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 March 2025
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.
Calquence recommended for EU approval in 1L MCL
31 March 2025
Calquence plus chemoimmunotherapy recommended for
approval in the EU by CHMP as first and only BTK inhibitor for
1st-line mantle cell lymphoma
Recommendation based on ECHO Phase III trial results which
demonstrated over 16 months of progression-free survival
improvement vs. chemoimmunotherapy alone
AstraZeneca's Calquence (acalabrutinib) in combination with
bendamustine and rituximab has been recommended for approval in the
European Union (EU) for the treatment of adult patients with
previously untreated mantle cell lymphoma (MCL) who are not
eligible for autologous hematopoietic stem cell
transplantation.
The Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) based its positive opinion on the
results from the ECHO Phase III
trial which were presented
at the European Hematology Association 2024
Congress.
Results from the ECHO trial showed Calquence plus
bendamustine and rituximab reduced the risk of disease progression
or death by 27% compared to standard-of-care chemoimmunotherapy
(hazard ratio [HR] 0.73; 95% confidence interval [CI] 0.57-0.94;
p=0.016). Median progression-free survival (PFS) was 66.4 months
for patients treated with the Calquence combination
versus 49.6 with chemoimmunotherapy alone.
This recommendation for Calquence as a combination treatment in the 1st-line
MCL setting follows the recent CHMP positive
opinion for Calquence as a monotherapy for the treatment of adult
patients with relapsed or refractory MCL.
Martin Dreyling, MD, Department of Medicine, University Hospital
LMU Munich, and investigator in the trial, said: "Results from the
pivotal ECHO trial demonstrated the significant benefits of
the Calquence combination in managing this rare and
aggressive cancer. Today's recommendation is an important advance
within the mantle cell lymphoma first-line treatment landscape,
especially for older patients who need a balance of efficacy and
tolerability."
Susan Galbraith, Executive Vice President, Oncology Haematology
R&D, AstraZeneca, said: "Today's positive recommendation from
the CHMP further reinforces the potential
of Calquence to advance first-line treatment options in
mantle cell lymphoma, with the Calquence combination demonstrating an almost one and
a half year improvement in progression-free survival in this
setting. If approved, Calquence has the potential to transform the standard
of care as the first BTK inhibitor approved for these patients in
Europe."
MCL is a rare and typically aggressive form of non-Hodgkin
lymphoma, often diagnosed at an advanced stage.1,2 It
is estimated that more than 6,000 patients were diagnosed with MCL
in the UK, France, Germany, Spain and Italy in
2024.3
The safety and tolerability of Calquence was consistent with its known safety
profile, and no new safety signals were
identified.
Calquence plus
bendamustine and rituximab is approved in the US and several other
countries in this setting based on the ECHO results. Regulatory
applications are currently under review in Japan and several other
countries in this indication.
Notes
Mantle cell lymphoma (MCL)
While MCL patients initially respond to treatment, patients do tend
to relapse.4 MCL
comprises about 3-6% of non-Hodgkin lymphomas, with an annual
incidence of 0.5 per 100,000 population in Western countries; It is
estimated that there are more than 21,000 patients diagnosed with
MCL in the US, UK, France, Germany, Spain, Italy, Japan and
China.5
ECHO
ECHO is a randomised, double-blind, placebo-controlled,
multi-centre Phase III trial evaluating the efficacy and safety
of Calquence plus bendamustine and rituximab compared to
SoC chemoimmunotherapy (bendamustine and rituximab) in adult
patients at or over 65 years of age (n=635) with previously
untreated MCL.6 Patients
were randomised 1:1 to receive either Calquence or placebo administered orally twice per
day, continuously, until disease progression or unacceptable
toxicity. Additionally, all patients received six 28-day cycles of
bendamustine on days 1 and 2 and rituximab on day 1 of each cycle,
followed by rituximab maintenance for two years if patients
achieved a response after induction therapy.6
The primary endpoint is PFS assessed by an Independent Review
Committee; other efficacy endpoints include overall survival (OS),
overall response rate (ORR), duration of response (DoR) and time to
response (TTR).6 The
trial was conducted in 27 countries across North and South America,
Europe, Asia and Oceania.6
The ECHO trial enrolled patients from May 2017 to March 2023,
continuing through the COVID-19 pandemic. Prespecified PFS and OS
analyses censoring for COVID-19 deaths were conducted to assess the
impact of COVID-19 on the study outcome in alignment with the FDA.
Patients with blood cancer remain at a disproportionately high risk
of severe outcomes from COVID-19, including hospitalisation and
death compared to the general population.6,7,8
Calquence
Calquence (acalabrutinib)
is a second-generation, selective inhibitor of Bruton's tyrosine
kinase (BTK). Calquence binds
covalently to BTK, thereby inhibiting its
activity.8 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 and Japan, approved for CLL in
the EU and many other countries worldwide and approved in China for
relapsed or refractory CLL and SLL. Calquence is
also approved for the treatment of adult patients with previously
untreated MCL in the US and other countries. It is also
approved for the treatment of adult patients with MCL who have
received at least one prior therapy in the US, China and several
other countries. Calquence is
not currently approved for the treatment of MCL in
Japan.
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/Nasdaq: 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.
Lymphoma Research Foundation. Mantle Cell Lymphoma. Available
at: https://lymphoma.org/aboutlymphoma/nhl/mcl/.
Accessed March 2025.
2.
National Organization for Rare Disorders. Mantle Cell Lymphoma.
Available at: https://rarediseases.org/rare-diseases/mantle-cell-lymphoma/.
Accessed March 2025.
3.
AstraZeneca 2024. Q3 2024 Financial Results. Available
at: https://www.astrazeneca.com/investor-relations.html.
Accessed March 2025.
4. Cheah C, Seymour J,
Wang ML. Mantle cell lymphoma. J Clin
Oncol. 2016;34(11):1256-1269.
doi: 10.1200/JCO.2015.63.5904.
5. Lynch
DT, Koya S, Acharya U, et al. Mantle Cell Lymphoma. Available
at: https://www.ncbi.nlm.nih.gov/books/NBK536985.
Accessed March 2025.
6.
ClinicalTrials.gov. A Study of BR Alone Versus in Combination With
Acalabrutinib in Subjects With Previously Untreated MCL. Available
at: https://clinicaltrials.gov/study/NCT02972840. Accessed
March 2025.
7. Luque-Paz
D, et al. B-cell malignancies and COVID-19:
a narrative review. Clin
Microbiology and Infection. 2023;
29(332-337).
8. Wu
J, et al. Acalabrutinib (ACP-196): a selective second-generation
BTK inhibitor. J Hematol
Oncol.
2016;9(21).
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.
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AstraZeneca
PLC
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Date:
31 March 2025
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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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