Entrectinib in Patients with Advanced or Metastatic NTRK Fusion-Positive Solid Tumours: Integrated Analysis of Three Phase 1-2 Trials
Open accessAbstract
Background Entrectinib is a potent inhibitor of tropomyosin receptor kinase (TRK) A, B, and C, which has been shown to have anti-tumour activity against NTRK gene fusion-positive solid tumours, including CNS activity due to its ability to penetrate the blood-brain barrier. We present an integrated efficacy and safety analysis of patients with metastatic or locally advanced solid tumours harbouring oncogenic NTRK1, NTRK2, and NTRK3 gene fusions treated in three ongoing, early-phase trials.Methods An integrated database comprised the pivotal datasets of three, ongoing phase 1 or 2 clinical trials (ALKA-372-001, STARTRK-1, and STARTRK-2), which enrolled patients aged 18 years or older with metastatic or locally advanced NTRK fusion-positive solid tumours who received entrectinib orally at a dose of at least 600 mg once per day in a capsule. All patients had an Eastern Cooperative Oncology Group performance status of 0-2 and could have received previous anti-cancer therapy (except previous TRK inhibitors). The primary endpoints, the proportion of patients with an objective response and median duration of response, were evaluated by blinded independent central review in the efficacy-evaluable population (ie, patients with NTRK fusion-positive solid tumours who were TRK inhibitor-naive and had received at least one dose of entrectinib). Overall safety evaluable population included patients from STARTRK-1, STARTRK-2, ALKA-372-001, and STARTRK-NG (NCT02650401; treating young adult and paediatric patients [aged ≤21 years]), who received at least one dose of entrectinib, regardless of tumour type or gene rearrangement. NTRK fusion-positive safety evaluable population comprised all patients who have received at least one dose of entrectinib regardless of dose or follow-up. These ongoing studies are registered with ClinicalTrials.gov, NCT02097810 (STARTRK-1) and NCT02568267 (STARTRK-2), and EudraCT, 2012-000148-88 (ALKA-372-001).Findings Patients were enrolled in ALKA-372-001 from Oct 26, 2012, to March 27, 2018; in STARTRK-1 from Aug 7, 2014, to May 10, 2018; and in STARTRK-2 from Nov 19, 2015 (enrolment is ongoing). At the data cutoff date for this analysis (May 31, 2018) the efficacy-evaluable population comprised 54 adults with advanced or metastatic NTRK fusion-positive solid tumours comprising ten different tumour types and 19 different histologies. Median follow-up was 12.9 months (IQR 8·77-18·76). 31 (57%; 95% CI 43·2-70·8) of 54 patients had an objective response, of which four (7%) were complete responses and 27 (50%) partial reponses. Median duration of response was 10 months (95% CI 7·1 to not estimable). The most common grade 3 or 4 treatment-related adverse events in both safety populations were increased weight (seven [10%] of 68 patients in the NTRK fusion-positive safety population and in 18 [5%] of 355 patients in the overall safety-evaluable population) and anaemia (8 [12%] and 16 [5%]). The most common serious treatment-related adverse events were nervous system disorders (three [4%] of 68 patients and ten [3%] of 355 patients). No treatment-related deaths occurred.Interpretation Entrectinib induced durable and clinically meaningful responses in patients with NTRK fusion-positive solid tumours, and was well tolerated with a manageable safety profile. These results show that entrectinib is a safe and active treatment option for patients with NTRK fusion-positive solid tumours. These data highlight the need to routinely test for NTRK fusions to broaden the therapeutic options available for patients with NTRK fusion-positive solid tumours.Funding Ignyta/F Hoffmann-La Roche.
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The FDA has approved entrectinib and larotrectinib for use in patients with solid tumors with NTRK fusion.
“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 [84]
In patients with NTRK fusion-positive solid tumors treated with entrectinib, 57% had an objective response.
“At a median follow-up of 12.9 months, 57% of patients had an objective response”
From Update on Targeted Therapy and Immunotherapy for Metastatic Colorectal Cancer (2024) · cites this paper as [84]
In patients with NTRK fusion-positive solid tumors treated with entrectinib, 7% had a complete response.
“and 7% of patients had a complete response”
From Update on Targeted Therapy and Immunotherapy for Metastatic Colorectal Cancer (2024) · cites this paper as [84]
Among the fifty-four patients included in the entrectinib study, four individuals had metastatic colorectal cancer.
“Among the fifty-four patients included in the study, four individuals had metastatic colorectal cancer.”
From Update on Targeted Therapy and Immunotherapy for Metastatic Colorectal Cancer (2024) · cites this paper as [84]
Entrectinib and larotrectinib have demonstrated activity in patients with solid tumors with NTRK fusion.
“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 [84]
Two therapies, larotrectinib and entrectinib, are FDA-approved for use in colorectal cancer with NTRK mutation.
“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 [84]
The FDA approved entrectinib for NTRK tumors.
“Subsequently, the FDA approved entrectinib for NTRK tumors.”
