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Association details:
Evidence:
Evidence Level:
Sensitive: A1 - Approval
Source:
Published date:
10/20/2023
Excerpt:
ROZLYTREK is a kinase inhibitor indicated for the treatment of...Adult and pediatric patients older than 1 month of age with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, as detected by an FDA-approved test without a known acquired resistance mutation.
Evidence Level:
Sensitive: A1 - Approval
Title:

entrectinib (Rozlytrek ®) is accepted for use within NHSScotland.

Published date:
02/05/2021
Excerpt:
entrectinib (Rozlytrek) is accepted for use within NHSScotland....as monotherapy for the treatment of adult and paediatric patients 12 years of age and older with solid tumours expressing a neurotrophic tyrosine receptor kinase (NTRK) gene fusion
Evidence Level:
Sensitive: A1 - Approval
Published date:
07/31/2020
Excerpt:
Rozlytrek is a cancer medicine. It can be used for treating patients from 12 years of age with solid tumours (cancer growths) that have a genetic abnormality called NTRK gene fusion.
Evidence Level:
Sensitive: A1 - Approval
Source:
Published date:
08/15/2019
Excerpt:
ROZLYTREK is a kinase inhibitor indicated for the treatment of...Adult and pediatric patients 12 years of age and older with solid tumors that...have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation
Evidence Level:
Sensitive: A2 - Guideline
Source:
Title:

ESMO Clinical Practice Guideline update on the use of systemic therapy in advanced thyroid cancer

Published date:
04/28/2022
Excerpt:
Recommendation...Entrectinib is an option for treating adults and adolescents aged ≥12 years with metastatic or unresectable NTRK fusion-positive solid tumours that have progressed in spite of standard-of-care treatment…
DOI:
https://doi.org/10.1016/j.annonc.2022.04.009
Evidence Level:
Sensitive: A2 - Guideline
Source:
Published date:
08/14/2020
Excerpt:
...entrectinib and larotrectinib are recommended as second-line or subsequent treatment options for patients with NTRK gene fusion-positive solid tumors…
Evidence Level:
Sensitive: B - Late Trials
Title:

FDA grants Priority Review to Roche’s personalised medicine entrectinib

Published date:
02/19/2019
Excerpt:
Roche...announced that the US Food and Drug Administration (FDA) has accepted the company’s New Drug Applications (NDAs) and granted Priority Review for entrectinib for the treatment of adult and paediatric patients with neurotrophic tropomyosin receptor kinase (NTRK) fusion-positive locally advanced or metastatic solid tumors...
Evidence Level:
Sensitive: B - Late Trials
Title:

Ignyta Granted Breakthrough Therapy Designation for Entrectinib by U.S. Food and Drug Administration

Published date:
05/15/2017
Excerpt:
Ignyta, Inc...announced that the U.S. Food and Drug Administration (FDA) has granted a Breakthrough Therapy Designation (BTD) to entrectinib for the treatment of NTRK fusion-positive, locally advanced or metastatic solid tumors...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Go to data
Title:

Study Of Entrectinib (Rxdx-101) in Children and Adolescents With Locally Advanced Or Metastatic Solid Or Primary CNS Tumors And/Or Who Have No Satisfactory Treatment Options

Excerpt:
...- Part B: Primary brain tumors with NTRK1/2/3 or ROS1 gene fusions; gene fusions are defined as those predicted to translate into a fusion protein with a functional TRKA/B/C or ROS1 kinase domain, without a concomitant second oncodriver as determined by a nucleic acid-based diagnostic testing method...
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

666P - Updated efficacy and safety data of entrectinib in patients (pts) with locally advanced/metastatic NTRK fusion-positive (fp) solid tumours

Published date:
10/16/2023
Excerpt:
Adults with measurable, locally advanced/metastatic NTRK-fp solid tumours and ≥12 months’ follow-up from first on-study scan, who received ≥1 dose of entrectinib, were efficacy evaluable….Median survival follow-up was 38.7 months. ORR was 62.4% (95% CI 55.2–69.2); the table shows responses in histologies with n>10. Median DoR was 29.4 months (95% CI 17.2–36.8). Median PFS and OS were 15.7 months (95% CI 13.7–22.9) and 38.2 months (95% CI 28.6–56.5), respectively....In this updated analysis, entrectinib was well tolerated and continued to induce clinically meaningful responses in pts with NTRK-fp solid tumours.
Evidence Level:
Sensitive: C3 – Early Trials
Title:

