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Larotrectinib in patients with TRK fusion-positive solid tumours: a pooled analysis of three phase 1/2 clinical trials
Open accessAbstract
Background The selective TRK inhibitor larotrectinib was approved for paediatric and adult patients with advanced TRK fusion-positive solid tumours based on a primary analysis set of 55 patients. The aim of our analysis was to explore the efficacy and long-term safety of larotrectinib in a larger population of patients with TRK fusion-positive solid tumours.Methods Patients were enrolled and treated in a phase 1 adult, a phase 1/2 paediatric, or a phase 2 adolescent and adult trial. Some eligibility criteria differed between these studies. For this pooled analysis, eligible patients were aged 1 month or older, with a locally advanced or metastatic non-CNS primary, TRK fusion-positive solid tumour, who had received standard therapy previously if available. This analysis set includes the 55 patients on which approval of larotrectinib was based. Larotrectinib was administered orally (capsule or liquid formulation), on a continuous 28-day schedule, to adults mostly at a dose of 100 mg twice daily, and to paediatric patients mostly at a dose of 100 mg/m 2 (maximum of 100 mg) twice daily. The primary endpoint was objective response as assessed by local investigators in an intention-to-treat analysis. Contributing trials are registered with ClinicalTrials.gov, NCT02122913 (active not recruiting), NCT02637687 (recruiting), and NCT02576431 (recruiting).Findings Between May 1, 2014, and Feb 19, 2019, 159 patients with TRK fusion-positive cancer were enrolled and treated with larotrectinib. Ages ranged from less than 1 month to 84 years. The proportion of patients with an objective response according to investigator assessment was 121 (79%, 95% CI 72-85) of 153 evaluable patients, with 24 (16%) having complete responses. In a safety population of 260 patients treated regardless of TRK fusion status, the most common grade 3 or 4 larotrectinib-related adverse events were increased alanine aminotransferase (eight [3%] of 260 patients), anaemia (six, 2%), and decreased neutrophil count (five [2%]). The most common larotrectinib-related serious adverse events were increased alanine aminotransferase (two [<1%] of 260 patients), increased aspartate aminotransferase (two [<1%]), and nausea (two [<1%]). No treatment-related deaths occurred.Interpretation These data confirm that TRK fusions define a unique molecular subgroup of advanced solid tumours for which larotrectinib is highly active. Safety data indicate that long-term administration of larotrectinib is feasible.Funding Bayer and Loxo Oncology.
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In the citing paper
“In this trial, 8 of 159 patients had colon cancer”
From Update on Targeted Therapy and Immunotherapy for Metastatic Colorectal Cancer (2024) · cites this paper as [85]
In the citing paper
“with a median duration of 3.7 months.”
From Update on Targeted Therapy and Immunotherapy for Metastatic Colorectal Cancer (2024) · cites this paper as [85]
In the citing paper
“Nevertheless, entrectinib and lartotrectinib have demonstrated activity in patients with solid tumors with NTRK fusion”
From Update on Targeted Therapy and Immunotherapy for Metastatic Colorectal Cancer (2024) · cites this paper as [85]
In the citing paper
“4 patients with colon cancer had a response to therapy”
From Update on Targeted Therapy and Immunotherapy for Metastatic Colorectal Cancer (2024) · cites this paper as [85]
In the citing paper
“and the FDA has approved their use for these patients.”
From Update on Targeted Therapy and Immunotherapy for Metastatic Colorectal Cancer (2024) · cites this paper as [85]
In the citing paper
“Two therapies, larotrectinib and entrectinib, are FDA-approved for use in CRC with NTRK mutation.”
From Update on Targeted Therapy and Immunotherapy for Metastatic Colorectal Cancer (2024) · cites this paper as [85]
In the citing paper
“Based on the efficacy across tumor types, larotrectinib was FDA-approved for tumors with NTRK fusions, including CRC.”
