Alectinib for the treatment of pretreated RET-rearranged advanced NSCLC: Results of the ETOP ALERT-lung trial.

Details

Serval ID
serval:BIB_A1D5ACC49E2E
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Alectinib for the treatment of pretreated RET-rearranged advanced NSCLC: Results of the ETOP ALERT-lung trial.
Journal
Lung cancer
Author(s)
Felip E., Smit E.F., Molina-Vila M.A., Dafni U., Massuti B., Berghmans T., de Marinis F., Passiglia F., Dingemans A.C., Cobo M., Viteri S., Britschgi C., Cuffe S., Provencio M., Merkelbach-Bruse S., Andriakopoulou C., Kammler R., Ruepp B., Roschitzki-Voser H., Peters S., Wolf J., Stahel R.
Working group(s)
ETOP 12-17 ALERT-lung Collaborators
ISSN
1872-8332 (Electronic)
ISSN-L
0169-5002
Publication state
Published
Issued date
12/08/2022
Peer-reviewed
Oui
Volume
172
Pages
94-99
Language
english
Notes
Publication types: Journal Article
Publication Status: aheadofprint
Abstract
Alectinib, a highly selective next generation ALK-inhibitor, has exhibited potent anti-tumour activity in RET-rearranged NSCLC in the preclinical stage.
ALERT-lung is a single-arm, phase II trial evaluating the activity of alectinib for the treatment of pretreated RET-rearranged advanced NSCLC. Alectinib was administered orally, 600 mg, twice per day until progression, refusal or unacceptable toxicity (treatment could continue beyond progression, if patient was deriving clinical benefit). Patient recruitment closed prematurely due to discouraging results for alectinib in a phase I/II study in the same indication.
All 14 patients who enrolled until the premature accrual closure, received at lease one dose of alectinib. Among them, median age was 61 years, majority (71 %) was female, never smokers, of ECOG PS 1. No objective response (complete or partial response) was recorded. Of the 13 evaluable patients, three (23 %) achieved and maintained disease stabilisation for 24 weeks. Up to 31 March 2021 (median follow-up 15.9 months), 12 PFS-events (92 %) were observed, with median PFS of 3.7 months (95 % C.I.: 1.8 - 7.3 months). Overall, three deaths (23 %) were reported. Seven patients (50 %) experienced grade ≥ 3 adverse events, while three discontinued treatment due to erythema multiforme of grade 3, related to alectinib. No treatment-related serious adverse event was reported.
Accrual into our trial was terminated early in response to other reports of limited activity of alectinib in patients with RET-fusion NSCLC and the emergence of more potent selective RET-inhibitors. Also in our trial, alectinib did not show the expected potential for anti-tumour activity in NSCLC.
Pubmed
Create date
05/09/2022 8:57
Last modification date
11/11/2022 6:39
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