Document Type

Article

Publication Date

2-25-2021

Publication Title

Cancer Discov

Abstract

Mobocertinib, an oral epidermal growth factor receptor (EGFR) inhibitor targeting EGFR gene mutations including exon 20 insertions (EGFRex20ins) in non-small cell lung cancer, was evaluated in a phase 1/2 dose-escalation/expansion trial (ClinicalTrials.gov NCT02716116). Dose escalation identified 160 mg daily as the recommended phase 2 dose and maximum tolerated dose. Among 136 patients treated with 160 mg daily, the most common any grade treatment-related adverse events (TRAEs; >25%) were diarrhea (83%), nausea (43%), rash (33%), and vomiting (26%), with diarrhea (21%) the only grade {greater than or equal to}3 TRAE >5%. Among 28 EGFRex20ins patients treated at 160 mg daily, the investigator-assessed confirmed response rate was 43% (12/28; 95% confidence interval (CI): 24-63%) with median duration of response of 14 months (5.0-not reached), and median progression-free survival of 7.3 months (4.4-15.6). Mobocertinib demonstrated antitumor activity in patients with diverse EGFRex20ins variants with a safety profile consistent with other EGFR inhibitors.

PubMed ID

33632775

ePublication

ePub ahead of print

Available for download on Saturday, February 26, 2022

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