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 January 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.
Dato-DXd approved in US for HR+ breast cancer
20 January 2025
Datroway (datopotamab
deruxtecan) approved in the US for patients
with
previously treated metastatic HR-positive, HER2-negative breast
cancer
First approval in the US for AstraZeneca and Daiichi Sankyo's
Datroway based on TROPION-Breast01 results showing 37% reduction in
the risk of disease progression or death vs.
chemotherapy
Datroway is the eighth new medicine of the 20 AstraZeneca has set
out to deliver by 2030
Datroway (datopotamab
deruxtecan or Dato-DXd) has been approved in the US for the
treatment of adult patients with unresectable or metastatic hormone
receptor (HR)-positive, HER2-negative (IHC 0, IHC 1+ or IHC
2+/ISH-) breast cancer who have received prior endocrine-based
therapy and chemotherapy for unresectable or metastatic
disease. The approval by the US Food and Drug Administration
(FDA) was based on results from the TROPION-Breast01 Phase
III trial.
Aditya Bardia, MD, MPH, Program Director of Breast Oncology and
Director of Translational Research Integration at the UCLA Health
Jonsson Comprehensive Cancer Center and Global Principal
Investigator for TROPION-Breast01, said: "Despite considerable
progress in the HR-positive, HER2-negative metastatic breast cancer
treatment landscape, new therapies are still needed to tackle the
frequent and complex challenge of disease progression after
endocrine and initial chemotherapy. The approval of datopotamab
deruxtecan, a novel TROP2-directed antibody drug conjugate, marks a
major therapeutic milestone and provides patients with metastatic
breast cancer a new treatment alternative to conventional
chemotherapy."
Dave Fredrickson, Executive Vice President, Oncology Haematology
Business Unit, AstraZeneca, said: "With this first approval
of Datroway in the US, we continue to deliver on our
ambition for antibody drug conjugates to improve upon and replace
conventional chemotherapy for the treatment of multiple cancers. We
are proud to bring Datroway to people living with metastatic
HR-positive, HER2-negative breast cancer, and this approval marks
the eighth new medicine of the 20 we have set out to deliver across
AstraZeneca by 2030."
Ken Keller, Global Head of Oncology Business, and President and
CEO, Daiichi Sankyo, Inc., said: "The approval
of Datroway provides patients with HR-positive,
HER2-negative breast cancer previously treated with endocrine-based
therapy and traditional chemotherapy with the opportunity to be
treated with a new TROP2-directed antibody drug conjugate earlier
in the metastatic setting. Datroway is the latest addition to our portfolio of
innovative cancer treatments and marks the fourth medicine from our
oncology pipeline to receive approval in the
US."
Caitlin Lewis, Senior Vice President of Strategy & Mission,
Living Beyond Breast Cancer, said: "Only one in three patients with
metastatic HR-positive, HER2-negative breast cancer live more than
five years following diagnosis, highlighting the urgent need for
additional effective therapies. The approval
of Datroway is a significant advance, offering patients
with metastatic HR-positive breast cancer a new and much-needed
treatment option."
In TROPION-Breast01, Datroway significantly reduced the risk of disease
progression or death by 37% compared to investigator's choice of
chemotherapy (hazard ratio [HR] 0.63; 95% confidence interval [CI]
0.52-0.76; p<0.0001) in patients with HR-positive, HER2-negative
metastatic breast cancer as assessed by blinded independent central
review (BICR). Median progression-free survival (PFS) was 6.9
months in patients treated with Datroway versus 4.9 months with
chemotherapy.
The safety profile of Datroway was consistent with the known profile of
this medicine with no new safety concerns identified. In
the Datroway arm, the interstitial lung disease (ILD)
rate was 4.2% and the majority of events were low
grade.
Datroway is a specifically
engineered TROP2-directed antibody drug conjugate (ADC) discovered
by Daiichi Sankyo and being jointly developed and commercialised by
AstraZeneca and Daiichi Sankyo.
Additional regulatory submissions for Datroway in breast cancer are under review in the EU,
China and other regions.
Notes
HR-positive breast cancer
In the US, more than 300,000 cases of breast cancer are diagnosed
annually.1 While
survival rates are high for those diagnosed with early breast
cancer, only about 30% of patients diagnosed with or who progress
to metastatic disease are expected to live five years following
diagnosis.2
Approximately 70% of diagnosed cases are considered what has been
historically called HR-positive, HER2-negative breast cancer
(measured as HER2 score of IHC 0, IHC 1+ or IHC
2+/ISH-).2 Endocrine
therapies are widely given consecutively in the early lines of
treatment for HR-positive metastatic breast
cancer.3 However,
after initial treatment, further efficacy from endocrine therapy is
often limited.3 The
current standard of care following endocrine therapy is
chemotherapy, which is associated with poor response rates and
outcomes.3-6
TROPION-Breast01
TROPION-Breast01 is a
global, randomised, multicentre, open-label Phase III trial
evaluating the efficacy and safety of
intravenous Datroway (6 mg/kg) once per 21-day cycle versus
investigator's choice of single-agent chemotherapy (eribulin,
capecitabine, vinorelbine or gemcitabine) in adult patients with
unresectable or metastatic HR-positive, HER2-negative (IHC 0, IHC
1+ or IHC 2+/ISH-) breast cancer who have progressed on and are not
suitable for endocrine therapy per investigator assessment and have
received at least one prior line of chemotherapy for unresectable
or metastatic disease.
