1116PD - Five-year survival rates for patients (pts) with metastatic melanoma (MM) treated with ipilimumab (IPI) in phase II trials

Date 29 September 2012
Event ESMO Congress 2012
Session Melanoma
Topics Cancer Immunology and Immunotherapy
Melanoma and other Skin Tumours
Presenter Celeste Lebbe
Authors C. Lebbe1, J.S. Weber2, M. Maio3, B. Neyns4, K. Harmankaya5, K. Chin6, D. Opatt McDowell7, L. Cykowski8, M.B. McHenry9, J.D. Wolchok10
  • 1Saint-louis Hospital, APHP University, Paris/FR
  • 2H. Lee Moffitt Cancer Center & Research Institute, 12902 - Tampa, FL/US
  • 3Division Of Medical Oncology And Immunotherapy, Azienda Ospedaliera Senese - Medical Oncology and Immunotherapy Unit, 53100 - Siena/IT
  • 4Medical Oncology, Vrije Universiteit Brussel, BE-1090 - Brussels/BE
  • 5Department Of General Clinical Dermatology, Medical University of Vienna, A-1090 - Vienna/AT
  • 6Global Clinical Research - Oncology, Bristol-Myers Squibb, 06492 - Wallingford/US
  • 7Global Medical, Bristol-Myers Squibb, 08540 - Lawrenceville/US
  • 8Global Clinical Operations, Bristol-Myers Squibb, 06492 - Wallingford/US
  • 9Global Biometrics Sciences, Bristol-Myers Squibb, 06492 - Wallingford/US
  • 10Medicine, Memorial Sloan-Kettering Cancer Center, New York/US

Abstract

Purpose

Two phase III, randomized trials showed statistically significant improvement in overall survival (OS) in MM pts treated with IPI and data from phase II/III studies of IPI suggest the potential for prolonged survival (beyond 4 yrs) in some pts with MM. Three phase I/II studies conducted at NCI demonstrated 5-yr survival rates of 13-25% (Prieto et al, CCR, 2012). Evaluation of the long-term survival benefit of IPI for MM pts from 3 additional completed phase II studies continues and we now report 5-yr survival data.

Methods

Trials included: (1) CA184-008, a single-arm study of IPI at 10 mg/kg in previously treated pts; (2) CA184-022, a dose-ranging study of IPI at 0.3, 3, or 10 mg/kg in previously treated pts with crossover from lower doses to 10 mg/kg allowed upon disease progression; and (3) CA184-007, a study of IPI at 10 mg/kg +/- prophylactic budesonide in treatment-naive and previously treated pts. IPI was given q 3 wks x 4 (induction); eligible pts could receive reinduction or maintenance IPI q 12 wks from Week 24. The analysis reports OS with updated last known alive date or death based on data collected through March 2012. Safety data for these trials have been previously published.

Results

Survival rates at 5 yrs ranged from 12-28% in pretreated pts and 38-50% in treatment-naive pts. The table summarizes median OS, previously reported yearly survival rates, and current 5-yr survival rates.

Trial N IPI dose (mg/kg) Median OS, months OS rate, %
1-yr 2-yr 3-yr 4-yr 5-yr
008 155* 10 10.2 47.2 32.8 23.3 19.7 18.2
022 72* 10 11.4 48.6 29.8 24.8 21.5 21.5
72* 3 8.7 39.3 24.2 19.7 18.2 16.5
73* 0.3 8.6 39.6 18.4 13.8 13.8 12.3
007 57 (total) 10 + placebo 19.3 62.4 41.8 34.4 32.0 32.0
32 30.5 71.4 56.6 42.5 37.7 37.7
25* 14.8 50.8 24.2 24.2 24.2 24.2
58 (total) 10 + budesonide 17.7 55.9 41.1 38.7 36.2 36.2
21 45.0 65.9 57.7 57.7 49.5 49.5
37* 8.5 49.9 31.6 28.4 28.4 28.4

*Previously treated; †Treatment naive.

Conclusions

Across studies, 5 yr OS rates appear similar to those at 4 years, suggesting that IPI monotherapy may result in prolonged survival in some pts with MM. Further research and analyses are needed to identify the pt population with MM most likely to achieve long term survival benefit from IPI therapy.

Disclosure

C. Lebbe: Participation to BMS Advisory Boards.

J.S. Weber: For BMS, only honoraria less than 10K dollars and advisory role in Ad Boards.

M. Maio: Paid Advisor in Boards from BMS and Roche.

B. Neyns: No conflict of interest to report with regards to this abstract.

K. Harmankaya: With Regards to conflict of interest in this abstract, unpaid investigator on this study.

K. Chin: Employed by BMS; Stock ownership.

D. Opatt McDowell: Employed by BMS; Stock ownership.

L. Cykowski: Employed by BMS; Stock ownership.

M.B. McHenry: Employed by BMS, Stock Ownership

J.D. Wolchok: I am a consultant to Bristol-Myers Squibb, Merck and Glaxo SmithKline. I receive research funding from Bristol-Myers Squibb.