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FORM 6-K
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Report
of Foreign Issuer
Pursuant
to Rule 13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For the
month of August 2017
Commission
File Number: 001-11960
AstraZeneca PLC
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This announcement contains inside information
17 August 2017 20:05 BST
LYNPARZA RECEIVES
ADDITIONAL AND BROAD
APPROVAL IN THE US FOR OVARIAN CANCER
Lynparza’s new tablet formulation approved as maintenance
treatment for women
with platinum-sensitive recurrent ovarian cancer regardless of
BRCA-mutation status
Lynparza tablets also indicated in BRCA-mutated ovarian cancer
beyond the third-line setting
Newly-approved tablet formulation means improved patient
convenience
AstraZeneca
and Merck & Co., Inc., (Merck: known as MSD outside the U.S.
and Canada) today announced that the US Food and Drug
Administration (FDA) has granted approval for the PARP inhibitor,
Lynparza (olaparib), as
follows:
●
New use of
Lynparza as a maintenance
treatment for recurrent, epithelial ovarian, fallopian tube or
primary peritoneal adult cancer who are in response to
platinum-based chemotherapy, regardless of BRCA
status;
●
New use of
Lynparza tablets (2 tablets
twice daily) as opposed to capsules (8 capsules twice
daily);
●
Lynparza tablets also now indicated
(conversion from the current accelerated
approval) for the use in patients with deleterious or
suspected deleterious germline BRCA-mutated advanced ovarian
cancer, who have been treated with three or more prior lines of
chemotherapy.
Sean
Bohen, Executive Vice President, Global Medicines Development and
Chief Medical Officer, AstraZeneca, said: “Physicians have
almost three years of clinical experience with Lynparza on the market and we are now
pleased to bring this important medicine, in a new tablet
formulation, to a broader group of women. Today’s approvals
validate more than 10 years of dedicated research behind
Lynparza, the world’s
first PARP inhibitor, which now provides oncologists with the
greater flexibility for use in terms of treatment settings. It
builds on our recently-announced collaboration with Merck, which
aims to further increase the number of treatment options available
to patients.”
Eric
Pujade-Lauraine, Head of the Women Cancers and Clinical Research
Department at Hôpitaux Universitaires Paris Centre, site
Hôtel-Dieu, AP-HP and Principal Investigator of the SOLO-2
trial, one of the trials supporting the approval, said:
“Today’s approval is welcome news for US patients with
ovarian cancer, who are now able to benefit from treatment with
olaparib irrespective of their BRCA-mutation status. This latest
regulatory milestone underscores the breadth and depth of clinical
data on olaparib, and not only demonstrates its efficacy as
maintenance therapy, but adds to the data presented earlier this
year showing sustained quality of life for patients undergoing
treatment for this serious disease.”
Roger
M. Perlmutter, President of Merck Research Laboratories, said:
“We congratulate AstraZeneca on the approval of these new
indications and the new dosage form and schedule for Lynparza, an important therapeutic
advance for many patients with ovarian cancer. This is a
significant first regulatory event in our collaboration with
AstraZeneca. We look forward to working with AstraZeneca in our
global collaboration to bring this medicine with its new
indications to patients.”
Two randomised trials supported the new approvals and the
conversion of accelerated approval to full approval which
was originally based on a single-arm trial:
●
SOLO-2 (n=295) confirmed the benefit of
Lynparza
in germline BRCA-mutated (gBRCAm)
patients, demonstrating a 70% reduced risk of disease progression
or death (HR 0.30 [95% CI, 0.22-0.41], P<0.0001) and improved
progression-free survival (PFS) to 19.1 vs 5.5 months for placebo
by investigator-assessed analysis.
●
Study 19 (n=265) showed that Lynparza reduced the risk of disease progression or death
by 65% and improved PFS compared with placebo in patients of any
BRCA status (HR 0.35 [95% CI, 0.25-0.49], P<0.0001; median PFS
of 8.4 months vs 4.8 months for placebo). Additionally, patients in
Study 19, treated with Lynparza as a maintenance therapy, had a median overall
survival (OS) of 29.8 months vs 27.8 months for placebo (HR 0.73
[95% CI, 0.55-0.95]).
