Updated Integrated Analysis of the Efficacy and Safety of Entrectinib in Locally Advanced or Metastatic
Adult
Aged
Aged, 80 and over
Benzamides
/ pharmacology
Biomarkers, Tumor
/ metabolism
Carcinoma, Non-Small-Cell Lung
/ drug therapy
Female
Humans
Indazoles
/ pharmacology
Lung Neoplasms
/ drug therapy
Male
Middle Aged
Neoplasm Metastasis
Protein-Tyrosine Kinases
/ metabolism
Proto-Oncogene Mas
Proto-Oncogene Proteins
/ metabolism
Young Adult
Journal
Journal of clinical oncology : official journal of the American Society of Clinical Oncology
ISSN: 1527-7755
Titre abrégé: J Clin Oncol
Pays: United States
ID NLM: 8309333
Informations de publication
Date de publication:
10 04 2021
10 04 2021
Historique:
pubmed:
2
3
2021
medline:
29
9
2021
entrez:
1
3
2021
Statut:
ppublish
Résumé
Genetic rearrangements of the tyrosine receptor kinase ROS proto-oncogene 1 ( The efficacy-evaluable population included adults with locally advanced or metastatic In total, 161 patients with a follow-up of ≥ 6 months were evaluable. The median treatment duration was 10.7 months (IQR, 6.4-17.7). The ORR was 67.1% (n = 108, 95% CI, 59.3 to 74.3), and responses were durable (12-month DoR rate, 63%, median DoR 15.7 months). The 12-month PFS rate was 55% (median PFS 15.7 months), and the 12-month OS rate was 81% (median OS not estimable). In 24 patients with measurable baseline CNS metastases by blinded independent central review, the intracranial ORR was 79.2% (n = 19; 95% CI, 57.9 to 92.9), the median intracranial PFS was 12.0 months (95% CI, 6.2 to 19.3), and the median intracranial DoR was 12.9 months (12-month rate, 55%). The safety profile in this updated analysis was similar to that reported in the primary analysis, and no new safety signals were found. Entrectinib continued to demonstrate a high level of clinical benefit for patients with
Identifiants
pubmed: 33646820
doi: 10.1200/JCO.20.03025
pmc: PMC8078299
doi:
Substances chimiques
Benzamides
0
Biomarkers, Tumor
0
Indazoles
0
MAS1 protein, human
0
Proto-Oncogene Mas
0
Proto-Oncogene Proteins
0
Protein-Tyrosine Kinases
EC 2.7.10.1
ROS1 protein, human
EC 2.7.10.1
entrectinib
L5ORF0AN1I
Banques de données
EudraCT
['2012-000148-88']
ClinicalTrials.gov
['NCT02097810', 'NCT02568267']
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1253-1263Subventions
Organisme : NCI NIH HHS
ID : P30 CA008748
Pays : United States
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