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 February 2026
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Fixed-duration Calquence combo approved in US
20 February 2026
Calquence plus venetoclax approved in the US as first
all-oral, fixed-duration combination for patients with chronic
lymphocytic leukaemia in the 1st-line setting
Calquence plus venetoclax demonstrated statistically significant
and clinically meaningful improvement in progression-free survival
vs. chemoimmunotherapy, with 77% of patients progression free at
three years in AMPLIFY Phase III trial
AstraZeneca's Calquence (acalabrutinib) in combination with
venetoclax has been approved in the US as the first all-oral,
fixed-duration regimen for the treatment of adult patients with
chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma
(SLL).
The approval by the US Food and Drug Administration
(FDA) was based on positive results from
the AMPLIFY Phase
III trial, which were presented at the American Society of
Hematology 2024 Annual Meeting and published
in The
New England Journal of Medicine.1,2
CLL is the most common type of leukaemia in
adults.3 An
estimated 18,500 people were treated for CLL in the 1st-line
setting in the US in 2024.4
Jennifer Brown, MD, PhD, Director of the CLL Center of the Division
of Hematologic Malignancies, Dana-Farber Cancer Institute, and the
Worthington and Margaret Collette Professor of Medicine at Harvard
Medical School, and principal investigator of the AMPLIFY trial,
said: "The continuous regimens frequently used to
treat chronic lymphocytic leukaemia often come with side
effects that may become burdensome to patients over time. The
US approval of the Calquence combination offers patients an
all-oral, 14-month, fixed-duration treatment option that is highly
effective and well-tolerated, and gives physicians greater
flexibility to tailor treatment plans for individual patient needs
and goals."
Dave Fredrickson, Executive Vice President, Oncology Haematology
Business Unit, AstraZeneca, said: "Today's approval
delivers the first all-oral, fixed-duration BTK
inhibitor-based regimen in the US for the treatment of chronic
lymphocytic leukaemia. This Calquence combination has the potential to
meaningfully change 1st-line chronic lymphocytic leukaemia
treatment decisions and underscores our commitment
to improving on the current standard of care for people
living with blood cancers."
Gwen Nichols, MD, Chief Medical Officer of Blood Cancer United,
formerly The Leukemia & Lymphoma Society, said:
"Managing an incurable blood cancer that
progresses slowly can often feel indefinite and overwhelming.
We welcome new treatment options that may ease the burden, restore
a sense of control and offer renewed hope for those navigating life
with chronic lymphocytic leukaemia."
Results from the AMPLIFY Phase III trial showed 77% of patients
treated with Calquence plus venetoclax were progression free at
three years, versus 67% of patients treated with standard-of-care
chemotherapy (investigator's choice of
fludarabine-cyclophosphamide-rituximab or
bendamustine-rituximab).2 Median
progression-free survival (PFS) was not reached versus 47.6 months
for chemoimmunotherapy.2 Further, Calquence plus
venetoclax reduced the risk of disease progression or death by 35%
compared to chemoimmunotherapy (based on hazard ratio 0.65; 95%
confidence interval 0.49-0.87; p=0.0038).2
Calquence plus venetoclax
is approved in
the European Union, Canada, UK and several other countries, and
regulatory applications for the regimen based on the AMPLIFY
results are currently under review in additional
countries.
The safety and tolerability of Calquence was consistent with its known safety
profile, and no new safety signals were
identified.
Notes
Chronic lymphocytic leukaemia (CLL)
CLL is the most prevalent type of leukaemia in adults, with an
estimated 40,000 people being treated for CLL in the first line in
the US, UK, France, Germany, Spain, Italy, Japan and China in
2024.4 Although
some people with CLL may not experience any symptoms at diagnosis,
others may experience symptoms, such as weakness, fatigue, weight
loss, chills, fever, night sweats, swollen lymph nodes and
abdominal pain.5 In
CLL, there is an accumulation of abnormal lymphocytes within the
blood, bone marrow and lymph nodes. As the number of abnormal cells
increases, there is less room within the marrow for the production
of normal white blood cells, red blood cells and
platelets.3 This
could result in infection, anaemia and bleeding. B-cell receptor
signalling through BTK is one of the essential growth pathways for
CLL.
AMPLIFY
AMPLIFY is a randomised, global, multi-centre, open-label Phase III
trial evaluating the efficacy and safety
of Calquence in
combination with venetoclax, with or without obinutuzumab, compared
to investigator's choice of chemoimmunotherapy
(fludarabine-cyclophosphamide-rituximab or bendamustine-rituximab)
in adult patients with previously untreated CLL without del(17p)
or TP53 mutation.6 Patients
were randomised 1:1:1 to receive either Calquence plus venetoclax, or Calquence plus venetoclax with obinutuzumab for a
fixed duration, or standard-of-care
chemoimmunotherapy.6 Both
the Calquence containing arms were administered for a
fixed duration of 14 cycles (each 28 days), and the
standard-of-care chemoimmunotherapy was administered for 6
cycles.6
The primary endpoint is PFS in the Calquence and venetoclax arm as assessed by an
Independent Review Committee, and PFS is a key secondary endpoint
in the Calquence plus venetoclax with obinutuzumab
arm.7 Other
key secondary endpoints include overall survival (OS) and
undetectable measurable residual disease.6 The
trial includes 27 countries across North and South America, Europe,
Asia and Oceania.6
The AMPLIFY trial enrolled patients from 2019 to 2021, continuing
through the COVID-19 pandemic.6
Calquence
Calquence (acalabrutinib)
is a second-generation, selective inhibitor of Bruton's tyrosine
kinase (BTK). Calquence binds
covalently to BTK, thereby inhibiting its
activity.7 In
B-cells, BTK signalling results in activation of pathways necessary
for B-cell proliferation, trafficking, chemotaxis and
adhesion.
