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2019-04-10

AstraZeneca: Lynparza approved in EU for the treatment of germline BRCA-mutated HER2-negative advanced breast cancer

AstraZeneca and MSD's Lynparza reduced the risk of disease progression
or death by 42% vs. chemotherapy in Phase III OlympiAD trial

First PARP inhibitor approved in the EU for patients with this
difficult-to-treat disease and third EU approval for Lynparza

AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck &
Co., Inc. inside the US and Canada) today announced the European
Commission has approved Lynparza (olaparib) as a monotherapy for the
treatment of adult patients with germline BRCA1/2-mutations (gBRCAm),
and who have human epidermal growth factor receptor 2 (HER2)-negative
locally-advanced or metastatic breast cancer.

Under the licensed indication, patients should have previously been
treated with an anthracycline and a taxane in the (neo)adjuvant or
metastatic setting unless they were unsuitable for these treatments.
Patients with hormone receptor (HR)-positive breast cancer should
also have progressed on or after prior endocrine therapy, or be
considered unsuitable for endocrine therapy.

Dave Fredrickson, Executive Vice President, Oncology, said: "With this
approval, Lynparza provides patients throughout the EU with a
targeted and oral chemotherapy-free treatment option for a
difficult-to-treat cancer. It also reinforces the importance of
testing for biomarkers including BRCA, hormone receptor and HER2
expression, helping physicians to make the most informed treatment
decisions for patients."

Roy Baynes, Senior Vice President and Head of Global Clinical
Development, Chief Medical Officer, MSD Research Laboratories, said:
"In the OlympiAD trial, which supported this approval, Lynparza
demonstrated a meaningful improvement in progression-free survival
compared to chemotherapy in patients with germline BRCA-mutated
metastatic breast cancer. We look forward to making this new option
available across the EU, where we hope it will improve outcomes for
many patients."

The approval was based on data from the randomised, open-label, Phase
III OlympiAD trial which tested Lynparza vs. physician's choice of
chemotherapy (capecitabine, eribulin, or vinorelbine). In the trial,
Lynparza provided patients with a statistically-significant median
progression-free survival improvement of 2.8 months (7.0 months for
Lynparza vs. 4.2 months for chemotherapy). Patients taking Lynparza
experienced an objective response rate (ORR) of 52%, which was double
the ORR for those in the chemotherapy arm (23%).

This is the third indication for Lynparza in the EU, and AstraZeneca
and MSD are working together to deliver Lynparza as quickly as
possible to more patients across multiple settings. Lynparza has a
broad clinical development programme, including the ongoing Phase III
OlympiA which is testing Lynparza as an adjuvant treatment in
patients with gBRCAm HER2-negative breast cancer.

About OlympiAD

OlympiAD was a global, randomised, open-label, multi-centre Phase III
trial of 302 patients, assessing the efficacy and safety of Lynparza
tablets (300mg twice daily) compared to the physician's choice of
chemotherapy (capecitabine, eribulin or vinorelbine); 205 patients
were randomised to receive Lynparza and 97 patients were randomised
to receive chemotherapy. Patients in the OlympiAD trial had germline
BRCA1- and/or BRCA2-mutated, HER2-negative (HR-positive or triple
negative) breast cancer and received Lynparza for treatment in the
metastatic setting.

Prior to enrolment, all patients were treated with an anthracycline
(unless it was contraindicated) and a taxane chemotherapy in the
neoadjuvant, adjuvant or metastatic setting. Patients with metastatic
breast cancer (71% of patients) had received no more than two
previous chemotherapy treatments for metastatic disease. Patients
with HR-positive breast cancer had received at least one endocrine
(hormonal) therapy (in the adjuvant or metastatic setting) and had
disease progression during therapy, unless they had disease for which
endocrine therapy was considered inappropriate. Previous treatment
with platinum chemotherapy in the neoadjuvant, adjuvant or metastatic
setting was allowed (28% of patients).

The most common adverse reactions (?20%) in the OlympiAD trial of
patients who received Lynparza were nausea (58%), anaemia (40%),
fatigue (including asthenia) (37%), vomiting (30%), neutropenia
(27%), respiratory tract infection (27%), leukopenia (25%), diarrhoea
(21%) and headache (20%). The percentage of patients who discontinued
treatment in the Lynparza arm was 5% vs. 8% in the chemotherapy arm.

About advanced breast cancer

Advanced/metastatic breast cancer refers to Stage III and IV breast
cancer. Stage III disease may also be referred to as locally-advanced
breast cancer, while metastatic disease is the most-advanced stage of
breast cancer (Stage IV) and occurs when cancer cells have spread
beyond the initial tumour site to other organs of the body outside
the breast. Since there is no cure for the disease, the goal of
current treatment is to delay disease worsening or death.

In 2018, there were an estimated 2.1 million new cases of breast
cancer worldwide - one in four cancer cases among women (24.2%). In
Europe the estimated 5-year prevalence of breast cancer in 2018 was
2,054,887 cases.1 Approximately 30% of women who are diagnosed with
early breast cancer will go on to develop advanced disease.

About BRCA

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 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 multiple indications in 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/media-centre/press-releases/2019/lynparza-si...)
that Lynparza became the first PARP inhibitor to demonstrate benefit
in gBRCAm 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 a monotherapy.
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
Matt Kent BioPharma +44 203 749 5906
Jennifer Hursit Other +44 203 749 5762
Christina Sweden +46 8 552 53 106
Malmberg
Hägerstrand
Michele US +1 302 885 2677
Meixell

Investor
Relations
Thomas Kudsk +44 203 749 5712
Larsen
Henry Wheeler Oncology +44 203 749 5797
Christer BioPharma (cardiovascular, metabolism) +44 203 749 5711
Gruvris
Nick Stone BioPharma (respiratory, renal) +44 203 749 5716
Josie Afolabi Other medicines +44 203 749 5631
Craig Marks Finance, fixed inco...

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