REG - AstraZeneca PLC - Datroway approved in US for 1L triple-negative BC

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RNS Number : 6558F  AstraZeneca PLC  26 May 2026

26 May 2026

 

Datroway approved in the US as first TROP2-directed antibody drug conjugate
for 1st-line treatment of patients with metastatic triple-negative breast
cancer who are not PD-1/PD-L1 inhibitor candidates

AstraZeneca and Daiichi Sankyo's Datroway is the only TROP2-directed antibody
drug conjugate to prolong overall survival in this setting vs. chemotherapy,
with an unprecedented median overall survival of approximately two years based
on the TROPION-Breast02 Phase III trial

 

Datroway has the potential to become the new standard of care in this setting

 

AstraZeneca and Daiichi Sankyo's Datroway (datopotamab deruxtecan) has been
approved in the US for the treatment of adult patients with unresectable or
metastatic triple-negative breast cancer (TNBC) who are not candidates for
PD-1/PD-L1 inhibitor therapy.

 

The approval follows Priority Review
(https://www.astrazeneca.com/media-centre/press-releases/2026/datroway-granted-priority-review-in-the-us-as-1st-line-treatment-for-patients.html)
by the Food and Drug Administration (FDA) based on results from the
TROPION-Breast02 Phase III trial which were presented
(https://www.astrazeneca.com/media-centre/press-releases/2025/datroway-demonstrated-an-unprecedented-median-overall-survival-improvement-of-five-months-vs-chemotherapy-as-1st-line-treatment-for-patients-with-metastatic-triple-negative-breast-cancer-for-whom-immunotherapy-was-not-an-option-in-tropion-breast02.html)
at the 2025 European Society for Medical Oncology Congress and published in
Annals of Oncology
(https://www.annalsofoncology.org/article/S0923-7534(26)00130-4/abstract) .

 

Tiffany A. Traina, MD, FASCO, Section Head, Triple-Negative Breast Cancer
Clinical Research Programme, Memorial Sloan Kettering Cancer Centre and
investigator for TROPION-Breast02, said: "Datopotamab deruxtecan is the first
and only medicine to significantly prolong overall survival in the 1st-line
setting compared to chemotherapy in patients with metastatic triple-negative
breast cancer who are not candidates for immunotherapy. This approval will
bring a much-needed treatment option for these patients."

 

Arlene Brothers, Executive Director, Triple Negative Breast Cancer Foundation,
said: "For seven out of 10 patients with metastatic triple-negative breast
cancer who are not candidates for immunotherapy, chemotherapy has remained the
only treatment option. Today's approval of Datroway means that for the first
time, these patients will have a new standard of care beyond traditional
chemotherapy at the outset of their treatment."

 

Dave Fredrickson, Executive Vice President, Oncology Haematology Business
Unit, AstraZeneca, said: "Triple-negative breast cancer is notoriously
difficult to treat. Patients with metastatic disease, especially those who are
unable to receive immunotherapy, urgently need more effective, durable and
tolerable treatment options, which extend survival. With today's approval, we
are proud to bring Datroway to a broad population of advanced triple-negative
breast cancer patients and we continue to study its promise as a mainstay
treatment across tumours, stages and settings."

 

Ken Keller, Global Head of Oncology Business, and President and CEO, Daiichi
Sankyo, Inc., said: "As the first antibody drug conjugate to demonstrate a
median overall survival of two years in the 1st-line metastatic setting of
triple-negative breast cancer, Datroway has the potential to redefine the
treatment landscape for these patients. With this approval, Datroway is now
approved for three indications in the US, including two for breast cancer,
underscoring its potential to play an important role across tumour types."

 

In the trial, Datroway demonstrated a statistically significant and clinically
meaningful 5.0-month improvement in median overall survival (OS) (hazard ratio
 HR  0.79; 95% confidence interval  CI  0.64-0.98; p=0.0290) and a 43%
reduction in patients' risk of disease progression or death (HR 0.57; 95% CI
0.47-0.69; p<0.0001) compared to chemotherapy as 1st-line treatment in this
patient population. Datroway was also associated with more robust treatment
responses, including an objective response rate (ORR) of 64% compared to an
ORR of 30% with chemotherapy.(1)

 

The safety profile of Datroway in TROPION-Breast02 was consistent with
previous clinical trials of Datroway in breast cancer.

 

This application was reviewed under Project Orbis, which provides a framework
for concurrent submission and review of oncology medicines among participating
international partners. As part of Project Orbis, reviews are ongoing in
Australia, Canada, Singapore and Switzerland. This initiative is designed to
bring effective cancer treatments to patients as early as possible. Additional
reviews are underway in the EU, China and Japan.

 

Based on the results of TROPION-Breast02, datopotamab deruxtecan (Datroway)
has been included in the NCCN Clinical Practice Guidelines in Oncology (NCCN
Guidelines(®)) as a Category 1 Preferred 1st-line treatment option for
patients with metastatic TNBC who are not candidates for immunotherapy. See
NCCN Guidelines(®) for detailed recommendations.(2)

( )

Datroway is a specifically engineered TROP2-directed DXd antibody drug
conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and
commercialised by AstraZeneca and Daiichi Sankyo.

 

Notes
 

Triple-negative breast cancer

TNBC accounts for approximately 15% of all breast cancer cases, with an
estimated 345,000 diagnoses globally each year.(3,4) In the US, an estimated
32,000 to 48,000 cases of TNBC were diagnosed in 2025, and approximately
11,000 patients with TNBC receive treatment in the 1st-line setting each
year.(5-7) TNBC is diagnosed more frequently in younger and premenopausal
women, and is more prevalent in Black and Hispanic women.(8-10) Metastatic
TNBC is the most aggressive type of breast cancer and has one of the worst
prognoses, with median OS of just 12 to 18 months and only about 15% of
patients living five years following diagnosis.(8,11,12)

 

While some breast cancers may test positive for oestrogen receptors,
progesterone receptors or overexpression of HER2, TNBC tests negative for all
three.(8) Due to its aggressive nature and absence of common breast cancer
receptors, TNBC is characteristically difficult to treat.(8) For patients with
metastatic disease with PD-L1 expressing tumours, the addition of
immunotherapy to chemotherapy has improved outcomes in the 1st-line
setting.(13,14) However, for approximately 70% of patients with metastatic
TNBC who are not candidates for immunotherapy, prior to the approval of
Datroway, chemotherapy was the only approved 1st-line treatment.(15)

 

TROP2 is a protein broadly expressed in several solid tumours, including
TNBC.(16) TROP2 is associated with increased tumour progression and poor
survival in patients with breast cancer.(17,18)

 

TROPION-Breast02

TROPION-Breast02 is a global, multicentre, randomised, open-label Phase III
trial evaluating the efficacy and safety of Datroway versus investigator's
choice of chemotherapy (paclitaxel, nab-paclitaxel, capecitabine, carboplatin
or eribulin) in patients with previously untreated locally recurrent
inoperable or metastatic TNBC for whom immunotherapy was not an option. This
included patients whose tumours did not express PD-L1 as well as patients with
PD-L1 expressing tumours who could not receive immunotherapy due to prior
exposure in early-stage disease, comorbidities or immunotherapy not being
accessible in their geography. Enrolment included patients with de novo or
recurrent disease, regardless of disease-free interval, and those with poor
prognostic factors such as stable brain metastases.

 

The dual primary endpoints of TROPION-Breast02 are progression-free survival
(PFS) as assessed by blinded independent central review and OS. Secondary
endpoints include PFS as assessed by investigator, ORR, duration of response,
disease control rate, pharmacokinetics and safety.

 

TROPION-Breast02 enrolled 644 patients at sites in Africa, Asia, Europe, North
America and South America. For more information, visit ClinicalTrials.gov
(https://www.clinicaltrials.gov/ct2/show/NCT05374512?term=TROPION&draw=2&rank=8)
.

 

Datroway

Datroway (datopotamab deruxtecan; datopotamab deruxtecan-dlnk in the US only)
is a TROP2-directed ADC. Designed using Daiichi Sankyo's proprietary DXd ADC
Technology, Datroway is one of seven DXd ADCs in the oncology pipeline of
Daiichi Sankyo, and one of the most advanced programmes in AstraZeneca's ADC
scientific platform. Datroway is comprised of a humanised anti-TROP2 IgG1
monoclonal antibody, developed in collaboration with Sapporo Medical
University, attached to a number of topoisomerase I inhibitor payloads (an
exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

 

Datroway is also approved in more than 40 countries/regions worldwide for the
treatment of adult patients with unresectable or metastatic HR-positive,
HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received
prior endocrine-based therapy and chemotherapy for unresectable or metastatic
disease based on results from the TROPION-Breast01
(https://www.clinicaltrials.gov/study/NCT05104866) trial.

 

Datroway is available in the US under accelerated approval for the treatment
of adult patients with locally advanced or metastatic EGFR-mutated non-small
cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and
platinum-based chemotherapy based on results from the TROPION-Lung05
(https://clinicaltrials.gov/study/NCT04484142) and TROPION-Lung01
(https://clinicaltrials.gov/study/NCT04656652) trials. Continued approval for
this indication in the US may be contingent upon verification and description
of clinical benefit in a confirmatory trial.

 

Datroway clinical development programme

A comprehensive global clinical development programme is underway with more
than 20 trials evaluating the efficacy and safety of Datroway across multiple
cancers, including NSCLC, TNBC and urothelial cancer. The programme includes
eight Phase III trials in lung cancer, five Phase III trials in breast cancer,
and one Phase III trial and one Phase II/III trial in urothelial cancer
evaluating Datroway as a monotherapy and in combination with other cancer
treatments in various settings.

 

Daiichi Sankyo collaboration

AstraZeneca and Daiichi Sankyo entered into a global collaboration to jointly
develop and commercialise Enhertu (trastuzumab deruxtecan) 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 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 TROP2-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.   Dent R, et al. Datopotamab deruxtecan in patients with untreated,
advanced triple-negative breast cancer (TROPION-Breast02): a randomised,
open-label, international, phase III trial. Ann Oncol. Published online April
3, 2026.

2.   Referenced with permission from the NCCN Guidelines. © National
Comprehensive Cancer Network(®) 2026. All rights reserved. Accessed May 2026.
To view the most recent and complete version of the guidelines, go online to
NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their
content, use or application and disclaims any responsibility for their
application or use in any way.

3.   O'Reilly D, et al. Overview of Recent Advances in Metastatic Triple
Negative Breast Cancer. World J Clin Oncol. 2021;12(3):164-182.

4.   World Health Organization. Breast Cancer. Available at:
https://www.who.int/news-room/fact-sheets/detail/breast-cancer
(https://www.who.int/news-room/fact-sheets/detail/breast-cancer) . Accessed
May 2026.

5.   National Breast Cancer Foundation, Inc. Triple Negative Breast Cancer.
Available at:
https://www.nationalbreastcancer.org/triple-negative-breast-cancer/#tnbc-stats
(https://www.nationalbreastcancer.org/triple-negative-breast-cancer/#tnbc-stats)
. Accessed May 2026.

6.   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
(https://www.cancer.org/cancer/types/breast-cancer/about/how-common-is-breast-cancer.html)
. Accessed May 2026.

7.   AstraZeneca. Investor Relations: Epidemiology. Available at:
https://www.astrazeneca.com/content/dam/az/Investor_Relations/Epidemiology-data-2024.xlsx
(https://www.astrazeneca.com/content/dam/az/Investor_Relations/Epidemiology-data-2024.xlsx)
.   Accessed May 2026.

8.   American Cancer Society. Triple-Negative Breast Cancer. Available at:
https://www.cancer.org/cancer/types/breast-cancer/about/types-of-breast-cancer/triple-negative.html
(https://www.cancer.org/cancer/types/breast-cancer/about/types-of-breast-cancer/triple-negative.html)
. Accessed May 2026.

9.   AstraZeneca. Investor Relations: Epidemiology. Available at:
https://www.astrazeneca.com/content/dam/az/Investor_Relations/Epidemiology-data-2024.xlsx
(https://www.astrazeneca.com/content/dam/az/Investor_Relations/Epidemiology-data-2024.xlsx)
.   Accessed May 2026.

10.  Martinez et al. Contribution of Clinical and Socioeconomic Factors to
Differences in Breast Cancer Subtype and Mortality Between Hispanic and
Non-Hispanic White Women. Breast Cancer Res Treat. 2017; 166(1):185-193.

11.  Vargas et al. Risk Factors for Triple-Negative Breast Cancer Among
Latina Women. Cancer Epidemiol Biomarkers Prev (2019) 28 (11):1771-1783.

12.  National Cancer Institute. SEER Cancer Stat Facts: Female Breast Cancer
Subtypes. Available at:
https://seer.cancer.gov/statfacts/html/breast-subtypes.html
(https://seer.cancer.gov/statfacts/html/breast-subtypes.html) . Accessed May
2026.

13.  Huppert, et al. Emerging Treatment Strategies for Metastatic
Triple-Negative Breast Cancer. Ther Adv Med Oncol. 2022;14:1-25.

14.  Cortes J, et al. Pembrolizumab Plus Chemotherapy in Advanced
Triple-Negative Breast Cancer. N Engl J Med. 2022;387:217-226.

15.  Geurts V, et al. Immunotherapy for Metastatic Triple Negative Breast
Cancer: Current Paradigm and Future Approaches. Curr Treat Options Oncol.
2023; 24:628-643.

16.  Punie, et al. Unmet Need for Previously Untreated Metastatic
Triple-Negative Breast Cancer: a Real-World Study of Patients Diagnosed from
2011 to 2022 in the United States. The Oncologist. 2025; 30(3):oyaf034.

17.  Rossi V, et al. Sacituzumab Govitecan in Triple-Negative Breast Cancer:
from Bench to Bedside, and Back Front Immunol. 2024 Aug;15:1447280.

18.  Lin H, et al. Significantly upregulated TACSTD2 and Cyclin D1 Correlate
with Poor Prognosis of Invasive Ductal Breast Cancer. Exp Mol Pathol.
2013:94(1):73-78.

19.  Goldenberg D, et al. The Emergence of Trophoblast Cell-Surface Antigen 2
(TROP-2) as a Novel Cancer Target. Oncotarget. 2018;9(48):28989-29006.

 

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

 

Matthew Bowden

Company Secretary

AstraZeneca PLC

 

 

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