Trastuzumab deruxtecan (3) – Enhertu®

• Clinical trials
  • The open-label, randomised, controlled Phase II DESTINY-Gastric01 trial enrolled adults (aged 20 years and over) with locally advanced or metastatic HER2-positive adenocarcinoma of the stomach or the gastro-oesophageal junction who had experienced disease progression during or after at least two previous treatment regimens, including a fluoropyrimidine, platinum and trastuzumab. In the two relevant study arms, trastuzumab deruxtecan was compared with treatment as the clinician deemed appropriate, with a choice of irinotecan or paclitaxel.
  • DESTINY-Gastric02 is an uncontrolled, open-label Phase II trial enrolling patients with non-resectable or metastatic HER2-positive adenocarcinoma of the stomach or the gastro-oesophageal junction who had experienced progression during or after trastuzumab-based first-line therapy.

a) Adults with advanced HER2-positive adenocarcinoma of the stomach or the gastro-oesophageal junction (GEJ); following prior trastuzumab-based first-line therapy

• The additional benefit is not proven.
• For adults with advanced HER2-positive adenocarcinoma of the stomach or the gastro-oesophageal junction (GEJ), following prior trastuzumab-based first-line therapy, the pharmaceutical manufacturer has not provided suitable data for the assessment of additional benefit in second-line therapy.
• The DESTINY-Gastric01 study includes patients who experienced disease progression during or after at least two previous treatment regimens, including trastuzumab (in third-line therapy), and does not include a patient population relevant to the benefit assessment in second-line therapy.
• The DESTINY-Gastric02 study is a single-arm study and does not allow for a comparison with the appropriate comparator therapy specified by the G-BA.
• Neither study is suitable for demonstrating the additional benefit of trastuzumab deruxtecan in second-line treatment.

b) Adults with advanced HER2-positive adenocarcinoma of the stomach or the gastro-oesophageal junction (GEJ); following at least two previous treatment regimens, including trastuzumab

• An additional benefit is not proven.
• For the benefit assessment in adults with advanced HER2-positive adenocarcinoma of the stomach or the gastro-oesophageal junction (GEJ), who have undergone at least two previous treatment regimens, including trastuzumab, the pharmaceutical manufacturer has not provided suitable data for the assessment of additional benefit in third-line therapy.
• The DESTINY-Gastric02 study is a single-arm study and does not allow for a comparison with the appropriate comparator therapy specified by the G-BA.
• Neither study is suitable for demonstrating the additional benefit of trastuzumab deruxtecan following at least two previous treatment regimens, including trastuzumab.

Courtesy translation only, please refer to the German original.