Form 6-K ASTRAZENECA PLC For: Jul 23
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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 July 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.
Etcamah approved in the EU for ER+ breast cancer
23 July 2026
Etcamah (camizestrant)
in combination with a CDK4/6 inhibitor approved in the EU for
1st-line advanced ER-positive breast
cancer
Approval based on SERENA-6 Phase III trial results which showed
combination reduced the risk of disease progression or death by 56%
in patients with an emergent ESR1 tumour mutation
First and only next-generation oral SERD and complete ER antagonist
approved in 1st-line and only option in combination with all widely
approved CDK4/6 inhibitors
Etcamah is
11th new AstraZeneca medicine of the 20 expected to launch by
2030
AstraZeneca's Etcamah (camizestrant) in combination with a
cyclin-dependent kinase (CDK) 4/6 inhibitor (palbociclib,
ribociclib or abemaciclib) has been approved in the European
Union (EU) for the treatment of adult patients with estrogen
receptor (ER)-positive, HER2-negative locally advanced or
metastatic breast cancer upon detection of ESR1 mutation and without disease progression
during 1st-line endocrine therapy in combination with a CDK4/6
inhibitor.
The approval by the European Commission follows
the positive
opinion of the Committee
for Medicinal Products for Human Use and was based on the positive
results from the pivotal SERENA-6 Phase III trial published
in The
New England Journal of Medicine.1
In a planned interim analysis, the Etcamah combination reduced the risk of disease
progression or death by 56% versus standard-of-care treatment with
an aromatase inhibitor (AI) (anastrozole or letrozole) in
combination with a CDK4/6 inhibitor (based on a hazard ratio [HR]
of 0.44; 95% confidence interval [CI]:0.31-0.60; p<0.00001;
median progression-free survival (PFS) 16.0 versus 9.2
months).
In Europe, breast cancer remains the leading cause of cancer death
among women, with more than 140,000 deaths in 2024 and more than
540,000 patients diagnosed in the same year.2 Hormone
receptor (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.3 More
than 97% of HR-positive breast cancer tumours are
ER-positive.4,5 Across
the UK, France, Germany, Spain and Italy, approximately 37,000
patients with HR-positive metastatic breast cancer are treated
with a medicine in the 1st-line setting; most frequently with
endocrine therapies paired with CDK4/6
inhibitors.6-8 However,
many patients have tumours that develop resistance to these
therapies, at which point treatment options are limited and
survival rates are low, with only approximately 36% of patients
anticipated to live beyond five years after
diagnosis.3,8 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
François-Clément Bidard MD, PhD, Professor of Medical
Oncology at Institut Curie & Versailles University
(Paris/Saclay) France and co-principal investigator for the trial,
said: "Today's approval is welcome news for the one in three
patients in Europe with this form of advanced breast cancer whose
tumours develop ESR1 mutations before disease progression and are
in urgent need of new options that both delay this progression and
extend the benefit of 1st-line treatments. As the first
pivotal trial to demonstrate the clinical value of monitoring
circulating tumour DNA in the 1st-line breast cancer setting,
SERENA-6 represents a significant advance in clinical practice and
it is now important to identify patients who may be able to benefit
from this combination and intervene promptly before their disease
progresses."
Dave Fredrickson, Executive Vice President, Oncology Haematology
Business Unit, AstraZeneca, said: "The approval of
the Etcamah combination marks an important shift in the
1st-line treatment paradigm for patients with ER-positive,
HER2-negative advanced breast cancer in Europe, providing a new
standard-of-care to address emerging resistance ahead of disease
progression. It also reflects the strength of AstraZeneca's
oncology pipeline and our commitment to translate innovative
science into practice-changing treatment options for
patients."
Data for the key secondary endpoints of time to second disease
progression (PFS2) and overall survival (OS) were immature at the
time of the interim analysis of the SERENA-6 trial, however, a
subsequent pre-planned analysis demonstrated a statistically
significant and clinically meaningful PFS2 benefit of 25.7 months
versus 19.1 months in favour of the Etcamah combination (HR: 0.63; 95% CI: 0.46-0.86;
p=0.00373) and OS continued to mature in favour of
the Etcamah combination (HR: 0.87; 95% CI: 0.57-1.30).
The trial will continue to assess OS as a key secondary
endpoint.
The safety profile of Etcamah in combination with palbociclib, ribociclib
or abemaciclib in the SERENA-6 trial was consistent with the known
safety profile of each medicine. No new safety concerns were
identified, and discontinuations were very low and similar in both
arms.1
SERENA-6 is the first global, double-blind, registrational Phase
III trial to use a circulating tumour DNA (ctDNA)-guided approach
to detect the emergence of endocrine resistance and inform a switch
in therapy before disease progression. The innovative trial design
used ctDNA monitoring via a blood test at the time of routine
tumour scans every two to three months to identify patients for
early signs of endocrine resistance via the emergence
of ESR1 mutations. Following detection of
an ESR1 mutation without disease progression, the
endocrine therapy of patients was switched
to Etcamah from ongoing treatment with an AI, while
continuing combination with the same CDK4/6
inhibitor.
Etcamah is also approved
in Japan, the United Arab Emirates and Saudi Arabia based
on the SERENA-6 Phase III trial. Regulatory applications
for Etcamah in this setting are currently under review
in several other countries including the US where
the US Food and Drug Administration
recently extended the
Prescription Drug User Fee Act date to review the updated results from the
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.11 More
than two million patients were diagnosed with breast cancer in
2024, with more than 690,000 deaths globally.11 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.3
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
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 Etcamah 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.
Etcamah
Etcamah (camizestrant) 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 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 and without disease progression
during 1st-line endocrine therapy based on the results from the
SERENA-6 trial.
The broad, robust and innovative Etcamah clinical development programme, including
the SERENA-4, 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.
Etcamah 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 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), 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 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. World Health Organization. GLOBOCAN Europe Fact
Sheet. Available at: https://gco.iarc.who.int/media/globocan/factsheets/populations/908-europe-fact-sheet.pdf.
Accessed July 2026.
3. National Cancer Institute.
Cancer Stat facts: Female breast cancer subtypes. Available
at: https://seer.cancer.gov/statfacts/html/breast-subtypes.html. Accessed
July 2026.
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.
6.
Cerner CancerMPact database. Accessed July 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.
11. 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.
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.
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AstraZeneca
PLC
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Date:
23 July 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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