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 October 2026
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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to the Commission pursuant to Rule 12g3-2(b) under the Securities
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
AZ & DS collaboration with Summit for Datroway
02 October
2026
AstraZeneca and Daiichi Sankyo announce clinical
collaboration
with Summit Therapeutics to
evaluate Datroway in combination
with ivonescimab across multiple tumour types
Builds on recently announced clinical collaboration between
AstraZeneca
and Summit to advance leading ADC combination strategy in
cancer
AstraZeneca and Daiichi Sankyo have entered into a clinical
collaboration agreement with Summit Therapeutics Inc. to
evaluate Datroway (datopotamab deruxtecan) in combination with ivonescimab across multiple
tumour types including lung and breast cancers. The companies
intend to begin with a Phase III trial in 1st-line triple-negative
breast cancer (TNBC).
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.
Susan Galbraith, Executive Vice President, Oncology Haematology
R&D, AstraZeneca, said: “Central to our strategy to
transform cancer outcomes is harnessing the power of immunotherapy
and antibody drug conjugate combinations to drive deeper, more
durable responses. We believe the combination of
Datroway
and ivonescimab has the potential to
make a meaningful difference in multiple tumour types including
lung and breast cancers.”
Dr. Maky Zanganeh, President and Co-Chief Executive Officer of
Summit Therapeutics, said: “We believe this collaboration
with Daiichi Sankyo and AstraZeneca reflects increasing conviction
in ivonescimab’s potential as a foundational next-generation
immunotherapy and advances our ambition for ivonescimab to become
the global PD-1 / VEGF partner of choice for novel combinations.
Beginning with a Phase III study in first-line triple negative
breast cancer, this collaboration represents an important expansion
of Summit’s global development program into breast cancer and
a path for additional solid tumour settings.”
John Tsai, Global Head, R&D, Daiichi Sankyo, said: “At
Daiichi Sankyo, we are focused on maximising the potential of our
DXd antibody drug conjugate portfolio through innovative
combinations and strategic collaborations that support the
continued advancement of our pipeline. We are encouraged by the
opportunity to explore ivonescimab in combination with
Datroway
to potentially deliver clinically
meaningful benefit to patients.”
Under the terms of this agreement, each company will contribute
their respective medicine for the planned combination trials which
will be sponsored by AstraZeneca or Daiichi Sankyo. AstraZeneca,
Daiichi Sankyo and Summit will each contribute to trial costs and
each company will retain development and commercial rights to their
respective medicines.
AstraZeneca also recently
announced an equity investment
which will help in part to support clinical collaborations
evaluating combinations with ivonescimab including this agreement
for Datroway, AstraZeneca’s separate agreement with Summit
for combinations with sonesitatug vedotin (Sone-Ve), and planned
future clinical collaborations intended to evaluate combinations
with other AstraZeneca cancer medicines, including additional
ADCs.
Ivonescimab is a novel, potential first-in-class bispecific
antibody combining the effects of immunotherapy via a blockade of
PD-1 with the anti-angiogenesis effects associated with blocking
VEGF into a single molecule. Ivonescimab is approved to treat
certain patients with non-small cell lung cancer (NSCLC) in China,
and a Biologics License Application (BLA) seeking approval in
EGFR-mutated NSCLC is under review by the US Food and Drug
Administration (FDA). Ivonescimab is currently being studied in
Phase III clinical trials in NSCLC, small cell lung cancer, biliary
tract cancer, bladder cancer, TNBC, head and neck squamous cell
carcinoma, colorectal cancer, and pancreatic cancer.
Notes
Datroway
Datroway (datopotamab
deruxtecan; datopotamab deruxtecan-dlnk in the US only) is a
TROP2-directed ADC. Designed using the proprietary DXd ADC
Technology of Daiichi Sankyo, 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 approved in more
than 30 countries/regions worldwide 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 also approved in
more than 45 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
and several other countries 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, 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 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 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.
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.
Date: 02 October
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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