Latest data from AURA study of lung cancer medicine AZD9291 demonstrates progression free survival of 13.5 months

AstraZeneca has announced latest data from the ongoing AURA study of AZD9291 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 of 13.5 months. These PFS findings relate to independently reviewed data from 63 patients with T790M tumours treated with AZD9291 at a dose of 80mg per day, and are based on only 38% of patients having tumour progression. The updated data also show an overall response rate with AZD9291 80mg of 54% (95% CI 41% to 67%) and a median duration of response of 12.4 months (95% CI 8.3 months to NC).

AZD9291 potential future treatment for advanced EGFRm NSCLC

AURA principal investigator Dr Pasi A. Jänne MD, PhD, Director, Lowe Center for Thoracic Oncology Dana-Farber Cancer Institute and Professor of Medicine Harvard Medical School, emphasised the sustained activity of AZD9291 as indicated by the key parameters of patient response: “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 (TKI) 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. There are currently no treatments specifically approved for patients with EGFRm T790M advanced NSCLC.

AZ also investigating AZD9291 in earlier disease and in combination with other pipeline assets

Antoine Yver, Head of Oncology, Global Medicines Development, AstraZeneca, said: “We are on track for a regulatory submission of AZD9291 in the US in the second quarter of this year. 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 ongoing AURA Phase I/II study is investigating AZD9291 in patients with advanced NSCLC and disease progression following treatment with an EGFR TKI. The updated results presented at the European Lung Cancer Conference (ELCC) build on previously reported data presented at the European Society for Medical Oncology 2014.

AstraZeneca is currently also investigating AZD9291 as first line therapy for EGFRm NSCLC patients, and in combination with MEDI4736, selumetinib and AZD6094 in NSCLC. Initial data will be presented at the American Society of Clinical Oncology annual meeting 2015.