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2019-04-29

AstraZeneca: Lynparza receives positive EU CHMP opinion for 1st-line maintenance treatment of BRCA-mutated advanced ovarian...

AstraZeneca and MSD's Lynparza is the only PARP inhibitor to
demonstrate an improvement in progression-free survival for patients
in this setting

AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck &
Co., Inc. inside the US and Canada) today announced that the
Committee for Medicinal Products for Human Use (CHMP) of the European
Medicines Agency has adopted a positive opinion, recommending
Lynparza (olaparib) as a 1st-line maintenance treatment of
BRCA-mutated advanced ovarian cancer.

The recommendation is for the use of Lynparza tablets as a maintenance
treatment of adult patients with advanced (FIGO stages III and IV)
BRCA1/2-mutated (germline and/or somatic) high-grade epithelial
ovarian, fallopian tube or primary peritoneal cancer who are in
response (complete or partial) following completion of first-line
platinum-based chemotherapy.

Dave Fredrickson, Executive Vice President, Oncology, said: "There
remains a significant unmet need in the treatment of advanced ovarian
cancer as 70% of women globally relapse within the first three years
after their initial treatment. The results of SOLO-1 demonstrate the
potential of using Lynparza earlier in the treatment pathway as a
maintenance therapy, and reinforce the importance of identifying a
patient's BRCA mutation status as soon as they are diagnosed."

Roy Baynes, Senior Vice President and Head of Global Clinical
Development, Chief Medical Officer, MSD Research Laboratories, said:
"Women with advanced ovarian cancer need and deserve new treatment
options. In the SOLO-1 trial, Lynparza demonstrated a significant
progression-free survival benefit as maintenance treatment for
patients with advanced BRCA-mutated ovarian cancer following response
to first-line platinum-based chemotherapy. If approved, this expanded
indication could change the way women in Europe with BRCA-mutated
advanced ovarian cancer are treated."

The positive opinion is based on data from the pivotal Phase III
SOLO-1 trial which showed that Lynparza reduced the risk of disease
progression or death by 70% vs. placebo following response to
platinum-based chemotherapy (HR 0.30 [95% CI 0.23-0.41], p<0.001). Of
those patients receiving Lynparza, 60.4% remained progression-free at
36 months vs. 26.9% of women in the placebo arm.

Lynparza is currently approved in 64 countries, including those in the
EU, for the maintenance treatment of platinum-sensitive relapsed
ovarian cancer regardless of BRCA status. It is approved in the US as
1st-line maintenance treatment of BRCAm advanced ovarian cancer
following response to platinum-based chemotherapy. It is also
approved in 38 countries, including the US, countries in the EU and
Japan, for germline BRCAm HER2-negative metastatic breast cancer
previously treated with chemotherapy; in the EU this includes locally
advanced breast cancer. Regulatory reviews are underway in other
jurisdictions for both ovarian cancer and breast cancer.

About SOLO-1

SOLO-1 was a Phase III randomised, double-blinded, placebo-controlled,
multicentre trial to evaluate the efficacy and safety of Lynparza
tablets (300mg twice daily) as maintenance monotherapy compared with
placebo, in patients with BRCAm advanced ovarian cancer following
1st-line platinum-based chemotherapy. The trial randomised 391
patients with a deleterious or suspected deleterious germline or
somatic BRCA1 or BRCA2 mutation who were in complete or partial
clinical response following platinum-based chemotherapy.

Patients were randomised (2:1) to receive Lynparza or placebo for up
to two years or until disease progression. Patients who had a partial
response at two years were permitted to stay on therapy at the
investigator's discretion. The primary endpoint was progression-free
survival (PFS) and key secondary endpoints included time to second
disease progression or death, time to first subsequent treatment and
overall survival.

The data were presented on 21 October 2018 at the Presidential
Symposium of the ESMO 2018 Congress in Munich, Germany and published
simultaneously online in the New England Journal of Medicine
(https://www.nejm.org/doi/full/10.1056/NEJMoa1810858).

