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Association details:
| Biomarker: | ALK positive |
|---|---|
| Cancer: | Non Small Cell Lung Cancer |
| Drug: | Ensacove (ensartinib) (ALK inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Ensartinib Secured Its First Approval for 1st Line Treatment in ALK+ NSCLC
Published date:
03/22/2022
Excerpt:
...Xcovery Holdings, Inc... announced that Xcovery’s affiliate Betta Pharmaceuticals has received the National Medical Products Administration (NMPA)’s approval of ensartinib in China for the first-line treatment of ALK-positive non-small cell lung cancer (NSCLC).
Source:
Title:
Ensartinib vs Crizotinib for Patients With Anaplastic Lymphoma Kinase-Positive Non–Small Cell Lung Cancer
Published date:
09/02/2021
Excerpt:
In the ITT population, the median PFS was significantly longer with ensartinib than with crizotinib (25.8 [range, 0.03-44.0 months] vs 12.7 months [range, 0.03-38.6 months]...In this randomized clinical trial, ensartinib showed superior efficacy to crizotinib in both systemic and intracranial disease. Ensartinib represents a new first-line option for patients with ALK-positive NSCLC.
DOI:
10.1001/jamaoncol.2021.3523
Trial ID:
Source:
Title:
PHASE III RANDOMIZED STUDY OF ENSARTINIB VS CRIZOTINIB IN ANAPLASTIC LYMPHOMA KINASE (ALK) POSITIVE NSCLC PATIENTS: EXALT3
Published date:
08/08/2020
Excerpt:
In patients with ALK+ NSCLC, ensartinib significantly prolonged PFS over crizotinib with a favorable safety profile...
Source:
Title:
Ensartinib in Non-small Cell Lung Cancer Patients With Positive ALK
Excerpt:
...For the expanded cohort portion of the study, patients must have NSCLC with ALK genomic alterations positive by FISH or IHC...
Trial ID:
Source:
Title:
1370P - Efficacy and safety of ensartinib in ALK-positive non-small cell lung cancer patients with brain metastases: A multicenter, open-label, single-arm, phase II study
Published date:
10/16/2023
Excerpt:
...we evaluated efficacy and safety of ensartinib, an ALK-TKI, in ALK+ NSCLC pts with BM….Ensartinib showed promising intracranial efficacy with high blood-brain barrier penetration and a tolerable safety profile in ALK+ NSCLC pts with BM.
Trial ID:
Source:
Title:
Ensartinib in advanced ALK-positive non-small cell lung cancer: a multicenter, open-label, two-staged, phase 1 trial
Published date:
12/21/2022
Excerpt:
Patients with advanced, ALK or ROS1-positive NSCLC were recruited from 2 centers in China....In all patients (43 ALK+ and 5 ROS1+), the ORR and disease control rates (DCR) were 64.6 % (1 CR and 30 PR) and 81.3% (8 SD), respectively. The median PFS was 16.79 months [95% confidence interval (CI), 8.11 to 25.47 months]….In 43 ALK positive patients, the ORR and DCR were 72.1% (95% CI, 58.1–86.1%) and 83.7% (95% CI, 72.2–95.2%), respectively. The mPFS was 18.23 months (95% CI, 8.77–27.70 months).
DOI:
10.21037/jtd-22-1606
Trial ID:
Source:
Title:
[Pharmacology and Clinical Evaluation of Ensartinib Hydrochloride Capsule]
Published date:
08/20/2020
Excerpt:
Ensartinib (X-396), a next-generation ALK tyrosine kinase inhibitor (ALK-TKI), has shown greater potency on inhibiting ALK activity and controlling brain metastases than crizotinib, which is indicated for the treatment of crizotinib-resistant, ALK-positive NSCLC patients.
DOI:
10.3779/j.issn.1009-3419.2020.102.34
Source:
Title:
Abstract 579: Ensartinib (X-396), a novel ALK TKI, in Chinese ALK-positive non-small cell lung cancer: A phase I, dose-escalation and expansion study
Published date:
05/15/2020
Excerpt:
Between March, 2017 and August, 2018, 48 patients were enrolled. 43 patients were locally detected ALK positive by FISH or IHC (VANTANA), 5 patients harbored with ROS1 fusion....In ALK positive patients, the ORR and DCR were 80.5% (33/41) and 87.8% (36/41). The ORRs and DCRs at ≥225mg were 68.6% (24/35) and 85.7% (30/35), respectively....Ensartinib was well tolerated in Chinese ALK-positive NSCLC patients with high antitumor activity.
DOI:
10.1158/1538-7445.AM2020-579
Trial ID:
