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Ipilimumab in advanced melanoma: added benefit for non-pretreated patients not proven
Date:6/12/2014

In early 2014, the German Institute for Quality and Efficiency in Health Care (IQWiG) assessed the added benefit of ipilimumab in non-pretreated patients with advanced melanoma. The drug manufacturer claimed a noticeable increase in survival time and thus an added benefit versus dacarbazine, the appropriate comparator therapy specified by the Federal Joint Committee (G-BA). However, the indirect comparison conducted by the company was too uncertain, and the postulated effect was biased in favour of ipilimumab. Hence an added benefit was not proven.

In two addenda, the Institute now also examined updated and corrected analyses by the company as well as a possible added benefit versus a second comparator therapy. The result remained unchanged, however: An added benefit of ipilimumab is not proven for non-pretreated patients versus any of the two comparator therapies.

Advantage in pretreated patients

Ipilimumab is a monoclonal antibody used in melanoma if the disease is so advanced that the melanoma can no longer be surgically removed or has formed metastases. In 2012, the manufacturer presented informative data for pretreated patients from a randomized controlled trial. These data indicated a major advantage of ipilimumab in survival time in comparison with "best supportive care". This advantage was associated with major risk of harm, however.

Effects in non-pretreated patients not interpretable

In October 2013, European approval was expanded to patients who have not been treated for their advanced melanoma. In a new dossier, the manufacturer subsequently also claimed an added benefit for this group versus the appropriate comparator therapy dacarbazine specified by the G-BA. IQWiG did not concur with this claim because the treatment effects presented by the manufacturer were not interpretable: The quality of the relevant indirect unadjusted comparison was too low, the results were bias
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Contact: Dr. Anna-Sabine Ernst
presse@iqwig.de
49-022-135-6850
Institute for Quality and Efficiency in Health Care
Source:Eurekalert

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