Repotrectinib (2) – Augtyro®

• 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.