MDX-010 Antibody, MDX-1379 Melanoma Vaccine, or MDX-010/MDX-1379 Combination Treatment for Patients With Unresectable or Metastatic Melanoma: trial

MDX-010 Antibody, MDX-1379 Melanoma Vaccine, or MDX-010/MDX-1379 Combination Treatment for Patients With Unresectable or Metastatic Melanoma

Population

HLA-A*0201-positive adults with unresectable stage III or IV melanoma whose disease had progressed during therapy for metastatic disease (previously treated)

Design

Randomised phase 3 trial (3:1:1) of ipilimumab 3 mg per kilogram every 3 weeks for up to four doses, given with or without a gp100 peptide vaccine, versus gp100 alone; reinduction was allowed. The abstract states the primary end point was overall survival. The registry record lists 1,783 enrolled; the paper randomised 676 HLA-A*0201-positive patients.

Primary endpoint

Arms

Ipilimumab plus gp100 (experimental, n = 403): Ipilimumab 3 mg per kilogram every 3 weeks for up to four doses plus gp100 peptide vaccine
Ipilimumab alone (experimental, n = 137): Ipilimumab 3 mg per kilogram every 3 weeks for up to four doses
gp100 alone (control, n = 136): gp100 peptide vaccine

People

Hodi FS, senior author Urba WJ

OSHR 0.68Δ median OS+3.6 monthsOSHR 0.66Δ median OS+3.7 months

Show the numbers

Results reported for MDX-010 Antibody, MDX-1379 Melanoma Vaccine, or MDX-010/MDX-1379 Combination Treatment for Patients With Unresectable or Metastatic Melanoma
Endpoint	Analysis	Ipilimumab plus gp100 / Ipilimumab alone	gp100 alone	Effect
OSRandomised population as described in the abstract (analysis population not stated there)	primaryHodi 2010	median 10 months	median 6.4 months	HR 0.68P<0.001Hazard ratio for death, ipilimumab plus gp100 versus gp100 alone. The abstract reports no confidence intervals and states no difference was detected between the two ipilimumab groups (hazard ratio 1.04; P=0.76).
OSRandomised population as described in the abstract (analysis population not stated there)	primaryHodi 2010	median 10.1 months	median 6.4 months	HR 0.66P=0.003Hazard ratio for death, ipilimumab alone versus gp100 alone.

Results reported for MDX-010 Antibody, MDX-1379 Melanoma Vaccine, or MDX-010/MDX-1379 Combination Treatment for Patients With Unresectable or Metastatic Melanoma
Endpoint	Analysis	Ipilimumab plus gp100 / Ipilimumab alone	gp100 alone	Effect
OSRandomised population as described in the abstract (analysis population not stated there)	primaryHodi 2010	median 10 months	median 6.4 months	HR 0.68P<0.001Hazard ratio for death, ipilimumab plus gp100 versus gp100 alone. The abstract reports no confidence intervals and states no difference was detected between the two ipilimumab groups (hazard ratio 1.04; P=0.76).
OSRandomised population as described in the abstract (analysis population not stated there)	primaryHodi 2010	median 10.1 months	median 6.4 months	HR 0.66P=0.003Hazard ratio for death, ipilimumab alone versus gp100 alone.

Illustrative — modelled from reported values, not trial data. OS, primary.

Show curves

Ipilimumab plus gp100 (experimental)
gp100 alone (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)

Months	Ipilimumab plus gp100	gp100 alone
0	100.0%	100.0%
6	66.0%	52.2%
13	40.6%	24.5%
19	26.8%	12.8%
25	17.7%	6.7%

Illustrative — modelled from reported values, not trial data. OS, primary.

Show curves

Ipilimumab alone (experimental)
gp100 alone (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)

Months	Ipilimumab alone	gp100 alone
0	100.0%	100.0%
6	66.2%	52.2%
13	41.0%	24.5%
19	27.1%	12.8%
25	18.0%	6.7%

Appears in

2010 Ipilimumab: anti-CTLA-4 survival trials and FDA approval (2010-2011)

Sources

Hodi FS, O'Day SJ, McDermott DF, Weber RW, Sosman JA, Haanen JB, et al. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med. 2010;363(8):711-23.
PubMed DOI