IQWiG finds further benefit for nivolumab, but not for Xultophy

18 November 2015

The German Institute for Quality and Efficiency in Health Care (IQWiG), which last month had already found an added benefit of the drug for patients with advanced melanoma (The Pharma Letter October 20, now examined in another dossier assessment whether Bristol-Myers Squibb’s (NYSE: BMY) Opdivo (nivolumab) also offers an added benefit over the appropriate comparator therapy in the treatment of non-small cell lung cancer (NSCLC).

According to the findings, there is an indication of major added benefit of nivolumab over the appropriate comparator therapy docetaxel for under-75-year-olds in relatively good general condition, and a hint of a non-quantifiable added benefit for over-75-year-olds in relatively good general condition. For patients in worse general condition, an added benefit is not proven due to a lack of study data.

The results for the outcome “overall survival” depended on age. Patients under the age of 75 years had a statistically-significant advantage of nivolumab. Their median survival time was 9.5 months, which is 3.5 months longer than in the docetaxel arm of the study (6 months): an indication of major added benefit. Over-75-year-olds, in contrast, had no advantage, and shorter overall survival cannot be excluded. Hence in older patients, there is no hint of an added benefit of nivolumab for this outcome.

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