IQWiG assessment of Keytruda (pembrolizumab) finds considerable added benefit in advanced melanoma- Merck Inc

The German Institute for Quality and Efficiency in Health Care (IQWiG) examined in a dossier assessment whether Keytruda (pembrolizumab), from Merck Inc, offers an added benefit over the appropriate comparator therapy for adults with advanced melanoma that can no longer be surgically removed or has already formed metastases. The drug manufacturer presented two randomized controlled trials for pretreated patients. A subpopulation of the study KEYNOTE 002 was relevant for the assessment, namely pretreated adults for whom dacarbazine was specified as chemotherapy in the comparator arm before randomization. However, the manufacturer dossier only provided analyses for the total study population so that no evaluable data were available for the relevant subpopulation.

According to the findings, an added benefit can be derived for different patient groups: In pretreated patients for whom ipilimumab is a suitable next treatment, severe and serious side effects as well as discontinuations due to side effects occur later under pembrolizumab. Overall, this results in an indication of a considerable added benefit. Treatment-naive adults whose tumour has no BRAF V600 mutation survive longer with the new drug and have advantages in one subdomain of quality of life. These advantages result in a hint of a minor added benefit.