Table 1. Summary of key efficacy results from randomised
trials:
|
Analysis
|
Reduction in the risk of disease progression or death
(PFS)
|
Reduction in the risk of death (OS)
|
|
SOLO-2
[gBRCAm]
|
Lynparza
|
70% (HR 0.30 [95% CI, 0.22-0.41], P<0.0001)
|
Data not yet mature
|
|
Placebo
|
|
Study 19
[PSR OC*]
|
Lynparza
|
65% (HR 0.35 [95% CI, 0.25-0.49], P<0.0001)
|
27% (HR 0.73 [95% CI, 0.55-0.95]
|
|
Placebo
|
*PSR =
Platinum-sensitive recurrent ovarian cancer
The
most-common adverse events reported in 20% or more of patients
across the SOLO-2 trial in the Lynparza arm were anaemia (44%), nausea
(76%), vomiting (37%), diarrhoea (33%), fatigue/asthenia (66%),
decreased appetite (22%), headache (25%), and dysgeusia (27%). The
most-common Grade 3 or 4 adverse events were anaemia (20%), nausea
(2.6%), vomiting (2.6%), diarrhoea (1.0%), fatigue/asthenia (4.1%),
and headache (0.5%). Discontinuation of Lynparza resulting from adverse events
was seen in 11% of patients. Dose interruptions of Lynparza due to an adverse reaction of
any grade was 45%. Dose reductions of Lynparza due to an adverse reaction was
25%.
The
most-common adverse events reported in 20% or more of patients
across the Study 19 trial in the Lynparza arm were anaemia (23%), nausea
(71%), vomiting (35%), diarrhoea (27%), fatigue (including
asthenia) (63%), decreased appetite (21%), and headache (21%). The
most-common Grade 3 or 4 adverse events were anaemia (7.4%), nausea
(2.2%), vomiting (2.2%), diarrhoea (2.2%), and fatigue (including
asthenia) (8.8%). Discontinuation of Lynparza resulting from adverse events
was seen in 4% of patients. Dose interruptions of Lynparza due to an adverse reaction of
any grade was 25%. Dose reductions of Lynparza due to an adverse reaction was
15%.
The
full data from the SOLO-2 trial can be found in the 25 July 2017
publication of The Lancet
Oncology.
Lynparza was first approved under the FDA’s
Accelerated Approval programme in December 2014, as a capsule
formulation, making it the first poly ADP-ribose polymerase (PARP)
inhibitor approved. Since
then, more than 3,000 advanced ovarian cancer patients have been
treated with Lynparza
capsules in its approved indication.
About SOLO-2
SOLO-2 was a Phase III, randomised, double-blinded, 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
gBRCA-mutated ovarian, fallopian tube and primary peritoneal
cancer. 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 and
were in complete or partial response. Eligible patients were
randomised to receive 300mg Lynparza tablets twice daily or placebo tablets twice
daily.
About Study 19
Study
19 was a Phase II, randomised, double-blinded, placebo-controlled,
multicentre trial, which evaluated the efficacy and safety of
Lynparza compared with
placebo in relapsed, high-grade serous ovarian cancer patients,
involving 82 sites across 16 countries. Patients received
Lynparza maintenance
monotherapy, at a dose of 400mg per day or matching placebo.
Treatment continued until disease progression if toxicities were
manageable.
About Lynparza
Lynparza 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 potential new
medicines targeting DDR mechanisms in cancer
cells. Lynparza
tablets are currently being tested in
combinations in a range of tumour types including breast, prostate,
and pancreatic cancers.
About the AstraZeneca and Merck Strategic Oncology
Collaboration
On 27 July 2017, AstraZeneca and Merck & Co., Inc., announced a
global strategic oncology collaboration to co-develop and
co-commercialise AstraZeneca’s Lynparza, the world’s first and leading PARP
inhibitor, and potential new medicine selumetinib, a MEK inhibitor,
for multiple cancer types. The collaboration is based on increasing
evidence that PARP and MEK inhibitors can be combined with
PDL-1/PD-1 inhibitors for a range of tumour types and is aimed at
maximising the potential of Lynparza to become the preferred backbone of combination
therapies. Working together, the companies will jointly
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 Ovarian Cancer
Worldwide, ovarian cancer is the 7th most-commonly diagnosed cancer
and the 8th most-common cause of cancer death in women. 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 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 New Oncology as one of
AstraZeneca’s five 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 majority 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 &
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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Adrian Kemp
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AstraZeneca PLC
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
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By: /s/
Adrian Kemp
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Name:
Adrian Kemp
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Title:
Company Secretary
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