DURVALUMAB granted Breakthrough Therapy designation by US FDA for treatment of
patients with PD-L1 positive urothelial bladder cancer
AstraZeneca and MedImmune, its global biologics research and development arm,
today announced that the US Food and Drug Administration (FDA) has granted
Breakthrough Therapy designation (BTD) for durvalumab (MEDI4736), an
investigational human monoclonal antibody directed against programmed death
ligand-1 (PD-L1), for the treatment of patients with PD-L1 positive inoperable
or metastatic urothelial bladder cancer whose tumour has progressed during or
after one standard platinum-based regimen.
Robert Iannone, Senior Vice President, Head of Immuno-Oncology, Global Medicines
Development at AstraZeneca said: “Metastatic bladder cancer is an area of
enormous unmet medical need. We are encouraged by this Breakthrough Therapy
designation. We look forward to working closely with the FDA to bring durvalumab
to bladder cancer patients as soon as possible.”
The Breakthrough Therapy designation is designed to expedite the development of
new drugs which are intended to treat a serious condition and which have shown
encouraging early clinical results, which demonstrate substantial improvement on
a clinically significant endpoint over available therapies or when there is
significant unmet medical need.
The Breakthrough Therapy designation for durvalumab was granted by the FDA on
the basis of early clinical data from a Phase I trial (Study 1108) in patients
with advanced metastatic urothelial bladder cancer whose tumour has progressed
during or after one standard platinum-based regimen. This represents the third
Breakthrough Therapy designation AstraZeneca has received from the FDA for
medicines in Oncology. This designation offers the opportunity for further
collaboration with the FDA for the durvalumab development programme. Data from
study 1108 have been submitted for presentation at a future medical meeting.
Durvalumab is also being tested in first-line bladder cancer as a monotherapy as
well as in combination with tremelimumab as part of the DANUBE Phase III trial
which achieved first patient in during the final quarter of 2015.
NOTES TO EDITORS
About bladder cancer
Urothelial bladder cancers arise from the epithelium of the bladder and are the
9th most common form of cancer worldwide. Based on the Global Burden of Disease
Cancer Collaboration, it is estimated that there were 400,000 incidents of
bladder cancer and 173,000 deaths worldwide for the year 2013. Metastatic
bladder cancer remains an area of great unmet medical need with 5-year overall
survival rates of less than 15%.
About durvalumab (MEDI4736)
Durvalumab is an investigational human monoclonal antibody directed against
programmed death ligand-1 (PD-L1). PD-L1 can be expressed by tumours to evade
detection by the immune system through binding to PD-1 on cytotoxic T
lymphocytes. Durvalumab blocks the PD-L1 interaction with PD-1, countering the
tumour’s immune-evading tactics. Durvalumab is being developed, alongside other
immunotherapies, to empower the patient’s immune system and attack the cancer.
Durvalumab is being investigated in an extensive clinical trial programme, as
monotherapy or in combination with tremelimumab, in NSCLC, head and neck,
bladder, gastric, pancreatic, HCC and blood cancers.
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 6 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 repair 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, innovation-driven biopharmaceutical business that
focuses on the discovery, development and commercialisation of prescription
medicines, primarily for the treatment of diseases in three main therapy areas –
respiratory, inflammation, autoimmune disease (RIA), cardiovascular and
metabolic disease (CVMD) and oncology – as well as in infection and
neuroscience. AstraZeneca operates in over 100 countries and its innovative
medicines are used by millions of patients worldwide. For more information
please visit: www.astrazeneca.com
CONTACTS
Media Enquiries
Neil Burrows UK/Global +44 20 7604 8032
Vanessa Rhodes UK/Global +44 20 7604 8037
Karen Birmingham UK/Global +44 20 7604 8120
Jacob Lund Sweden +46 8 553 260 20
Michele Meixell US +1 302 885 2677
Investor Enquiries
UK
Thomas Kudsk Larsen +44 7818 524185
Eugenia Litz RIA +44 7884 735627
Nick Stone CVMD +44 7717 618834
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Christer Gruvris Consensus Forecasts +44 7827 836825
US
Lindsey Trickett Oncology, ING +1 240 543 7970
Mitch Chan Oncology +1 240 477 3771
Dial / Toll-Free +1 866 381 7277
Key: RIA – Respiratory, Inflammation and Autoimmunity, CVMD – Cardiovascular and
Metabolic Disease,
ING – Infection, Neuroscience and Gastrointestinal
17 February 2016
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