Safety and efficacy of ipilimumab in melanoma patients who received prior immunotherapy on phase III study MDX010-020.

Authors

Howard Kaufman

Howard Kaufman

Rush University Medical Center, Chicago, IL

Howard Kaufman , Jose Lutzky , Joseph Clark , Kim Allyson Margolin , David H. Lawson , Asim Amin , Frances A. Collichio , Andrew Pecora , Walter John Urba , Kelly L. Bennett , David F. McDermott

Organizations

Rush University Medical Center, Chicago, IL, Mount Sinai Comprehensive Cancer Center, Miami Beach, FL, Loyola University Medical Center, Maywood, IL, University of Washington, Seattle, WA, Emory University School of Medicine, Atlanta, GA, Levine Cancer Institute, Charlotte, NC, The University of North Carolina at Chapel Hill, School of Medicine, Chapel Hill, NC, Hackensack University Medical Center, Hackensack, NJ, Earle A. Chiles Research Institute-Providence Cancer Center, Portland, OR, Bristol-Myers Squibb, Plainsboro, NJ, Dana-Farber Cancer Institute, Boston, MA

Research Funding

Pharmaceutical/Biotech Company

Background: MDX010-020 was a phase III comparison of ipilimumab (Ipi), gp100 vaccine or the combination for advanced melanoma. A subset of patients (pts) received other immunotherapy (IM) for advanced disease prior to receiving Ipi, providing the opportunity to evaluate safety and efficacy of Ipi following IM. A prior analysis has shown that pts receiving prior IL-2 had a similar overall survival (OS) to pts who had not received prior IL-2 [Hodi et al NEJM2010]; we now report expanded results for pts receiving any prior IM (interferons and/or interleukin). Methods: Eligible pts (n=676) had unresectable stage III/IV melanoma and were randomized 3:1:1 to q3 wks x 4 doses of Ipi + gp100 or Ipi + placebo or gp100 + placebo. All Ipi doses were 3 mg/kg i.v. OS was retrospectively analyzed for pts receiving any prior IM; immune-related adverse events (irAEs) during induction were evaluated for pts who received any prior IM (322 pts, 48%) and for pts who received prior IL-2 (154 pts, 23%). Results: Demography and OS are summarized below. irAEs of any grade were reported for 60% (Ipi) and 54% (Ipi + gp100) of pts receiving any prior IM. Those receiving prior IL-2 specifically had 73% (Ipi) and 58% (Ipi + gp100) incidence of any grade irAEs. Incidence was similar for those not receiving prior IM or prior IL-2. Diarrhea, rash, and pruritus were the most common events in all groups. Conclusions: Results for OS in this subgroup analysis were similar for both those receiving any prior IM and those who did not receive prior IM and to the overall 020 population. In addition, safety profiles were similar irrespective of prior immunotherapy. Clinical trial information: NCT00094653.

Ipi + gp100
n=403
Ipi + placebo
n=137
gp100 + placebo
n=136
N (%) receiving prior IM
Male/female, %
Mean age (range), yrs
ECOG 0/1/2/3, %
Stage III/IV/M1c, %
194 (48%)
66/34
54 (24-78)
59/39/1/1
2/98/73
55 (40%)
66/34
54 (24-78)
60/40/0/0
2/98/73
73 (53%)
55/45
54 (23-79)
58/40/3/0
1/99/74
Prior IM, OS hazard ratio (95% CI)
Ipi vs gp100
Ipi + gp100 vs gp100
n=322
0.54 (0.36, 0.82)
0.71 (0.53, 0.96)
No prior IM, OS hazard ratio (95% CI)
Ipi vs gp100
Ipi + gp100 vs gp100
n=354
0.69 (0.48, 0.99)
0.66 (0.49, 0.90)

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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

NCT00094653

Citation

J Clin Oncol 31, 2013 (suppl; abstr 9050)

DOI

10.1200/jco.2013.31.15_suppl.9050

Abstract #

9050

Poster Bd #

45E

Abstract Disclosures