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 June 2026
Commission
File Number: 001-11960
AstraZeneca PLC
1
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Cambridge
Biomedical Campus
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United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Datroway recommended for approval in EU for TNBC
29 June 2026
Datroway recommended for approval in the EU by CHMP
as 1st-line treatment for patients with metastatic triple-negative
breast cancer who are not candidates for
immunotherapy
Recommendation based on TROPION-Breast02 Phase III trial where
AstraZeneca and Daiichi Sankyo's Datroway showed a statistically
significant and clinically meaningful improvement for the dual
primary endpoints of overall survival and progression-free
survival
If approved, Datroway has the potential to be the first
TROP2-directed antibody drug conjugate for patients in the EU with
a demonstrated overall survival benefit as 1st-line
treatment
AstraZeneca and Daiichi Sankyo's Datroway (datopotamab deruxtecan) has been
recommended for approval in the European Union (EU) as monotherapy
for the 1st-line 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 Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) based its positive opinion on
results from the TROPION-Breast02 Phase III trial, which
were presented at
the 2025 European Society for Medical Oncology Congress and
published in Annals
of Oncology.
Susan Galbraith, Executive Vice President, Oncology Haematology
R&D, AstraZeneca, said: "As one of the hardest cancers to
treat, today only 15% of patients with metastatic triple-negative
breast cancer survive beyond five years. This positive opinion from
the CHMP marks an important step forward in bringing the potential
of Datroway to transform outcomes for patients with this
type of cancer in the EU."
John Tsai, MD, Global Head, R&D, Daiichi Sankyo, said:
"Triple-negative breast cancer remains one of the most aggressive
types of breast cancer, with limited treatment options for patients
with metastatic disease who are not candidates for immunotherapy
and are currently treated with traditional chemotherapy. This
positive recommendation by the CHMP underscores the potential
for Datroway to replace traditional chemotherapy in this
setting and we look forward to working closely with the EMA to
bring this new indication to patients in the
EU."
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=0.0291) compared to chemotherapy as 1st-line treatment
in this patient population. Median OS was 23.7 months for
patients treated with Datroway versus 18.7 months for those treated with
chemotherapy. Datroway reduced the risk of disease progression or
death by 43% compared to chemotherapy (HR 0.57; 95% CI 0.47-0.69;
p<0.0001) as assessed by blinded independent central review
(BICR). Datroway was also associated with more robust
treatment responses, including an objective response rate (ORR) of
62.5% compared to an ORR of 29.3% with
chemotherapy.1
The safety profile of Datroway in TROPION-Breast02 was consistent with
previous clinical trials of Datroway in breast cancer.
Datroway was approved in
the US in May 2026 for the treatment of adult patients with
unresectable or metastatic TNBC who are not candidates for
PD-1/PD-L1 inhibitor therapy. Additional reviews are underway in
China and Japan, as well as Australia, Canada, Singapore and
Switzerland as part of Project Orbis.
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.2,3 In
Europe, there are an estimated 83,000 diagnoses of TNBC each
year.2,4 TNBC
is diagnosed more frequently in younger and premenopausal women,
and is more prevalent in Black and Hispanic
women.5-7 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.5,8,9
While some breast cancers may test positive for oestrogen
receptors, progesterone receptors or overexpression of HER2, TNBC
tests negative for all three.5 Due
to its aggressive nature and absence of common breast cancer
receptors, TNBC is characteristically difficult to
treat.5 For
patients with metastatic disease with PD-L1 expressing tumours, the
addition of immunotherapy to chemotherapy has improved outcomes in
the 1st-line setting.10,11However,
for approximately 70% of patients with metastatic TNBC who are not
candidates for immunotherapy, prior to the approval
of Datroway, chemotherapy was the standard 1st-line
treatment.12
TROP2 is a protein broadly expressed in several solid tumours,
including TNBC.13 TROP2
is associated with increased tumour progression and poor survival
in patients with breast cancer.14,15
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 OS and
progression-free survival (PFS) as assessed by blinded independent
central review. 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.
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 trial.
Datroway is approved in
the US for the treatment of adult patients with unresectable or
metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor
therapy based on the results from the TROPION-Breast02
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 and TROPION-Lung01 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 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 and Datroway 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 TROP2-directed
ADC, Datroway, and next-generation oral
SERD, Etcamah.
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 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.
For Media contacts, click here.
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. O'Reilly D, et al. Overview of
Recent Advances in Metastatic Triple Negative Breast
Cancer. World J Clin
Oncol.
2021;12(3):164-182.
3. World Health Organization.
Breast Cancer. Available at: https://www.who.int/news-room/fact-sheets/detail/breast-cancer.
Accessed June 2026.
4. World Health Organization. Global
Cancer Observatory: Europe. Available at: https://gco.iarc.who.int/media/globocan/factsheets/populations/908-europe-fact-sheet.pdf.
Accessed June 2026.
5. 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.
Accessed June 2026.
6. 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.
7. Vargas et al. Risk Factors for
Triple-Negative Breast Cancer Among Latina
Women. Cancer Epidemiol Biomarkers
Prev (2019) 28
(11):1771-1783.
8. National Cancer Institute.
SEER Cancer Stat Facts: Female Breast Cancer Subtypes. Available
at: https://seer.cancer.gov/statfacts/html/breast-subtypes.html. Accessed
June 2026.
9. Huppert, et al. Emerging
Treatment Strategies for Metastatic Triple-Negative Breast
Cancer. Ther Adv Med
Oncol.
2022;14:1-25.
10. Cortes J, et al. Pembrolizumab Plus
Chemotherapy in Advanced Triple-Negative Breast
Cancer. N Engl J
Med.
2022;387:217-226.
11. Geurts V, et al. Immunotherapy for
Metastatic Triple Negative Breast Cancer: Current Paradigm and
Future Approaches. Curr Treat Options
Oncol. 2023;
24:628-643.
12. 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.
13. Rossi V, et al. Sacituzumab
Govitecan in Triple-Negative Breast Cancer: from Bench to Bedside,
and Back Front
Immunol. 2024
Aug;15:1447280.
14. 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.
15. 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.
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: 29 June 2026
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By: /s/
Matthew Bowden
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Name:
Matthew Bowden
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Title:
Company Secretary
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