欧盟批准阿斯利康/第一三共 Enhertu 用于 HER2 阳性早期乳腺癌辅助治疗，为例行落地且无新增信息

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6-K
1
a6054a.htm
ENHERTU APPROVED IN EU FOR HER2-POSITIVE EBC
a6054a
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 October 2026
Commission
File Number: 001-11960
AstraZeneca PLC
1
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Enhertu approved in EU for HER2-positive eBC
27 October 2026
Enhertu
approved in the EU as adjuvant
treatment for patients with residual disease after neoadjuvant
treatment for HER2-positive early breast cancer
Based on DESTINY-Breast05 Phase III trial which showed AstraZeneca
and Daiichi Sankyo’s Enhertu reduced the risk of invasive
disease recurrence or death by 53% vs. T-DM1
First EU approval of Enhertu in the curative-intent early breast
cancer setting
AstraZeneca and Daiichi Sankyo’s
Enhertu
(trastuzumab
deruxtecan) has been approved in the European Union (EU) as a
monotherapy for the adjuvant treatment of adult patients with
resected HER2-positive breast cancer who have residual invasive
disease after neoadjuvant taxane-based and HER2-targeted
treatment.
The approval by the European Commission follows the
positive
opinion
of the Committee for Medicinal Products for Human
Use of the European Medicines Agency and is based on results from
the
DESTINY-Breast05
Phase III trial
presented
at the
2025 European Society for Medical Oncology Congress and
subsequently published in
The
New England Journal of Medicine
.
1
Sibylle Loibl, MD, PhD, German Breast Group (GBG) and Goethe
University Medicine Frankfurt, Frankfurt am Main and lead
investigator of the DESTINY-Breast05 trial, said: “For
patients with HER2-positive early breast cancer and residual
invasive disease after neoadjuvant therapy, reducing the risk of
disease recurrence is critical for sustained long-term outcomes.
The EU approval of trastuzumab deruxtecan, which demonstrated a
more than 50 per cent reduction in risk of recurrence compared to
standard of care in DESTINY-Breast05, has the potential to change
how we treat eligible patients in this setting.”
Dave Fredrickson, Executive Vice President, Oncology Haematology
Business Unit, AstraZeneca, said: “The goal of treatment in
early breast cancer is to help as many patients as possible achieve
cure. Unfortunately, despite treatment advances, some patients
still face recurrence in the long term. The approval of
Enhertu
in the adjuvant setting for patients
with residual disease after neoadjuvant treatment has the potential
to establish a new benchmark in this curative-intent setting, with
more than 92 per cent of patients alive and free of invasive
disease at three years.”
Ken Keller, Global Head of Oncology Business, and President and
CEO, Daiichi Sankyo, Inc., said: “By bringing
Enhertu
into the adjuvant setting, we are
advancing this treatment option earlier in the course of disease
for patients with HER2-positive early breast cancer. This first
approval of
Enhertu
in early breast cancer in the EU reflects our
continued commitment to bringing innovative medicines into earlier
treatment settings, where there is significant potential to improve
long-term outcomes for patients.”
In DESTINY-Breast05,
Enhertu
significantly reduced the risk of invasive disease
recurrence or death (invasive disease-free survival [IDFS]) by 53%
(based on a hazard ratio [HR] of 0.47; 95% confidence interval [CI]
0.34-0.66; p<0.0001) compared to trastuzumab emtansine (T-DM1)
in patients with HER2-positive breast cancer with residual invasive
disease following neoadjuvant therapy.
Enhertu
demonstrated a three-year IDFS rate of 92.4% (95%
CI 89.7-94.4) compared to 83.7% with T-DM1 (95% CI
80.2-86.7).
The safety profile of
Enhertu
was consistent with the known profile with no new
safety concerns identified.
Enhertu
is now approved in more
than 35 countries for the adjuvant treatment of adult patients with
HER2-positive breast cancer who have residual invasive disease
following neoadjuvant trastuzumab (with or without pertuzumab) and
taxane-based treatment based on the DESTINY-Breast05
trial.
Enhertu
is a specifically
engineered HER2-directed DXd antibody drug conjugate (ADC)
discovered by Daiichi Sankyo and being jointly developed and
commercialised by AstraZeneca and Daiichi
Sankyo.
Financial considerations
Following this approval in the EU, an amount of $75 million is due
from AstraZeneca to Daiichi Sankyo as a milestone payment for the
adjuvant HER2-positive early breast cancer indication. Sales
of
Enhertu
in most EU territories are recognised by Daiichi
Sankyo. For further details on the financial arrangements, please
consult the collaboration agreement from
March
2019
.
