1129P - Ipilimumab (IPI) expanded access program (EAP) for patients (pts) with stage III/IV melanoma: safety data by subgroups

Date 01 October 2012
Event ESMO Congress 2012
Session Poster presentation III
Topics Cancer Immunology and Immunotherapy
Melanoma and other Skin Tumours
Presenter Donald Lawrence
Authors D. Lawrence1, D.F. McDermott2, O. Hamid3, J.S. Weber4, J.D. Wolchok5, J. Richards6, A. Amin7, K. Bennett8, A. Balogh9, F.S. Hodi10
  • 1Massachusetts General Hospital Cancer Center, Boston/US
  • 2Division Of Hematology/oncology, Beth Israel Deaconess Medical Center, Boston/US
  • 3Neuro-oncology Clinic, The Angeles Clinic and Research Institute, Los Angeles/US
  • 4H. Lee Moffitt Cancer Center & Research Institute, 12902 - Tampa, FL/US
  • 5Medicine, Memorial Sloan-Kettering Cancer Center, New York/US
  • 6Oncology Hematology, Oncology Specialists SC, 60068 - Park ridge/US
  • 7Levine Cancer Institute, Carolinas Medical Center, 28211 - Charlotte/US
  • 8Global Medical, Bristol-Myers Squibb, 08536 - Plainsboro/US
  • 9Global Biometrics Sciences, Bristol-Myers Squibb, B-1420 - Brain-l'Alleud/BE
  • 10Melanoma Center, Dana-Farber Cancer Institute, Boston/US

Abstract

Background

Treatment protocol CA184-045, a component of the EAP, provides a large safety database for IPI. Study 045 included pts with disease characteristics typically excluded from registrational clinical trials such as ECOG PS of 2, asymptomatic brain metastases (BM) and primary ocular (OM) and mucosal (MM) melanoma. We now report safety data by subgroups for pts treated in the US at 3 mg/kg from March 2010 through July 2011.

Table: 1129P

Total N = 2017 Age Group Melanoma Sub-type
< 65 yrs n = 1250 ≥ 65 yrs n = 767 BM** n = 686 OM** n = 118 MM** n = 112 All others n = 1150
Demographics, % Males < 65 yrs Received all 4 induction doses 64 62 59 61 – 58 69 – 60 67 72 49 50 63 59 51 58 53 65 57 65
Discontinuations, % Disease progression Study drug toxicity Adverse event Study terminated Other 93* 49 4 2 21 17 92* 52 3 1 20 16 93* 46 6 3 22 16 94* 56 4 3 16 15 93* 55 3 2 22 11 98* 55 5 2 25 11 92* 45 4 1 23 19
Select Grade 3/4 drug-related AEs, % Diarrhea Colitis GI Perforations Hepatitis Brain edema Pruritus Rash 3 3 0.3 <0.01 0.1 0.5 0.5 3 2 0.2 0 0.2 0.2 0.4 5 3 0.5 0.1 0.1 1 0.8 4 3 0.4 0 0.4 0.6 0.9 4 3 0.8 0 0 0.8 0 0.9 2 0 0 0 2 0 3 3 0.3 0.1 0 0.4 0.4
Deaths, % Disease Study drug toxicity 31 28 0.2 32 29 0.3 30 26 0 41 37 0.3 33 32 0 36 34 0 25 22 0.2

**Not mutually exclusive; *Off treatment before re-induction; ‡Terminated in US after FDA approval of IPI; † ≤ 70 days of last induction dose Conclusions: The incidence of Grade 3/4 drug-related AEs in pts with BM, OM and MM was similar to that for pts without the subtypes. Pts ≥ 65 yrs and < 65 yrs had similar AE profiles. These data suggest that treatment with IPI was generally tolerable for pts in select subgroups.

Methods

Eligible pts had unresectable Stage III or IV melanoma that progressed on at least 1 systemic therapy and had no alternate treatment options. Treatment algorithms were used for identification and management of immune-related adverse events (AEs). During induction, pts received 3 mg/kg IPI iv q 3 wks up to 4 doses. All AEs and on-study deaths were collected. This analysis includes events through 70 days post last induction dose.

Results

2017 pts were included in this analysis; 96% were Stage IV and 92% were ECOG 0-1. Median number of doses during induction was 4, except 3 for BM. Data from pts < 65 or ≥ 65 yrs and those with BM, OM, MM, or all others are summarized.

Disclosure

D.F. McDermott: BMS advisory board participant

O. Hamid: Speaker for BMS - Reimbursed Clinic reimbursed for work done on research trials.

J.S. Weber: BMS only honoraria less thank 10K dollars and advisory role in ad boards.

J.D. Wolchok: I am a consultant to BMS, Merck and GSK. I receive research funding from BMS.

J. Richards: Consultant and speaker for BMS.

A. Amin: Participated in the BMS speaker's bureau and advisory board during the last 2 years; unpaid investigator on EAP.

K. Bennett: Employed by BMS; Stock Ownership.

A. Balogh: Employed by BMS.

F.S. Hodi: Nonpaid consultant and received clinical trial support from BMS.

All other authors have declared no conflicts of interest.