It is good news for people with stomach cancer: On the basis of a comparative study by the manufacturer that started before approval, IQWiG now sees a considerable additional benefit for patients with advanced HER2-positive adenocarcinoma of the stomach or the gastroesophageal junction with therapy with trastuzumab deruxtecan.

The antibody-drug conjugate trastzumab deruxtecan is approved for several indications and is used to treat various tumors (such as those in the breast or lungs). In an early benefit assessment, the Institute for Quality and Efficiency in Health Care (IQWiG) has now re-examined whether trastzumab deruxtecan offers advantages over the appropriate comparator therapy in adults with advanced HER2-positive adenocarcinoma of the stomach or gastroesophageal junction – who have already received a previous trastuzumab-based therapy regimen in first-line therapy. Stomach cancer is called HER2-positive if the tumor cells have a large number of receptors of the HER2 type, to which growth factors dock that stimulate cell division.

Trastuzumab deruxtecan had already been approved for this indication in December 2022. However, the subsequent early benefit assessment came to the conclusion that “added benefit not proven” because the manufacturer had not submitted suitable data. Now he himself has applied for a further benefit assessment based on new scientific findings. The basis for this is the DESTINY-Gastric04 study, which was initiated by the manufacturer before approval in May 2021 and compares a therapy with trastuzumab deruxtecan with the current standard therapy ramucirumab plus paclitaxel. According to IQWiG, not only in terms of overall survival, but also in terms of side effects, “the positive effects of trastuzumab deruxtecan clearly outweigh the negative effects: In summary, there is an indication of a considerable additional benefit. This means that meaningful data are now available on whether trastuzumab deruxtecan offers advantages compared to the previous standard of care.”

Katrin Nink, Head of Division in IQWiG’s Drug Evaluation Department, emphasises that the manufacturer has launched a suitable direct comparative study in parallel to the authorisation: “Time and again, we see that the manufacturers’ study planning is primarily geared towards authorisation and that questions of early benefit assessment remain unanswered. The example of the DESTINY-Gastric04 study shows that it is possible and also necessary to plan and start the necessary comparative studies compared to the previous standard of care before a drug is approved. The sooner the better. In order to promote this, appropriate incentives must also be provided in a possible AMNOG reform.”

The dossier evaluation is part of the early benefit assessment in accordance with the Drug Market Reorganization Act (AMNOG), for which the Federal Joint Committee (G-BA) is responsible. After publication of the dossier evaluation, the G BA conducts a comment procedure and decides on the extent of the additional benefit.

Original Paper:

[A25-128 ] Trastuzumab deruxtecan (adenocarcinoma of the stomach or gastroesophageal junction) – benefit assessment according to § 35a SGB V

Editor: X-Press Journalistenbüro GbR

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