Repotrectinib monotherapy (TRIDENT-1) — NTRK-fusion+ solid tumors (pan-tumor, TKI-naive or post-prior TRK-TKI)
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| Components | DRUG-REPOTRECTINIB |
|---|
| ID | REG-REPOTRECTINIB-NTRK-PAN-TUMOR |
|---|---|
| Type | Regimen |
| Status | reviewed 2026-04-29 | pending_clinical_signoff |
| Diseases | None declared |
| Sources | SRC-ESMO-NSCLC-METASTATIC-2024 SRC-NCCN-NSCLC-2025 SRC-TRIDENT1-DRILON-2024 |
Notes
TRIDENT-1 NTRK cohort: TKI-naive ORR 58%, mPFS not reached (≥1 yr follow-up), intracranial activity demonstrated. TKI-pretreated NTRK ORR 50% incl. activity against solvent-front (G595R, G623R) and gatekeeper resistance mutations that compromise larotrectinib / entrectinib. FDA approval 2024-06 covers pan-tumor NTRK-fusion+ scope independent of organ-of-origin. Mechanistic edge: rigid macrocyclic scaffold designed to bypass canonical TRK resistance positions. Lead-in dosing (160 mg QD x 14d → 160 mg BID) critical to manage CNS/vestibular AE — direct BID worsens vestibular toxicity. Pediatric ≥12 yo dosing 160 mg QD lead-in then 160 mg BID (adult scheme) per FDA label.
Used By
No reverse references found in the YAML corpus.