Summary of PFSi,ii

+------------------------------------+----------------+---------------+
| |Lynparza (n=260)|Placebo (n=131)|
+------------------------------------+----------------+---------------+
|Number of patients with event (%)iii|102 (39) |96 (73) |
+------------------------------------+----------------+---------------+
|Median PFS (in months) |Not reached |13.8 |
+------------------------------------+----------------+---------------+
|Hazard ratio (95% CI) |0.30 (0.23-0.41) |
+------------------------------------+----------------+---------------+
|P-value |p<0.001 |
+------------------------------------+----------------+---------------+

i Investigator-assessed

ii Median (interquartile range) duration of follow-up 40.7 months
(34.9-42.9) for Lynparza and 41.2 months (32.2-41.6) for placebo

iii Analysis was done at 50.6% maturity

The SOLO-1 safety profile was in line with that observed in prior
clinical trials. The most common adverse events (AEs) ? 20% were
nausea (77%), fatigue (63%), vomiting (40%), anaemia (39%) and
diarrhoea (34%). The most common ? Grade 3 AEs were anaemia (22%) and
neutropenia (9%). Some 71% of patients on Lynparza remained on the
recommended starting dose. Additionally, 88% of patients on Lynparza
continued treatment without an AE-related discontinuation.

About ovarian cancer

Ovarian cancer is a leading cause of cancer death in women worldwide,
with a five-year survival rate of 19%.1 In 2018, there were over
295,000 new cases diagnosed and around 185,000 deaths.2 For
newly-diagnosed advanced ovarian cancer, the primary aim of treatment
is to delay progression of the disease for as long as possible and
maintain the patient's quality of life with the intent of achieving
complete remission or cure.3,4,5,6

About BRCA mutations

Breast cancer susceptibility genes 1/2 (BRCA1 and BRCA2) are human
genes that produce proteins responsible for repairing damaged DNA and
play an important role maintaining the genetic stability of cells.
When either of these genes is mutated, or altered, such that its
protein product either is not made or does not function correctly,
DNA damage may not be repaired properly, and cells become unstable.
As a result, cells are more likely to develop additional genetic
alterations that can lead to cancer.

About Lynparza

Lynparza (olaparib) is a first-in-class PARP inhibitor and the first
targeted treatment to block DNA damage response (DDR) in
cells/tumours harbouring a deficiency in homologous recombination
repair (HRR), such as mutations in BRCA1 and/or BRCA2. Inhibition of
PARP with Lynparza leads to the trapping of PARP bound to DNA
single-strand breaks, stalling of replication forks, their collapse
and the generation of DNA double-strand breaks and cancer cell death.
Lynparza is being tested in a range of tumour types with defects and
dependencies in the DDR.

Lynparza, which is being jointly developed and commercialised by
AstraZeneca and MSD, is approved for advanced ovarian cancer and
metastatic breast cancer and has been used in over 20,000 patients
worldwide. On 26 February 2019, AstraZeneca and MSD announced
(https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2...)
that Lynparza became the first PARP inhibitor to demonstrate benefit
in germline BRCAm metastatic pancreatic cancer in the Phase III POLO
trial.

Lynparza has the broadest and most advanced clinical trial development
programme of any PARP inhibitor, and AstraZeneca and MSD are working
together to understand how it may affect multiple PARP-dependent
tumours as a monotherapy and in combination across multiple cancer
types. Lynparza is the foundation of AstraZeneca's industry-leading
portfolio of potential new medicines targeting DDR mechanisms in
cancer cells.

About the AstraZeneca and MSD strategic oncology collaboration

In July 2017, AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US,
known as MSD outside the United States and Canada, announced a global
strategic oncology collaboration to co-develop and co-commercialise
Lynparza, the world's first PARP inhibitor, and potential new
medicine selumetinib, a MEK inhibitor, for multiple cancer types.
Working together, the companies will develop Lynparza and selumetinib
in combination with other potential new medicines and as
monotherapies. Independently, the companies will develop Lynparza and
selumetinib in combination with their respective PD-L1 and PD-1
medicines.

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 six
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 Oncology as one of AstraZeneca's four 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, Tumour Drivers 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 therapy areas - Oncology, Cardiovascular, Renal & Metabolism
and Respiratory. AstraZeneca operates in over 100 countries and its
innovative medicines are used by millions of patients worldwide. For
more information, please visit astrazeneca.com
(http://www.astrazeneca.com/) and follow us on Twitter @AstraZeneca
(https://twitter.com/AstraZeneca).

Media Relations
Gonzalo Viña +44 203 749 5916
Rob Skelding Oncology +44 203 749 5821
Rebecca Einhorn Oncology +1 301 518 4122
...

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