Repotrectinib (2) – Augtyro®
Non-small cell lung cancer, ROS1-positive
Characteristics
| Start date | 01.05.2025 – Marketing authorisation: 13.01.2025 |
|---|---|
| Resolution | 16.10.2025 |
| INN | Repotrectinib |
| Brand name | Augtyro® |
| Pharm. company | Bristol-Myers Squibb GmbH & Co. KGaA |
| G-BA Procedure ID | D-1199 |
| ATC code | L01EX28 Other protein kinase inhibitors (L01EX) |
| ICD-10 codes (AIS) | C34.0Malignant neoplasm of carina, C34.1Malignant neoplasm of upper lobe, bronchus or lung, C34.2Malignant neoplasm of middle lobe, bronchus or lung, C34.3Malignant neoplasm of lower lobe, bronchus or lung, C34.8Malignant neoplasm of overlapping sites of bronchus and lung, C34.9Malignant neoplasm of unspecified part of bronchus or lung |
| Alpha-ID codes (AIS) | I111155Carcinoma of the upper lobe bronchus, I116693Non-small cell lung cancer, I24595Carcinoma of the main bronchus, I30015Lung carcinoma of the middle lobe, I30021Lung carcinoma of the lower lobe, I30022Malignant neoplasm of the bronchi and lungs, overlapping several sub-areas |
| Therapeutic area | Oncological diseases |
| Reason for procedure | Initial assessment |
| Therapeutic indication of the resolution |
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AUGTYRO is indicated as monotherapy for the treatment of adult patients with advanced ROS1-positive non-small cell lung cancer (NSCLC). |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Erwachsene mit ROS1-positivem, fortgeschrittenem oder metastasiertem nicht-kleinzelligen Lungenkarzinom (NSCLC); keine Vorbehandlung mit einem ROS1-Inhibitor | |
| b1) | Erwachsene mit ROS1-positivem, fortgeschrittenem oder metastasiertem nicht-kleinzelligen Lungenkarzinom (NSCLC); Vorbehandlung mit einem ROS1-Inhibitor und mit einer PD-L1-Expression ≥ 50 % | |
| b2) | Erwachsene mit ROS1-positivem, fortgeschrittenem oder metastasiertem nicht-kleinzelligen Lungenkarzinom (NSCLC); Vorbehandlung mit einem ROS1-Inhibitor und mit einer PD-L1-Expression < 50 % |
Studies and Results
- Clinical trials
- This Phase II trial is investigating the efficacy, safety and pharmacokinetics of repotrectinib.
a) Adults with ROS1-positive, advanced or metastatic non-small cell lung cancer (NSCLC); no prior treatment with a ROS1 inhibitor
- The additional benefit is not proven.
- The pharmaceutical manufacturer is submitting the results of the ongoing, single-arm, pivotal TRIDENT-1 trial for the benefit assessment.
- As the TRIDENT-1 study is a single-arm study, it does not allow for an assessment of the additional benefit of repotrectinib compared with the appropriate comparator therapy and is therefore not suitable for the benefit assessment of repotrectinib.
- MAIC analyses using aggregated data from the comparator arm are generally not considered appropriate in the context of benefit assessment.
- An additional benefit is therefore not proven for the treatment of adults with ROS1-positive advanced or metastatic NSCLC who have not previously received TKI therapy.
- With regard to patient group a), the validity of the resolution is limited until 1 July 2027, based on the expected results of the Phase III TRIDENT-3 trial.
b1) Adults with ROS1-positive, advanced or metastatic non-small cell lung cancer (NSCLC); pre-treatment with a ROS1 inhibitor and with PD-L1 expression ≥ 50%
- The additional benefit is not proven.
- For the benefit assessment, the pharmaceutical manufacturer presents only the results of the ongoing, single-arm, pivotal Phase II TRIDENT-1 trial in adults with ROS1-positive advanced or metastatic NSCLC who have previously been treated with a ROS1 inhibitor, without providing further details on the proportion of patients with PD-L1 expression ≥ 50% or < 50%.
- There is no comparison with the appropriate comparator therapy for the assessment of additional benefit.
b2) Adults with ROS1-positive, advanced or metastatic non-small cell lung cancer (NSCLC); previously treated with a ROS1 inhibitor and with PD-L1 expression < 50 %
- An additional benefit is not proven.
- For the benefit assessment, the pharmaceutical manufacturer presents only the results of the ongoing, single-arm, pivotal Phase II TRIDENT-1 trial in adults with ROS1-positive advanced or metastatic NSCLC who have previously been treated with a ROS1 inhibitor, without providing further details on the proportion of patients with PD-L1 expression ≥ 50% or < 50%.
- There is no comparison with the appropriate comparator therapy for the assessment of additional benefit.
Courtesy translation only, please refer to the German original.
Associated procedures
| Repotrectinib (2) | Augtyro® | Bristol-Myers Squibb GmbH & Co. KGaA | Non-small cell lung cancer, ROS1-positive | 585–1,620 | 100% additional benefit not proven | |
| Repotrectinib (1) | Augtyro® | Bristol-Myers Squibb GmbH & Co. KGaA | Solid tumours, NTRK gene fusion, aged ≥ 12 years | 390–770 | 100% additional benefit not proven |
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