Repotrectinib in <i>ROS1</i> Fusion–Positive Non–Small-Cell Lung Cancer
Репотрецтиниб при немелкоклеточном раке легкого с ROS1-реаранжировкой
2024-01-10
SCID: 54.1/bb5nj4zm
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G2032R mutationPhase 2 TRIDENT-1 trial (NCT03093116)ROS1 fusion–positive non–small-cell lung cancerRepotrectinibTreatment-related adverse events (dizziness, dysgeusia, paresthesia)
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Abstract (AI)
BACKGROUND: G2032R. METHODS: fusion-positive NSCLC. The primary efficacy end point in the phase 2 trial was confirmed objective response; efficacy analyses included patients from phase 1 and phase 2. Duration of response, progression-free survival, and safety were secondary end points in phase 2. RESULTS: G2032R mutation had a response. A total of 426 patients received the phase 2 dose; the most common treatment-related adverse events were dizziness (in 58% of the patients), dysgeusia (in 50%), and paresthesia (in 30%), and 3% discontinued repotrectinib owing to treatment-related adverse events. CONCLUSIONS: fusion-positive NSCLC, regardless of whether they had previously received a ROS1 TKI. Adverse events were mainly of low grade and compatible with long-term administration. (Funded by Turning Point Therapeutics, a wholly owned subsidiary of Bristol Myers Squibb; TRIDENT-1 ClinicalTrials.gov number, NCT03093116.).
Key Findings
1
Among 426 patients receiving the phase 2 dose, the most common treatment-related adverse events were dizziness (58%), dysgeusia (50%), and paresthesia (30%).
2
Efficacy analyses pooled patients from phase 1 and phase 2, with secondary end points including duration of response and progression-free survival.
3
Repotrectinib demonstrated activity in ROS1 fusion–positive NSCLC regardless of prior receipt of a ROS1 tyrosine kinase inhibitor.
4
Repotrectinib induced responses in tumors harboring the ROS1 G2032R resistance mutation.
5
Repotrectinib showed confirmed objective responses in patients with ROS1 fusion–positive non–small-cell lung cancer enrolled in the trial.
6
Treatment-related adverse events led to discontinuation of repotrectinib in 3% of patients, and most adverse events were low grade and compatible with long-term administration.
Research Object
Repotrectinib treatment in ROS1 fusion–positive non–small-cell lung cancer patients
Research Subject
Efficacy (confirmed objective response, duration of response, progression-free survival) and safety (treatment-related adverse events, discontinuation rates) of repotrectinib in ROS1 fusion–positive NSCLC, including patients with prior ROS1 TKI exposure and G2032R mutation responses
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2024-01-10
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Cited by4
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