Indication of considerable added benefit for patients with progression during or shortly after platinum-based therapy.

Nivolumab (trade name: Opdivo) has been approved since June 2017 for adults with squamous cell carcinoma of the head and neck. The drug is an option if platinum-based chemotherapy is not sufficiently effective against this form of cancer. In recent years, nivolumab has repeatedly been subject to early benefit assessments conducted by the Institute for Quality and Efficiency in Health Care (IQWiG) for other oncological indications. IQWiG has now investigated whether the drug has an added benefit for patients in the new therapeutic indication.

According to the findings, there is an indication of considerable added benefit for patients who have progressed during platinum-based chemotherapy or up to six months after completion of this treatment. No data were available for patients with later progression. Hence for these patients, an added benefit of nivolumab in comparison with the appropriate comparator therapy is not proven. The data of the study subpopulation with progression during or up to six months after platinum-based therapy resulted in an indication of considerable added benefit for the outcome “overall survival”. In addition, there was a hint of notably lesser harm in comparison with methotrexate for an outcome in the category of side effects, namely the overall rate of severe adverse events.

Non-serious adverse events were partly less common, partly more common than in the comparator arm, with some of the data not being usable. None of these findings calls the positive effects into question. In the overall consideration, there is therefore an indication of considerable added benefit of nivolumab for adult patients with progression occurring during or up to six months after platinum-based therapy.