Clinical Data
Larotrectinib efficacy and safety have been evaluated in three clinical trials in patients with cancers with NTRK gene fusion [1-3]. Patients were to have unresectable or metastatic solid tumours progressing following systemic therapy or requiring surgery with substantial morbidity for locally-advanced disease [1, 2].
Patients were prospectively identified as carrying the NTRK gene fusion, detected by molecular profiling as routinely performed at each site, and consecutively enrolled into one of three open-label, single-arm protocols [1, 2]:
- A phase 1 study in adults (LOXO-TRK-14001; NCT02122913);
- A phase 1/2 study in children (SCOUT; NCT02637687); and
- A phase 2 “basket” study in adolescents and adults (NAVIGATE; NCT02576431).
Patients with and without documented NTRK gene fusion were allowed to participate in LOXO-TRK-14001 and SCOUT. Patients enrolled to NAVIGATE were required to have TRK fusion-positive cancer.
Click on the following links to learn more about the currently available efficacy and safety outcomes from these trials.
- Efficacy in adults
- Efficacy in primary CNS tumours
- Efficacy in paediatrics
- Mechanisms of acquired resistance
- Safety in adults & paediatrics
References
- VITRAKVI® (larotrectinib), USA Prescribing Information. 2021.
- VITRAKVI® (larotrectinib), EMA Summary of medicinal Product Characteristics. 2022.