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AstraZeneca: Calquence data to show improved progression-free survival in Phase III front-line chronic lymphocytic leukaemi...

Robust early-stage pipeline advancements and presentations across
multiple scientific platforms demonstrate potential to improve
treatment outcomes in blood cancers with high unmet need

AstraZeneca will present the first data from the Phase III ELEVATE-TN
trial assessing Calquence (acalabrutinib), a next-generation
selective Bruton's tyrosine kinase (BTK) inhibitor, in patients with
previously untreated chronic lymphocytic leukaemia (CLL), as well as
data from novel-combination trials across multiple blood cancers at
the 2019 American Society of Hematology (ASH) Annual Meeting and
Exposition in Orlando, USA, December 7-10.[1]

The Company will present over 30 abstracts, including seven oral
presentations, in CLL, mantle cell lymphoma (MCL), acute myeloid
leukaemia (AML), diffuse large B-cell lymphoma (DLBCL) and multiple
myeloma (MM). Key data include:

· The first presentation of data from the pivotal Phase III
ELEVATE-TN trial evaluating Calquence in combination with
obinutuzumab and Calquence monotherapy versus obinutuzumab combined
with chlorambucil chemotherapy in previously untreated CLL

· Long-term efficacy, safety and tolerability data on Calquence in
relapsed or refractory CLL from the Phase I/II ACE-CL-001 trial

· First-time data on roxadustat as a potential new treatment for
anaemia in patients with primary myelodysplastic syndrome (MDS)

Dave Fredrickson, Executive Vice President, Oncology Business Unit
said: "AstraZeneca continues to demonstrate its strength in
haematology, presenting new research at ASH that spans targeted
therapies across eight blood cancers. This year we are especially
excited to present the ELEVATE-TN data demonstrating the impressive
efficacy and tolerability of Calquence in 1st-line chronic
lymphocytic leukaemia."

Key headline data from the Calquence Phase III ELEVATE-TN trial

Efficacy measure Calquence Calquence monotherapy N Obinutuzumab plus
plus = 179 chlorambucil N =
obinutuzumab 177
N =
Stratified analysis,
median follow-up 28
Hazard ratio for PFS HR 0.10 HR 0.20 n/a
endpoint (vs. (primary (secondary endpoint)
obinutuzumab + endpoint) 95% CI 0.13-0.30, median 22.6
chlorambucil), 95% CI p<0.0001 months
stratified 0.06-0.17, median not reached
analysis P<0.0001
median not

Select adverse events (AEs) include infusion reactions, which were
less frequent with Calquence plus obinutuzumab (13%) than with
obinutuzumab plus chlorambucil (40%). Additionally, AEs led to
treatment discontinuation in 11% of patients on Calquence plus
obinutuzumab, 9% of patients on Calquence, and 14% of patients on
obinutuzumab plus chlorambucil. With >2 y of follow-up, 79% of
patients in both the Calquence-containing arms remain on Calquence as
a monotherapy. Other select AEs (Calquence plus obinutuzumab or
Calquence vs chlorambucil plus obinutuzumab) included atrial
fibrillation (any grade: 3% or 4% vs. 1%), bleeding (any grade/Grade
?3: 43%/2% or 39%/2% vs. 12%/0%), and hypertension (Grade ?3: 3% or
2% vs. 3%).

Full data from the ELEVATE-TN trial will be presented at ASH by the
primary investigators. AstraZeneca has submitted Calquence for US
regulatory review in 1st-line and relapsed/refractory CLL.

Raising the bar for CLL treatment outcomes with Calquence

In addition to the oral presentation of the ELEVATE-TN results, key
presentations include:

· An oral presentation on preliminary data from a Phase II
investigator-initiated trial evaluating Calquence combined with
obinutuzumab and venetoclax in patients with previously untreated
CLL, including high-risk disease status and a trial-in-progress
poster detailing an ongoing Phase III trial to evaluate this novel
combination in patients with previously untreated CLL without
del(17p) or TP53 mutation.

· Long-term (42-month) follow-up results from the Phase I/II
ACE-CL-001 trial confirming Calquence initial efficacy from this
trial for the treatment of relapsed or refractory CLL and providing
additional data on duration of response and long-term tolerability.

