# EDGAR Filing Document

**Accession Number:** 0000901832
**File Stem:** 0001654954-26-006239
**Filing Date:** 2026-6
**Character Count:** 18393
**Document Hash:** 84437cb19590579099374cdd39731fcb
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001654954-26-006239.hdr.sgml**: 20260629

**ACCESSION NUMBER**: 0001654954-26-006239

**CONFORMED SUBMISSION TYPE**: 6-K

**PUBLIC DOCUMENT COUNT**: 1

**CONFORMED PERIOD OF REPORT**: 20260629

**FILED AS OF DATE**: 20260629

**DATE AS OF CHANGE**: 20260629

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** ASTRAZENECA PLC
- **CENTRAL INDEX KEY:** 0000901832
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 000000000
- **STATE OF INCORPORATION:** X0
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 6-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-11960
- **FILM NUMBER:** 261131150

**BUSINESS ADDRESS:**
- **ADDRESS IS A NON US LOCATION:** YES
- **STREET 1:** 1 FRANCIS CRICK AVENUE
- **STREET 2:** CAMBRIDGE BIOMEDICAL CAMPUS
- **CITY:** CAMBRIDGE
- **PROVINCE COUNTRY:** X0
- **ZIP:** CB2 0AA
- **BUSINESS PHONE:** 011 44 20 7304 5000

**MAIL ADDRESS:**
- **ADDRESS IS A NON US LOCATION:** YES
- **STREET 1:** 1 FRANCIS CRICK AVENUE
- **STREET 2:** CAMBRIDGE BIOMEDICAL CAMPUS
- **CITY:** CAMBRIDGE
- **PROVINCE COUNTRY:** X0
- **ZIP:** CB2 0AA

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** ZENECA GROUP PLC
- **DATE OF NAME CHANGE:** 19930422

 **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 Francis Crick Avenue

Cambridge Biomedical Campus

Cambridge CB2 0AA

United Kingdom

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F X Form 40-F __

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ______

Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.

Yes __ No X

If "Yes" is marked, indicate below the file number assigned to the Registrant in connection with Rule 12g3-2(b): 82-_____________

 **AstraZeneca PLC**

INDEX TO EXHIBITS

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;

 ***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 <u>presented</u> at the 2025 European Society for Medical Oncology Congress and published in *<u>Annals of Oncology</u>*.

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.<sup>1</sup>

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.

 **<u>Notes</u>**

 **Triple-negative breast cancer**

TNBC accounts for approximately 15% of all breast cancer cases, with an estimated 345,000 diagnoses globally each year.<sup>2,3</sup> In Europe, there are an estimated 83,000 diagnoses of TNBC each year.<sup>2,4</sup> TNBC is diagnosed more frequently in younger and premenopausal women, and is more prevalent in Black and Hispanic women.<sup>5-7</sup> 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.<sup>5,8,9</sup>

While some breast cancers may test positive for oestrogen receptors, progesterone receptors or overexpression of HER2, TNBC tests negative for all three.<sup>5</sup> Due to its aggressive nature and absence of common breast cancer receptors, TNBC is characteristically difficult to treat.<sup>5</sup> For patients with metastatic disease with PD-L1 expressing tumours, the addition of immunotherapy to chemotherapy has improved outcomes in the 1st-line setting.<sup>10,11</sup>However, 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.<sup>12</sup>

TROP2 is a protein broadly expressed in several solid tumours, including TNBC.<sup>13</sup> TROP2 is associated with increased tumour progression and poor survival in patients with breast cancer.<sup>14,15</sup>

 **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 <u>ClinicalTrials.gov</u>.

 ***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 <u>TROPION-Breast01</u> 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 <u>TROPION-Lung05</u> and <u>TROPION-Lung01</u> 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 <u>March 2019</u> and *Datroway* in <u>July 2020</u>, 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.

 **<u>AstraZeneca</u>**

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 <u>astrazeneca.com</u> and follow the Company on Social Media <u>@AstraZeneca</u>.

 **Contacts**

For details on how to contact the Investor Relations Team, please click <u>here</u>. For Media contacts, click <u>here</u>.

 **References**

&nbsp;&nbsp;&nbsp;&nbsp; 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.

&nbsp;&nbsp;&nbsp;&nbsp; 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.

&nbsp;&nbsp;&nbsp;&nbsp; 3. World Health Organization. Breast Cancer. Available at: <u>https://www.who.int/news-room/fact-sheets/detail/breast-cancer</u>. Accessed June 2026.

&nbsp;&nbsp;&nbsp;&nbsp; 4. World Health Organization. Global Cancer Observatory: Europe. Available at: <u>https://gco.iarc.who.int/media/globocan/factsheets/populations/908-europe-fact-sheet.pdf</u>. Accessed June 2026.

&nbsp;&nbsp;&nbsp;&nbsp; 5. American Cancer Society. Triple-Negative Breast Cancer. Available at: <u>https://www.cancer.org/cancer/types/breast-cancer/about/types-of-breast-cancer/triple-negative.html</u>. Accessed June 2026.

&nbsp;&nbsp;&nbsp;&nbsp; 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.

&nbsp;&nbsp;&nbsp;&nbsp; 7. Vargas et al. Risk Factors for Triple-Negative Breast Cancer Among Latina Women. *Cancer Epidemiol Biomarkers Prev* (2019) 28 (11):1771-1783.

&nbsp;&nbsp;&nbsp;&nbsp; 8. National Cancer Institute. SEER Cancer Stat Facts: Female Breast Cancer Subtypes. Available at: <u>https://seer.cancer.gov/statfacts/html/breast-subtypes.html</u>. Accessed June 2026.

&nbsp;&nbsp;&nbsp;&nbsp; 9. Huppert, et al. Emerging Treatment Strategies for Metastatic Triple-Negative Breast Cancer. *Ther Adv Med Oncol*. 2022;14:1-25.

&nbsp;&nbsp;&nbsp;&nbsp; 10. Cortes J, et al. Pembrolizumab Plus Chemotherapy in Advanced Triple-Negative Breast Cancer. *N Engl J Med*. 2022;387:217-226.

&nbsp;&nbsp;&nbsp;&nbsp; 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.

&nbsp;&nbsp;&nbsp;&nbsp; 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.

&nbsp;&nbsp;&nbsp;&nbsp; 13. Rossi V, et al. Sacituzumab Govitecan in Triple-Negative Breast Cancer: from Bench to Bedside, and Back *Front Immunol*. 2024 Aug;15:1447280.

&nbsp;&nbsp;&nbsp;&nbsp; 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.

&nbsp;&nbsp;&nbsp;&nbsp; 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**

 <u>SIGNATURES</u>

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.

AstraZeneca PLC

Date: 29 June 2026

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| By: /s/ Matthew Bowden |
| Name: Matthew Bowden |
| Title: Company Secretary |

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