Novel EGFR-TKI drug shows favourable antitumour activity in NSCLC

Treatment with the novel EGFR tyrosine kinase inhibitors (EGFR-TKI) abivertinib at 300 mg twice a day appears to be effective in patients with EGFR T790M-positive nonsmall cell lung cancer (NSCLC), while having manageable side effects, according to the results of a phase II trial.

The current analysis included 227 patients (median age 59 years, 65.2 percent female) adult Chinese patients received abivertinib at 300-mg twice a day in continual 21-day cycles. The median range of abivertinib exposure was 24.6 weeks.

Over a median follow-up period was 19.2 months, 109 out of 209 evaluable patients showed response. The primary endpoint of objective response rate was 52.2 percent (95 percent confidence interval [CI], 45.2–59.1), while the disease control rate was 88.0 percent (95 percent CI, 82.9–92.1). The median duration of response was 8.5 months (95 percent CI, 6.1–9.2)

The median progression-free survival was 7.5 months (95 percent CI, 6.0–8.8), and the median overall survival was 24.9 months (95 percent CI, 22.4–not reachable).

All 227 patients developed at least one adverse event (AE), with 96.9 percent having treatment-related AEs. The most common treatment-related AEs were elevation in alanine aminotransferase (51.4 percent) and in aspartate aminotransferase (50.7 percent) levels, diarrhoea (46.4 percent), and rash (30.7 percent).

Treatment-related serious AEs occurred in 13.7 percent of patients. There were 10 deaths (4.4 percent) documented, but none of them was deemed related to treatment.