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
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Enhertu recommended in EU for HER2+ solid tumours
26 May 2026
Enhertu recommended for approval in the EU by CHMP
for patients with previously treated HER2-positive metastatic solid
tumours
Based on three Phase II trials of AstraZeneca and Daiichi Sankyo's
Enhertu which showed clinically meaningful responses across a broad
range of tumours
If approved, Enhertu would become the first HER2-directed therapy
and
antibody drug conjugate to receive a tumour agnostic indication in
the EU
AstraZeneca and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) has
been recommended for
approval in the European Union (EU) as a
monotherapy for the
treatment of adult patients with unresectable or metastatic
HER2-positive (immunohistochemistry [IHC] 3+) solid tumours
who have received prior treatment and who have no satisfactory
treatment options.
The Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) based
its positive opinion on results from a subgroup of
patients with HER2-positive (IHC 3+) tumours across
three Phase II trials, DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02,
in which Enhertu demonstrated
clinically meaningful responses across a broad range of
tumours.
Susan Galbraith, Executive Vice President, Oncology Haematology
R&D, AstraZeneca, said: "HER2-directed therapies have already
transformed care for certain HER2-expressing cancers, including
breast and gastric cancers. However,
many other cancers
overexpress HER2, and targeted treatment options remain unavailable
for most of these tumour types. This positive CHMP opinion
underscores the importance of precision oncology and marks an
important step toward bringing a new targeted option to more
patients in the EU living with HER2-positive solid
tumours."
John Tsai, Global Head, R&D, Daiichi Sankyo, said: "This
positive CHMP opinion acknowledges the clinical value
of Enhertu as the potential first HER2-directed
medicine and antibody drug conjugate available for patients with
HER2-positive metastatic solid tumours in the
EU. Enhertu offers meaningful responses for patients
with advanced cancers that overexpress HER2 who have limited
treatment options. We look forward to continuing to work with the
EMA to bring Enhertu to these patients."
In the DESTINY-PanTumor02 Phase II trial, Enhertu demonstrated a confirmed objective response
rate (ORR) of 51.4% and median duration of response (DOR) of 14.2
months in previously treated patients with centrally or locally
assessed IHC 3+ solid tumours (n=111) including either biliary
tract, bladder, cervical, endometrial,
ovarian, pancreatic or other tumours. In
DESTINY-Lung01, Enhertu demonstrated a confirmed ORR of 52.9% and
median DOR of 6.9 months in patients with centrally confirmed IHC
3+ non-small cell lung cancer (NSCLC) (n=17). In
DESTINY-CRC02, Enhertu demonstrated a confirmed ORR of 46.9% and
median DOR of 5.5 months in patients with centrally confirmed IHC
3+ colorectal cancer (n=64).
The safety profile of Enhertu was consistent with previous clinical trials
with no new safety concerns identified.
Enhertu has received a
tumour agnostic indication in the US and other countries based on
the DESTINY-PanTumor02 trial.
Additional regulatory submissions for Enhertu are under review in the EU, including in
combination with pertuzumab for the 1st-line treatment of patients
with unresectable or metastatic HER2-positive (IHC 3+ and ISH+)
breast cancer based on data from the DESTINY-Breast09 Phase
III trial and for patients with HER2-positive (IHC 3+ and ISH+)
breast cancer who have residual invasive disease after neoadjuvant
HER2-targeted treatment based on data from
the DESTINY-Breast05 Phase
III 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.
Notes
HER2 expression in solid tumours
HER2 is a tyrosine kinase receptor growth-promoting protein
expressed on the surface of various tissue cells throughout the
body and is involved in normal cell growth.1 HER2
protein overexpression may occur as a result
of HER2 gene amplification and is often associated
with aggressive disease and poor prognosis in some
cancers.2
HER2-directed therapies have been used to treat HER2 overexpression
in breast, gastric and salivary gland cancers in the
EU.1,3-5 Although
HER2 is overexpressed in additional solid tumour types including
biliary tract, lung, bladder, cervical, colorectal, endometrial,
ovarian and pancreatic cancers, HER2 testing is not routinely
performed for these additional tumour types and there are currently
no HER2 directed treatments approved in the EU to treat a broad
range of solid tumours.6,7
DESTINY-PanTumor02
DESTINY-PanTumor02 is a global, multicentre, multi-cohort,
open-label, Phase II trial evaluating the efficacy and safety
of Enhertu (5.4mg/kg) for the treatment of previously
treated HER2-expressing tumours, including biliary tract, bladder,
cervical, endometrial, ovarian, pancreatic cancer or other
tumours.
The primary endpoint of DESTINY-PanTumor02 is confirmed ORR as
assessed by investigator. Secondary endpoints include DOR, disease
control rate (DCR), progression-free survival (PFS), overall
survival (OS), safety, tolerability and pharmacokinetics. Results
from DESTINY-PanTumor02 were published in
the Journal
of Clinical Oncology.8
DESTINY-PanTumor02 enrolled 267 HER2-positive (IHC 3+ [n=111] and
IHC 2+ [n=156]) adult patients at multiple sites in Asia, Europe,
North America, South America and Oceania. For more information
about the trial, visit ClinicalTrials.gov.
DESTINY-Lung01
DESTINY-Lung01 is a global, open-label, two-cohort, Phase II
trial evaluating the efficacy and safety
of Enhertu (5.4mg/kg
or 6.4mg/kg) in patients with HER2-mutant or HER2-overexpressing unresectable or
metastatic NSCLC who had progressed after one or more systemic
therapies.
