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Experimental Lung Cancer Drug Delays Disease by More Than a Year

Median progression-free survival is 13.5 months for AZD9291

The latest findings have been reported from the ongoing AURA study of AZD9291 (Astra Zeneca) in patients with advanced epidermal growth factor receptor mutation positive (EGFRm) non–small-cell lung cancer (NSCLC), who also have the T790M resistance mutation.

The data demonstrated a median progression-free survival (PFS) of 13.5 months. This result relates to independently reviewed data from 63 patients with T790M tumors treated with AZD9291 at a dosage of 80 mg/day, and is based on only 38% of patients having tumor progression.

The updated data also show an overall response rate with AZD9291 80 mg of 54% and a median duration of response of 12.4 months.

AZD9291 is a once-daily, selective, irreversible EGFR tyrosine kinase inhibitor (TKI) designed to target both the activating sensitizing mutation, EGFRm, and T790M, the genetic mutation responsible for EGFR TKI treatment resistance in up to approximately two-thirds of cases of EGFRm advanced NSCLC. No treatments are currently approved for patients with EGFRm T790M advanced NSCLC.

The ongoing phase I/II AURA trial is investigating AZD9291 in patients with advanced NSCLC and disease progression following treatment with an EGFR TKI. As of December 2, 2014, 283 patients with EGFRm advanced NSCLC and acquired resistance to EGFR TKIs were enrolled –– 31 patients in dose-escalation cohorts and 252 patients in expansion cohorts. Of these patients, 163 had T790M tumors confirmed by central testing.

In patients treated with AZD9291 80 mg, the most common all-cause adverse events (AEs) of any grade included rash (38%) and diarrhea (36%). Investigator-determined treatment-related AEs of grade 3 or greater occurred in 14% of patients.

As of March 19, 2015, interstitial lung disease-related events were reported in approximately 2.7% of more than 1,000 patients dosed with AZD9291.

AZD9291 is also being investigated as first-line therapy for patients with EGFRm NSCLC, and in combination with MEDI4736 (anti-programmed death ligand-1 [PDL1] immunotherapy), selumetinib (a MEK inhibitor), and AZD6094 (a MET inhibitor) in patients with NSCLC. Initial data will be presented at the upcoming American Society of Clinical Oncology (ASCO) annual meeting.

Source: AstraZeneca; April 17, 2015.

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