Form 6-K ASTRAZENECA PLC For: Sep 14
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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 September 2026
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
20-F X Form 40-F __
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(1):
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(7): ______
Indicate
by check mark whether the registrant by furnishing the information
contained in this Form is also thereby furnishing the information
to the Commission pursuant to Rule 12g3-2(b) under the Securities
Exchange Act of 1934.
Yes __
No X
If
“Yes” is marked, indicate below the file number
assigned to the Registrant in connection with Rule 12g3-2(b):
82-_____________
AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Update on SERENA-4 Phase III trial
This announcement contains inside information
14 September 2026
Update on SERENA-4 Phase III trial
of Etcamah in combination with
palbociclib in upfront 1st-line advanced ER-positive breast
cancer
SERENA-4 trial did not meet primary objective of statistically
significant improvement in progression-free survival, however a
numerical improvement was observed
Etcamah is the only oral SERD to demonstrate benefit in 1st-line
setting and is approved for patients with an emergent ESR1 tumour
mutation based on SERENA-6
The SERENA-4 Phase III trial of
AstraZeneca's Etcamah (camizestrant) in combination
with palbociclib, a cyclin-dependent kinase (CDK) 4/6
inhibitor, did not meet the primary endpoint of progression-free
survival (PFS), however a numerical improvement was
observed in the upfront 1st-line treatment of patients
with estrogen receptor (ER)-positive, HER2-negative advanced breast
cancer who have not received any systemic treatment for advanced
disease. The trial evaluated the Etcamah combination versus treatment with an
aromatase inhibitor (anastrozole) in combination with
palbociclib.
Susan Galbraith, Executive Vice President, Oncology Haematology
R&D, AstraZeneca, said: "Whilst we are disappointed by the
SERENA-4 outcome, it sharpens our focus on maximising the number of
patients who can benefit from Etcamah today based on SERENA-6 and reinforces the
importance of ESR1 testing for patients on first-line therapy.
Early breast cancer represents an important opportunity, and we
remain confident in the long-term potential
of Etcamah in the early setting as we advance our
broader programme."
The safety profile of Etcamah in combination with palbociclib in SERENA-4
was consistent with the known safety profile of each medicine, with
no new safety concerns identified. Data will be shared in due
course.
Etcamah in combination
with a CDK4/6 inhibitor (palbociclib, ribociclib or
abemaciclib) is approved in the US, EU, Japan and several
other countries for the treatment of adult patients
with hormone receptor (HR)-positive (or ER-positive),
HER2-negative locally advanced or metastatic breast cancer upon
detection or emergence of ESR1 mutation during 1st-line endocrine-based
therapy, based on the results from the SERENA-6 Phase III
trial.
Etcamah is currently being
evaluated in the most comprehensive oral SERD development programme
in early breast cancer. Encompassing approximately 10,000 patients,
the CAMBRIA-1 and CAMBRIA-2 Phase III trials are designed for
patients at both intermediate and high risk of recurrence in the
adjuvant setting, evaluating Etcamah as a monotherapy, in combination with CDK4/6
inhibitors and following CDK4/6 inhibitor treatment to address
areas of unmet need in HR-positive, HER2-negative breast
cancer.
Notes
ER-positive breast cancer
Breast cancer is the second most common cancer and one of the
leading causes of cancer-related deaths
worldwide.1 More
than two million patients were diagnosed with breast cancer in
2024, with more than 690,000 deaths globally.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
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.2 ERs
often drive the growth of HR-positive breast cancer
cells.3 More than
97% of HR-positive breast cancer tumours are
ER-positive.4,5
SERENA-4
SERENA-4 is a Phase III, double-blind, randomised trial evaluating
the efficacy and safety of camizestrant in combination with
palbociclib, a CDK4/6 inhibitor, versus treatment with an aromatase
inhibitor (AI) (anastrozole) in combination with palbociclib in
patients with ER-positive, HER2-negative advanced breast cancer
(patients with either locally advanced disease, or metastatic
disease).
The global trial enrolled 1,371 adult patients, newly diagnosed
with Stage IV de novo or recurrent disease who had not received
any systemic treatment for metastatic disease. Patients with
recurrence from early-stage disease had received at least 24 months
of standard adjuvant endocrine therapy (AI or tamoxifen), and at
least 12 months had elapsed since the last dose of adjuvant AI
therapy without disease progression on
treatment.
The primary endpoint of the SERENA-4 trial is PFS as assessed by
investigator, with secondary endpoints including OS, PFS2, and
health-related quality of life (HRQOL).
Etcamah
Etcamah is a potent,
next-generation oral selective estrogen receptor degrader (SERD)
and complete ER antagonist, administered orally, once
daily. The recommended dose of Etcamah in combination with a CDK4/6 inhibitor is
75mg.
Etcamah in combination
with a CDK4/6 inhibitor (palbociclib, ribociclib or
abemaciclib) is approved in the US, EU, Japan and several
other countries for the treatment of adult patients with
HR-positive (or ER-positive), HER2-negative locally advanced or
metastatic breast cancer upon detection or emergence
of ESR1 mutation during 1st-line endocrine-based
therapy, based on the results from the SERENA-6 Phase III
trial.
The broad, robust and innovative Etcamah clinical development programme, including
the CAMBRIA-1 and CAMBRIA-2 Phase III trials, is evaluating the
safety and efficacy of Etcamah 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.
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 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 (fulvestrant) 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, Etcamah.
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 Etcamah or endocrine therapy 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. Sung H, et al. Global cancer
statistics 2024: GLOBOCAN estimates of incidence and mortality
worldwide for 34 cancers in 186 countries. CA Cancer J
Clin. 2026; DOI:
10.3322/caac.70090.
2. National Cancer Institute.
Cancer Stat facts: Female breast cancer subtypes. Available
at: https://seer.cancer.gov/statfacts/html/breast-subtypes.html.
Accessed September 2026.
3. 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.
4. Bae S, et al. Poor prognosis of
single hormone receptor positive breast cancer: similar outcome as
triple-negative breast cancer. BMC Cancer. 2015; 15:138.
5. Cserni G, et al. Estrogen Receptor
Negative and Progesterone Receptor Positive Breast Carcinomas-How
Frequent are they? Pathol. Oncol.
Res. 2011;
17:663-668.
Matthew Bowden
Company Secretary
AstraZeneca PLC
This announcement contains information that AstraZeneca PLC is
obliged to make public pursuant to the EU Market Abuse Regulation
(596/2014) and the assimilated EU Market Abuse Regulation
(596/2014) as it forms part of the law of the United Kingdom by
operation of the European Union (Withdrawal) Act 2018. This
announcement was submitted for publication, through the agency of
the contact person(s) set out above, at 21:15 BST 11 September
2026.
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:
14 September 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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