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AstraZeneca: AstraZeneca reports top-line result of tremelimumab monotherapy trial in mesothelioma

Trial did not meet primary endpoint of improving overall survival in
challenging to treat mesothelioma patients with no currently approved
treatment options in the second-line setting

Tremelimumab remains key component of Immuno-Oncology combination
strategy across multiple tumour types

AstraZeneca and MedImmune, its global biologics research and
development arm, today announced that DETERMINE, the Phase IIb
clinical trial of 10 mg/kg tremelimumab monotherapy in second or
third-line treatment of unresectable malignant mesothelioma, did not
meet its primary endpoint of overall survival.

Robert Iannone, Senior Vice President, Head of Immuno-Oncology, Global
Medicines Development at AstraZeneca, said: "We are disappointed that
tremelimumab monotherapy did not demonstrate a survival benefit in
this patient population with no approved medicines beyond first-line
treatment. However, we remain confident in tremelimumab's clinical
activity in combination, as shown in our recently published Study 006
trial of tremelimumab and durvalumab in non-small cell lung cancer."

In addition to investigation as monotherapy for patients with
mesothelioma, tremelimumab is being studied in combination with
AstraZeneca's anti-PD-L1 investigational immunotherapy durvalumab in
multiple tumour types, including non-small cell lung cancer (NSCLC),
squamous cell carcinoma of the head and neck, bladder, pancreatic,
gastric and liver cancers. Preclinical data have suggested that
targeting both PD-L1 and CTLA-4 may have additive or synergistic
effects.1 In the recently published Study 006
combination treatment with durvalumab and tremelimumab demonstrated
antitumour activity in patients with locally advanced or metastatic
NSCLC, irrespective of PD-L1 status.2

The Company will complete a full evaluation of the final DETERMINE
data, which will be submitted for presentation at an upcoming medical
meeting in 2016.



1Stewart et al. Preclinical modeling of immune checkpoint blockade
(P2012). J Immunol 2013: 190 (1 Meeting

Abstracts): Abstract 214.7.

2Antonia S, et al. Safety and antitumour activity in a Phase 1b study
of combined checkpoint blockade with anti- PD-L1 (durvalumab) and
anti-CTLA-4 (tremelimumab) in non-small cell lung cancer. The Lancet
Oncology. Available at
Accessed February


AstraZeneca · 2 Kingdom Street · London · W2 6BD

T: +44 20 7604 8000 · F: +44 20 7604 8270 ·

AstraZeneca PLC

No. 2723534, Registered Office,

2 Kingdom Street, London W2 6BD

3Delgermaa V et al. Global mesothelioma deaths reported to the World
Health Organization between 1994 and

2008. Bull World Health Organ. 2011 Oct 1;89(10):716-24, 724A-724C

4Driscoll T et al. The global burden of disease due to occupational
carcinogens. Am J Ind Med. 2005


About Mesothelioma

Mesothelioma is a rare and deadly form of cancer that affects the
lining of the lungs or abdomen. There is a high unmet medical need
for mesothelioma treatments, with median overall survival 9 to 12
months after initial diagnosis.3 The disease causes approximately

43,000 deaths per year globally.4 In 2015, tremelimumab was granted
Orphan Drug

the U.S. Food and Drug Administration.

About the DETERMINE trial

DETERMINE (NCT01843374) is a randomised, double-blind,
placebo-controlled Phase IIb global trial with 571 patients across
multiple countries. The trial evaluated the safety and efficacy of
tremelimumab versus placebo in the treatment of unresectable pleural
or peritoneal malignant mesothelioma.

About Tremelimumab

Tremelimumab is an investigational, selective human antibody directed
against cytotoxic T- lymphocyte-associated protein 4 (CTLA-4). By
blocking the activity of CTLA-4, tremelimumab "releases the brakes"
on T cell activation and boosts the immune response against cancer
cells. Tremelimumab is being investigated in an extensive clinical
trial programme, as monotherapy or in combination with durvalumab, in
NSCLC, bladder, head and neck, gastric, pancreatic, HCC and blood
cancers. In 2015, the U.S. Food and Drug

Administration granted tremelimumab Fast Track Designation and Orphan
Drug Designation as a potential treatment for malignant mesothelioma,
an aggressive, rare form of cancer that

affects the lining of the lungs and abdomen.

About Durvalumab

Durvalumab is an investigational human monoclonal antibody directed
against programmed death ligand-1 (PD-L1). PD-L1 expression enables
tumours to evade detection from the immune system through binding to
PD-1 on cytotoxic T lymphocytes. Durvalumab blocks

PD-L1 interaction with both PD-1 and CD80 on T cells, countering the
tumour's immune- evading tactics. Durvalumab is being developed
alongside other immunotherapies to

activate the patient's immune system to attack the cancer. Durvalumab
is being investigated

in an extensive clinical trial programme, as monotherapy or in
combination with tremelimumab, in NSCLC, bladder, head and neck,
gastric, pancreatic, HCC and blood

cancers. In 2015, durvalumab received Fast Track Designation for the
treatment of patients

with PD-L1-positive metastatic SCCHN, and in 2016, durvalumab was
granted Breakthrough Designation by the U.S. Food and Drug
Administration as a potential treatment for metastatic urothelial
bladder cancer.

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
cardiovascular, metabolic, respiratory, inflammation, autoimmune,
oncology, infection and neuroscience diseases. AstraZeneca operates
in over 100 countries and its innovative medicines are used by
millions of patients worldwide. For more information, please visit:


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
Thomas Kudsk Larsen +44 7818 524185
Eugenia Litz RIA +44 7884 735627
Nick Stone CVMD +44 7717 618834
Craig Marks Finance +44 7881 615764
Christer Gruvris Consensus Forecasts +44 7827 836825
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


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