Exploring a potential treatment option for a challenging comorbidity
in blood cancer

· An oral presentation on first-time data from a global Phase III
trial evaluating roxadustat to treat anaemia in patients with primary
MDS. Considered a type of cancer, MDS is a group of diverse bone
marrow disorders in which the bone marrow does not produce enough
healthy blood cells. Approximately one in three MDS patients can
progress to AML.[2]

Exploring potential new medicines from the pipeline and new treatment
strategies for aggressive or treatment-resistant blood cancers

· In AML, an oral presentation and four poster presentations,
including results from an Imfinzi (durvalumab) and azacitidine
combination for the 1st-line treatment of older,
chemotherapy-ineligible patients and data from a Phase I/II clinical
trial of AZD2811(nanoparticles) as a monotherapy or in combination
with azacitidine in previously untreated or relapsed/refractory
patients who are not eligible for intensive induction therapy.

· In DLBCL, five abstracts, including a poster presentation
detailing the ongoing Phase I PRISM trial of Calquence in four
different combinations with potential new medicines targeting STAT3,
ATR, CD47 and BRD4.

· In MM, three poster presentations, including results of a Phase I
trial of MEDI2228, a BCMA antibody-PBD conjugate and potential new
medicine, as a monotherapy and in combinations with bortezomib and
DNA-damage response medicines and results from an in vitro trial of
AZD4785 alone or with proteasome inhibitors targeting mutant KRAS.

Key AstraZeneca presentations at ASH 2019

Lead author Abstract title Presentation details
Sharman, J. ELEVATE TN: Phase Oral Presentation Saturday 7 December 07:30
3 Study of ET Orange County Convention Center, Hall D
Combined with
Obinutuzumab (O)
or Alone vs O Plus
Chlorambucil (Clb)
in Patients (Pts)
With Treatment
-Naive Chronic
Leukemia (CLL)
Lampson, Preliminary Safety Oral Presentation Saturday 7 December 07:45
BL. and Efficacy ET Orange County Convention Center, Hall D
Results from a
Phase 2 Study of
Venetoclax and
Obinutuzumab in
Patients with
Untreated Chronic
Leukemia (CLL)
Frei, CR. Treatment Patterns Oral Presentation Monday 9 December 15:15 ET
and Outcomes of Orange County Convention Center, Valencia A
1205 Patients on (W415A)
Novel Agents in
the US Veterans
(VHA) System:
Results from
Retrospective EMR
and Chart Review
Study in the Real
-World Setting
Goyal, RK. Overall Survival, Oral Presentation Monday 9 December 15:15 ET
Adverse Events, Orange County Convention Center, Valencia A
and Economic (W415A)
Burden in Medicare
Patients with
Leukemia Receiving
Furman, RR. Acalabrutinib Poster Presentation Sunday 8 December 18:00 -
Monotherapy in 20:00 ET Orange County Convention Center,
Patients with Hall B
Leukemia: 42-Month
Follow-Up of a
Phase 2 Study
Brown, JR. A Phase 3 Trial Poster Presentation Monday 9 December 18:00 -
Comparing the 20:00 ET Orange County Convention Center,
Efficacy and Hall B
Safety of
Acalabrutinib in
Combination with
Venetoclax with or
Compared with
Choice of
in Patients with
Untreated Chronic
Leukemia (CLL)
without del(17p)
or TP53 Mutation
Mantle cell
Kabadi, S. Overall Survival, Oral Presentation Saturday 7 December 08:00
Adverse Events, ET Orange County Convention Center, W308
and Economic
Burden in Medicare
-Insured Patients
with Mantle Cell
Lymphoma Receiving
Ryan, K. Characteristics of Poster Presentation Sunday 8 December 18:00 -
Mantle Cell 20:00 ET Orange County Convention Center,
Lymphoma (MCL) and Hall B
Leukemia (CLL)
Patients Treated
with Acalabrutinib
in a Real World
Setting in the
United States
Zeidan, A. Efficacy and Oral Presentation Monday 9 December 16:30 ET
Safety of Orange County Convention Center, Chapin
Azacitidine (AZA) Theater (W320)
in Combination
with the Anti-PD
-L1 Durvalumab
(durva) for the
Treatment of Older
Patients (pts)
with Acute Myeloid
Leukemia (AML) Who
Are Unfit for
Chemotherapy (IC)

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