Repotrectinib (Augtyro)

Repotrectinib (Augtyro) is approved for the treatment of adult patients with locally advanced or metastatic ROS1-positive non–small cell lung cancer.

The regulatory decision is based on the phase 1/2 TRIDENT-1 study, in which repotrectinib elicited an objective response rate (ORR) of 79% in TKI-naive patients and the median duration of response (DOR) was 34.1 months. 

In those who were pretreated with 1 prior ROS1 TKI and who did not receive prior chemotherapy, the ORR was 38%.

In this group, the median DOR was 14.8 months.

Of measurable central nervous system (CNS) metastases at baseline, responses in intracranial lesions were reported in 7 of 8 TKI-naive patients and 5 of 12 TKI-pretreated patients.

Repotrectinib has the potential to become a new standard of care option for patients with locally advanced or metastatic ROS1 fusion-positive lung cancer.

In patients who previously received treatment with a TKI the confirmed ORR was 42%, in patients pretreated with one TKI and platinum-based chemotherapy, 28%, in those pretreated with two prior TKIs without chemotherapy, 36%, in those pretreated with 1 TKI without chemotherapy, and 59% in those with a ROS1 G2032R solvent front mutation.

  1. The most frequent treatment-emergent adverse effect was dizziness.

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