre, HA6 2RN - Northwood/UK

Abstract

Background

Ipilimumab (Ipi) is a fully human monoclonal antibody against CTLA-4 which acts to promote an anti-tumour immune response. Previous phase III randomised controlled trials showing improved overall survival (OS) in metastatic or unresectable cutaneous melanoma excluded those of ocular (OM) or mucosal (MuM) origin and provided no data for acral melanoma (AM). These patients (pts) were permitted Ipi treatment in the setting of the EAP. Participating UK centres were asked to report data relating to the outcome of Ipi treatment in pts with rare melanoma types.

Methods

Patients with unresectable stage III/IV disease were treated within the Ipi EAP protocol at an induction dose of 3mg/kg for up to 4 cycles. RECIST criteria were used for response assessment at baseline, 12 weeks and every 12 weeks thereafter. Documentation of adverse events (AEs) and immune-related AEs (ir-AEs) was according to CTCAE v3.0.

Results

27 pts; 18 ocular (66%), 5 acral (19%) and 4 mucosal (15%); received at least one cycle of Ipi across 8 UK centres. All had previously received one or more lines of therapy for their disease. Two pts (40%) with AM had a partial response (PR), with a median duration of response of 22 wks (range: 20-24).One pt (25%) with MuM and 3 pts (17%) with OM had stable disease (SD), with a further OM pt demonstrating a mixed response. The median progression free survival (PFS) was 12 wks for the single MuM case and 14.5 wks (range: 6-64) in OM. 5 episodes of G3 ir-AEs were reported in 4 pts (3 colitis, 2 hepatitis), and 2 G3/4 AEs of fatigue. These resolved on steroid therapy.

Conclusion

Partial responses were seen in metastatic acral but not mucosal or ocular melanoma in this setting. Given the small sample size it is difficult to accurately interpret outcome data. Activity of ipilimumab in rare melanoma subtypes needs to be assessed in prospective studies.

Disclosure

J. Larkin: I have received honoraria from BMS.

P. Corrie: I have undertaken consultancy work and advisory Boards for BMS.

J. Nobes: I have been sponsored by BMS to attend conferences.

E. Marshall: I have received previous honoraria for serving on an advisory board for BMS.

S. Kumar: I have served on the advisory board for BMS.

R. Plummer: I have received honoraria for advisory boards to BMS.

P. Nathan: I have received compensation for advisory board and speakers panel from BMS.

All other authors have declared no conflicts of interest.