From Update on Targeted Therapy and Immunotherapy for Metastatic Colorectal Cancer (2024) · cites this paper as [84]
In patients with NTRK fusion-positive solid tumors treated with entrectinib, the median duration of response was 10 months.
“the median duration of response was 10 months.”
From Update on Targeted Therapy and Immunotherapy for Metastatic Colorectal Cancer (2024) · cites this paper as [84]
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- Authors
- Doebele, R. C., Drilon, A., Paz-Ares, L., Siena, S., Shaw, A. T., Farago, A. F., Blakely, C. M., Seto, T., Cho, B. C., Tosi, D., Besse, B., Chawla, S. P., Bazhenova, L., Krauss, J. C., Chae, Y. K., Barve, M., Garrido-Laguna, I., Liu, S. V., Conkling, P., John, T., Fakih, M., Sigal, D., Loong, H. H., Buchschacher, G. L., Garrido, P., Nieva, J., Steuer, C., Overbeck, T. R., Bowles, D. W., Fox, E., Riehl, T., Chow-Maneval, E., Simmons, B., Cui, N., Johnson, A., Eng, S., Wilson, T. R., & Demetri, G. D.
- Affiliations
- University of Colorado Anschutz (US)
- Memorial Sloan Kettering Cancer Center (US)
- Spanish National Cancer Research Centre (ES)
- University of Milan (IT)
- Massachusetts General Hospital (US)
- University of California, San Francisco (US)
- National Hospital Organization Kyushu Cancer Center (JP)
- Institut Gustave Roussy (FR)
- Sarcoma Oncology Center (US)
- Moores Cancer Center (US)
- University of Michigan (US)
- Northwestern University (US)
- Mary Crowley Cancer Research Center (US)
- Georgetown University (US)
- Virginia Oncology Associates (US)
- Austin Health (AU)
- City Of Hope National Medical Center (US)
- Scripps Clinic (US)
- Chinese University of Hong Kong (HK)
- Universidad de Alcalá (ES)
- University of Southern California (US)
- Emory University (US)
- University of Göttingen (DE)
- Children's Hospital of Philadelphia (US)
- Genentech (US)
- Ignyta (United States) (US)
- Harvard University (US)
- Corresponding author
- Demetri, George D
- ORCID
- Doebele, Robert C
- Drilon, Alexander
- Paz-Ares, Luis
- Siena, Salvatore
- Shaw, Alice T
- Farago, Anna F
- Blakely, Collin M
- Seto, Takashi
- Besse, Benjamin
- Chawla, Sant P
- Bazhenova, Lyudmila
- Krauss, John C
- Chae, Young Kwang
- Barve, Minal
- Liu, Stephen V
- Conkling, Paul
- John, Thomas
- Fakih, Marwan
- Sigal, Darren
- Loong, Herbert H
- Buchschacher, Gary L
- Garrido, Pilar
- Nieva, Jorge
- Steuer, Conor
- Overbeck, Tobias R
- Bowles, Daniel W
- Fox, Elizabeth
- Simmons, Brian
- Cui, Na
- Johnson, Ann
- Wilson, Timothy R
- Venue
- The Lancet Oncology
- Publisher
- Elsevier BV
- Published
- 2020-02
- Volume
- 21
- Issue
- 2
- Pages
- 271-282
- ISSN
- 1470-2045 (ISSN-L)
- PMC
- PMC7461630
- OpenAlex
- W2996574710
- Cited by
- 1,790
- References
- 32
- Citations by year
- 2026: 181 · 2025: 241 · 2024: 285 · 2023: 317 · 2022: 351 · 2021: 258 · 2020: 150 · 2019: 2 · 2018: 1 · 2014: 1
- FWCI
- 139.90
- 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)
- YUHSpace (Yonsei University Medical Library) (submittedVersion, cc-by-nc-nd)
- Minerva Access (University of Melbourne) (submittedVersion)
- GoeScholar The Publication Server of the Georg-August-Universität Göttingen (Georg-August-Universität Göttingen) (submittedVersion, other-oa)
- GoeScholar The Publication Server of the Georg-August-Universität Göttingen (Georg-August-Universität Göttingen) (submittedVersion, cc-by)
- Funders
- Ludwig Institute for Cancer Research
- Alex's Lemonade Stand Foundation for Childhood Cancer
- Dr. Miriam and Sheldon G. Adelson Medical Research Foundation
- F. Hoffmann-La Roche
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Sarcoma Diagnosis and Treatment
- Health Sciences › Medicine › Pathology and Forensic Medicine › Cancer Mechanisms and Therapy
- Keywords
- entrectinib, NTRK gene fusions, TRK inhibitors, metastatic solid tumors
- MeSH terms
- Aged, Antineoplastic Agents, Benzamides, Female, Humans, Indazoles, Male, Membrane Glycoproteins, Middle Aged, Neoplasm Metastasis, Neoplasms, Time Factors, Biomarkers, Tumor, Treatment Outcome, Clinical Trials, Phase I as Topic, Clinical Trials, Phase II as Topic, Receptors, Nerve Growth Factor, Receptor, trkC, Receptor, trkB, Receptor, trkA, Protein Kinase Inhibitors, Gene Fusion
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