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AstraZeneca: AstraZeneca provides top-line results from Lynparza GOLD trial in advanced gastric cancer

AstraZeneca today announced that Lynparza (olaparib) in combination
with paclitaxel chemotherapy, compared with paclitaxel chemotherapy
alone, did not meet the primary endpoint of overall survival (OS) in
the Phase III GOLD trial in advanced gastric cancer patients, in
either the overall population or patients whose tumour tested
negative for Ataxia-Telangectasia Mutated (ATM) protein. Whilst there
was a numerical survival trend in the Lynparza plus paclitaxel arm,
it did not meet statistical significance.

Sean Bohen, Executive Vice President, Global Medicines Development and
Chief Medical Officer at AstraZeneca, said: "While there was a
numerical trend for survival benefit with Lynparza plus paclitaxel in
the GOLD trial, we are disappointed that this did not reach
statistical significance. The particular regimen in the GOLD study,
at a low dose and in combination with chemotherapy, differs from
other Phase III trials in the Lynparza programme. We look forward to
presenting the GOLD data and remain confident in Lynparza's clinical
activity in a range of tumour types, including its approved use in
BRCA-mutated ovarian cancer."

GOLD was a randomised, double-blinded, placebo-controlled, multicentre
Phase III trial to assess the efficacy and safety of Lynparza in
combination with paclitaxel, compared with paclitaxel alone. The
trial enrolled Asian patients with advanced HER2-negative gastric
cancer (including the gastro-oesophageal junction) who had progressed
following 1st-line therapy. The trial, conducted in China, Japan,
South Korea and Taiwan where gastric cancer is particularly
prevalent, enrolled a total of 525 patients - 18% of whom had tumours
that tested ATM negative by immunohistochemistry (IHC). Lynparza was
given orally at a dose of 100mg twice daily in combination with
paclitaxel IV infusion over 1 hour at 80mg/m2 weekly on days 1, 8 and
15 of a 28 day schedule.

The reported incidence of adverse events for Lynparza in combination
with paclitaxel compared with paclitaxel alone was similar.

A full evaluation of the data is ongoing and the results will be
submitted for presentation at an upcoming medical meeting.

Lynparza is approved in over 40 countries for use as monotherapy for
the maintenance treatment of adult patients with platinum-sensitive
relapsed BRCA-mutated (germline and/or somatic) high grade serous
epithelial ovarian, fallopian tube or primary peritoneal cancer who
are in response (complete or partial) to platinum-based chemotherapy.
It is approved in the US as monotherapy in patients with deleterious
or suspected deleterious germline BRCA-mutated advanced ovarian
cancer who have been treated with three or more prior lines of

- ENDS -


About Gastric Cancer

Gastric and Gastroesophageal Junction (GEJ) adenocarcinomas account
for around 84% of all cancers of the stomach. The incidence of
gastric cancer (GC) is disproportionally high in East Asia, where
annual incidence is around 9 times higher than those in the G6
countries combined.¹

About Lynparza

Lynparza (olaparib) is an innovative, first-in-class oral poly
ADP-ribose polymerase (PARP) inhibitor that exploits tumour DNA
damage response (DDR) pathway deficiencies to preferentially kill
cancer cells. Lynparza is the foundation of AstraZeneca's
industry-leading portfolio of compounds targeting DNA damage response
(DDR) mechanisms in cancer cells. Lynparza is the first PARP
inhibitor to be approved by regulatory authorities in the EU and US
for the treatment of women with BRCA-mutated (BRCAm) ovarian 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

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, 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:

¹Kantar Health, CancerMpact


Neil Burrows UK/Global +44 7842 350541
Vanessa UK/Global +44 7880 400690
Karen UK/Global +44 7818 524012
Jacob Lund Sweden +46 8 553 260 20
Michele US +1 302 885 2677
Thomas Kudsk +44 7818 524185
Eugenia Litz RIA +44 7884 735627
Nick Stone CVMD, RIA +44 7717 618834
Henry OncologyFinance +44 7788 354619+44 7881 615764
Christer ING, Consensus Forecasts +44 7827 836825
Lindsey Oncology, ING +1 240 543 7970
Mitch Chan Oncology +1 240 477 3771
Dial / Toll +1 866 381 7277

Key: RIA - Respiratory, Inflammation and Autoimmunity, CVMD -
Cardiovascular and Metabolic Disease, ING - Infection, Neuroscience
and Gastrointestinal


Författare WKR

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