Long-term survival in patients with metastatic melanoma who received ipilimumab in four phase II trials.

Authors

null

Celeste Lebbé

Hôpital Saint-Louis, Paris, France

Celeste Lebbé , Jeffrey S. Weber , Michele Maio , Bart Neyns , Kaan Harmankaya , Omid Hamid , Steven O'Day , Kevin M. Chin , Diane Opatt McDowell , Lori Cykowski , Brent McHenry , Jedd D. Wolchok

Organizations

Hôpital Saint-Louis, Paris, France, Moffitt Cancer Center, Comprehensive Melanoma Research Center, Tampa, FL, University Hospital of Siena, Istituto Toscano Tumori, Siena, Italy, UZ Brussel, Brussels, Belgium, Department of Dermatology, Division of General Dermatology, Medical University of Vienna, Vienna, Austria, The Angeles Clinic and Research Institute, Santa Monica, CA, The Beverly Hills Cancer Center, Beverly Hills, CA, Bristol-Myers Squibb, Wallingford, CT, Bristol-Myers Squibb, Lawrenceville, NJ, Memorial Sloan-Kettering Cancer Center, New York, NY

Research Funding

Pharmaceutical/Biotech Company

Background: Ipilimumab (Ipi) has shown improved overall survival (OS) in two phase III trials of patients (pts) with metastatic melanoma (MM), with survival follow-up of >4 years in one trial. The present analyses provide survival follow-up of >5 years in four phase II trials of Ipi in MM. Methods: Pts with MM were enrolled in one of four phase II trials: (1) CA184-004, a biomarker study with Ipi at 3 or 10 mg/kg in treatment-naive (TN) and previously treated (PT) pts; (2) CA184-007, with Ipi at 10 mg/kg +/- prophylactic budesonide in TN and PT pts; (3) CA184-008, a single-arm study with Ipi at 10 mg/kg in PT pts; and (4) CA184-022, a dose-ranging study of Ipi at 0.3, 3, or 10 mg/kg in PT pts (crossover from lower dose groups to 10 mg/kg was allowed upon disease progression). Ipi was administered q3 wk x4 (induction), followed by maintenance (q12 wk from week 24) in eligible pts. Some pts were retreated with Ipi at 10 mg/kg upon disease progression. Along with survival data collected through March 2012 for studies 007, 008, and 022, we report updated 5-year OS data for study 004 collected through September 2012. Results: Five-year OS rates for TN and PT pts are reported in studies 007, 008, and 022, with combined analyses for TN and PT pts within each dose group in study 004 (Table). The results show that survival rates reach a plateau beginning at year 3. Conclusions: In pts who received Ipi at 3 or 10 mg/kg in phase II studies, regardless of prior treatment, a proportion (12.3–49.5%) remained alive 5 years after the start of treatment. These results demonstrate long-term survival with Ipi therapy in MM. An ongoing phase III trial will compare OS for Ipi at 3 vs 10 mg/kg in pts with MM. Clinical trial information: NCT00162123.

Trial N (prior Tx) Ipi dose
(mg/kg)
Median OS,
months
OS rate, %
1-yr 2-yr 3-yr 4-yr 5-yr
004 42
(14 TN, 28 PT)
10 11.2 45.2 27.7 20.1 17.6 17.6
40
(14 TN, 26 PT)
3 12.8 52.0 31.2 22.7 22.7 17.0
008 155 (PT) 10 10.2 47.2 32.8 23.3 19.7 18.2
022 72 (PT) 10 11.4 48.6 29.8 24.8 21.5 21.5
72 (PT) 3 8.7 39.3 24.2 19.7 18.2 16.5
73 (PT) 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 (TN) 30.5 71.4 56.6 42.5 37.7 37.7
25 (PT) 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 (TN) 45.0 65.9 57.7 57.7 49.5 49.5
37 (PT) 8.5 49.9 31.6 28.4 28.4 28.4

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Abstract Details

Meeting

2013 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Melanoma/Skin Cancers

Track

Melanoma/Skin Cancers

Sub Track

Melanoma/Skin Cancers

Clinical Trial Registration Number

NCT00162123

Citation

J Clin Oncol 31, 2013 (suppl; abstr 9053)

DOI

10.1200/jco.2013.31.15_suppl.9053

Abstract #

9053

Poster Bd #

45H

Abstract Disclosures