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 May 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.
US FDA decision date on camizestrant extended
27 May 2026
US FDA decision date extended for SERENA-6 filing of
camizestrant
to enable review of additional data
The US Food and Drug Administration (FDA) has informed AstraZeneca
that it will extend the Prescription Drug User Fee Act (PDUFA) date
to review additional data requested to support the New Drug
Application (NDA) for camizestrant in combination with a
cyclin-dependent kinase (CDK) 4/6 inhibitor (palbociclib,
ribociclib or abemaciclib) for the 1st-line treatment of patients
with hormone receptor (HR)-positive, HER2-negative advanced breast
cancer whose tumours have an emergent ESR1 mutation.
The NDA is based on positive results from the pivotal SERENA-6
Phase III trial presented at the 2025 American Society of Clinical
Oncology (ASCO) Annual Meeting and simultaneously published
in The
New England Journal of Medicine.1 The
FDA granted Breakthrough Therapy Designation for the camizestrant
combination in this setting in May 2025.
In April 2026, the FDA's Oncologic Drugs Advisory
Committee did not reach a majority vote in favour of
the benefit of switching to camizestrant in combination with a
CDK4/6 inhibitor after detection of an ESR1 mutation in circulating tumour DNA (ctDNA)
prior to radiographic progression, based on the SERENA-6 Phase III
trial. Subsequently, the Company has provided additional
analyses requested by the FDA in support of the application,
including ctDNA clearance data linked to longer-term efficacy
outcomes that will be presented on 02 June at ASCO
2026.
Susan Galbraith, Executive Vice President, Oncology Haematology
R&D, AstraZeneca, said: "We are committed to continuously
advancing the clinical landscape in oncology in pursuit of
improving outcomes for patients. The SERENA-6 treatment strategy
epitomises this approach by monitoring patients for the emergence
of ESR1 mutations in ctDNA and testing if a switch
of endocrine backbone therapy at this point improves outcomes. We
look forward to continuing the dialogue with the FDA in order to
bring the benefits of camizestrant with this innovative treatment
strategy to eligible patients in the US as quickly as
possible."
On 22 May, the European Medicines Agency's Committee for Medicinal
Products for Human Use adopted a positive
opinion recommending
approval of the camizestrant combination in this setting based on
the results of the SERENA-6 Phase III trial.
Camizestrant is approved in the United Arab Emirates and Saudi
Arabia in this setting. Regulatory applications are also currently
under review in Japan and several other countries based on the
SERENA-6 Phase III trial.
Notes
HR-positive breast cancer
Breast cancer is the second most common cancer and one of the
leading causes of cancer-related deaths
worldwide.2 More
than two million patients were diagnosed with breast cancer in
2022, with more than 665,000 deaths globally.2 In
the US, breast
cancer is the most common cancer in women, with more than 300,000
new cases of the disease diagnosed annually, and more than 42,000
deaths.3 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.4
HR-positive breast cancer, characterised by the expression of
estrogen or progesterone receptors, or both, is the most common
subtype of breast cancer with 70% of tumours considered HR-positive
and HER2-negative.4 Estrogen
receptor (ERs) often drive the growth of HR-positive breast cancer
cells.5
Globally, approximately 200,000 patients with HR-positive breast
cancer are treated with a medicine in the 1st-line setting; most
frequently with endocrine therapies that target ER-driven disease,
which are often paired with CDK4/6 inhibitors.6-8 In
the US, approximately 37,000 patients with HR-positive metastatic
breast cancer are treated with these therapies in the 1st-line
setting.6-8 However,
resistance to these therapies develops in many
patients.8 Once
this occurs, treatment options are limited and survival rates are
low with approximately 36% of patients anticipated to live beyond
five years after diagnosis.4,8
Mutations in the ESR1 gene are a key driver of endocrine
resistance and are associated with poor outcomes, emerging during
treatment of the disease and becoming more prevalent as the disease
progresses.9,10 Approximately
30% of patients with endocrine sensitive HR-positive disease
develop ESR1 mutations during 1st-line treatment before
disease progression.6
The optimisation of endocrine therapy and overcoming
resistance to enable patients to continue benefiting from
these treatments, as well as identifying new therapies
for those who are less likely to benefit, are active areas of focus
for breast cancer research.
SERENA-6
SERENA-6 is a Phase III, double-blind, randomised trial evaluating
the efficacy and safety of camizestrant in combination with a
CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib) versus
treatment with an AI (anastrozole or letrozole) in combination with
a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib) in
patients with HR-positive, HER2-negative advanced breast cancer
(patients with either locally advanced disease, or metastatic
disease) whose tumours have an emergent ESR1 mutation.
