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Bending the Curve Trial by Trial
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TRIDENT-1

A Study of Repotrectinib (TPX-0005) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements

Phase 1/2NCT03093116

Population
ROS1 fusion-positive NSCLC, TKI-naive and previously treated with one ROS1 TKI
Design
Registrational phase 1-2 trial of repotrectinib in advanced solid tumours including ROS1 fusion-positive NSCLC. Phase 2 dose: 160 mg daily for 14 days, then 160 mg twice daily. Primary efficacy endpoint in phase 2 confirmed objective response; efficacy analyses include phase 1 and phase 2 patients. Efficacy population per the full text: patients with ROS1-positive NSCLC who started repotrectinib at any dose by 15 October 2021; responses by blinded independent central review; data cutoff 19 December 2022. Median follow-up 24.0 months (TKI-naive cohort) and 21.5 months (one prior TKI cohort) at the cutoff (full text).
Primary endpoint
ORR
Arms
  • Repotrectinib (experimental): Repotrectinib 160 mg daily for 14 days, then 160 mg twice daily
People
Drilon A
Show the numbers
Results reported for TRIDENT-1
EndpointAnalysisRepotrectinibControlEffect
ORRROS1 fusion-positive NSCLC, no previous ROS1 TKI (n=71)primaryDrilon 202479% (68–88%)—56 of 71 patients responded.
DORNo previous ROS1 TKI (n=71)primaryDrilon 2024median 34.1 months—95% CI 25.6 to could not be estimated.
PFSNo previous ROS1 TKI (n=71)primaryDrilon 2024median 35.7 months—95% CI 27.4 to could not be estimated.
ORROne previous ROS1 TKI, no chemotherapy (n=56)primaryDrilon 202438% (25–52%)—21 of 56 patients responded; 10 of 17 patients (59%) with the ROS1 G2032R mutation responded.
DOROne previous ROS1 TKI, no chemotherapy (n=56)primaryDrilon 2024median 14.8 months—95% CI 7.6 to could not be estimated.
PFSOne previous ROS1 TKI, no chemotherapy (n=56)primaryDrilon 2024median 9 months (6.8–19.6)——
Results reported for TRIDENT-1
EndpointAnalysisRepotrectinibControlEffect
ORRROS1 fusion-positive NSCLC, no previous ROS1 TKI (n=71)primaryDrilon 202479% (68–88%)—56 of 71 patients responded.
DORNo previous ROS1 TKI (n=71)primaryDrilon 2024median 34.1 months—95% CI 25.6 to could not be estimated.
PFSNo previous ROS1 TKI (n=71)primaryDrilon 2024median 35.7 months—95% CI 27.4 to could not be estimated.
ORROne previous ROS1 TKI, no chemotherapy (n=56)primaryDrilon 202438% (25–52%)—21 of 56 patients responded; 10 of 17 patients (59%) with the ROS1 G2032R mutation responded.
DOROne previous ROS1 TKI, no chemotherapy (n=56)primaryDrilon 2024median 14.8 months—95% CI 7.6 to could not be estimated.
PFSOne previous ROS1 TKI, no chemotherapy (n=56)primaryDrilon 2024median 9 months (6.8–19.6)——
Illustrative — modelled from reported values, not trial data. DOR, primary.
0%25%50%75%100%020406080Months (modelled)
  • Repotrectinib (experimental)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsRepotrectinib
0100.0%
2165.3%
4341.7%
6427.2%
8517.8%
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%020406080Months (modelled)
  • Repotrectinib (experimental)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsRepotrectinib
0100.0%
2265.2%
4541.7%
6727.2%
8917.8%
Primary publication: Drilon A, Camidge DR, Lin JJ, Kim SW, Solomon BJ, Dziadziuszko R, et al. Repotrectinib in ROS1 Fusion-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2024;390(2):118-131. PubMedDOI

Appears in

Sources

  1. Drilon A, Camidge DR, Lin JJ, Kim SW, Solomon BJ, Dziadziuszko R, et al. Repotrectinib in ROS1 Fusion-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2024;390(2):118-131.

    PubMedDOI