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Four-year survival rates for patients with metastatic melanoma who received ipilimumab in phase II clinical trials.


ABSTRACT: This analysis was carried out to evaluate the long-term survival of patients with metastatic melanoma who received ipilimumab, a fully human monoclonal antibody that binds to cytotoxic T-lymphocyte antigen-4, in clinical trials.Patients received ipilimumab in one of three completed phase II clinical trials (CA184-008, CA184-022, and CA184-007). Previously treated patients were enrolled in all studies, and treatment-naïve patients were also included in study CA184-007. Patients received ipilimumab at a dose of 10 mg/kg in studies CA184-008 and CA184-007, and at doses of 0.3, 3, or 10 mg/kg in study CA184-022. Ipilimumab was given every 3 weeks for four doses, and eligible patients could receive ipilimumab maintenance therapy every 12 weeks. In study CA184-022, patients could cross over to be retreated with ipilimumab at 10 mg/kg upon disease progression. Ongoing survival follow-up is conducted in a companion study, CA184-025.Four-year survival rates [95% confidence interval (95% CI)] for previously treated patients who received ipilimumab at 0.3, 3, or 10 mg/kg were 13.8% [6.1-22.5], 18.2% [9.5-27.6], and 19.7% [13.4-26.5] to 28.4% [13.9-44.2], respectively. In treatment-naïve patients who received ipilimumab at 10 mg/kg, 4-year survival rates were 37.7% [18.6-57.4] to 49.5% [23.8-75.4].These results demonstrate durable survival in a significant proportion of patients with metastatic melanoma who received ipilimumab therapy.

SUBMITTER: Wolchok JD 

PROVIDER: S-EPMC4081656 | biostudies-other | 2013 Aug

REPOSITORIES: biostudies-other

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Four-year survival rates for patients with metastatic melanoma who received ipilimumab in phase II clinical trials.

Wolchok J D JD   Weber J S JS   Maio M M   Neyns B B   Harmankaya K K   Chin K K   Cykowski L L   de Pril V V   Humphrey R R   Lebbé C C  

Annals of oncology : official journal of the European Society for Medical Oncology 20130510 8


<h4>Background</h4>This analysis was carried out to evaluate the long-term survival of patients with metastatic melanoma who received ipilimumab, a fully human monoclonal antibody that binds to cytotoxic T-lymphocyte antigen-4, in clinical trials.<h4>Patients and methods</h4>Patients received ipilimumab in one of three completed phase II clinical trials (CA184-008, CA184-022, and CA184-007). Previously treated patients were enrolled in all studies, and treatment-naïve patients were also included  ...[more]

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