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Update from the ongoing phase 1/2 registrational trial of repotrectinib: results in TKI-naïve and TKI-pretreated patients with NTRK fusion-positive advanced solid tumors (TRIDENT-1)

 B. Besse  ;  C. Springfeld  ;  C. Baik  ;  A. Hervieu  ;  B. Solomon  ;  V. Moreno  ;  L. Bazhenova  ;  K. Goto  ;  Y.C. Kim  ;  S. Lu  ;  M. Sun  ;  D. Trone  ;  S. Thamake  ;  B.C. Cho  ;  A. de Langen  ;  S. Popat  ;  J. Wolf  ;  D. Moro-Sibilot  ;  J. Fang  ;  A. Drilon 
 EUROPEAN JOURNAL OF CANCER, Vol.174 : S75-S76, 2022-10 
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Background: Repotrectinib is a selective, highly potent, next-generation ROS1 and TRK inhibitor that is currently under evaluation in the global registrational phase 1/2 TRIDENT-1 trial. Early clinical data from the TRIDENT-1 trial was presented in a plenary session at the 2021 AACR-NCI-EORTC conference. Repotrectinib was generally well tolerated. In NTRK fusion-positive tyrosine kinase inhibitor (TKI)-naïve (expansion cohort [EXP]-5) and TRK TKI-pretreated (EXP-6) patients with advanced solid tumors, confirmed overall response rates (cORR) per investigator assessment were 41% (95% CI: 18–67) and 48% (95% CI: 27–69), respectively. Efficacy was also observed in patients whose cancers developed solvent front mutations following prior TRK TKI treatment, with investigator-assessed cORR of 62% (95% CI: 32–86).
Materials and methods: TRIDENT-1 (NCT03093116) is an ongoing trial enrolling patients whose cancers harbor a ROS1 or NTRK gene fusion. Patients enter 1 of 6 defined EXPs based on cancer type and prior therapy. The primary efficacy endpoint is cORR by Blinded Independent Central Review using RECIST v1.1. Safety and tolerability are also assessed.
Results: The data cutoff for the present safety analysis was 11 February 2022. All treated patients were evaluable for safety (n = 380). The most common (>35% of patients) treatment-emergent adverse events (TEAE) were dizziness (60%), dysgeusia (48%), and constipation (35%). The majority (76%) of reported dizziness cases were grade 1 and no events of dizziness led to treatment discontinuation. Most treatment-related AEs (TRAE) were grade 1 or 2. Grade ≥3 TRAEs were observed in 21% of patients; no grade 5 TRAEs were observed. Dose reductions and discontinuations due to TEAEs were reported in 32% and 10% of patients, respectively. Safety results in patients with NTRK fusion-positive advanced solid tumors were similar to those in the overall population. Updated safety and efficacy data for NTRK fusion-positive TKI-naïve (EXP-5) and TKI-pretreated (EXP-6) patients will be available for presentation.
Conclusions: In the ongoing registrational phase 1/2 TRIDENT-1 trial, repotrectinib generally was well tolerated in 380 patients. The most common TEAE was low-grade dizziness. Updated efficacy and safety data from this ongoing trial will be presented.
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Cho, Byoung Chul(조병철) ORCID logo https://orcid.org/0000-0002-5562-270X
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