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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)
DC Field | Value | Language |
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dc.contributor.author | 조병철 | - |
dc.date.accessioned | 2023-04-07T01:17:27Z | - |
dc.date.available | 2023-04-07T01:17:27Z | - |
dc.date.issued | 2022-10 | - |
dc.identifier.issn | 0959-8049 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/193865 | - |
dc.description.abstract | 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. | - |
dc.description.statementOfResponsibility | restriction | - |
dc.language | English | - |
dc.publisher | Elsevier Science Ltd | - |
dc.relation.isPartOf | EUROPEAN JOURNAL OF CANCER | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.title | 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) | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | B. Besse | - |
dc.contributor.googleauthor | C. Springfeld | - |
dc.contributor.googleauthor | C. Baik | - |
dc.contributor.googleauthor | A. Hervieu | - |
dc.contributor.googleauthor | B. Solomon | - |
dc.contributor.googleauthor | V. Moreno | - |
dc.contributor.googleauthor | L. Bazhenova | - |
dc.contributor.googleauthor | K. Goto | - |
dc.contributor.googleauthor | Y.C. Kim | - |
dc.contributor.googleauthor | S. Lu | - |
dc.contributor.googleauthor | M. Sun | - |
dc.contributor.googleauthor | D. Trone | - |
dc.contributor.googleauthor | S. Thamake | - |
dc.contributor.googleauthor | B.C. Cho | - |
dc.contributor.googleauthor | A. de Langen | - |
dc.contributor.googleauthor | S. Popat | - |
dc.contributor.googleauthor | J. Wolf | - |
dc.contributor.googleauthor | D. Moro-Sibilot | - |
dc.contributor.googleauthor | J. Fang | - |
dc.contributor.googleauthor | A. Drilon | - |
dc.identifier.doi | 10.1016/S0959-8049(22)01000-0 | - |
dc.contributor.localId | A03822 | - |
dc.relation.journalcode | J00809 | - |
dc.identifier.eissn | 1879-0852 | - |
dc.identifier.url | https://www.ejcancer.com/article/S0959-8049(22)01000-0/fulltext | - |
dc.contributor.alternativeName | Cho, Byoung Chul | - |
dc.contributor.affiliatedAuthor | 조병철 | - |
dc.citation.volume | 174 | - |
dc.citation.startPage | S75 | - |
dc.citation.endPage | S76 | - |
dc.identifier.bibliographicCitation | EUROPEAN JOURNAL OF CANCER, Vol.174 : S75-S76, 2022-10 | - |
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