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Soft Tissue Tumors

(P 419) PROSPECTIVE REAL-WORLD STUDY OF LAROTRECTINIB (LARO) IN PATIENTS (PTS) WITH TRK FUSION SOLID TUMORS: INTERIM ANALYSIS OF ON-TRK

    Author(s)

  • Jonathan C. Trent, MD, PhD

    Director
    Sarcoma Medical Research Program, University of Miami – Sylvester Comprehensive Cancer Center
    Miami, Florida, United States

    • Co-Author(s)

  • HW

    Huanmin Wang, MD

    Beijing Children’s Hospital, Capital Medical University
    Beijing, Beijing, China (People's Republic)

  • Tanya C. Watt, MD

    Associate Professor
    University of Texas Southwestern Medical Center
    Dallas, Texas, United States

  • WC

    Wonyoung Choi, MD

    National Cancer Center
    Goyang, Kyonggi-do, Republic of Korea

  • FS

    Freimut H. Schilling, MD (he/him/his)

    Head of department Pediatric Oncology
    Luzerner Kantonsspital (LUKS)
    Lucerne, Luzern, Switzerland

  • Julia Glade Bender, MD

    Vice Chair for Clinical Research, Department of Pediatrics
    Memorial Sloan Kettering Cancer Center
    New York, New York, United States

  • BK

    Benjamin Kasenda, MD

    Universitätsspital Basel (USB)
    Basel, Basel-Stadt, Switzerland

  • GT

    Ghazaleh Tabatabai, Prof

    Department for Neurology & Neuro-Oncology, University Hospital Tübingen and Hertie Institute for Clinical Brain Research, Center for Neuro-Oncology, Comprehensive Cancer Center, Eberhard Karls University Tübingen
    Tübingen, Baden-Wurttemberg, Germany

  • DB

    Domnita-Ileana Burcoveanu, MD, MSc

    Bayer HealthCare Pharmaceuticals, Inc.
    Basel, Basel-Stadt, Switzerland

  • NN

    Natascha Neu, MSc

    Chrestos GmbH
    Essen, Nordrhein-Westfalen, Germany

  • CC

    Carlos P. Carrasco, MD

    Bayer HealthCare Pharmaceuticals, Inc.
    Essen, Nordrhein-Westfalen, Germany

  • David S. S. Hong, MD

    Professor
    The University of Texas MD Anderson Cancer Center
    Houston, Texas, United States

  • TL

    Theodore W. Laetsch, MD

    The Children’s Hospital of Philadelphia, University of Pennsylvania Philadelphia
    Philadelphia, Pennsylvania, United States

Objective: NTRK gene fusions are oncogenic drivers in various tumors including sarcomas. Laro is a highly selective, central nervous system (CNS)-active TRK inhibitor approved for tumor-agnostic use in pediatric and adult pts with TRK fusion cancer. ON-TRK aims to assess laro long-term safety and efficacy in pts with TRK fusion cancer treated in real-world settings. Here, we report interim results for sarcoma and other tumors.

Methods: ON-TRK (NCT04142437) is an ongoing, open-label, non-interventional, multi-cohort, prospective study enrolling pediatric and adult pts with locally advanced or metastatic TRK fusion cancer. Laro dosing is determined by the treating physician. The primary endpoint is safety while secondary endpoints assess efficacy.

Results: At data cutoff (December 19, 2024), 157 pts were enrolled, of whom 120 had ≥6 months of follow-up and were included in the interim analysis. Median age at enrollment was 47 years (range 0–81). There were 11 (9%) pts with infantile fibrosarcoma (IFS) and 22 (18%) pts with non-IFS soft tissue sarcoma. Safety data are reported in the Table. The efficacy analysis included 111 pts. Best overall response was available for 96 pts. For the 66 response-evaluable pts with non-primary CNS tumors and 30 pts with response-evaluable CNS primary tumors, objective response rate (%, 95% CI) was 61 (48–72) and 23 (10–42); 24-week disease control rate (%, 95% CI) was 77 (65–87) and 53 (34–72); and median progression-free survival (months [mo], 95% CI) was 20 (10–not estimable [NE]) and 4 (3–11), respectively. Median duration of response (mo, 95% CI) was not reached ([NR] 13–NE) in pts with non-primary CNS tumors and 4 (1–NE) in pts with CNS primary tumors. Median overall survival for 111 pts with survival data (mo, 95% CI) was NR (28–NE) and 12 (7–NE), respectively.

Conclusion: Laro demonstrated manageable safety and favorable response rates and survival in a prospective, real-world trial.

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