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.
FDA ODAC vote on camizestrant in breast cancer
01 May
2026
Update on FDA Advisory Committee vote on camizestrant in
combination with a CDK4/6 inhibitor for advanced HR-positive breast
cancer
The US Food and Drug Administration's (FDA) Oncologic Drugs
Advisory Committee (ODAC) did not reach a majority vote in favor of
the benefit risk profile of AstraZeneca's 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,
based on the SERENA-6 Phase III trial. The Committee voted 3 to
6.
In July 2025, the FDA accepted the New Drug Application (NDA) for
camizestrant in combination with a CDK4/6 inhibitor 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 (BTD) for the
camizestrant combination in this setting in May
2025.
The FDA is not bound by the Committee's guidance but takes its
advice into consideration. AstraZeneca will continue to work with
the FDA as it completes its review of the application.
Kevin Kalinsky, MD, MS, FASCO, Division Director of Medical
Oncology, Winship Cancer Institute of Emory University and
investigator for the trial, said: "Patients with this specific form
of breast cancer are in urgent need of new treatments that delay
disease progression. Today's recommendation by the ODAC is
disappointing, as new options and innovative treatment strategies
which address emerging resistance ahead of disease progression and
deterioration in quality of life are needed in the 1st-line
setting."
Susan Galbraith, Executive Vice President, Oncology Haematology
R&D, AstraZeneca, said: "New innovations and novel treatment
strategies that provide benefit to patients are required to drive
advances in this 1st-line setting, and so we are disappointed with
the mixed outcome of today's ODAC meeting. We strongly believe in
the results of the SERENA-6 trial, and are encouraged that the
Committee saw camizestrant as a safe and effective potential new
medicine. We remain confident in the clinical benefit the
combination can bring to patients by changing therapeutic strategy
at the earliest opportunity, and are committed to challenging the
status quo in the pursuit of innovation that optimises outcomes for
patients."
Results from a planned interim analysis of the SERENA-6 Phase III
trial showed a highly statistically significant and clinically
meaningful 56% reduction in the risk of disease progression or
death with the camizestrant combination 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).1 Median
PFS was 16.0 months for patients who switched to the camizestrant
combination versus 9.2 months for the comparator arm, and nearly
one third (29.7%) of patients in the camizestrant arm showed
sustained disease control at 24 months of treatment, versus 5.4%
patients in the AI arm.1
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, 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 camizestrant combination (HR: 0.63; 95% CI:
0.46, 0.86; p = 0.00373) and OS continued to mature in favour of
the camizestrant combination (HR: 0.87, CI: 0.57-1.30). The trial
will continue to assess OS as a key secondary endpoint. Additional
analyses of patient reported outcome (PRO)
measures published
in Annals
of Oncology showed
that the camizestrant combination demonstrated consistent
benefit in delaying time to deterioration (TTD) in quality of life
and reduced the risk of deterioration in patient-reported cancer
symptoms and functioning, where
the camizestrant combination reduced the risk of
deterioration in global health status and quality of life by 46%
compared with the AI combination (HR 0.54; 95% CI, 0.34-0.84;
nominal p<0.001).2
The safety profile of camizestrant 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.
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 camizestrant from
ongoing treatment with an AI, while continuing combination with the
same CDK4/6 inhibitor.
Regulatory applications for camizestrant in this setting are also
under review in the EU, Japan and several other
countries.
Notes
HR-positive breast cancer
Breast cancer is the second most common cancer and one of the
leading causes of cancer-related deaths
worldwide.3 More
than two million patients were diagnosed with breast cancer in
2022, with more than 665,000 deaths globally.3 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.4 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.5
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.5 Estrogen
receptor (ERs) often drive the growth of HR-positive breast cancer
cells.6
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.7-9 In
the US, approximately 37,000 patients with HR-positive metastatic
breast cancer are treated with these therapies in the 1st-line
setting.7-9 However,
resistance to these therapies develops in many
patients.9 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.5,9
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.10,11 Approximately
30% of patients with endocrine sensitive HR-positive disease
develop ESR1 mutations
during 1st-line treatment before disease
progression.7
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 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,
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 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. Bidard FC, et al. First-Line
Camizestrant for Emerging ESR1-Mutated Advanced Breast
Cancer. N Engl J
Med 2025; DOI:
10.1056/NEJMoa2502929.
2. Mayer E, et al. Patient-reported
outcomes in the SERENA-6 trial of camizestrant plus CDK4/6
inhibitor in patients with advanced breast cancer and emergent ESR1
mutations during first-line endocrine-based
therapy. Ann Oncol 2026; 37(2):180-193.
3. 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.
4. 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 April 2026.
5. National Cancer Institute. Cancer
Stat facts: Female breast cancer subtypes. Available
at: https://seer.cancer.gov/statfacts/html/breast-subtypes.html.
Accessed April 2026.
6. 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.
7.
Cerner CancerMPact database. Accessed April 2026.
8. 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.
9. 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.
10. Brett O, et al. ESR1 mutation as an
emerging clinical biomarker in metastatic hormone
receptor-positive breast cancer. Breast Cancer
Res. 2021;
23:85.
11. 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: 01 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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