AZD9291, an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, was highly active in patients with lung cancer with the EGFR T790M mutation who had experienced disease progression during prior therapy with EGFR tyrosine kinase inhibitors, a study published in The New England Journal of Medicine has shown.
For the study, researchers enrolled 253 patients diagnosed with advanced lung cancer with an EGFR mutation and had radiographically documented disease progression after previous treatment with tyrosine kinase inhibitors. Patients received AZD9291 at doses of 20 to 240mg once daily.
Efficacy results showed that the overall objective response rate was 51% (95% CI: 45-58). The response rate among 127 evaluable patients with centrally confirmed EGFR T790M was 61% (95% CI: 52-70).
Among 61 evaluable patients without centrally confirmed EGFR T790M, the response rate was 21% (95% CI: 12-34).
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The researchers found that the median progression-free survival was 9.6 months (95% CI: 8.3-NR) and 2.8 months (95% CI: 2.1-4.3) in EGFR T790M-positive and -negative patients, respectively.
In regard to safety, the most common all-cause adverse events were diarrhea, rash, nausea, and decreased appetite, and no dose-limiting toxicities occurred at the doses studied.