REG - AstraZeneca PLC - Enhertu recommended in EU for HER2+ solid tumours

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RNS Number : 6562F  AstraZeneca PLC  26 May 2026

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
(https://www.astrazeneca.com/media-centre/press-releases/2023/enhertu-demonstrated-clinically-meaningful-survival-across-multiple-her2-expressing-advanced-solid-tumours-in-destiny-pantumor02-phase-ii-trial.html)
, DESTINY-Lung01
(https://www.astrazeneca.com/media-centre/press-releases/2022/enhertu-continues-to-demonstrate-clinically-meaningful-tumour-response-in-patients-with-her2-mutant-metastatic-non-small-cell-lung-cancer.html)
 and DESTINY-CRC02
(https://www.astrazeneca.com/media-centre/press-releases/2023/enhertu-demonstrated-clinically-meaningful-and-durable-responses-in-patients-across-multiple-her2-expressing.html)
, 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
(https://www.astrazeneca.com/media-centre/press-releases/2025/enhertu-plus-pertuzumab-reduced-the-risk-of-disease-progression-or-death-vs-thp-as-1st-line-therapy-in-patients-with-her2-positive-metastatic-breast-cancer.html)
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
(https://www.astrazeneca.com/media-centre/press-releases/2025/enhertu-reduced-the-risk-of-disease-recurrence-or-death-by-53-vs-t-dm1-in-patients-with-high-risk-her2-positive-early-breast-cancer.html)
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
(https://ascopubs.org/doi/full/10.1200/JCO.23.02005) .(8)

 

DESTINY-PanTumor02 enrolled 267 HER2-positive (IHC 3+  urn:newsml:reuters.com:*:n=111 and IHC 2+
 urn:newsml:reuters.com:*: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 (https://clinicaltrials.gov/ct2/show/NCT04482309) .

 

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 (https://www.nejm.org/) and results from the HER2 overexpressing
cohort were published in The Lancet Oncology
(https://www.thelancet.com/journals/lanonc/home) .(9,10)

 

DESTINY-Lung01 enrolled 181 adult patients (HER2-mutant  urn:newsml:reuters.com:*: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 (https://www.clinicaltrials.gov/study/NCT03505710) .

 

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
(https://www.thelancet.com/journals/lanonc/home) .
(https://www.thelancet.com/journals/lanonc/home) (11
(https://www.thelancet.com/journals/lanonc/home) )

 

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
(https://clinicaltrials.gov/ct2/show/NCT04744831) .

 

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 (https://clinicaltrials.gov/study/NCT04622319)
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 (https://clinicaltrials.gov/study/NCT05113251) 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
(https://clinicaltrials.gov/study/NCT04784715)  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
(https://clinicaltrials.gov/study/NCT03529110) 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 (https://clinicaltrials.gov/study/NCT03734029) 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 (https://clinicaltrials.gov/study/NCT04494425)  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
(https://www.clinicaltrials.gov/study/NCT04644237) and/or DESTINY-Lung05
(https://clinicaltrials.gov/study/NCT05246514) 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
(https://clinicaltrials.gov/study/NCT03329690) , DESTINY-Gastric02
(https://clinicaltrials.gov/study/NCT04014075)  and/or DESTINY-Gastric04
(https://clinicaltrials.gov/study/NCT04704934) 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
(https://clinicaltrials.gov/study/NCT04482309) , DESTINY-Lung01
(https://clinicaltrials.gov/study/NCT03505710) , DESTINY-CRC02
(https://www.clinicaltrials.gov/study/NCT04744831)  and/or HERALD
(https://jrct.mhlw.go.jp/en-latest-detail/jRCT2080224635)  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
(https://www.astrazeneca.com/media-centre/press-releases/2019/astrazeneca-and-daiichi-sankyo-enter-collaboration-for-novel-her-2-targeting-antibody-drug-conjugate.html)
 and Datroway (datopotamab deruxtecan) in July 2020
(https://www.astrazeneca.com/media-centre/press-releases/2020/astrazeneca-and-daiichi-sankyo-enter-collaboration-to-develop-and-commercialise-new-antibody-drug-conjugate.html#!)
, 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 (https://www.astrazeneca.com/)
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 (http://www.astrazeneca.com/)  and follow the
Company on Social Media @AstraZeneca
(https://www.linkedin.com/company/astrazeneca) .

Contacts

For details on how to contact the Investor Relations Team, please click here
(https://www.astrazeneca.com/investor-relations.html#Contacts) . For Media
contacts, click here (https://www.astrazeneca.com/media-centre/contacts.html)
.

 

References

1.   Iqbal N, Iqbal N. Human Epidermal Growth Factor Receptor 2 (HER2) in
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(https://pubmed.ncbi.nlm.nih.gov/25276427/) . 2014;2014:852748.

2.   Cheng X. A comprehensive review of HER2 in cancer biology and
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2024;15(7):903.

3.   Benli Y, et al. HER2-targeted therapy in colorectal cancer: a
comprehensive review. Clin Transl Oncol
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4.   Uy NF, et al. HER2 in non-small cell lung cancer: a review of emerging
therapies. Cancers (https://www.mdpi.com/2072-6694/14/17/4155) (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 (https://www.mdpi.com/1718-7729/31/9/419) .
2024;31(9):5652-5661.

6.   Omar N, et al. HER2: An emerging biomarker in non-breast and
non-gastric cancers. Pathogenesis
(https://www.sciencedirect.com/science/article/pii/S2214663615000036) .
2015;2(3):1-9.

7.   Ismail A, et al. HER2 alterations across solid tumors: implications for
comprehensive testing. Oncologist (https://pubmed.ncbi.nlm.nih.gov/40828885/)
. 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
(https://ascopubs.org/doi/full/10.1200/JCO.23.02005) . 2023;42(1):47-58.

9.   Li B, et al. Trastuzumab Deruxtecan in HER2-Mutant Non-Small-Cell Lung
Cancer. N Engl J Med (https://www.nejm.org/doi/full/10.1056/NEJMoa2112431) .
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
(https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(24)00064-0/abstract)
. 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
(https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(24)00380-2/abstract)
. 2024;25(9):1147-1162.

 

Matthew Bowden

Company Secretary

AstraZeneca PLC

 

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