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Association details:
| Biomarker: | NTRK1 fusion |
|---|---|
| Cancer: | Solid Tumor |
| Drug: | Vitrakvi (larotrectinib) (TrkB receptor inhibitor, TrkC kinase inhibitor, TrkA receptor inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Bayer receives approval for precision oncology treatment Vitrakvi™ in China
Published date:
04/13/2022
Excerpt:
Bayer today announced that the Center of Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) approved larotrectinib, under the brand name Vitrakvi™, for the treatment of adult and pediatric patients with advanced solid tumors that harbor a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion.
Source:
Title:
Bayer receives approval for Vitrakvi in Japan
Published date:
03/23/2021
Excerpt:
Bayer announced today that the Japanese Ministry of Health, Labor and Welfare (MHLW) has granted marketing authorization for larotrectinib, under the brand name Vitrakvi, for the treatment of Neurotrophic Tyrosine Receptor Kinase (NTRK) fusion-positive advanced or recurrent solid tumors.
Source:
Published date:
09/19/2019
Excerpt:
Vitrakvi as monotherapy is indicated for the treatment of adult and paediatric patients with solid tumours that display a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion...
Source:
Published date:
11/26/2018
Excerpt:
VITRAKVI is a kinase inhibitor indicated for the treatment of adult and pediatric patients with solid tumors that...have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation.
Test:
Source:
Title:
ESMO Clinical Practice Guideline update on the use of systemic therapy in advanced thyroid cancer
Published date:
04/28/2022
Excerpt:
Recommendations...Larotrectinib is an option for the treatment of adults and adolescents aged ≥12 years with metastatic NTRK fusion-positive solid tumours, not amenable to surgery, that have progressed following treatment...
DOI:
https://doi.org/10.1016/j.annonc.2022.04.009
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…
Source:
Title:
NICE recommends VITRAKVI® for children and adults with TRK fusion driven cancer
Published date:
04/21/2020
Excerpt:
...VITRAKVI (larotrectinib) was recommended by the National Institute for Health and Care Excellence (NICE) for the treatment of advanced neurotrophic tyrosine receptor kinase (NTRK) fusion-positive solid tumours...
Source:
Title:
A Study to Test the Safety of the Investigational Drug Larotrectinib in Adults That May Treat Cancer
Excerpt:
...Proof of a malignancy harboring a NTRK fusion...
Trial ID:
Source:
Title:
Larotrectinib long-term efficacy and safety in adult patients (pts) with tropomyosin receptor kinase (TRK) fusion cancer.
Published date:
05/25/2023
Excerpt:
In this expanded dataset with extended follow-up, larotrectinib continues to demonstrate rapid and durable responses, extended survival, and a favorable safety profile in adults with TRK fusion cancer, including those with CNS metastases.
DOI:
10.1200/JCO.2023.41.16_suppl.3141
Trial ID:
Source:
Title:
463P - Efficacy and safety of larotrectinib in a pooled analysis of patients (Pts) with tropomyosin receptor kinase (TRK) fusion cancer with an extended follow-up
Published date:
09/05/2022
Excerpt:
The overall best ORR was 74% (95% confidence interval [CI] 67–81): 50 (30%) complete response (CR), including 10 (6%) pathological CR, 72 (44%) partial response, 22 (13%) stable disease...The 48-month OS rate was 66% (95% CI 57–75)….With an extended follow-up, larotrectinib demonstrated durable and deepening responses, extended survival benefit and a favourable safety profile. This highlights the importance of identifying NTRK gene fusions in cancer pts.
Trial ID:
Source:
Title:
Overall survival (OS) of patients with TRK fusion–positive cancer receiving larotrectinib versus standard of care (SoC): A matching-adjusted indirect comparison (MAIC) using real-world data (RWD).
Published date:
06/02/2022
Excerpt:
85 larotrectinib patients and 28 SoC patients were included. After matching, log-rank testing suggested no difference between the 2 groups (P=0.26), and larotrectinib was associated with a 78% lower risk of death (adjusted HR: 0.22 [95% confidence interval: 0.09, 0.54]; P=0.001), compared to SoC....This analysis suggests longer overall survival with larotrectinib, compared to SoC, in adult patients with TRK fusion cancer.