The primary endpoint of DESTINY-Lung01 is confirmed ORR by
independent central review. Key secondary endpoints include DOR,
DCR, PFS, OS and safety. Results from the HER2 mutant cohort were published
in The
New England Journal of Medicine and results from the HER2 overexpressing
cohort were published in The
Lancet Oncology.9,10
DESTINY-Lung01 enrolled 181 adult patients (HER2-mutant [n=91] and
HER2-overexpressing [n=90; IHC 3+, n=17 and IHC 2+, n=73]) at
multiple sites in Asia, Europe and North America. For more
information about the trial, visit ClinicalTrials.gov.
DESTINY-CRC02
DESTINY-CRC02 is a global, randomised, two-arm, parallel,
multicentre, Phase II trial evaluating the efficacy and safety of
two doses (5.4mg/kg or 6.4mg/kg) of Enhertu in patients with locally advanced,
unresectable or metastatic HER2-positive (IHC 3+ or IHC 2+)
colorectal cancer of BRAF wild-type, RAS wild-type or RAS mutant
tumour types previously treated with standard therapy. The trial
was conducted in two stages. In the first stage, patients (n=80)
were randomised 1:1 to receive either 5.4mg/kg or 6.4mg/kg
of Enhertu. In the second stage, additional patients (n=42)
were enrolled in the 5.4mg/kg arm.
The primary endpoint in DESTINY-CRC02 is confirmed ORR as assessed
by blinded independent central review. Secondary endpoints include
DOR, DCR, investigator-assessed confirmed ORR, clinical benefit
ratio, PFS, OS and safety. Results from DESTINY-CRC02 were
published in The
Lancet Oncology.11
DESTINY-CRC02 enrolled 122 adult patients (including 64 patients
with IHC 3+ receiving 5.4mg/kg) at multiple sites in Asia, Europe,
North America and Oceania. For more information about the trial,
visit ClinicalTrials.gov.
Enhertu
Enhertu is a
HER2-directed ADC. Designed using Daiichi Sankyo's
proprietary DXd ADC Technology, 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) is
approved in the US as an adjuvant treatment for adult patients with
HER2-positive breast cancer who have residual invasive disease
following trastuzumab (with or without pertuzumab) and taxane-based
treatment based on the DESTINY-Breast05 trial.
Enhertu (5.4mg/kg)
followed by THP is approved in China and the US 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.
Continued approval in China for this indication may be contingent
upon verification and description of clinical benefit in a
confirmatory trial.
Enhertu (5.4mg/kg) in
combination with pertuzumab is approved in the US, Switzerland,
United Arab Emirates and Saudi Arabia as a first-line treatment for
adult patients with unresectable or metastatic HER2-positive (IHC
3+ or ISH+) breast cancer, as determined by an FDA-approved
test, based on the results from the DESTINY-Breast09 trial.
Enhertu (5.4mg/kg) is
approved in more than 95 countries/regions 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 95 countries/regions 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 70 countries/regions 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 have
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 75 countries/regions 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 85 countries/regions 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 15 countries/regions worldwide for
the treatment of adult patients with unresectable or metastatic
HER2-positive (IHC 3+) solid tumours who have received prior
systemic treatment and have no satisfactory alternative treatment
options based on efficacy results from the DESTINY-PanTumor02, DESTINY-Lung01, DESTINY-CRC02 and/or HERALD trials.
Continued approval in the US 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, 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
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, AstraZeneca and Daiichi Sankyo are aiming to
improve outcomes in previously treated HER2-positive, HER2-low and
HER2-ultralow metastatic breast cancer, and expanding 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, 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. Iqbal N, Iqbal N. Human
Epidermal Growth Factor Receptor 2 (HER2) in Cancers:
Overexpression and Therapeutic
Implications. Mol Biol
Int.
2014;2014:852748.
2. Cheng X. A comprehensive review of
HER2 in cancer biology and therapeutics. Genes (Basel). 2024;15(7):903.
3. Benli Y, et al.
HER2-targeted therapy in colorectal cancer: a comprehensive
review. Clin
Transl Oncol.
2025;27(9):3607-3624.
4. Uy NF, et al. HER2 in
non-small cell lung cancer: a review of emerging
therapies. Cancers (Basel).
2022;14(17):4155.
5. Haigh JE, et al. The
clinical utilisation and duration of treatment with HER2-directed
therapies in HER2-positive recurrent or metastatic salivary gland
cancers. Curr
Oncol. 2024;31(9):5652-5661.
6. Omar N, et al. HER2: An
emerging biomarker in non-breast and non-gastric
cancers. Pathogenesis.
2015;2(3):1-9.
7. Ismail A, et al. HER2
alterations across solid tumors: implications for comprehensive
testing. Oncologist. 2025;30(9):258.
8. Meric-Bernstam F, et
al. Efficacy and Safety of Trastuzumab Deruxtecan in Patients With
HER2-Expressing Solid Tumors: Primary Results From the
DESTINY-PanTumor02 Phase II Trial. J
Clin Oncol.
2023;42(1):47-58.
9. Li B, et al. Trastuzumab Deruxtecan
in HER2-Mutant Non-Small-Cell Lung Cancer. N
Engl J Med. 2022;386:241-251
10. Smit E, et al. Trastuzumab deruxtecan in
patients with metastatic non-small-cell lung cancer
(DESTINY-Lung01): primary results of the HER2-overexpressing
cohorts from a single-arm, phase 2 trial. Lancet
Oncol.
2024;25(4):439-454
11. Raghav K, et al. Trastuzumab deruxtecan
in patients with HER2-positive advanced colorectal cancer
(DESTINY-CRC02): primary results from a multicentre, randomised,
phase 2 trial. Lancet
Onco.
2024;25(9):1147-1162.
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: 26 May 2026
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By: /s/
Matthew Bowden
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Name:
Matthew Bowden
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Title:
Company Secretar
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