Trastuzumab deruxtecan (3) – Enhertu®
Adenocarcinoma (AC) of the stomach or gastro-oesophageal junction, HER2-positive, after trastuzumab-based therapy
Characteristics
| Start date | 01.02.2023 – Marketing authorisation: 12.12.2022 |
|---|---|
| Resolution | 20.07.2023 repealed subpopulations |
| INN | Trastuzumab deruxtecan |
| Brand name | Enhertu® |
| Pharm. company | Daiichi Sankyo Deutschland GmbH |
| G-BA Procedure ID | D-901 |
| ATC code | L01FD04 HER2 inhibitors (L01FD) |
| ICD-10 codes (AIS) | C16.0Malignant neoplasm of cardiac orifice, C16.1Malignant neoplasm of fundus of stomach, C16.2Malignant neoplasm of body of stomach, C16.3Malignant neoplasm of gastric antrum, C16.4Malignant neoplasm of prepylorus, C16.6Malignant neoplasm of greater curvature of stomach, not classifiable to C16.0-C16.4, C16.8Malignant neoplasm of overlapping sites of stomach, C16.9Gastric cancer NOS |
| Alpha-ID codes (AIS) | I103100Malignant neoplasm of the gastroesophageal junction, I107038Malignant neoplasm of the anterior stomach wall n.c, I17994Stomach cancer, I25400Malignant neoplasm of the pylorus, I29937Malignant neoplasm of the ventricular fundus, I29941Malignant neoplasm of the corpus ventriculi, I29944Malignant neoplasm of the antrum pyloricum, I29950Malignant neoplasm of the large gastric curvature |
| Therapeutic area | Oncological diseases Adenocarcinoma (AC) |
| Reason for procedure | New therapeutic indication |
| Regulatory status | Conditional Approval |
| Specialty | Bundling ACT change |
| Therapeutic indication of the resolution |
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|
Enhertu is used as monotherapy for the treatment of adult patients with advanced HER2-positive adenocarcinoma of the stomach or gastroesophageal junction (GEJ) who have received a prior trastuzumab-based therapeutic regimen |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Adults with advanced HER2-positive adenocarcinoma of the stomach or gastroesophageal junction (GEJ); after prior first-line trastuzumab-based therapy | Docetaxel or - irinotecan or- paclitaxel or - ramucirumab in combination with paclitaxel |
| b) | Adults with advanced HER2-positive adenocarcinoma of the stomach or gastroesophageal junction (GEJ); after at least two prior treatment regimens, including trastuzumab | Trifluridin/Tipiracil |
Studies and Results
|
No. of studies
(best subpopulation) |
0 (Data not accepted) |
|---|---|
|
Study design
(best subpopulation) |
Data not accepted (Dossier: H2H vs. ACT) |
| Reason for dividing into subpopulations (G-BA) | Previous treatment |
| ACT change | 21.02.2023 – Neue Leitlinien |
- 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.
Associated procedures
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