Blueprint
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 September
2017
Commission File
Number: 001-11960
AstraZeneca
PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge CB2
0AA
United
Kingdom
Indicate by check
mark whether the registrant files or will file annual reports under
cover of Form 20-F or Form 40-F.
Form
20-F X Form 40-F __
Indicate by check
mark if the registrant is submitting the Form 6-K in paper as
permitted by Regulation S-T Rule 101(b)(1):
Indicate by check
mark if the registrant is submitting the Form 6-K in paper as
permitted by Regulation S-T Rule 101(b)(7): ______
Indicate by check
mark whether the registrant by furnishing the information contained
in this Form is also thereby furnishing the information to the
Commission pursuant to Rule 12g3-2(b) under the Securities Exchange
Act of 1934.
Yes __
No X
If
“Yes” is marked, indicate below the file number
assigned to the Registrant in connection with Rule 12g3-2(b):
82-_____________
7 September 2017 12:30 BST
CELGENE AND ASTRAZENECA PROVIDE UPDATE
ON THE FUSION CLINICAL TRIAL PROGRAMME
AstraZeneca
and MedImmune, its global biologics research and development arm,
have been informed by partner Celgene that the US Food and Drug
Administration (FDA) has placed a partial clinical hold on five
trials and a full clinical hold on one trial in the Celgene FUSION
programme. The trials
are testing Imfinzi (durvalumab), an
anti-PD-L1 agent, in combination with immunomodulatory agents, with
or without chemotherapy, in blood cancers such as multiple myeloma, chronic
lymphocytic leukaemia and lymphoma.
The
decision by the FDA was based on risks identified in other trials
for an anti-PD-1 agent, pembrolizumab, in patients with multiple
myeloma in combination with immunomodulatory agents. No imbalance
has been observed in the FUSION programme; however, the clinical
holds allow for additional information to be collected to further
understand the risk benefit profile of the programme. The FDA has
taken similar action with other combination trials in patients with
multiple myeloma.
Patients
enrolled in the trials on partial clinical hold who are receiving
clinical benefit from treatment may remain on treatment. Patients
enrolled in the trial on full clinical hold will be discontinued
from treatment. No new patients will be enrolled into the listed
trials.
Other
trials with Imfinzi in
haematological malignancies and other tumour types continue
unchanged.
The
trials placed on partial clinical hold are:
|
●
|
MEDI4736-MM-001: A
Phase Ib multicenter, open-label study to determine the recommended
dose and regimen of durvalumab either as monotherapy or in
combination with pomalidomide with or without low-dose
dexamethasone in patients with relapsed and refractory multiple
myeloma
|
|
●
|
MEDI4736-MM-003: A
Phase II, multicenter, open-label study to determine the safety and
efficacy for the combination of durvalumab and daratumumab in
patients with relapsed and refractory multiple
myeloma
|
|
●
|
MEDI4736-MM-005: A
Phase II, multicenter, single-arm study to determine the efficacy
for the combination of durvalumab plus daratumumab in patients with
relapsed and refractory multiple myeloma that have progressed while
on current treatment regimen containing
daratumumab
|
|
●
|
MEDI4736-NHL-001: A
Phase I/II, open-label, multi-center study to assess the safety and
tolerability of durvalumab as monotherapy and in combination
therapy in subjects with lymphoma or chronic lymphocytic leukaemia.
The only arm in this trial for which enrolment is suspended is the
arm with the durval REVLIMID® and rituximab
combination
|
|
●
|
MEDI4736-DLBCL-001:
A Phase II, open-label, multicenter study to evaluate the safety
and clinical activity of durvalumab in combination with rituximab,
cyclophosphamide, doxorubicin, vincristine, prednisone (R-CHOP) or
with lenalidomide plus R-CHOP (R2 CHOP) in patients with previously
untreated, high risk diffuse large
B Cell lymphoma
|
The
trial placed on full clinical hold is:
|
●
|
MEDI4736-MM-002: A
Phase Ib multicenter, open-label study to determine the recommended
dose and regimen of durvalumab in combination with lenalidomide
with and without low-dose dexamethasone in subjects with newly
diagnosed multiple myeloma
|
The
trials that will continue to enrol are:
|
●
|
MEDI4736-MDS-001: A
randomised, multicenter, open-label, Phase II trial evaluating the
efficacy and safety of azacitidine subcutaneous in combination with
durvalumab in previously untreated subjects with higher-risk
myelodysplastic syndromes or in elderly (>= 65 Years) acute
myeloid leukaemia subjects not eligible for haematopoietic
stem cell
transplantation
|
|
●
|
CC-486-MDS-006: A
Phase II, international, multicenter, randomised, open-label,
parallel group to evaluate the efficacy and safety of CC-486 alone
in combination with durvalumab in subjects with myelodysplastic
syndromes who fail to achieve an objective response to treatment
with azacitidine for injection or
decitabine
|
In
April 2015, Celgene entered into a strategic collaboration with
MedImmune to develop and commercialise durvalumab for haematologic
malignancies. The use of durvalumab in combination with other
agents for the treatment of patients with haematologic malignancies
is not approved by the FDA, and the safety and efficacy of those
combinations have not been established.
About Celgene
Celgene
Corporation, headquartered in Summit, New Jersey, is an integrated
global biopharmaceutical company engaged primarily in the
discovery, development and commercialization of innovative
therapies for the treatment of cancer and inflammatory diseases
through next-generation solutions in protein homeostasis,
immuno-oncology, epigenetics, immunology and
neuro-inflammation. For more information, please visit
www.celgene.com.
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.
|
Media
Relations
|
|
|
|
Esra
Erkal-Paler
|
UK/Global
|
+44 203
749 5638
|
|
Karen
Birmingham
|
UK/Global
|
+44 203
749 5634
|
|
Rob
Skelding
|
UK/Global
|
+44 203
749 5821
|
|
Matt
Kent
|
UK/Global
|
+44 203
749 5906
|
|
Jacob
Lund
|
Sweden
|
+46
8 553 260 20
|
|
Michele
Meixell
|
US
|
+1 302
885 2677
|
|
Investor
Relations
|
|
|
|
Thomas
Kudsk Larsen
|
|
+44 203
749 5712
|
|
Craig
Marks
|
Finance,
Fixed Income, M&A
|
+44
7881 615 764
|
|
Henry
Wheeler
|
Oncology
|
+44 203
749 5797
|
|
Mitchell
Chan
|
Oncology
|
+1 240
477 3771
|
|
Nick
Stone
|
Respiratory,
Brilinta
|
+44 203
749 5716
|
|
Christer
Gruvris
|
Diabetes;
Autoimmunity, Neuroscience & Infection
|
+44 203
749 5711
|
|
US toll
free
|
|
+1 866
381 7277
|
Adrian Kemp
Company Secretary, 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.
Date:
7th
September 2017
|
|
By: /s/
Adrian Kemp
|
|
|
Name:
Adrian Kemp
|
|
|
Title:
Company Secretary
|