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2017-12-06

AstraZeneca: AstraZeneca to highlight its commitment to blood cancers at the 2017 American Society of Hematology Annual Mee...

First data presentation of Calquence, recently approved in the US for
patients with previously-treated mantle cell lymphoma

New data on five potential new medicines in development across six
types of blood cancer

AstraZeneca, along with Acerta Pharma, its haematology research and
development centre of excellence, and MedImmune, its global biologics
research and development arm, will highlight significant progress in
blood cancer research at the 59th 2017 American Society of Hematology
(ASH) Annual Meeting & Exhibition in Atlanta, USA. Presentations will
include new data from AstraZeneca's emerging haematology portfolio in
several cancer types including mantle cell lymphoma (MCL), chronic
lymphocytic leukaemia (CLL), hairy cell leukaemia (HCL), acute
myeloid leukaemia (AML), multiple myeloma and diffuse large B-cell
lymphoma (DLBCL).

Sean Bohen, Executive Vice President, Global Medicines Development and
Chief Medical Officer at AstraZeneca, said: "Following the recent
accelerated approval of AstraZeneca's first medicine for a blood
cancer, Calquence, we will share a broad range of new data at ASH
highlighting our scientific progress in haematology as we seek to
develop potential medicines that advance patient care."

Efficacy and safety of Calquence in the management of
previously-treated MCL

Following the US Food and Drug Administration (FDA) accelerated
approval
(https://www.multivu.com/players/English/8133451-astrazeneca-calquence-fd...)
of Calquence (acalabrutinib), a kinase inhibitor indicated for the
treatment of adult patients with MCL who have received at least one
prior therapy, data from the pivotal Phase II ACE-LY-004 clinical
trial on which the accelerated approval was based, will be presented
for the first time (Abstract #155
(https://ash.confex.com/ash/2017/webprogram/Paper100664.html)). New
details of the trial will be shared, including median time to
response, pre-specified patient subgroup efficacy analyses, as well
as safety analyses, further characterising the clinical profile of
Calquence in this patient population.

Calquence as monotherapy and in combination in multiple CLL patient
populations

Results will be presented from the Phase Ib/II ACE-CL-003 trial
evaluating Calquence and obinutuzumab in treatment-naïve and
previously-treated CLL patients (Abstract #432
(https://ash.confex.com/ash/2017/webprogram/Paper100491.html)), which
highlight the safety profile and activity of the combination.
Long-term follow-up safety and efficacy data from the Phase I/II
ACE-CL-001 clinical trial which tested Calquence as a monotherapy in
a large cohort of patients with relapsed or refractory CLL (Abstract
#498 (https://ash.confex.com/ash/2017/webprogram/Paper100575.html))
will expand on findings previously reported; these data will
highlight the favourable duration of response in this patient
population.

Early-stage haematology portfolio

· AstraZeneca will present additional data from its haematology
portfolio, including findings from a Phase I trial of moxetumomab
pasudotox, an anti-CD22 recombinant immunotoxin and potential new
medicine in development for the treatment of people with
previously-treated HCL (Abstract: #2765
(https://ash.confex.com/ash/2017/webprogram/Paper100821.html))

· Early data on AZD2811, a novel nanoparticle inhibitor of aurora
kinase B being tested in AML (Abstract #1368
(https://ash.confex.com/ash/2017/webprogram/Paper100896.html))

· Preclinical data from trials on MEDI2228, a BCMA-targeting
pyrrolobenzodiazepine-linked antibody drug conjugate being tested in
multiple myeloma (Abstract #3153
(https://ash.confex.com/ash/2017/webprogram/Paper102936.html))

· Data from a trial of vistusertib (AZD2014), a dual mTORC1/2
inhibitor being tested in DLBCL (Abstract #4113
(https://ash.confex.com/ash/2017/webprogram/Paper100440.html)).

- ENDS -

NOTES TO EDITORS

A full list of company-sponsored abstracts to be presented at ASH are
as follows:

Abstract Number Title Presentation
Details
Abstract Efficacy and safety Oral session,
#155 (https://ash.confex.com/ash/2017/w of acalabrutinib Saturday,
ebprogram/Paper100664.html) monotherapy in December 9, 1
patients with p.m.
relapsed/refractory ESTLocation:
mantle cell lymphoma Georgia World
in the Phase II ACE Congress
-LY-004 study Center,
Building A,
Level 4, A411
-A412
Abstract Pharmacodynamic Poster
#1741 (https://ash.confex.com/ash/2017/ evaluation of sessions,
webprogram/Paper100335.html) acalabrutinib in Saturday,
relapsed/refractory December 9,
and treatment-naive 5:30-7:30 p.m.
patients with chronic ESTLocation:
lymphocytic leukemia Georgia World
in the Phase I/II ACE Congress
-CL-001 study Center,
Building A,
Level 1, Hall
A2
Abstract Exposure-response of
#1268 (https://ash.confex.com/ash/2017/ the Bruton tyrosine
webprogram/Paper102381.html) kinase inhibitor,
acalabrutinib in the
treatment of
hematologic
malignancies
Abstract: Concurrent treatment
#1243 (https://ash.confex.com/ash/2017/ with Pim kinase
webprogram/Paper106198.html) inhibitor
downregulates
alternative non
-homologous end
-joining repair and
decreases genomic
instability in FLT3
-ITD cells treated
with topoisomerase 2
inhibitors
Abstract Preclinical and early
#1368 (https://ash.confex.com/ash/2017/ Phase I clinical data
webprogram/Paper100896.html) of AZD2811
nanoparticle in AML,
an aurora B kinase
inhibitor
Abstract Acalabrutinib with Oral session,
#432 (https://ash.confex.com/ash/2017/w obinutuzumab in Sunday,
ebprogram/Paper100491.html) relapsed/refractory December 10,
and treatment-naive 1:15 p.m.
patients with chronic ESTLocation:
lymphocytic leukemia: Georgia World
The Phase Ib/II ACE Congress
-CL-003 study Center,
Building B,
Level 5, Murphy
BR 3-4
Abstract Acalabrutinib Oral session,
#498 (https://ash.confex.com/ash/2017/w monotherapy in Sunday,
ebprogram/Paper100575.html) patients with December 10,
relapsed/refractory 5:45 p.m.
chronic lymphocytic ESTLocation:
leukemia: Updated Georgia World
results from the Congress
Phase I/II ACE-CL-001 Center,
study Building B,
Level 5, Murphy
BR 3-4
Abstract: Negative minimal Poster Session,
#2765 (https://ash.confex.com/ash/2017/ residual disease Sunday,
webprogram/Paper100821.html) associated with December 10, 6
extended response to -8 p.m.
moxetumomab pasudotox ESTLocation:
in patients with Georgia World
relapsed/refractory Congress
hairy cell leukemia: Center,
Long-term follow-up Building A,
of bone marrow Level 1, Hall
immunohistochemistry A2
analyses from a Phase
I study
Abstract: Preclinical
#3153 (https://ash.confex.com/ash/2017/ evaluation of
webprogram/Paper102936.html) MEDI2228, a BCMA
-targeting
pyrrolobenzodiazepine
-linked antibody drug
conjugate for the
treatment of multiple
myeloma
Abstract Adverse events,
#3442 (https://ash.confex.com/ash/2017/ resource use, and
webprogram/Paper105169.html) economic burden in
patients with mantle
cell lymphoma in the
United States
Abstract Pooled analysis of Poster
#4326 (https://ash.confex.com/ash/2017/ safety data from ...

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