From Update on Targeted Therapy and Immunotherapy for Metastatic Colorectal Cancer (2024) · cites this paper as [85]
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Metadata
- Authors
- Hong, D. S., DuBois, S. G., Kummar, S., Farago, A. F., Albert, C. M., Rohrberg, K. S., van Tilburg, C. M., Nagasubramanian, R., Berlin, J. D., Federman, N., Mascarenhas, L., Geoerger, B., Dowlati, A., Pappo, A. S., Bielack, S., Doz, F., McDermott, R., Patel, J. D., Schilder, R. J., Tahara, M., Pfister, S. M., Witt, O., Ladanyi, M., Rudzinski, E. R., Nanda, S., Childs, B. H., Laetsch, T. W., Hyman, D. M., & Drilon, A.
- Affiliations
- The University of Texas MD Anderson Cancer Center (US)
- Harvard University (US)
- Stanford Medicine (US)
- Massachusetts General Hospital (US)
- Seattle Children's Hospital (US)
- University of Copenhagen (DK)
- Vanderbilt University Medical Center (US)
- University of California, Los Angeles (US)
- University of Southern California (US)
- Université Paris-Saclay (FR)
- University Hospitals Cleveland Medical Center (US)
- St. Jude Children's Research Hospital (US)
- Olgahospital (DE)
- Université Paris Descartes (FR)
- Cancer Trials Ireland (IE)
- University of Chicago (US)
- Thomas Jefferson University (US)
- National Cancer Center Hospital East (JP)
- German Cancer Research Center (DE)
- Memorial Sloan Kettering Cancer Center (US)
- Bayer (United States) (US)
- The University of Texas Southwestern Medical Center (US)
- Corresponding author
- Drilon, Alexander
- ORCID
- Hong, David S
- DuBois, Steven G
- Kummar, Shivaani
- Farago, Anna F
- Albert, Catherine M
- Rohrberg, Kristoffer S
- Nagasubramanian, Ramamoorthy
- Berlin, Jordan D
- Federman, Noah
- Mascarenhas, Leo
- Geoerger, Birgit
- Dowlati, Afshin
- Pappo, Alberto S
- Bielack, Stefan
- Doz, François
- McDermott, Ray
- Patel, Jyoti D
- Tahara, Makoto
- Pfister, Stefan M
- Witt, Olaf
- Ladanyi, Marc
- Rudzinski, Erin R
- Nanda, Shivani
- Childs, Barrett H
- Laetsch, Theodore W
- Hyman, David M
- Drilon, Alexander
- Venue
- The Lancet Oncology
- Publisher
- Elsevier BV
- Published
- 2020-04
- Volume
- 21
- Issue
- 4
- Pages
- 531-540
- ISSN
- 1470-2045 (ISSN-L)
- PMC
- PMC7497841
- OpenAlex
- W3008107700
- Cited by
- 1,028
- References
- 25
- Citations by year
- 2026: 106 · 2025: 148 · 2024: 162 · 2023: 178 · 2022: 202 · 2021: 171 · 2020: 60
- FWCI
- 86.25
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- The Lancet Oncology (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- eScholarship (California Digital Library) (submittedVersion)
- Funders
- Loxo Oncology
- Bayer Corporation
- Bayer Fund
- Topics
- Health Sciences › Medicine › Oncology › Sarcoma Diagnosis and Treatment
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Cancer Genomics and Diagnostics
- Keywords
- larotrectinib, TRK inhibitors, objective response rate, long-term safety, adverse events, childhood cancer, adult cancer, metastatic cancer, pooled analysis of clinical trials, alanine aminotransferase elevation, neutropenia, anemia, complete response, dose-limiting toxicity
- MeSH terms
- Adolescent, Adult, Aged, Aged, 80 and over, Child, Child, Preschool, Female, Humans, Infant, Infant, Newborn, Male, Middle Aged, Neoplasms, Proteins, Pyrazoles, Pyrimidines, Vesicular Transport Proteins, Young Adult
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