Following disease progression or discontinuation
of Datroway or chemotherapy, patients had the option to
receive a subsequent treatment at the discretion of their
physician. Crossover between trial arms was not
permitted.
The dual primary endpoints of TROPION-Breast01 are PFS as assessed
by BICR and OS. Key secondary endpoints include ORR, duration of
response, investigator-assessed PFS, disease control rate, time to
first subsequent therapy and safety. The PFS data and additional
results for key secondary endpoints of TROPION-Breast01 were
published in the Journal
of Clinical Oncology.
TROPION-Breast01 enrolled 732 patients in Africa, Asia, Europe,
North America and South America. For more information
visit ClinicalTrials.gov.
Datroway
Datroway (datopotamab
deruxtecan-dlnk in the US; datopotamab deruxtecan in rest of world)
is a TROP2-directed ADC. Designed using Daiichi Sankyo's
proprietary DXd ADC Technology, Datroway is one of six DXd ADCs in the oncology
pipeline of Daiichi Sankyo, and one of the most advanced programmes
in AstraZeneca's ADC scientific platform. Datroway is comprised of a humanised anti-TROP2 IgG1
monoclonal antibody, developed in collaboration with Sapporo
Medical University, attached to a number of topoisomerase I
inhibitor payloads (an exatecan derivative, DXd) via
tetrapeptide-based cleavable linkers.
Datroway (6mg/kg) is
approved in the US and Japan for the treatment of adult patients
with unresectable or metastatic HR-positive, HER2-negative (IHC 0,
IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior
endocrine-based therapy and chemotherapy for unresectable or
metastatic disease based on the results from the TROPION-Breast01
Phase III trial.
Datroway clinical development
programme
A comprehensive global clinical development programme is underway
with more than 20 trials evaluating the efficacy and safety
of Datroway across multiple cancers, including non-small
cell lung cancer, triple-negative breast cancer (TNBC) and
HR-positive, HER2-negative breast cancer. The programme includes
seven Phase III trials in lung cancer and five Phase III trials in
breast cancer evaluating Datroway as a monotherapy and in combination with
other anticancer treatments in various
settings.
Daiichi Sankyo collaboration
AstraZeneca and Daiichi Sankyo entered into a global collaboration
to jointly develop and commercialise Enhertu (trastuzumab deruxtecan)
in March
2019 and Datroway in July
2020, except in Japan where
Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi
Sankyo is responsible for the manufacturing and supply
of Enhertu and Datroway.
AstraZeneca in breast cancer
Driven by a growing
understanding of breast cancer biology, AstraZeneca is starting to
challenge, and redefine, the current clinical paradigm for how
breast cancer is classified and treated to deliver even more
effective treatments to patients in need - with the bold ambition
to one day eliminate breast cancer as a cause of
death.
AstraZeneca has a comprehensive portfolio of approved and promising
compounds in development that leverage different mechanisms of
action to address the biologically diverse breast cancer tumour
environment.
With Enhertu, a HER2-directed ADC, AstraZeneca and Daiichi
Sankyo are aiming to improve outcomes in previously treated
HER2-positive and HER2-low metastatic breast cancer and are
exploring its potential in earlier lines of treatment and in new
breast cancer settings.
In HR-positive breast cancer, AstraZeneca continues to improve
outcomes with foundational medicines Faslodex and Zoladex (goserelin) and aims to reshape the
HR-positive space with first-in-class AKT
inhibitor, Truqap (capivasertib), and next-generation SERD and
potential new medicine camizestrant. AstraZeneca is also
collaborating with Daiichi Sankyo to explore the potential of
TROP2-directed ADC, Datroway, in this setting.
PARP inhibitor Lynparza (olaparib) is a targeted treatment option
that has been studied in early and metastatic breast cancer
patients with an inherited BRCA mutation. AstraZeneca with MSD
(Merck & Co., Inc. in the US and Canada) continue to
research Lynparza in these settings and to explore its
potential in earlier disease.
To bring much-needed treatment options to patients with TNBC, an
aggressive form of breast cancer, AstraZeneca is evaluating the
potential of Datroway alone and in combination with
immunotherapy Imfinzi (durvalumab), Truqap in
combination with chemotherapy, and Imfinzi in combination with other oncology
medicines, including Lynparza and Enhertu.
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.
American Cancer Society. Key Statistics for Breast Cancer.
Available at:
https://www.cancer.org/cancer/types/breast-cancer/about/how-common-is-breast-cancer.html.
Accessed January 2025.
2. National Cancer
Institute. Surveillance, Epidemiology and End Results Program.
Available at: https://seer.cancer.gov/statfacts/html/breast-subtypes.html.
Accessed January 2025.
3. Manohar P, et al. Updates in
endocrine therapy for metastatic breast
cancer. Cancer Biol
Med. 2022 Feb 15;
19(2):202-212.
4. Cortes J, et al. Eribulin
monotherapy versus treatment of physician's choice in patients with
metastatic breast cancer (EMBRACE): a phase 3 open-label randomised
study. Lancet. 2011;377:914-923.
5. Yuan P, et al. Eribulin mesilate
versus vinorelbine in women with locally recurrent or metastatic
breast cancer: A randomised clinical
trial. Eur
J Cancer.
2019;112:57-65.
6.
Jerusalem G, et al.
Everolimus Plus Exemestane vs Everolimus or Capecitabine
Monotherapy for Estrogen Receptor-Positive, HER2-Negative Advanced
Breast Cancer. JAMA
Oncol.
2018;4(10):1367-1374.
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:
20 January 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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