Recommended Citation
Riely GJ, Neal JW, Camidge DR, Spira AI, Piotrowska Z, Costa DB, Tsao AS, Patel JD, Gadgeel SM, Bazhenova L, Zhu VW, West HL, Mekhail T, Gentzler RD, Nguyen D, Vincent S, Zhang S, Lin J, Bunn V, Jin S, Li S, and Janne PA. Activity and Safety of Mobocertinib (TAK-788) in Previously Treated Non-Small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations From a Phase 1/2 Trial. Cancer Discov 2021.
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