Notes
HER2-positive early breast cancer
Breast cancer is the most common cancer in women worldwide and the
leading cause of cancer-related deaths among
women.
2
Approximately 2.4 million breast
cancer cases were diagnosed in 2024, with more than 690,000 deaths
globally.
2
In Europe, approximately 540,000 cases
of breast cancer were diagnosed in 2024, with more than 140,000
deaths.
3
HER2 is a tyrosine kinase receptor growth-promoting protein
expressed on the surface of many types of tumours including breast
cancer.
4
HER2 protein overexpression may occur
as a result of HER2 gene amplification and is often associated with
aggressive disease and poor prognosis in breast
cancer.
4
Approximately one in five cases of
breast cancer is considered HER2-positive.
5
HER2-positive early breast cancer is generally treated across two
phases: the neoadjuvant (pre-surgical) phase and the adjuvant or
post-neoadjuvant (post-surgical) phase. For patients treated before
surgery, achieving pathologic complete response (pCR) –
defined as no evidence of invasive cancer cells in the removed
breast tissue or lymph nodes following neoadjuvant treatment
– is an early indicator of improved long-term
survival.
6
However, approximately half of
patients (39-66%) treated before surgery do not achieve pCR,
increasing their risk of recurrence.
7-11
Post-surgery therapy offers a key opportunity to reduce this risk
and prevent progression to metastatic disease.
12-14
Yet approximately one in four patients
with residual disease treated with the historic adjuvant standard
of care still experience invasive disease or
death.
12-15
Once disease becomes metastatic,
five-year survival falls from around 90% to approximately
30%.
15
DESTINY-Breast05
DESTINY-Breast05
is a
global, multicentre, randomised, open-label, Phase III trial
evaluating the efficacy and safety of
Enhertu
(5.4mg/kg) versus T-DM1 in patients with
HER2-positive early breast cancer with residual invasive disease in
breast or axillary lymph nodes following neoadjuvant therapy and a
high risk of recurrence. High risk of recurrence was defined as
presentation with inoperable cancer (prior to neoadjuvant therapy)
or pathologically positive axillary lymph nodes following
neoadjuvant therapy.
The primary endpoint of DESTINY-Breast05 is investigator-assessed
IDFS, which is defined as the time from randomisation until first
invasive local, axillary or distant recurrence or death from any
cause. The key secondary endpoint is investigator-assessed DFS.
Other secondary endpoints include overall survival, distant
recurrence-free interval, brain metastases-free interval and
safety.
DESTINY-Breast05 enrolled 1,635 patients in Asia, Europe, North
America, Oceania and South America. For more information about the
trial, visit
ClinicalTrials.gov
.
Enhertu
Enhertu
is a HER2-directed ADC.
Designed using the proprietary DXd ADC Technology of
Daiichi Sankyo,
Enhertu
is the lead ADC in the oncology portfolio of
Daiichi Sankyo and the most advanced programme in
AstraZeneca’s ADC scientific platform.
Enhertu
consists of a HER2 monoclonal antibody attached
to a number of topoisomerase I inhibitor payloads (an
exatecan derivative, DXd) via tetrapeptide-based cleavable
linkers.
Enhertu
(5.4mg/kg)
followed by THP is approved in more than five countries as a
neoadjuvant treatment for adult patients with
HER2-positive (IHC 3+ or ISH+) Stage II or Stage III
breast cancer based on the results from the
DESTINY-Breast11
trial.
Enhertu
(5.4mg/kg) is approved
in more than 35 countries worldwide for the adjuvant treatment of
adult patients with HER2-positive breast cancer who have residual
invasive disease following neoadjuvant trastuzumab (with or without
pertuzumab) and taxane-based treatment based on the
DESTINY-Breast05
trial.
Enhertu
(5.4mg/kg) in
combination with pertuzumab is approved in more than 40 countries
worldwide as a 1st-line treatment for adult patients with
unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast
cancer, as determined by a locally or regionally approved test,
based on the results from the
DESTINY-Breast09
trial.
Enhertu
(5.4mg/kg) is
approved in more than 100 countries worldwide for the
treatment of adult patients with unresectable or metastatic
HER2-positive (IHC 3+ or ISH+) breast cancer who have received a
prior anti-HER2-based regimen, either in the metastatic setting or
in the neoadjuvant or adjuvant setting, and have developed disease
recurrence during or within six months of completing therapy based
on the results from the
DESTINY-Breast03
trial.
