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 September 2026
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Imfinzi+Imdelltra improved OS in small cell lung
8 September 2026
Imfinzi plus Imdelltra demonstrated a statistically significant and
highly clinically meaningful improvement in overall survival and
progression-free survival in 1st-line extensive-stage small cell
lung cancer
Imfinzi is the first and only immunotherapy in combination
with
a bispecific T-cell engager to show survival benefit in this
setting
DeLLphi-305 Phase III trial results reinforce Imfinzi as the
backbone
immunotherapy for small cell lung cancer across stages of
disease
Positive high-level results from a planned interim analysis of the
DeLLphi-305 Phase III trial showed Imfinzi (durvalumab) plus
Amgen's Imdelltra® (tarlatamab)
demonstrated a statistically significant and highly clinically
meaningful improvement in overall survival (OS)
versus Imfinzi alone as a 1st-line maintenance treatment.
The trial included patients with extensive-stage small cell lung
cancer (ES-SCLC) who had not progressed following standard
induction treatment with Imfinzi in combination with platinum
chemotherapy (investigator's choice of carboplatin or cisplatin)
and etoposide.
Imfinzi plus tarlatamab
also demonstrated a statistically significant and clinically
meaningful improvement in the secondary endpoints of
progression-free survival (PFS) and objective response
rate.
In 2026, an estimated 195,000 people globally will be treated for
ES-SCLC, a highly aggressive, fast-growing form of lung cancer
characterised by rapid tumour progression and metastatic spread to
organs such as the brain and liver.1,2 Immune
checkpoint inhibitors such as Imfinzi have led to significant improvements in OS
in ES-SCLC, establishing a 1st-line standard of care. However, many
patients still experience disease progression due to the aggressive
nature of the disease and median OS with the current standard of
care is approximately one year.3
Susan Galbraith, Executive Vice President, Oncology Haematology
R&D, AstraZeneca, said: "These results show
that Imfinzi-based induction therapy followed by maintenance
treatment with Imfinzi plus tarlatamab demonstrates an
unprecedented improvement in overall survival for patients with
this highly aggressive form of lung
cancer. Imfinzi continues
to reshape how lung cancer is treated, establishing new standards
of care across multiple settings, and these new findings further
underscore its role as the backbone immunotherapy of choice for
small cell lung cancer."
Jacob Sands, MD, Associate Chief of the Lowe Center for Thoracic
Oncology at Dana-Farber Cancer Institute, said: "Given the
aggressive nature of small cell lung cancer, many patients quickly
relapse on current therapy and never reach second-line treatment.
These patients do not have time to wait, making substantial
progress in the first-line setting critically important. In my
career treating people with extensive-stage small cell lung cancer,
these are among the most compelling survival results I have seen,
indicating the potential to reshape the natural history of small
cell lung cancer. DeLLphi-305 represents an unprecedented milestone
and suggests we may be entering a new era where meaningfully longer
survival is possible for more patients."
Overall, the safety and tolerability profile
of Imfinzi plus tarlatamab was consistent with the
known safety profiles of the individual treatments, with no new
safety signals identified. These data will be presented at a
forthcoming medical meeting and shared with global regulatory
authorities.
Imfinzi is approved in the
US, EU, Japan, China and many other countries around the world as
the standard-of-care treatment for ES-SCLC and limited-stage SCLC
(LS-SCLC) based on the CASPIAN and ADRIATIC Phase III trials,
respectively.
Notes
Small cell lung cancer
Lung cancer is the leading cause of cancer death globally,
accounting for almost one in five (19%) cancer
deaths.4,5 Lung
cancer is broadly split into non-small cell lung cancer (NSCLC) and
SCLC, with about 15% classified as SCLC.6 About
two-thirds of SCLC patients are diagnosed with ES-SCLC, in which
the cancer has spread widely through the lung or to other parts of
the body.3 While
survival rates have improved in recent years following the
introduction of immune checkpoint inhibitors, prognosis is still
poor, with only 18.1% of LS-SCLC patients and 3.6% of ES-SCLC
patients alive five years after diagnosis.2
DeLLphi-305
The DeLLphi-305 trial is sponsored by Amgen, with partial funding
and Imfinzi provided by AstraZeneca. It is a global
Phase III, randomised, open-label clinical trial evaluating the
efficacy and safety of Imfinzi in combination with tarlatamab compared
to Imfinzi alone as 1st-line maintenance treatment for
patients with ES-SCLC who have not progressed following induction
treatment with Imfinzi in combination with platinum chemotherapy
and etoposide.
Tarlatamab is a first-in-class targeted immunotherapy that binds to
both DLL3 on tumour cells and CD3 on T cells, thereby activating T
cells to kill DLL3-expressing SCLC cells. DLL3 is a protein that is
expressed on the surface of SCLC cells in ~85-96% of patients with
SCLC, but is minimally expressed on healthy cells.
