This announcement contains inside information
26 October 2016 07:00
LYNPARZA PHASE III SOLO-2 TRIAL SHOWS SIGNIFICANT PROGRESSION-FREE SURVIVAL
BENEFIT
Trial studied Lynparza as maintenance treatment for women with BRCA-mutated
metastatic ovarian cancer
Initial findings show safety profile with Lynparza tablets was consistent with
previous studies
AstraZeneca today announced positive results from the Phase III SOLO-2 trial
designed to determine the efficacy of Lynparza (olaparib) tablets (300mg twice
daily) as a monotherapy for the maintenance treatment of platinum-sensitive
relapsed, BRCA-mutated ovarian cancer. Results from the trial demonstrate a
clinically-meaningful and statistically-significant improvement of progression
-free survival (PFS) among patients treated with Lynparza compared to placebo
and provide additional evidence to support the potential use of Lynparza in this
patient population.
Importantly, the median PFS in the Lynparza arm of SOLO-2 substantially exceeded
that observed in the Phase II maintenance study in patients with platinum
-sensitive relapsed ovarian cancer (Study 19).1
Sean Bohen, Executive Vice President, Global Medicines Development and Chief
Medical Officer at AstraZeneca, said: "We are pleased with the robust
improvement in progression-free survival demonstrated by Lynparza in the SOLO-2
trial. We will work with regulatory authorities to make Lynparza tablets
available as quickly as possible to patients with ovarian cancer. We remain
committed to investigating the full potential of Lynparza, both as monotherapy
and in combinations, and to identifying all patients who may benefit from this
important medicine."
Initial findings demonstrate that safety profile with Lynparza tablets was
consistent with previous studies. Full results of SOLO-2 will be presented at a
forthcoming medical meeting.
Today's positive results follow the Fast Track Designation for Lynparza by the
US FDA earlier this year, in patients with a BRCA mutation who have platinum
-sensitive, relapsed ovarian cancer.
About SOLO-2
SOLO-2 was a Phase III, multicentre trial designed to determine the efficacy of
Lynparza tablets as a maintenance monotherapy compared with placebo, in patients
with platinum-sensitive relapsed or recurrent BRCA-mutated (BRCAm) ovarian
cancer. In SOLO-2, patients with either germline or somatic BRCAm status were
eligible for enrolment, although due to the lack of widespread availability of
tumour BRCA testing, most patients were enrolled on blood-based germline
testing. Those few patients who were enrolled based on a tumour test were also
found to have a germline BRCA mutation. Patients were randomised to receive
either Lynparza tablets (300mg twice daily) or placebo until disease
progression.[1] (http://aboutblank#_edn1)
The trial, conducted in collaboration with the European Network for
Gynaecological Oncological Trial Groups (ENGOT) and Groupe d'Investigateurs
National pour l'Etude des Cancers de l'Ovaire et du sein (GINECO), randomised
295 patients with documented germline BRCA1 or BRCA2 mutations who had received
at least 2 prior lines of platinum-based chemotherapy.
About AstraZeneca in ovarian cancer
Worldwide, ovarian cancer is the 7th most commonly diagnosed
cancer[2] (http://aboutblank#_edn2) and the 8th most common cause of cancer
death in women.[3] (http://aboutblank#_edn3) The risk of developing ovarian
cancer is increased in women with specific inherited genetic abnormalities,
including BRCA mutations. AstraZeneca is committed to the continued development
of our R&D portfolio for ovarian cancer, with a focus on improved care for all
patients, including the development of targeted therapies for patients with
specific gene mutations such as BRCA.
About Lynparza
Lynparza (olaparib) is an innovative, first-in-class oral poly ADP-ribose
polymerase (PARP) inhibitor that may exploit tumour DNA damage response (DDR)
pathway deficiencies to preferentially kill cancer cells. It is approved by
regulatory authorities in the EU and US for the treatment of women with BRCAm
ovarian cancer. Lynparza is the foundation of AstraZeneca's industry-leading
portfolio of compounds targeting DNA damage response (DDR) mechanisms in cancer
cells.
About ENGOT
ENGOT (European Network for Gynaecological Oncological Trial groups) is a
research network of the European Society of Gynaecological Oncology (ESGO) and
was founded in 2007. Currently, ENGOT consists of 19 cooperative groups from 15
European countries. ENGOT's ultimate goal is to bring the best treatment to
gynaecological cancer patients through the best science, and enabling every
patient in every European country to access a clinical trial. ENGOT coordinates
and promotes multinational clinical trials within Europe on patients with
gynaecological cancer. This coordination is particularly relevant for academic
clinical trials, translational research, research on rare diseases, and for
clinical trials sponsored by the industry.
About GINECO
GINECO (Groupe d'Investigateurs National pour l'Etude des Cancers de l'Ovaire et
du sein) is the French Cooperative Group in Oncology labelled by INCA (Institut
National du Cancer or French NCI) for developing and conducting gynaecological
and advanced breast cancer clinical trials at the national and international
level. The network is nationwide with 700 specialized investigators belonging to
more than 150 public or private oncology units. The GINECO group was founded in
1993 and is member of international consortia such as ENGOT and GCIG
(Gynecologic Cancer InterGroup). GINECO was the ENGOT leading group for SOLO-2
trial.
About AstraZeneca in Oncology
AstraZeneca has a deep-rooted heritage in Oncology and offers a quickly growing
portfolio of new medicines that have 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 advancing 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 main therapy areas - Oncology,
Cardiovascular & Metabolic Diseases and Respiratory. The Company also is
selectively active in the areas of autoimmunity, neuroscience and infection.
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 and follow us on Twitter @AstraZeneca.
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References
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[1] (http://aboutblank#_ednref1) National Institutes of Health. Olaparib
Treatment in BRCA Mutated Ovarian Cancer Patients After Complete or Partial
Response to Platinum Chemotherapy. Available at:
http://clinicaltrials.gov/show/NCT01874353. Last accessed October 2016.
[2] (http://aboutblank#_ednref2) Cancer Research UK. Ovarian cancer incidence
statistics. Available at: http://www.cancerresearchuk.org/cancer
-info/cancerstats/types/ovary/incidence/uk-ovarian-cancer-incidence-statistics.
Last accessed June 2016.
[3] (http://aboutblank#_ednref3) Cancer Research UK. Ovarian cancer mortality
statistics. Available at: http://www.cancerresearchuk.org/cancer
-info/cancerstats/types/ovary/mortality/ Last accessed June 2016.
Positive results in AstraZeneca Lynparza trial
| Source: AstraZeneca PLC