Enhertu
(5.4mg/kg) is
approved in more than 75 countries worldwide for the
treatment of adult patients with unresectable or metastatic hormone
receptor (HR) positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or
HER2-ultralow (IHC 0 with membrane staining) breast cancer, as
determined by a locally or regionally approved test, that has
progressed on one or more endocrine therapies in the metastatic
setting based on the results from the
DESTINY-Breast06
trial.
Enhertu
(5.4mg/kg) is
approved in more than 100 countries worldwide for the
treatment of adult patients with unresectable or metastatic
HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a
prior systemic therapy in the metastatic setting or developed
disease recurrence during or within six months of completing
adjuvant chemotherapy based on the results from
the
DESTINY-Breast04
trial.
Enhertu
(5.4mg/kg) is
approved in more than 80 countries worldwide for the treatment
of adult patients with unresectable or metastatic NSCLC whose
tumours have activating
HER2
(
ERBB2
) mutations, as detected by a locally or
regionally approved test, and who have received a prior systemic
therapy based on the results from the
DESTINY-Lung02
and/or
DESTINY-Lung05
trials.
Continued approval in China and the US for
this indication may be contingent upon verification and
description of clinical benefit in a confirmatory
trial.
Enhertu
(6.4mg/kg) is
approved in more than 90 countries worldwide for the
treatment of adult patients with locally advanced or metastatic
HER2-positive (IHC 3+ or IHC 2+/ISH+) gastric or gastroesophageal
junction (GEJ) adenocarcinoma who have received a prior
trastuzumab-based regimen based on the results from the
DESTINY-Gastric01
,
DESTINY-Gastric02
and/or
DESTINY-Gastric04
trials.
Enhertu
(5.4mg/kg) is approved
in more than 50 countries worldwide for the treatment of adult
patients with unresectable or metastatic HER2-positive (IHC 3+)
solid tumours who have received prior treatment and have no
satisfactory alternative treatment options based on efficacy
results from the
DESTINY-PanTumor02
,
DESTINY-Lung01
,
DESTINY-CRC02,
DESTINY-PanTumor03
and/or
HERALD
trials. Continued approval in the US
and China for this indication may be contingent upon verification
and description of clinical benefit in a confirmatory
trial.
Enhertu
clinical development
programme
A comprehensive global clinical development programme is underway
evaluating the efficacy and safety of
Enhertu
as a monotherapy or in combination or sequentially
with other cancer medicines across multiple HER2 targetable
cancers.
Daiichi Sankyo collaboration
AstraZeneca and Daiichi Sankyo entered into a global
collaboration to jointly develop and
commercialise
Enhertu
in
March
2019
and
Datroway
(datopotamab deruxtecan)
in
July
2020
, except in Japan where
Daiichi Sankyo maintains exclusive rights for each ADC.
Daiichi Sankyo is responsible for the manufacturing and
supply of
Enhertu
and
Datroway
.
AstraZeneca in breast cancer
AstraZeneca is advancing a leading breast cancer portfolio across
subtypes and stages, with five approved medicines across 12
indications and seven ongoing Phase III trials.
In HER2-positive breast cancer, AstraZeneca is aiming to
establish new standards of care across the disease continuum
with
Enhertu
, with a focus on improving outcomes as early as
possible.
In HR-positive metastatic breast cancer, AstraZeneca is focused on
extending the benefit of endocrine-based therapies by tackling key
resistance mechanisms with
Etcamah
(camizestrant), a next-generation oral SERD,
and
Truqap
(capivasertib), a first-in-class AKT inhibitor,
while expanding the role of the antibody drug conjugates
Enhertu
and
Datroway
for patients no longer suitable for
endocrine-based therapy.
Etcamah
is also being evaluated in early-stage
disease.
In triple-negative breast cancer (TNBC), AstraZeneca is
advancing the treatment landscape by developing tailored approaches
that move more patients beyond conventional chemotherapy. This
includes
Datroway,
which is evolving the standard of care in
metastatic TNBC and is also being evaluated in earlier settings and
in combination with immunotherapy
Imfinzi
(durvalumab)
and bispecific antibody ivonescimab.
In germline
BRCA
-mutated (g
BRCA
m) breast cancer, AstraZeneca has redefined
treatment with the PARP inhibitor
Lynparza
(olaparib) and is now building on this
foundation with saruparib, a PARP1-selective inhibitor being
evaluated in combination with
Etcamah
for patients with g
BRCA
m or
PALB2
m, HR-positive, HER2-negative metastatic breast
cancer.
