Pasi A. Jänne, MD, PhD, from the Dana-Farber Cancer Institute, discusses the efficacy and safety of mobocertinib in previously treated patients with EGFR exon 20-mutated non–small cell lung cancer (NSCLC).

Patients with EGFR-mutant NSCLC make up only about 1-2% of patients with NSCLC. This disease carries a worse prognosis than other EGFR mutations because there are currently no FDA-approved therapies that target exon 20 mutations, and current EGFR tyrosine kinase inhibitors (TKIs) and chemotherapy provide limited benefit for these patients.

As Dr. Jänne explains, mobocertinib (previously known as TAK-788) is a TKI designed to selectively target EGFR and human EGFR2 (HER2) exon 20 insertion mutations. Mobocertinab demonstrated clinically meaningful benefit and a manageable safety profile in previously treated patients with EGFR exon 20-mutated NSCLC, according to phase 1/2 data presented during the International Association for the Study of Lung Cancer (IASLC) 2020 World Conference on Lung Cancer. The confirmed objective response rate in patients previously treated with platinum-based chemotherapy was 26% per an independent review committee (IRC) and 35% per investigator assessment. Additionally, the median progression-free survival (mPFC) was 7.3 months by IRC and investigator assessment. In a second cohort of patients who received a prior EGFR TKI, the confirmed overall response rate was 23% per IRC and 35% per investigator assessment. The mPFS was 7.3 months by IRC and 7.1 months by investigator assessment. 

Overall, the safety profile of mobocertinib was consistent with the known profiles of other EGFR TKIs. 

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