264P - Updated analysis of entrectinib in a subset of Chinese (mainland China, Hong Kong, Taiwan) patients (pts) with NTRK fusion-positive (fp) solid tumours and ROS1-fp non-small cell lung cancer (NSCLC)

Published date:
11/28/2022
Excerpt:
This updated analysis with longer follow-up provides further evidence that entrectinib is associated with deep and durable responses in Chinese pts with NTRK-fp solid tumours or ROS1-fp NSCLC.
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Updated analysis of the efficacy and safety of entrectinib in patients (pts) with locally advanced/metastatic NTRK fusion-positive (NTRK-fp) solid tumors.

Published date:
05/26/2022
Excerpt:
Median survival follow-up was 30.6 months. ORR was 61.3% (n = 92/150; 95% CI: 53.1–69.2), including 25 complete responses. Responses were observed in all tumor types with n>1 (Table). Median DoR, PFS and OS were 20.0 months (95% CI 13.2–31.1), 13.8 months (95% CI 10.1–20.0), and 37.1 months (95% CI 27.2–not estimable [NE]), respectively. In pts with and without investigator-assessed baseline CNS metastases (n = 31 / n = 119), ORR was 61.3% (95% CI 42.2–78.2) and 61.3% (95% CI 52.0–70.1) respectively. In this updated analysis, entrectinib continued to demonstrate deep and durable responses and was well tolerated in pts with NTRK-fp solid tumors with or without baseline CNS metastases.
DOI:
10.1200/JCO.2022.40.16_suppl.3099
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Entrectinib in children and young adults with solid or primary CNS tumors harboring NTRK, ROS1 or ALK aberrations (STARTRK-NG)

Published date:
04/08/2022
Excerpt:
Phase 1, dose escalation of oral, once-daily entrectinib, enrolled patients aged <22 years with solid tumors with/without target NTRK1/2/3, ROS1, or ALK fusions….In patients with fusion-positive tumors, ORR was 57.7% (95% CI 36.9-76.7)….Entrectinib resulted in rapid and durable responses in pediatric patients with solid tumors harboring NTRK1/2/3 or ROS1 fusions.
DOI:
10.1093/neuonc/noac087
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Entrectinib in Chinese (mainland China, Hong Kong, Taiwan) patients (pts) with locally advanced/metastatic ROS1 fusion positive (fp) NSCLC and NTRK-fp solid tumours

Published date:
03/23/2022
Excerpt:
Adult Chinese pts with ROS1- and TRK- TKI-naïve, ROS1-fp locally advanced/metastatic NSCLC or NTRK-fp solid tumours were enrolled....In Chinese pts with locally advanced/metastatic ROS1-fp NSCLC or NTRK fp solid tumours, with or without baseline CNS metastases, entrectinib induced deep and durable responses.
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Updated Integrated Analysis of the Efficacy and Safety of Entrectinib in Patients with NTRK Fusion-Positive Solid Tumors

Published date:
02/10/2022
Excerpt:
Patients with locally advanced/metastatic NTRK fusion-positive solid tumors...Median follow-up was 25.8 months; 61.2% of patients had a complete (n = 19) or partial response (n = 55). Median DoR was 20.0 months (95% CI, 13.0-38.2); median PFS 13.8 months (95% CI, 10.1-19.9)...With additional clinical experience, entrectinib continues to demonstrate durable systemic and intracranial responses, and can address the unmet need of a CNS-active treatment in patients with NTRK fusion-positive solid tumors.
DOI:
10.1158/1078-0432.CCR-21-3597
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Efficacy and safety exposure-response analyses of entrectinib in patients with advanced or metastatic solid tumors

