AstraZeneca said this morning that its investigational lung cancer drug AZD9291 delayed disease progression by more than a year.
Latest findings from the ongoing AURA study showed median progression free survival of 13.5 months in patients with advanced epidermal growth factor receptor mutation positive (EGFRm) non-small cell lung cancer, who also have the T790M resistance mutation.
Updated data also show an overall response rate with AZD9291 80mg of 54% and a median duration of response of 12.4 months, the firm said.
AZD9291 is a once daily, selective, irreversible EGFR tyrosine kinase inhibitor designed to reach more NSCLC patients by also targeting a second mutation, T790M, which is detected in 60% of patients and causes the most common form of EGFR-therapy resistance.
There are currently no treatments specifically approved for patients with EGFRm T790M advanced NSCLC. AZ’ drug has been granted Breakthrough Therapy designation, Orphan Drug and Fast Track status by the US Food and Drug Administration.
Selumetinib gets Orphan status
Meanwhile, the FDA has assigned AZ’ MEK inhibitor selumetinib with Orphan Drug status for the treatment of treatment of uveal melanoma, a rare disease in which cancer cells form in the tissues of the eye.
The drug, originally licensed from Array BioPharma, could potentially become the first effective treatment for patients with the condition.