2023 Targeted Therapies of Lung Cancer Meeting (Poster)-P1.08. Pivotal Data Update from the Phase 1/2 TRIDENT-1 Trial of Repotrectinib in Patients with ROS1+ Advanced Non-Small Cell Lung Cancer (NSCLC)

P1.08. Pivotal Data Update from the Phase 1/2 TRIDENT-1 Trial of Repotrectinib in Patients with ROS1+ Advanced Non-Small Cell Lung Cancer (NSCLC)

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The phase 1/2 TRIDENT-1 trial evaluated the efficacy and safety of repotrectinib, a next-generation ROS1 and TRK tyrosine kinase inhibitor (TKI), in patients with ROS1 fusion-positive non-small cell lung cancer (NSCLC). The study included both TKI-naïve and TKI-pretreated patients.<br /><br />In the TKI-naïve cohort, the confirmed objective response rate (cORR) was 78.9%, with a duration of response (DOR) of 13.3 months. In the TKI-pretreated cohorts, the cORR ranged from 37.5% to 42.3%, with a DOR of 8.3 to 15.5 months.<br /><br />Intracranial efficacy was observed in both TKI-naïve and TKI-pretreated patients with measurable brain metastases. Repotrectinib also demonstrated activity in patients with the ROS1 G2032R resistance mutation, with a cORR of 58.8% and a 6-month probability of remaining in response of 70%.<br /><br />The safety profile of repotrectinib was manageable, with most treatment-related adverse events (TRAEs) being grade 1 or 2. The most common TRAE was low-grade dizziness. Dose modifications due to TRAEs were common, but no events of dizziness or ataxia led to treatment discontinuation.<br /><br />Overall, repotrectinib showed durable clinical activity in both TKI-naïve and TKI-pretreated patients with ROS1 fusion-positive NSCLC. The drug was well tolerated, and its safety profile was consistent across age and sex subgroups.<br /><br />These findings suggest that repotrectinib could be a potential new treatment option for patients with ROS1 fusion-positive NSCLC. Further research is ongoing in the TRIDENT-1 trial to evaluate the efficacy and safety of repotrectinib in different patient subgroups and in combination with other therapies.

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Guilherme Harada, Memorial Sloan Kettering Cancer Center, United States

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Speaker Guilherme Harada, Memorial Sloan Kettering Cancer Center, United States

Topic Poster Listing

Keywords

TRIDENT-1 trial

repotrectinib

ROS1 fusion-positive NSCLC

tyrosine kinase inhibitor

TKI-naïve

TKI-pretreated

objective response rate

duration of response

intracranial efficacy

safety profile