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AstraZeneca lung drug shows promise

pharmafile | April 20, 2015 | News story | Sales and Marketing AZ, AZD9291, AstraZeneca, European Lung Cancer Congress, NSCLC, Orphan 

AstraZeneca’s non-small cell lung cancer offering AZD9291 has been shown to delay disease progression by over a year.

Data presented at a recent European Lung Cancer Congress covered its ongoing AURA study of the drug in patients with advanced epidermal growth factor receptor mutation positive (EGFRm) non-small cell lung cancer (NSCLC), who also have the T790M resistance mutation.

It demonstrated a median progression free survival of 13.5 months the firm notes, and in addition an overall response rate with AZD9291 80mg of 54% – and a median duration of response of 12.4 months.

Presenting the findings at the conference was the AURA principal investigator Dr Pasi Jänne, who is a director at the Lowe Center for Thoracic Oncology Dana-Farber Cancer Institute – and a Havard Professor: “There are few treatment options currently available for patients with advanced EGFRm non-small cell lung cancer who experience disease progression due to a second mutation known as T790M.

“Management is usually limited to chemotherapy or re-challenge with EGFR tyrosine kinase inhibitors. As AURA continues to mature, and the trend in progression free survival and durable clinical response is maintained, this may support the potential for AZD9291 as a future treatment option for advanced EGFRm NSCLC.”

AZD9291 is a once-daily, selective, irreversible EGFR tyrosine kinase inhibitor designed to target both the activating sensitising 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.

AstraZeneca notes there are currently no treatments specifically approved for patients with EGFRm T790M advanced NSCLC, for which its drug received breakthrough therapy designation for previously.

The UK company is clearly on a roll with orphan status drugs in oncology, just last week its cancer medicine selumetinib gained this status for treating uveal melanoma – and days before that its tremelimumab was granted the same title in the setting of malignant mesothelioma. 

Antoine Yver who is the head of oncology within the global medicines development unit at AstraZeneca, says: “We are committed to developing novel medicines that address the significant unmet need in lung cancer by focusing on the genetic drivers underlying the disease.”

Yver adds: “Our extensive clinical research programme is also investigating the potential of AZD9291 in earlier disease and in combination with other pipeline assets including immuno-oncology molecules. With this comprehensive approach, our goal is to develop a broad range of potential treatment options for patients with EGFR mutation positive non-small cell lung cancer.”

The firm says it is on track for a regulatory submission of AZD9291 in the US in the second quarter of this year. 

Brett Wells

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