AstraZeneca presents new data on Faslodex in breast cancer and provides immuno-oncology update at ESMO 2016 congress

Phase III FALCON trial demonstrates superiority of Faslodex over Arimidex in the 1st-line treatment of hormone-receptor positive (HR+) advanced breast cancer

Immuno-Oncology data reinforce commitment to lung and head and neck cancers

30 September 2016

AstraZeneca, along with its global biologics research and development arm, MedImmune, will showcase the growing potential of its  broad portfolio of cancer medicines through 46 scientific presentations, at the European Society for Medical Oncology (ESMO) 2016 Congress in Copenhagen, Denmark, from 7-11 October 2016.

Highlights include new 1st-line data demonstrating superiority of Faslodex (fulvestrant) to a standard-of-care, aromatase inhibitor medicine, Arimidex (anastrazole), in postmenopausal women with HR+ locally-advanced or metastatic breast cancer who have not been previously treated with any hormonal medicine. The Company will also present updated safety and efficacy data from the Study 1108 durvalumab monotherapy cohort in non-small cell lung cancer (NSCLC) and head and neck squamous cell carcinoma (HNSCC), in addition to a comparative analysis of PD-L1 diagnostic assays in 500 HNSCC tumour samples.

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “Faslodex is an important treatment option for women with breast cancer. The FALCON trial illustrates how an approved medicine can further improve outcomes in patients with metastatic breast cancer. Additionally, our immuno-oncology presentations demonstrate our commitment to advancing innovation in lung and head and neck cancers, with pivotal data anticipated in the coming year.”

Progress in Advanced Breast Cancer
With a strong heritage in breast cancer research, AstraZeneca is addressing the need for treatment advances in this area. Approximately 30% of women with early breast cancer go on to develop advanced/metastatic disease, with median overall survival (OS) of only two to three years. Although advanced breast cancer (Stage III/IV) is generally incurable, it is still treatable and the goal is to improve both the length and quality of life for patients.

Faslodex, a recommended medicine for the three quarters of women with advanced breast cancer whose tumour carries the oestrogen receptor (ER), is the only hormone therapy for advanced/metastatic breast cancer that slows tumour growth by binding to and degrading the ER.

Advanced breast cancer presentations at ESMO 2016 Congress will focus on:

  • New data from the Phase III FALCON trial Faslodex 500mg compared to Arimidex 1mg in the 1st line treatment of women with HR+ locally advanced or metastatic breast cancer (Abstract # LBA14_PR – oral presentation). This trial is included in the official Congress Press Programme.
  • New insights on the relationship between progression-free survival and OS in HR+ advanced breast cancer using 1st-line treatment data for Faslodex 500mg and Arimidex (Abstract # 250P).
  • Plans for a Phase II trial to investigate the addition of the PD-L1 antibody, durvalumab, to taxane-anthracycline containing chemotherapy in women with triple-negative breast cancer (TBNC) (Abstract # 221TiP). TNBC tends to occur in younger women and spreads more quickly than most other types of breast cancer.

Advancing medicines in Immuno-Oncology
At ESMO 2016 Congress, AstraZeneca will present a range of new and updated data from its Immuno-Oncology programme, including:

  • Updated results from the Phase I/II trial (Study 1108) of durvalumab in patients with NSCLC (Abstract # 1216PD), and HNSCC (Abstract # 2085 – oral presentation).
  • Early data from a Phase Ib trial (SCORES) of durvalumab combined with AZD9150 (a STAT3 inhibitor) or AZD5069 (a CXCR2 antagonist) in patients with HNSCC and advanced solid malignancies (Abstract # 1049PD).
  • A comparative analysis of multiple diagnostic assays used to evaluate PD-L1 expression in HNSCC (Abstract # 955PD).

The Company will also present preliminary findings of a Phase I trial with MEDI0562, a novel anti-OX40 agonistic monoclonal antibody (mAb), in adult patients with advanced solid tumours (Abstract # 1052PD). Activating OX40 boosts anti-tumour immunity by promoting the survival and proliferation of cancer-fighting T cells

Beyond immuno-oncology, AstraZeneca will present data from:

  • SELECT-1, a Phase III, placebo-controlled trial of the combination of selumetinib and docetaxel in patients with locally advanced or metastatic KRASm NSCLC (Abstract # LBA47_PR).

  • GOLD, a Phase III trial of Lynparza (olaparib) in combination with paclitaxel in patients with advanced gastric cancer who have progressed following 1st-line therapy (Abstract # LBA25).


To view and download additional supporting material including backgrounders, infographics and images, please visit: This site will be live throughout ESMO 2016 Congress.

About AstraZeneca in Oncology
AstraZeneca has a deep-rooted heritage in Oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With at least six new medicines to be launched between 2014 and 2020 and a broad pipeline of small molecules and biologics in development, we are committed to advance New Oncology as one of AstraZeneca’s six Growth Platforms focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy, as illustrated by our investment in Acerta Pharma in haematology.

By harnessing the power of four scientific platforms - Immuno-Oncology, the genetic drivers of cancer and resistance, DNA Damage Response and antibody drug conjugates - and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.

About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Respiratory & Autoimmunity, Cardiovascular & Metabolic Diseases, and Oncology. The Company is also active in inflammation, infection and neuroscience through numerous collaborations. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit:    


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