Together, these efforts support AstraZeneca's ambition to cure more
patients with early breast cancer, improve survival in metastatic
disease, and ultimately eliminate breast cancer as a cause of
death.
AstraZeneca is collaborating with Daiichi Sankyo to
develop and commercialise
Enhertu
and
Datroway,
with MSD (Merck & Co., Inc. in the
US and Canada) to develop and commercialise
Lynparza
and with Summit Therapeutics on the clinical
development of ivonescimab in combination with
Datroway.
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
.
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.
References
1.
Loibl S, et al. Trastuzumab Deruxtecan in Residual
HER2-Positive Early Breast Cancer.
N Engl J
Med
.
2026;394:845-857.
2.
World Health Organization.
Global
Status Report on Cancer 2026: The Future We Choose Together.
Available at
https://www.who.int/publications/i/item/9789240123977
.
Accessed October 2026.
3.
World Health Organization. Breast Fact Sheet.
Available at
https://gco.iarc.who.int/media/globocan/factsheets/cancers/20-breast-fact-sheet.pdf
.
Accessed October
2026.
4.
Cheng X. A Comprehensive Review of HER2 in Cancer
Biology and Therapeutics.
Genes
(Basel)
.
2024;15(7):903.
5.
Tarantino P, et al. ESMO Expert Consensus
Statements (ECS) on the Definition, Diagnosis, and Management of
HER2-low Breast Cancer.
Ann Oncol
. 2023;34(8):645-659.
6.
Spring LM, et al. Pathological complete response
after neoadjuvant chemotherapy and impact on breast cancer
recurrence and survival: a comprehensive meta-analysis.
Clin Cancer
Res
.
2020;26(12):2838–2284.
7.
Schneeweiss A, et al. Pertuzumab plus trastuzumab
in combination with standard neoadjuvant anthracycline-containing
and anthracycline-free chemotherapy regimens in patients with
HER2-positive early breast cancer: a randomized phase II cardiac
safety study (TRYPHAENA).
Ann Oncol
. 2013;24(9):2278-2284.
8.
Swain SM, et al. Pertuzumab, trastuzumab, and
standard anthracycline- and taxane-based chemotherapy for the
neoadjuvant treatment of patients with HER2-positive localized
breast cancer (BERENICE): a phase II, open-label, multicenter,
multinational cardiac safety study.
Ann Oncol
. 2018;29(3):646-653.
9.
Huober J, et al. Atezolizumab with neoadjuvant
anti-human epidermal growth factor receptor 2 therapy and
chemotherapy in human epidermal growth factor receptor 2-positive
early breast cancer: primary results of the randomized phase III
IMpassion050 trial.
J Clin
Oncol
.
2022;40(25):2946-2956.
10.
Masuda N, et al. A randomized, 3-arm, neoadjuvant,
phase 2 study comparing docetaxel + carboplatin + trastuzumab +
pertuzumab (TCbHP), TCbHP followed by trastuzumab emtansine and
pertuzumab (T-DM1+P), and T-DM1+P in HER2-positive primary breast
cancer.
Breast Cancer Res
Treat
.
2020;180:135-146.
11.
Gao
H, et al. De-escalated neoadjuvant taxane plus trastuzumab and
pertuzumab with or without carboplatin in HER2-positive early
breast cancer (neoCARHP): a multicentre, open-label, randomised,
phase 3 trial. Presented at ASCO Annual Meeting 2025.
12.
Geyer CE, et al.
Survival with Trastuzumab Emtansine in Residual HER2-Positive
Breast Cancer.
N
Engl J Med
.
2025;392(3):249-257.
13.
von Minckwitz G, et al. Trastuzumab Emtansine for
Residual Invasive HER2-Positive Breast Cancer.
N Engl J
Med
.
2019;380(7):617-628.
14.
Zaborowski AM and Wong SM. Neoadjuvant Systemic
Therapy for Breast Cancer.
BJS
. 2023;110(7):765-772.
15.
Mahtani R, et al. Human Epidermal Growth Factor
Receptor 2-Positive (HER2+) Early Breast Cancer Treatment and
Outcomes by Risk of Recurrence: A Retrospective US Electronic
Health Records Study.
Cancers
(Basel)
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2025;17(11):1848.
16.
National Cancer Institute. SEER Cancer Stat Facts:
Female Breast Cancer. Available at:
https://seer.cancer.gov/statfacts/html/breast-subtypes.html
.
Accessed October 2026.
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:
27 October 2026
By: /s/
Matthew Bowden
Name:
Matthew Bowden
Title:
Company Secretary