Sie sind bereits registriert?
Loggen Sie sich mit Ihrem Universimed-Benutzerkonto ein:
Sie sind noch nicht registriert?
Registrieren Sie sich jetzt kostenlos auf universimed.com und erhalten Sie Zugang zu allen Artikeln, bewerten Sie Inhalte und speichern Sie interessante Beiträge in Ihrem persönlichen Bereich zum späteren Lesen. Ihre Registrierung ist für alle Unversimed-Portale gültig. (inkl. allgemeineplus.at & med-Diplom.at)
Oral Tyrosine Kinase Inhibitor for EGFR Exon 20-Insertion-Positive NSCLC
Mobocertinib is a first-in-class irreversible tyrosine kinase inhibitor that was designed to selectively target in-frame EGFR exon 20 insertion (EGFRex20ins) mutations in non–small-cell lung cancer (NSCLC). In a multicenter phase 1/2 nonrandomized study, 114 patients with EGFRex20ins-positive NSCLC previously treated with platinum-based chemotherapy received mobocertinib (160 mg once daily) until disease progression or unacceptable toxicity.
At a median 14.2 months' follow up, the objective response rate by independent review — the primary endpoint — was 28% (95% confidence interval, 20%–37%). An additional 50% of patients had stable disease, for a disease control rate of 78%. The median duration of response was 17.5 months (95% CI, 7.4–20.3 months), median progression-free survival was 7.3 months (95% CI, 5.5–9.2 months), and median overall survival was 24.0 months (95% CI, 14.6–28.8 months). The most common treatment-related adverse events of any grade were diarrhea (91%), rash (45%), and paronychia (38%). Grade >3 adverse events occurred in 69% of patients and were considered treatment-related in 47%. Adverse events led to dose reduction in 25% of patients and to treatment discontinuation in 17%, most commonly owing to diarrhea (4%), nausea (4%), vomiting (2%), decreased appetite (2%), and stomatitis (2%).
This study was the basis for the recent FDA approval of mobocertinib for the treatment of adult patients with locally advanced or metastatic EGFR exon 20 insertion–mutant metastatic NSCLC who have received prior platinum-based chemotherapy. Mobocertinib joins amivantamab, an EGFR-MET-bispecific antibody, as a treatment option in this subset of patients. Patients with EGFRex20 insertion–positive NSCLC make up approximately 1% to 2% of the over 1.5 million patients worldwide with NSCLC. Mobocertinib represents an important treatment option for this group, but attention to toxicity will be crucial.
Zhou C et al.
Title: Treatment outcomes and safety of mobocertinib in platinum-pretreated patients with EGFR exon 20 insertion–positive metastatic non–small cell lung cancer: A phase 1/2 open-label nonrandomized clinical trial.
Source: JAMA Oncol 2021 Dec 1; [e-pub]. (Abstract/FREE Full Text)