阿斯利康以 Form 6-K 向 SEC 补报 Etcamah（camizestrant）联合 CDK4/6 抑制剂获 FDA 加速批准用于一线 HR+/HER2- 伴 ESR1 突变晚期乳腺癌——该批准与 Guardant360 CDx 伴随诊断授权已于 2026-09-04 公开并被本系统处理

----- a5662t.htm -----
6-K
1
a5662t.htm
ETCAMAH APPROVED IN THE US FOR HR+ BREAST CANCER
a5662t
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.
Etcamah approved in the US for HR+ breast cancer
07 September
2026
Etcamah
in
combination with a CDK4/6 inhibitor approved in the US for 1st-line
advanced HR-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
Innovative treatment strategy has potential to reshape 1st-line
treatment paradigm for patients in this setting
AstraZeneca's
Etcamah
(camizestrant) in combination with a
cyclin-dependent kinase (CDK) 4/6 inhibitor (abemaciclib,
palbociclib or ribociclib) has been approved in the US for the
treatment of adult patients with hormone receptor (HR)-positive,
HER2-negative, locally advanced or metastatic breast cancer upon
detection of
ESR1
mutation during aromatase inhibitor (AI) and
CDK4/6 inhibitor therapy, based on a US Food and Drug
Administration (FDA)-authorised test.
The accelerated approval was based on 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
Kevin Kalinsky, MD, MS, FASCO, Division Director of Medical
Oncology, Winship Cancer Institute of Emory University and
investigator for the trial, said: "This combination provides an
important new option for the one in three patients with this form
of advanced breast cancer whose tumours
develop
ESR1
mutations before clinical or radiographic
disease progression. Today's approval will enable clinicians to
promptly intervene and change therapeutic strategy at an earlier
opportunity ahead of disease progression, rather than waiting
until the cancer becomes harder to treat, and patient outcomes
and quality of life worsen."
Dave Fredrickson, Executive Vice President, Oncology Haematology
Business Unit, AstraZeneca, said: "Today's approval is the tenth
granted by the FDA this year across AstraZeneca's portfolio and our
fourth in breast cancer alone. The
Etcamah
combination reflects AstraZeneca's
leadership in redefining breast cancer care by pioneering a new
approach using circulating tumour DNA and is the first and only
medicine of its type in the 1st-line setting."
In a planned interim analysis of the SERENA-6
trial,
Etcamah
in combination with a CDK4/6 inhibitor
reduced the risk of disease progression or death by 56% versus
standard-of-care treatment with an 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 PFS 16.0 versus 9.2 months). While 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, 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
In the US, breast cancer is the most common cancer in women,
with more than 300,000 new patients diagnosed annually, and more
than 42,000 deaths.
2
Approximately
37,000 patients with HR-positive metastatic breast cancer in the US
are treated with a medicine in the 1st-line setting, most
frequently with endocrine therapies that target estrogen receptor
(ER)-driven disease, which are often paired with CDK4/6
inhibitors.
3-5
However,
resistance to these therapies frequently develop in many
patients.
5
Once
this occurs, treatment options are limited and survival rates are
low with just over a third of patients anticipated to live beyond
five years after diagnosis.
5,6
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.
7,8
Approximately
30% of patients with endocrine sensitive HR-positive disease
develop
ESR1
mutations during 1st-line treatment before
disease progression.
3
Concurrently with this approval, the FDA also approved a companion
diagnostic test to detect emerging
ESR1
resistance mutations in the circulating
tumour DNA (ctDNA) of patients with HR-positive, HER2-negative
advanced or metastatic breast cancer. SERENA-6 is the first
global, double-blind, registrational Phase III trial to use a
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 more than 30 countries across the globe, including in the EU,
Japan, Canada, the UK 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.
9
More
than two million patients were diagnosed with breast cancer in
2024, with more than 690,000 deaths globally.
9
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.
6
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.
6
ERs
often drive the growth of HR-positive breast cancer
cells.
10
Globally, more than 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.
3-5
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
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 and without disease progression
during 1st-line endocrine therapy based on the results from the
SERENA-6 Phase III 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.
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. 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 September 2026.
3.
Cerner CancerMPact database. Accessed September 2026.
4. 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.
5. 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.
6. National Cancer Institute. Cancer Stat facts:
Female breast cancer subtypes. Available at:
https://seer.cancer.gov/statfacts/html/breast-subtypes.html
.
Accessed September 2026.
7. Brett O, et al. ESR1 mutation as an
emerging clinical biomarker in metastatic hormone receptor-positive
breast cancer.
Breast Cancer
Res
. 2021;
23:85.
8. 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.
9. 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.
10. 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.
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.
AstraZeneca
PLC
Date:
07 September 2026
By: /s/
Matthew Bowden
Name:
Matthew Bowden
Title:
Company Secretary