Home > Publications database > Repotrectinib in NTRK fusion-positive advanced solid tumors: a phase 1/2 trial. > print

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005     20260205152952.0
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037 _ _ |a DKFZ-2026-00289
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100 1 _ |a Besse, Benjamin
|0 0000-0001-5090-8189
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245 _ _ |a Repotrectinib in NTRK fusion-positive advanced solid tumors: a phase 1/2 trial.
260 _ _ |a [New York, NY]
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|b Springer Nature
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520 _ _ |a Early-generation TRK tyrosine kinase inhibitors (TKIs) approved for treating NTRK fusion-positive (NTRK+) solid tumors provide clinical benefit; however, resistance emerges. Repotrectinib is a next-generation ROS1/TRK TKI with a compact macrocyclic structure designed to improve durability of response. TRIDENT-1 is a registrational phase 1/2 trial assessing repotrectinib, a next-generation ROS1/TRK TKI, in adults with advanced solid tumors, including NTRK+ disease. The primary endpoint was confirmed objective response; secondary endpoints included duration of response (DOR), progression-free survival (PFS), overall survival and safety. Median follow-up ranged between 21.3 months and 25.7 months. In the TKI-naive cohort (n = 51; 95% confidence interval (CI)), the response rate was 59% (44-72); the median DOR was not estimable (NE); and the median PFS was 30.3 months (9.0-NE). In the TKI-pretreated cohort (n = 69; 95% CI), the response rate was 48% (36-60); the median DOR was 9.8 months (7.4-13.0); and the median PFS was 7.4 months (3.9-9.7). Of 30 TKI-pretreated patients with NTRK solvent front mutations, 16 had a response (53%; 95% CI: 34-72). Intracranial responses were observed in two of three TKI-naive patients and in four of six TKI-pretreated patients with measurable intracranial disease at baseline. Among all treated patients (n = 565), the most common any-grade treatment-related adverse event (TRAE) was dizziness (57%); most TRAEs were low grade; and 4% discontinued repotrectinib due to a TRAE. Here repotrectinib demonstrated durable systemic and intracranial responses with generally low-grade adverse events in patients with NTRK+ solid tumors, including those with previous TRK TKI treatment and solvent front mutations. These results support the use of repotrectinib to treat patients with NTRK+ solid tumors. ClinicalTrials.gov identifier: NCT03093116 .
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700 1 _ |a Lin, Jessica J
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700 1 _ |a Bazhenova, Lyudmila
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700 1 _ |a Goto, Koichi
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700 1 _ |a de Langen, Adrianus Johannes
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700 1 _ |a Kim, Dong-Wan
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700 1 _ |a Wolf, Jürgen
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700 1 _ |a Springfeld, Christoph
|0 0000-0003-3843-101X
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700 1 _ |a Popat, Sanjay
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700 1 _ |a Lim, Darren W T
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700 1 _ |a Nagasaka, Misako
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700 1 _ |a Hong, Jung Yong
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700 1 _ |a Baik, Christina S
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700 1 _ |a Hervieu, Alice
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700 1 _ |a Moreno, Victor
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700 1 _ |a Yang, Nong
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700 1 _ |a Kollengode, Kanthi
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700 1 _ |a Yang, Haisu
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700 1 _ |a Xu, Yuanfang
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700 1 _ |a Calvet, Christophe Y
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700 1 _ |a Yuan, Yong
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700 1 _ |a Hammell, Amy B
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700 1 _ |a Drilon, Alexander
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700 1 _ |a Solomon, Benjamin J
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