Osimertinib demonstrated better clinically-meaningful efficacy and a well-characterized safety profile compared to platinum pemetrexed among patients with epidermal growth factor receptor (EGFR) T790M-positive advanced non-small cell lung cancer (NSCLC) following progression on EGFR-tyrosine kinase inhibitor (TKI) treatment, according to results presented at the International Association for the Study of Lung Cancer (IASLC) 17th Annual World Conference on Lung Cancer in Austria.1
Osimertinib is a potent, irreversible, central nervous system (CNS)-active, EGFR-TKI selective for sensitizing (EGFRm) and T790M resistance mutations. Osimertinib is indicated for the treatment of patients with locally-advanced or metastatic EGFR T790M-positive NSCLC.
The authors presented results of the AURA3 (NCT02151981) trial, a phase 3, open-label, randomized study assessing the efficacy and safety of osimertinib versus platinum-based chemotherapy plus pemetrexed among patients with EGFR T790M-positive advanced NSCLC.
Four hundred and nineteen patients were randomized to either receive osimertinib (279 patients) or platinum-pemetrexed (140 patients). Sixty-four percent of the patients were female, 65% Asian, 68% never smoker, 34% with CNS metastases, and 66% with EGFR exon 19 deletion.
Patients treated with osimertinib had a median progression-free survival (PFS) of 10.1 months, compared with 4.4 months for patients treated with platinum-pemetrexed. The objective response rate (ORR) was also improved among patients treated with osimertinib (71%) compared to platinum-pemetrexed (31%). Median duration of response was 9.7 months with osimertinib and 4.1 months with platinum-pemetrexed.
Grade 3 or higher adverse events (AEs) were reported in 6% (16) of patients treated with osimertinib and 34% (46) treated with platinum-pemetrexed. The most common AEs in the group treated with osimertinib were diarrhea and rash.
The authors concluded that the results establish a new standard of care for these patients.
- Papadimitrakopoulou V, Wu YL, Ahn M, et al. Randomised phase III Study of osimertinib vs platinum-pemetrexed for EGFR T790M-positive advanced NSCLC (AURA3). Paper presented at: International Association for the Study of Lung Cancer 17th World Conference on Lung Cancer; December 2016; Vienna, Austria.