The global trial enrolled 315 adult patients with histologically
confirmed HR-positive, HER2-negative advanced breast cancer,
undergoing treatment with an AI in combination with a CDK4/6
inhibitor as 1st-line treatment. The primary endpoint of the
SERENA-6 trial is PFS as assessed by investigator, with secondary
endpoints including OS, and PFS2 by investigator
assessment.
Camizestrant
Camizestrant is an investigational, potent, next-generation oral
selective estrogen receptor degrader (SERD) and complete ER
antagonist that is currently in Phase III trials for the treatment
of HR-positive breast cancer.
AstraZeneca's broad, robust and innovative clinical development
programme, including the SERENA-6, SERENA-4, CAMBRIA-1 and
CAMBRIA-2 trials, is evaluating the safety and efficacy of
camizestrant when used as a monotherapy or in combination with
CDK4/6 inhibitors to address a number of areas of unmet need in
HR-positive, HER2-negative breast cancer.
Camizestrant has demonstrated anti-cancer activity across a range
of preclinical models, including those with ER-activating
mutations. In the SERENA-2 Phase II trial, camizestrant
demonstrated a statistically significant and clinically meaningful
improvement in PFS versus Faslodex (fulvestrant) in the overall trial
population, including in patients with ESR1 tumour mutations irrespective of prior
treatment with CDK4/6 inhibitors in patients with ER-positive
locally advanced or metastatic breast cancer, previously treated
with endocrine therapy. The SERENA-1 Phase I trial demonstrated
that camizestrant is well tolerated and has a promising anti-tumour
profile when administered alone or in combination with palbociclib,
ribociclib and abemaciclib; three widely used CDK4/6
inhibitors.
AstraZeneca in breast cancer
Driven by a growing understanding of breast cancer biology,
AstraZeneca is challenging, and redefining, 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 (trastuzumab deruxtecan), a HER2-directed
antibody drug conjugate (ADC), AstraZeneca and Daiichi Sankyo are
aiming to improve outcomes in previously treated HER2-positive,
HER2-low and HER2-ultralow metastatic breast cancer, and expanding
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), the TROP-2-directed
ADC, Datroway (datopotamab deruxtecan), and
next-generation oral SERD and potential new medicine
camizestrant.
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. AstraZeneca is also
exploring the potential of saruparib, a potent and selective
inhibitor of PARP1, in combination with camizestrant
in BRCA-mutated, HR-positive, HER2-negative advanced
breast cancer.
To bring much-needed treatment options to patients with
triple-negative breast cancer, an aggressive form of breast cancer,
AstraZeneca is collaborating with Daiichi Sankyo to evaluate the
potential of Datroway alone and in combination with
immunotherapy Imfinzi (durvalumab).
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 Disease, 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. Bidard FC, et al. First-Line
Camizestrant for Emerging ESR1-Mutated Advanced Breast
Cancer. N Engl J
Med 2025; DOI:
10.1056/NEJMoa2502929.
2. Bray F, et al. Global cancer
statistics 2022: GLOBOCAN estimates of incidence and mortality
worldwide for 36 cancers in 185 countries. CA Cancer J
Clin. 2024; 1- 35.
DOI:10.3322/caac.21834.
3. 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 May 2026.
4. National Cancer Institute. Cancer
Stat facts: Female breast cancer subtypes. Available
at: https://seer.cancer.gov/statfacts/html/breast-subtypes.html.
Accessed May 2026.
5. Scabia V, et al. Estrogen receptor
positive breast cancers have patient specific hormone sensitivities
and rely on progesterone receptor. Nat Commun. 2022;
10.1038/s41467-022-30898-0.
6.
Cerner CancerMPact database. Accessed May 2026.
7. Lin M, et al. Comparative Overall
Survival of CDK4/6 Inhibitors Plus Endocrine Therapy vs. Endocrine
Therapy Alone for Hormone receptor-positive, HER2-negative
metastatic breast cancer. J Cancer. 2020; 10.7150/jca.48944.
8. Lloyd M R, et al. Mechanisms of
Resistance to CDK4/6 Blockade in Advanced Hormone
Receptor-positive, HER2-negative Breast Cancer and Emerging
Therapeutic Opportunities. Clin Cancer
Res. 2022;
28(5):821-30.
9. Brett O, et al. ESR1 mutation as an
emerging clinical biomarker in metastatic hormone
receptor-positive breast cancer. Breast Cancer
Res. 2021;
23:85.
10. Zundelevich A, et al. ESR1 mutations are
frequent in newly diagnosed metastatic and loco-regional recurrence
of endocrine-treated breast cancer and carry worse
prognosis. Breast Cancer
Res. 2020;
22:16.
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: 27 May 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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