EGFR exon 20 insertions account for approximately 5% of total EGFR mutations in Asian NSCLC populations. However, there is no currently approved drug which can target the EGFR exon 20 insertions in NSCLC. In a phase 1/2 study, the therapeutic efficacy of TAK-788 in NSCLC patients carrying EGFR exon 20 insertions has been investigated. Among the 28 recruited patients, 12 (42.8%) had baseline CNS metastasis; all had received at least one prior systemic therapy (15 patients had received ³ 3 prior therapies). The objective response rate (ORR) was 42.8% (12 had PR; 0 had CR) and the disease control rate (DCR) was 85.6% (12 had SD). The median progression free survival (PFS) was 7.3 months (95% CI, 4.4-NR months). These results suggest that TAK-788 is a potent therapeutic agent for NSCLC patients carrying an EGFR exon 20 insertions.
J Clin Oncol 37, 2019 (suppl; abstr 9007)