Results were presented during the 2016 European Society for Medical Oncology Congress demonstrating that Yervoy® (ipilimumab) compared to placebo improves survival in stage III melanoma patients who are at high risk of recurrence following complete surgical resection. In the study, Yervoy compared with placebo significantly improved overall survival (OS) with five-year OS rates at 65.4% in the Yervoy group and 54.4% in the placebo group.
Melanoma is less common than non-melanoma skin cancer, but tends to be much more aggressive. Of the more than one million new diagnoses of skin cancer each year, roughly 68,000 involve melanoma. More than 8,000 people die of melanoma each year in the United States. What makes melanoma so dangerous is that it is more likely than other types of skin cancer to spread (metastasize) to other parts of the body. Melanoma can occur anywhere on the body. The first signs of melanoma may be a mole that changes in appearance, bleeds, or has more than one color or an irregular shape.
Standard treatment for stage III melanoma typically involves surgery to remove the cancer. Because many patients will experience a recurrence following treatment with surgery alone, doctors have been searching for an appropriate therapy to be administered after surgery to improve outcomes.
Yervoy is a monoclonal antibody approved for the treatment of advanced melanoma. Yervoy targets a molecule known as CTLA4. CTLA4 is found on the surface of T cells and is thought to inhibit immune responses. By targeting this molecule, Yervoy may enhance the immune system’s response against tumor cells. Yervoy was approved in March 2011 for the treatment of melanoma that has spread to other sites or cannot be surgically removed.
The current study evaluating adjuvant Yervoy treatment was initiated in 2008, and conducted by the European Organization for Research and Treatment of Cancer (EORTC). The study involved 99 centers across 19 countries from the EORTC’s pan-European network and specialized infrastructure. The trial enrolled adult patients who underwent complete resection of stage III cutaneous melanoma (excluding lymph node metastasis ≤1 mm or in-transit metastasis). Patients were treated with Yervoy 10 mg/kg or placebo as an intravenous infusion every 3 weeks for 4 doses, followed by Yervoy 10 mg/kg or placebo every 12 weeks from Week 24 to Week 156 (three years), or until documented disease recurrence or unacceptable toxicity.
The primary endpoint was recurrence-free survival (RFS), defined as the time between the date of randomization and the date of first recurrence or death. Yervoy significantly improved RFS across all patient groups. Updated five-year results demonstrated RFS remained significantly longer for Yervoy with a median RFS of 27.6 months versus 17.1 months for placebo. Yervoy also improved OS, the estimated five-year OS rate was 65.4% for Yervoy versus 54.4% for placebo.
The demonstration that Yervoy® improves patient outcomes when used to treat stage III melanoma is the first significant advance in the management of earlier stage melanomas in years. Additional clinical trials will undoubtedly evaluate Yervoy® in stage II patients and explore combination with other novel melanoma therapies to see if outcomes can be further improved.
Reference: Eggermont AM, Chiaron-Seleni V, Grobb JJ, et al. Ipilimumab (IPI) vs placebo (PBO) after complete resection of stage III melanoma: final overall survival results the EORTC 18071 randomized, double-blind, phase 3 trial. Proceedings from the annual meeting of the 2016 European Society for Medical Oncology (ESOM). Abstract #LBA2_PR.
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