DOI:
10.1200/JCO.2022.40.16_suppl.6579
Source:
Title:
Efficacy and safety of larotrectinib in pediatric patients with tropomyosin receptor kinase (TRK) fusion-positive cancer: An expanded dataset.
Published date:
05/26/2022
Excerpt:
The INV-assessed best ORR for the 93 evaluable pts was 84% (95% confidence interval [CI] 75–91): 35 (38%) complete response (CR; including two pending confirmation and 10 pathological CR), 43 (46%) partial response (two pending confirmation), 11 (12%) stable disease, two (2%) progressive disease...In this expanded dataset, larotrectinib continues to demonstrate rapid and durable tumor-agnostic efficacy, extended survival, and a favorable safety profile in pediatric pts with TRK fusion-positive cancer.
DOI:
10.1200/JCO.2022.40.16_suppl.10030
Source:
Title:
535P - Larotrectinib efficacy and safety in adult patients with tropomyosin receptor kinase (TRK) fusion cancer
Published date:
09/13/2021
Excerpt:
We report an updated analysis of the efficacy and safety of larotrectinib in adult pts with TRK fusion cancer....ORR was 67% (95% CI 58–75): 12% complete responses; 55% partial responses (3 pts pending confirmation); 20% stable disease; 9% progressive disease; and 4% not determined. ORR in 15 evaluable pts with baseline CNS metastases was 73% (95% CI 45–92)....larotrectinib continues to demonstrate robust and durable tumour-agnostic efficacy with extended survival benefits in adults with TRK fusion cancer, including those with CNS metastases.
Source:
Title:
Survival benefits of larotrectinib in an integrated dataset of patients with TRK fusion cancer
Published date:
09/14/2020
Excerpt:
These data confirm that treatment with larotrectinib offers extended survival benefit in pts with TRK fusion cancer. Larotrectinib continued to demonstrate a favourable long-term safety profile. Screening pts for NTRK gene fusions should be actively considered.
Trial ID:
Source:
Title:
Activity and safety of larotrectinib in adult patients with TRK fusion cancer: an expanded data set
Published date:
09/03/2020
Excerpt:
...TRK fusions involved NTRK1 (43%)...The ORR was 71% (95% CI 62-79): 10% complete response, 60% partial response...In patients with brain metastases, the ORR was 71% (95% CI 42-92; 10 of 14 patients, all partial responses)....In an expanded data set of adults with TRK fusion cancer, larotrectinib demonstrated robust and durable tumor-agnostic efficacy and favorable safety, supporting TRK testing in patients with solid tumors of any type.
Source:
Title:
Larotrectinib efficacy and safety in TRK fusion cancer: An expanded clinical dataset showing consistency in an age and tumor agnostic approach
Published date:
10/01/2018
Excerpt:
Larotrectinib is an effective tumor-agnostic treatment for TRK fusion cancer with a favorable safety profile. Screening patients for NTRK gene fusions in solid tumors should be actively considered.
DOI:
https://doi.org/10.1093/annonc/mdy430
Source:
Title:
Larotrectinib for paediatric solid tumours harbouring NTRK gene fusions: phase 1 results from a multicentre, open-label, phase 1/2 study
Published date:
03/29/2018
Excerpt:
This multicentre, open-label, phase 1/2 study was done at eight sites in the USA and enrolled infants, children, and adolescents aged 1 month to 21 years with locally advanced or metastatic solid tumors...The TRK inhibitor larotrectinib was well tolerated in paediatric patients and showed encouraging antitumour activity in all patients with TRK fusion-positive tumors.
DOI:
10.1016/S1470-2045(18)30119-0
Trial ID:
Source:
Title:
Efficacy of Larotrectinib in TRK Fusion–Positive Cancers in Adults and Children
Excerpt:
In conclusion, TRK fusions defined a unique molecular subgroup of advanced solid tumors in children and adults in whom larotrectinib was highly active. Durable responses were observed without regard to the age of the patient, tumor tissue, and fusion status.
DOI:
10.1056/NEJMoa1714448
Trial ID:
