REG - AstraZeneca PLC - Enhertu approved in two HER2+ early BC settings

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RNS Number : 6125E  AstraZeneca PLC  18 May 2026

18 May 2026

Enhertu approved in the US for two new indications for patients with
HER2-positive early breast cancer

Approved for use before surgery based on DESTINY-Breast11 Phase III trial

 

Approved for use following surgery based on DESTINY-Breast05 Phase III trial

 

Two new indications bring AstraZeneca and Daiichi Sankyo's Enhertu into
curative-intent setting, reinforcing its role across stages of HER2-positive
breast cancer

 

AstraZeneca and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) has been
approved by the US Food and Drug Administration (FDA) for both the neoadjuvant
and adjuvant treatment of patients with HER2-positive early breast cancer
based on results from the DESTINY-Breast11 and DESTINY-Breast05 Phase III
trials, respectively.

 

In the neoadjuvant setting, Enhertu followed by a taxane, trastuzumab, and
pertuzumab (THP) has been approved for the treatment of adult patients with
HER2-positive Stage II or Stage III breast cancer. In the adjuvant setting,
Enhertu has been approved for the treatment of adult patients with
HER2-positive breast cancer who have residual invasive disease following
trastuzumab (with or without pertuzumab) and taxane-based treatment.

 

Shanu Modi, MD, Medical Oncologist, Memorial Sloan Kettering Cancer Center,
said: "HER2-positive breast cancer is an aggressive disease, and our goal is
to reduce the risk of recurrence for patients as early as possible to achieve
the best long-term outcomes. The neoadjuvant setting offers the earliest
opportunity to improve outcomes, while the adjuvant setting provides another
important chance to prevent recurrence for patients with residual disease
after surgery. These two new indications in HER2-positive early breast cancer
will evolve how we treat patients in these settings and support trastuzumab
deruxtecan as a potential new standard of care in early-stage disease."

 

Dave Fredrickson, Executive Vice President, Oncology Haematology Business
Unit, AstraZeneca, said: "HER2-positive early disease is considered highly
curable, however up to one in four patients still experience disease
recurrence, underscoring the need for new options in this setting. These
approvals mark an important step forward, expanding the possibility of
cure to more patients for the first time in many years and positioning
Enhertu as a foundational treatment in early breast cancer."

 

Ken Keller, Global Head of Oncology Business, and President and CEO, Daiichi
Sankyo, Inc. said: "Enhertu has redefined the treatment of HER2-expressing
breast cancer with practice-changing data across six breast cancer indications
in seven years. Enhertu is now approved in the US across both early and
metastatic HER2-positive breast cancer, accomplishing what we set out to
achieve a little over a decade ago for patients at the start of our
comprehensive clinical development programme."

 

Victoria Smart, Senior Vice President, Mission, Susan G. Komen, said:
"Providing patients with early breast cancer more options to help prevent
progression to metastatic disease can lead to improved outcomes. Progression
and recurrence remain among the most significant unmet needs for those
diagnosed with early breast cancer, and continued advances in treatment bring
new hope to patients and families facing this disease."

 

In DESTINY-Breast11
(https://www.astrazeneca.com/media-centre/press-releases/2025/enhertu-followed-by-thp-before-surgery-resulted-in-a-pcr-in-67-of-patients-in-db11.html)
, Enhertu followed by THP as a neoadjuvant treatment demonstrated a pathologic
complete response (pCR) rate of 67.3% compared with 56.3% for dose-dense
doxorubicin and cyclophosphamide followed by THP  ddAC-THP , an improvement of
11.2% (95% confidence interval  CI  3.9-18.3; p=0.003). At the time of the pCR
analysis, 29 patients (4.5%) had event-free survival (EFS) events, and 12
patients (1.9%) had overall survival (OS) events. The results were published
in Annals of Oncology
(https://www.annalsofoncology.org/article/S0923-7534(25)04968-3/fulltext) .(1)

 

In 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)
, Enhertu as an adjuvant treatment reduced the risk of invasive disease
recurrence or death (invasive disease-free survival  IDFS ) by 53% compared to
trastuzumab emtansine (T-DM1) in patients with HER2-positive breast cancer
with residual invasive disease following neoadjuvant therapy (hazard ratio
 HR  0.47; 95% CI 0.34-0.66; p<0.0001). At three years, 92.4% of patients
in the Enhertu arm were alive and free of invasive disease, compared with
83.7% of those in the T-DM1 arm, with 51 (6%) events in the Enhertu arm and
102 (12%) in the T-DM1 arm. The results were published in The New England
Journal of Medicine (https://www.nejm.org/) .(2)

( )

Data from both trials were presented at the 2025 European Society for Medical
Oncology (ESMO) Congress.

 

Based on the DESTINY-Breast05 results, trastuzumab deruxtecan (Enhertu) has
been included in the NCCN Clinical Practice Guidelines in Oncology (NCCN
Guidelines(®)) as a Category 1 recommended treatment in the adjuvant setting
for patients with HER2-positive early breast cancer with residual disease and
a high risk of recurrence following preoperative therapy. See NCCN
Guidelines(®) for detailed recommendations.

 

No new safety concerns were identified with Enhertu in the DESTINY-Breast11 or
DESTINY-Breast05 trials.

 

In DESTINY-Breast11, Enhertu followed by THP showed similar rates of
drug-related overall adverse events (AEs) and interstitial lung disease
(ILD)/pneumonitis as ddAC-THP, and lower rates of Grade 3 or higher AEs,
serious AEs, AEs leading to treatment interruptions, left ventricular
dysfunction and haematological toxicities.

 

In DESTINY-Breast05, Enhertu and T-DM1 showed similar rates of overall
drug-related AEs and Grade 3 or higher AEs. Adjudicated drug-related
ILD/pneumonitis occurred in 9.6% of patients in the Enhertu arm and 1.6% of
patients in the T-DM1 arm. The majority of ILD/pneumonitis events were low
grade in both arms. There were seven Grade 3 events and two deaths (Grade 5)
in the Enhertu arm.

 

The DESTINY-Breast11 and DESTINY-Breast05 US regulatory submissions were both
reviewed under Project Orbis, which provides a framework for concurrent
submission and review of oncology medicines among participating international
partners. Separate regulatory applications for both trials are also under
review in other countries. DESTINY-Breast05 previously received Priority
Review
(https://www.astrazeneca.com/media-centre/press-releases/2026/enhertu-granted-priority-review-in-the-us-as-post-neoadjuvant-treatment-for-patients-with-her2-positive-early-breast-cancer.html)
and Breakthrough Therapy Designation by the FDA.

 

Enhertu is already approved in more than 95 countries, including the US, as a
treatment for patients with HER2-positive metastatic breast cancer.

 

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 these approvals in the US, an amount of $155 million is due from
AstraZeneca to Daiichi Sankyo as milestone payments for both these
indications. Sales of Enhertu in the US are recognised by Daiichi Sankyo. For
further details on the financial arrangements, please consult the
collaboration agreement from 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)
.

 

Notes

 

HER2-positive early 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 breast cancer
cases were diagnosed in 2022, with an estimated 665,000 deaths globally.(3) In
the US, more than 320,000 cases of breast cancer are diagnosed annually with
over 42,000 deaths.(4)

 

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the
surface of many types of tumours, including breast cancer.(5) 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.(5) An
estimated one in five cases of breast cancer is considered HER2-positive.(6)
Approximately one in three patients with HER2-positive early-stage breast
cancer is considered high-risk, meaning they are more likely to experience
disease recurrence and have a poor prognosis, and up to one in four will
experience disease recurrence.(7,8)

 

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.

 

In the neoadjuvant setting, the current standard of care in many regions of
the world involves combination chemotherapy regimens.(9) In the US, the
current standard of care consists of a combination regimen of carboplatin,
trastuzumab, pertuzumab and a taxane.(9,10) For patients with HER2-positive
early breast cancer, achieving pCR, defined as no evidence of invasive cancer
cells in the removed breast tissue or lymph nodes following treatment with
neoadjuvant treatment, is an early indicator of improved long-term
survival.(11) Approximately half of patients (39-66%) who receive neoadjuvant
treatment do not reach pCR, putting them at increased risk of disease
recurrence.(12-16)

( )

In the adjuvant setting, despite receiving additional treatment with
current standard of care for residual disease, some patients still experience
invasive disease or death.(17) Once patients are diagnosed with metastatic
disease, the five-year survival rate drops from nearly 90% to approximately
30%.(18)

( )

DESTINY-Breast11

DESTINY-Breast11 is a global, multicentre, randomised, open-label, Phase III
trial evaluating the efficacy and safety of neoadjuvant Enhertu (5.4mg/kg)
monotherapy or Enhertu followed by THP compared to ddAC-THP in patients with
high-risk HER2-positive early-stage breast cancer.

 

Patients were randomised 1:1:1 to receive either eight cycles of Enhertu
monotherapy; four cycles of Enhertu followed by four cycles of THP; or four
cycles of ddAC followed by four cycles of THP.

 

The Enhertu monotherapy arm was closed early following a recommendation from
the Independent Data Monitoring Committee.

 

The primary endpoint of DESTINY-Breast11 is rate of pCR - defined as no
evidence of invasive cancer cells in the removed breast cancer tissue or lymph
nodes following treatment. Secondary endpoints include EFS, invasive
disease-free survival, overall survival and safety.

 

DESTINY-Breast11 enrolled 927 patients across multiple sites in Asia, Europe,
North America and South America. For more information about the trial, visit
ClinicalTrials.gov (https://clinicaltrials.gov/study/NCT05113251) .

 

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.

 

Patients were randomised 1:1 to receive 14 cycles of Enhertu or T-DM1.

 

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. Secondary endpoints include
investigator-assessed DFS, overall survival, distant recurrence-free interval,
brain metastasis-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
(https://clinicaltrials.gov/study/NCT04622319?term=Destiny-Breast05%20&rank=1)
.

 

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 (IHC 3+ or ISH+) 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 the US and China as a
neoadjuvant treatment for adult patients with HER2-positive (IHC 3+ or ISH+)
Stage II or 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 1st-line treatment for
adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+)
breast cancer 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 authorised 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 non-small
cell lung cancer (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://clinicaltrials.gov/study/NCT04744831)  and/or HERALD
(https://jrct.mhlw.go.jp/en-latest-detail/jRCT2080224635) trials. Continued
approval 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 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 (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

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alone or followed by paclitaxel, trastuzumab, and pertuzumab for high-risk
HER2-positive early breast cancer (DESTINY-Breast11): a randomised,
open-label, multicentre, phase III trial. Ann Oncol. 2026;37(2):166-179.

2.   Loibl S, et al. Trastuzumab deruxtecan in residual HER2-positive early
breast cancer. N Engl J Med. 2026;394(9):845-857.

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. Accessed May 2026.

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7.   Mahtani R, et al. Human epidermal growth factor receptor 2-positive
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13.  Swain SM, et al. Pertuzumab, trastuzumab, and standard anthracycline-
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14.  Huober J, et al. Atezolizumab with neoadjuvant anti-human epidermal
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15.  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.
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16.  Gao HF, 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
the ASCO Annual Meeting 2025.

17.  Geyer CE, et al. Survival with trastuzumab emtansine in residual
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Accessed May 2026

 

Disclosure: Dr. Modi provides consulting and advisory services to AstraZeneca
(and Daiichi Sankyo).

 

Matthew Bowden

Company Secretary

AstraZeneca PLC

 

 

 

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