Efficacy of Larotrectinib in TRK Fusion–Positive Cancers in Adults and Children
Open accessAbstract
BACKGROUND: Fusions involving one of three tropomyosin receptor kinases (TRK) occur in diverse cancers in children and adults. We evaluated the efficacy and safety of larotrectinib, a highly selective TRK inhibitor, in adults and children who had tumors with these fusions. METHODS: We enrolled patients with consecutively and prospectively identified TRK fusion-positive cancers, detected by molecular profiling as routinely performed at each site, into one of three protocols: a phase 1 study involving adults, a phase 1-2 study involving children, or a phase 2 study involving adolescents and adults. The primary end point for the combined analysis was the overall response rate according to independent review. Secondary end points included duration of response, progression-free survival, and safety. RESULTS: A total of 55 patients, ranging in age from 4 months to 76 years, were enrolled and treated. Patients had 17 unique TRK fusion-positive tumor types. The overall response rate was 75% (95% confidence interval [CI], 61 to 85) according to independent review and 80% (95% CI, 67 to 90) according to investigator assessment. At 1 year, 71% of the responses were ongoing and 55% of the patients remained progression-free. The median duration of response and progression-free survival had not been reached. At a median follow-up of 9.4 months, 86% of the patients with a response (38 of 44 patients) were continuing treatment or had undergone surgery that was intended to be curative. Adverse events were predominantly of grade 1, and no adverse event of grade 3 or 4 that was considered by the investigators to be related to larotrectinib occurred in more than 5% of patients. No patient discontinued larotrectinib owing to drug-related adverse events. CONCLUSIONS: Larotrectinib had marked and durable antitumor activity in patients with TRK fusion-positive cancer, regardless of the age of the patient or of the tumor type. (Funded by Loxo Oncology and others; ClinicalTrials.gov numbers, NCT02122913 , NCT02637687 , and NCT02576431 .).
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TRK kinase inhibitors larotrectinib and entrectinib have been approved for solid tumors harboring an NTRK-fusion gene.
“The TRK kinase inhibitors larotrectinib and entrectinib have been approved for solid tumors harboring a NTRK-fusion gene (7).”
From KRAS mutation in pancreatic cancer (2021) · cites this paper as [7]
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- Authors
- Drilon, A., Laetsch, T. W., Kummar, S., DuBois, S. G., Lassen, U. N., Demetri, G. D., Nathenson, M., Doebele, R. C., Farago, A. F., Pappo, A. S., Turpin, B., Dowlati, A., Brose, M. S., Mascarenhas, L., Federman, N., Berlin, J., El-Deiry, W. S., Baik, C., Deeken, J., Boni, V., Nagasubramanian, R., Taylor, M., Rudzinski, E. R., Meric-Bernstam, F., Sohal, D. P. S., Ma, P. C., Raez, L. E., Hechtman, J. F., Benayed, R., Ladanyi, M., Tuch, B. B., Ebata, K., Cruickshank, S., Ku, N. C., Cox, M. C., Hawkins, D. S., Hong, D. S., & Hyman, D. M.
- Affiliations
- University of Southern California (US)
- From Memorial Sloan Kettering Cancer Center (A. Drilon, J.F.H., R.B., M.L., D.M.H.) and Weill Cornell Medical College (A. Drilon, D.M.H.), New York; University of Texas Southwestern Medical Center–Children’s Health, Dallas (T.W.L.); Stanford Cancer Center, Stanford University, Palo Alto (S.K.), Children’s Hospital Los Angeles, Keck School of Medicine, University of Southern California (L.M.), and UCLA David Geffen School of Medicine (N.F.), Los Angeles, and Loxo Oncology, South San Francisco (B.B.T....
- Inova Health System (US)
- ORCID
- Drilon, Alexander
- Laetsch, Theodore W.
- Kummar, Shivaani
- DuBois, Steven G.
- Lassen, Ulrik N.
- Nathenson, Michael
- Doebele, Robert C.
- Farago, Anna F.
- Pappo, Alberto S.
- Turpin, Brian
- Dowlati, Afshin
- Brose, Marcia S.
- Mascarenhas, Leo
- Federman, Noah
- Berlin, Jordan
- Baik, Christina
- Deeken, John
- Boni, Valentina
- Nagasubramanian, Ramamoorthy
- Taylor, Matthew
- Rudzinski, Erin R.
- Sohal, Davendra P.S.
- Ma, Patrick C.
- Raez, Luis E.
- Hechtman, Jaclyn F.
- Benayed, Ryma
- Ladanyi, Marc
- Ebata, Kevin
- Ku, Nora C.
- Hawkins, Douglas S.
- Hong, David S.
- Hyman, David M.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2018-02-22
- Volume
- 378
- Issue
- 8
- Pages
- 731-739
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC5857389
- OpenAlex
- W2790254562
- Cited by
- 2,824
- References
- 17
- Citations by year
- 2026: 270 · 2025: 290 · 2024: 280 · 2023: 309 · 2022: 405 · 2021: 449 · 2020: 408 · 2019: 292 · 2018: 114 · 2017: 3
- FWCI
- 238.28
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- The Research Repository @ WVU (West Virginia University) (submittedVersion)
- eScholarship (California Digital Library) (submittedVersion)
- Research at the University of Copenhagen (University of Copenhagen) (submittedVersion)
- Funders
- Loxo Oncology
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Sarcoma Diagnosis and Treatment
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Cancer Genomics and Diagnostics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
- Keywords
- larotrectinib, Trk receptors, TRK inhibitors, targeted therapy, childhood cancer, adult cancer, overall response rate, progression-free survival, drug safety, adverse events
- MeSH terms
- Adolescent, Adult, Aged, Antineoplastic Agents, Child, Child, Preschool, Female, Humans, Infant, Male, Middle Aged, Neoplasms, Protein Kinases, Pyrazoles, Pyrimidines, Oncogene Proteins, Fusion, Disease-Free Survival, Receptor Protein-Tyrosine Kinases, Kaplan-Meier Estimate, Young Adult
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