Astrazeneca presenterar nya data för Faslodex på ESMO

Astrazeneca presenterar nya data för Faslodex på ESMO
Fas III studien FALCON visade att Faslodex var bättre än Arimidex i första linjens behandling på patienter med  (HR+) avancerad bröstcancer

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).