IQWiG finds that added benefit of Boehringer’s Giotrif depends on mutation status

The German Institute for Quality and Efficiency in Health Care (IQWiG), in an early benefit assessment under the Act on the Reform of the Market for Medicinal Products (AMNOG), examined whether German family-owned drug major Boehringer Ingelheim’s Giotrif (afatinib) offers an added benefit over the appropriate comparator therapy.

Giotrif has been approved in Germany since September 2013 for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGF receptor mutations who have not been treated with an EGF receptor tyrosine-kinase inhibitor (EGFR TKI).

Evaluable data were only available for non-pre-treated patients in relatively good general condition (ECOG PS 0 or 1), said the IQWiG. According to the findings, there is an indication of a major added benefit in patients with the EGFR mutation Del19, and a hint of a minor added benefit of afatinib in patients under the age of 65 with L858R mutation. In contrast, the Institute found an indication of lesser benefit versus the comparator therapy in patients with other EGFR mutations. Boehringer Ingelheim presented no relevant data for pre-treated patients, the agency noted.