Therapeutic efficacy of Repotrectinib

1. Locally Advanced or Metastatic ROS1-Positive NSCLC

The efficacy of Repotrectinib was evaluated in TRIDENT-1, a multicenter, single-arm, open-label,  multi-cohort clinical trial (NCT03093116).

Efficacy results are summarized in Table 5.

Among TKI-naïve patients, 8 had measurable CNS metastases at baseline as assessed by BICR;  responses in intracranial lesions were observed in 7 of these 8 patients. Among the TKI pretreated  patients with no prior platinum-based chemotherapy, 12 had measurable CNS metastases at  baseline as assessed by BICR; responses in intracranial lesions were observed in 5 of these 12  patients.

Among the 56 ROS1 inhibitor-pretreated patients, 8 had resistance mutations following TKI  therapy. Responses were observed in 6 of these 8 patients; responders included patients with  solvent front (G2032R), gatekeeper (L2026M), and other mutations (S1986F/Y).

from FDA，2023.11