Calquence is approved for
the treatment of chronic lymphocytic leukaemia (CLL) and small
lymphocytic lymphoma (SLL) in the US, Japan and China, and approved
for CLL in Europe and many other countries. Calquence is also approved as a fixed-duration
treatment for the treatment of adult patients with previously
untreated CLL in combination with venetoclax in the US, and in
combination with venetoclax, with or without obinutuzumab, in
Europe, Canada, the U.K. and several other
countries. Calquence is
also approved for the treatment of adult patients with previously
untreated mantle cell lymphoma (MCL) in the US, Europe, Japan and
other countries. It is also approved for the treatment of adult
patients with MCL who have received at least one prior therapy in
China and several other countries.
As part of an extensive clinical development
programme, Calquence is currently being evaluated as a single
treatment and in combination with standard-of-care
chemoimmunotherapy for patients with multiple B-cell blood cancers,
including CLL, MCL and diffuse large B-cell
lymphoma.
AstraZeneca in haematology
AstraZeneca is pushing the boundaries of science to redefine care
in haematology. Our goal is to help transform the lives of patients
living with malignant, rare and other related haematologic diseases
through innovative medicines and approaches that are shaped by
insights from patients, caregivers and
physicians.
In addition to our marketed products, we are spearheading the
development of novel therapies designed to target underlying
drivers of disease across multiple scientific platforms. Our
acquisitions of Alexion, with expertise in rare, non-malignant
blood disorders, and Gracell Biotechnologies Inc., pioneers of
autologous cell therapies, expand our haematology pipeline and
enable us to reach more patients with high unmet needs through the
end-to-end discovery, development and delivery of novel
therapies.
AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition
to provide cures for cancer in every form, following the science to
understand cancer and all its complexities to discover, develop and
deliver life-changing medicines to
patients.
The Company's focus is on some of the most challenging cancers. It
is through persistent innovation that AstraZeneca has built one of
the most diverse portfolios and pipelines in the industry, with the
potential to catalyse changes in the practice of medicine and
transform the patient experience.
AstraZeneca has the vision to redefine cancer care and, one day,
eliminate cancer as a cause of death.
AstraZeneca
AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led
biopharmaceutical company that focuses on the discovery,
development, and commercialisation of prescription medicines in
Oncology, Rare Diseases, and BioPharmaceuticals, including
Cardiovascular, Renal & Metabolism, and Respiratory &
Immunology. Based in Cambridge, UK, AstraZeneca's innovative
medicines are sold in more than 125 countries and used by millions
of patients worldwide. Please visit astrazeneca.com and
follow the Company on Social Media @AstraZeneca.
Contacts
For details on how to contact the Investor Relations Team, please
click here.
For Media contacts, click here.
References
1.
Brown, J et al. Fixed-duration acalabrutinib plus venetoclax with
or without obinutuzumab versus chemoimmunotherapy for first-line
treatment of chronic lymphocytic leukemia: interim analysis of the
multicenter, open-label, randomized, Phase 3 AMPLIFY Trial.
Presented at ASH 2024. Abstract 1009. 2024.
2. Brown J, et al. Fixed-duration
acalabrutinib combinations in untreated chronic lymphocytic
leukemia. NEJM. 2025;392:748-762.
3. National Cancer Institute. Chronic
lymphocytic leukemia treatment (PDQ®)-Patient
version. Available at: https://www.cancer.gov/types/leukemia/patient/cll-treatment-pdq.
Accessed February 2026.
4. AstraZeneca 2024. Full Year
and Q4 2024 Financial Results Epidemiology Spreadsheet. Available
at: https://www.astrazeneca.com/investor-relations.html.
Accessed February 2026.
5. American Cancer Society. Signs
and Symptoms of Chronic Lymphocytic Leukemia. Available
at: https://www.cancer.org/cancer/types/chronic-lymphocytic-leukemia/detection-diagnosis-staging/signs-symptoms.html.
Accessed February 2026.
6. ClinicalTrials.gov. Study of
Acalabrutinib (ACP-196) in Combination With Venetoclax (ABT-199),
With and Without Obinutuzumab (GA101) Versus Chemoimmunotherapy for
Previously Untreated CLL (AMPLIFY). Available
at: https://clinicaltrials.gov/study/NCT03836261.
Accessed February 2026.
7. Wu J, et al. Acalabrutinib
(ACP-196): a selective second-generation BTK
inhibitor. J Hematol
Oncol.
2016;9(21).
Matthew Bowden
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: 20 February 2026
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By: /s/
Matthew Bowden
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Name:
Matthew Bowden
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Title:
Company Secretary
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