Published date:
02/03/2022
Excerpt:
Among the 89 patients with evaluable efficacy data included in the exposure-efficacy analysis, 73% (65/89) achieved a complete or partial response….Model-described tumor shrinkage rates were 8-12 times greater than growth rates in both ROS-1-positive NSCLC patients and NTRK fusion-positive solid tumor patients. Entrectinib exposure distribution was similar in responders and non-responders....These analyses supported that entrectinib at 600 mg/day provides an acceptable benefit-risk ratio in adults with NTRK-, ROS1-, or ALK-positive tumors, considered as rare disease.
DOI:
10.1007/s00280-022-04402-w.
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

533P - Efficacy and safety of entrectinib in patients with locally advanced/metastatic NTRK fusion-positive (NTRK-fp) solid tumours

Published date:
09/13/2021
Excerpt:
Median BICR DoR was 20.0 months (95% CI 13.0–38.2). Median BICR PFS was 13.8 months (95% CI 10.1–19.9); median OS was 33.8 months (95% CI 23.4–46.4)....In this updated analysis, in a larger cohort of patients with locally advanced/metastatic NTRK-fp solid tumours and longer follow-up, entrectinib continued to have clinically meaningful efficacy and was well tolerated.
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Patient-reported outcomes from STARTRK-2: a global phase II basket study of entrectinib for ROS1 fusion-positive non-small-cell lung cancer and NTRK fusion-positive solid tumours

Published date:
04/27/2021
Excerpt:
SA-PRO populations comprised patients with NTRK fusion-positive solid tumours (N = 88) or ROS1 fusion-positive non-small-cell lung cancer (N = 180) who received one or more doses of entrectinib...Both cohorts reported low-to-moderate symptom burden at baseline, which was maintained or trended towards clinically meaningful improvement.
DOI:
10.1016/j.esmoop.2021.100113
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

The European Medicines Agency review of entrectinib for the treatment of adult or paediatric patients with solid tumours who have a neurotrophic tyrosine receptor kinase gene fusions and adult patients with non-small-cell lung cancer harbouring ROS1 rearrangements

Published date:
03/15/2021
Excerpt:
In patients with NTRK-positive solid tumours, the objective response rate (ORR) was 63.5% [95% confidence interval (CI) 51.5% to 74.4%] and the median duration of response (DOR) was 12.9 months (95% CI 9.3-not estimable)....Entrectinib induced clinically meaningful and durable objective responses in patients with NTRK-fusion positive solid tumours...
DOI:
10.1016/j.esmoop.2021.100087
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

540P - Entrectinib in patients with ROS1 fusion-positive non-small cell lung cancer (NSCLC) or NTRK fusion-positive solid tumours: Analysis of response by line of therapy

Published date:
09/14/2020
Excerpt:
...74 pts with NTRK+ solid tumours...data demonstrate similar responses to entrectinib in pts with ROS1+ NSCLC and NTRK+ solid tumours regardless of prior therapy exposure, supporting its use irrespective of number of prior lines of systemic therapy; ORR was >70% in pts receiving entrectinib as first-line therapy. Table: 540P
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Efficacy and safety of entrectinib in patients (pts) with NTRK-fusion positive (NTRK-fp) solid tumors: An updated integrated analysis.

Published date:
05/13/2020
Excerpt:
In this updated analysis, including more pts and longer follow-up, entrectinib continued to demonstrate clinically meaningful responses in pts with NTRK-fp solid tumors…
DOI:
10.1200/JCO.2020.38.15_suppl.3605
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Entrectinib in patients with advanced or metastatic NTRK fusion-positive solid tumours: integrated analysis of three phase 1–2 trials

Published date:
12/11/2019
Excerpt:
Entrectinib induced durable and clinically meaningful responses in patients with NTRK fusion-positive solid tumours…These results show that entrectinib is a safe and active treatment option for patients with NTRK fusion-positive solid tumours.
DOI:
https://doi.org/10.1016/S1470-2045(19)30691-6
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Efficacy and safety of entrectinib in patients with NTRK fusion-positive (NTRK-fp) Tumors: Pooled analysis of STARTRK-2, STARTRK-1 and ALKA-372-001

Published date:
10/01/2018
Excerpt:
In this multicenter, pooled analysis of global clinical trials, entrectinib was well tolerated overall and induced clinically meaningful, durable systemic responses in pts with NTRK-fp solid tumors, type agnostic, with and without CNS disease.
DOI:
https://doi.org/10.1093/annonc/mdy424.017