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Considerable added benefit of ipilimumab in advanced melanoma
Date:11/9/2012

The humanized antibody ipilimumab (trade name Yervoy) has been approved since August 2011 for the treatment of adult patients with advanced melanoma (black skin cancer) who have already been treated. The term "advanced" means that the melanoma can no longer be removed by an operation or that metastases have formed. The German Institute for Quality and Efficiency in Health Care (IQWiG) has examined the added benefit of the drug pursuant to the Act on the Reform of the Market for Medicinal Products (AMNOG). According to the findings, the drug offers major advantages with respect to overall survival, but is accompanied by major potential harm in the form of side effects. The overall conclusion is that ipilimumab offers considerable added benefit.

"Best supportive care" as appropriate comparator therapy

As specified by the Federal Joint Committee (G-BA), ipilimumab was to be compared with so-called "best supportive care". This means the best possible supportive therapy, optimized for the individual patient, which guarantees alleviation of the symptoms and improvement in the quality of life.

The only study relevant to this benefit assessment compared ipilimumab in combination with "best supportive care" with "best supportive care" alone. This study was informative (randomized controlled trial, RCT) and included three parallel study arms. Patients in arm 1 were treated with ipilimumab. Patients in arm 2 were treated with ipilimumab and an experimental tumour vaccine (gp100), which has been examined in studies since 1996, but which has not yet been submitted for approval. The patients in the comparator arm (arm 3) were given a placebo and the tumour vaccine. All patients in the study were also given "best supportive care".

In its assessment, the Institute came to the conclusion that the administration of gp 100 had no relevant influence on the effects of ipilimumab measured in this study, in comparison to "best supportive
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Contact: Dr. Anna-Sabine Ernst
presse@iqwig.de
0049-022-135-6856
Institute for Quality and Efficiency in Health Care
Source:Eurekalert

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