T he March 25 approval of ipilimumab (Yervoy) by the U.S. Food and Drug Administration was a milestone for the embattled field of cancer immuno-therapy. As the first agent to increase overall survival in a phase III melanoma trial, ipilimumab appeared to vindicate the immune surveillance hypothesis of cancer first proposed in 1957. That hypothesis, which posits that the immune system plays a ke...

Ipilimumab is a monoclonal antibody against cytotoxic T lymphocyte-associated molecule-4 and is thought to promote anti-tumor activity by enhancing cell mediated immunity. It is one of the few therapies shown to improve overall survival in metastatic melanoma. Given its mechanism of action, the drug is associated with significant immune-related adverse events with the gastrointestinal system be...

Approximately 30% of patients treated with ipilimumab will develop gastrointestinal toxicity. The immunological drivers that underpin the clinical observations in human tissues are poorly understood. We report here on the immune consequences of ipilimumab treatment in the colorectal mucosa of patients with treatment-related colitis. Using immunohistochemistry, we evaluated the immune infiltrate...

INTRODUCTION Few randomized controlled trials have compared new treatments for metastatic melanoma. We sought to examine the relative treatment effect of talimogene laherparepvec compared with ipilimumab and vemurafenib. METHODS A systematic literature review of treatments for metastatic melanoma was undertaken but a valid network of evidence could not be established because of a lack of comp...

BACKGROUND : Ipilimumab is a monoclonal antibody that antagonizes cytotoxic T lymphocyte antigen-4, a negative regulator of the immune system. The authors report on advanced refractory melanoma patients treated in a compassionate use trial of ipilimumab at the Memorial Sloan-Kettering Cancer Center. METHODS : Patients with advanced refractory melanoma were treated in a compassionate use trial...

Ipilimumab (BMS734016; MDX 101; MDX-010; MDX-CTLA-4; MDX-CTLA4) is an anti-CTLA-4 monoclonal antibody, which is in development by Medarex Inc. and Bristol-Myers Squibb as treatment for malignant melanoma, prostate cancer, lymphoma, and lung cancer. It is currently in phase III development for the melanoma and prostate cancer indications, and phase II for lymphoma and non-small cell lung cancer ...

BACKGROUND There are limited real-world data on health care resource utilization (HCRU) among advanced melanoma patients. The objective of this study was to describe HCRU and health care costs associated with the management of advanced melanoma patients receiving ipilimumab. METHODS This retrospective multinational, observational study included advanced melanoma patients from Australia, Germa...

PURPOSE Intratumoral interleukin-2 (IL-2) is effective but does not generate systemic immunity. Intravenous ipilimumab produces durable clinical response in a minority of patients, with potentially severe toxicities. Circulating anti-tumor T cells activated by ipilimumab may differ greatly from tumor-infiltrating lymphocytes activated by intratumoral ipilimumab in phenotypes and functionality. ...

PURPOSE This retrospective analysis was conducted to characterize ipilimumab exposure-response relationships for measures of efficacy and safety in patients with advanced melanoma. EXPERIMENTAL DESIGN Data were pooled from 498 patients who received ipilimumab monotherapy at 0.3, 3, or 10 mg/kg in 1 of 4 completed phase II clinical trials. The relationships between steady-state ipilimumab trou...

We evaluated neoadjuvant ipilimumab in patients with surgically operable regionally advanced melanoma in order to define markers of activity in the blood and tumor as assessed at baseline (before ipilimumab) and early on-treatment. Patients were treated with ipilimumab (10 mg/kg intravenously every 3 weeks ×2 doses) bracketing surgery. Tumor and blood biospecimens were obtained at baseline and ...