In the trial, 563 patients who completed Imfinzi-based induction treatment were randomised 1:1 to
receive either Imfinzi in combination with tarlatamab
or Imfinzi alone until progression or unacceptable
toxicity. Following tarlatamab infusion on Cycle 1 Day 1 and Cycle
1 Day 8, patients were monitored in a healthcare setting for 1 to 2
hours (6 to 8 hours in certain regions including Europe). The trial
included patients with both treated and untreated asymptomatic
brain metastases at baseline.
The primary endpoint is OS for Imfinzi plus tarlatamab
versus Imfinzi alone. PFS is a key secondary
endpoint.
Imfinzi
Imfinzi (durvalumab) is a
human monoclonal antibody that binds to the PD-L1 protein and
blocks the interaction of PD-L1 with the PD-1 and CD80 proteins,
countering the tumour's immune-evading tactics and releasing the
inhibition of immune responses.
In addition to its indications in SCLC, Imfinzi is the global standard of care based on OS
in the curative-intent setting of unresectable, Stage III NSCLC in
patients whose disease has not progressed after chemoradiotherapy
(CRT). Additionally, Imfinzi is approved as a perioperative treatment in
combination with neoadjuvant chemotherapy in resectable NSCLC, and
in combination with a short course of Imjudo (tremelimumab) and chemotherapy for the
treatment of metastatic NSCLC.
Imfinzi is also approved
in combination with chemotherapy in locally advanced or metastatic
biliary tract cancer and in combination
with Imjudo in unresectable hepatocellular carcinoma
(HCC). It is also approved as a monotherapy in unresectable HCC in
Japan, China and the EU, and in resectable, early-stage and locally
advanced gastric and gastroesophageal junction cancers in the US
and the EU. Additionally, in April 2026, Imfinzi in combination with Imjudo, lenvatinib and transarterial chemoembolisation
(TACE) demonstrated a
statistically significant and clinically meaningful improvement in
the primary endpoint of PFS versus TACE alone for patients with
unresectable HCC eligible for embolisation in the EMERALD-3 Phase
III trial.
Perioperative Imfinzi in combination with neoadjuvant chemotherapy
is approved for cisplatin-eligible muscle-invasive bladder cancer
(MIBC). Imfinzi in combination with Bacillus
Calmette-Guérin (BCG) induction and maintenance therapy is
approved in the US and other countries for patients with
BCG-naïve, high-risk non-muscle-invasive bladder cancer. In
May 2026, positive high-level
results from the VOLGA
Phase III trial showed that perioperative treatment
with Imfinzi in combination with neoadjuvant enfortumab
vedotin (EV) demonstrated statistically significant and clinically
meaningful improvements in event-free survival (EFS) and OS in
patients with MIBC who were ineligible for or had declined
cisplatin-based chemotherapy. In addition,
perioperative Imfinzi plus Imjudo in combination with neoadjuvant EV
demonstrated a statistically significant and clinically meaningful
improvement in EFS and a favourable trend for OS; however, the OS
data were not statistically significant at this planned interim
analysis and will be formally reassessed at a subsequent analysis.
In July 2026, positive high-level results from the NILE Phase III
trial showed Imfinzi plus chemotherapy demonstrated a
statistically significant and clinically meaningful improvement in
OS versus chemotherapy as 1st-line treatment for patients with
PD-L1 high unresectable, locally advanced or metastatic urothelial
cancer.
Imfinzi in combination
with chemotherapy followed by Imfinzi monotherapy is approved as a 1st-line
treatment for primary advanced or recurrent endometrial cancer
(mismatch repair deficient disease only in US, EU and
China). Imfinzi in combination with chemotherapy followed
by Lynparza (olaparib) and Imfinzi is approved for patients with mismatch
repair proficient advanced or recurrent endometrial cancer in EU
and Japan.
Since the first approval in May 2017, more than 470,000 patients
have been treated with Imfinzi. As part of a broad development
programme, Imfinzi is being tested as a single treatment and in
combinations with other anti-cancer treatments for patients with
NSCLC, bladder cancer, breast cancer, ovarian cancer and several
gastrointestinal cancers.
AstraZeneca in lung cancer
AstraZeneca is working to bring patients with lung cancer closer to
cure through the detection and treatment of early-stage disease,
while also pushing the boundaries of science to improve outcomes in
the resistant and advanced settings. By defining new therapeutic
targets and investigating innovative approaches, the Company aims
to match medicines to the patients who can benefit
most.
The Company's comprehensive portfolio includes leading lung cancer
medicines and the next wave of innovations,
including Tagrisso (osimertinib) and Iressa (gefitinib); Imfinzi and Imjudo; Enhertu (trastuzumab deruxtecan)
and Datroway (datopotamab deruxtecan) in
collaboration with Daiichi Sankyo; Orpathys (savolitinib) in collaboration with
HUTCHMED; as well as a pipeline of potential new medicines and
combinations across diverse mechanisms of
action.
AstraZeneca is a founding member of the Lung Ambition Alliance, a
global coalition working to accelerate innovation and deliver
meaningful improvements for people with lung cancer, including and
beyond treatment.
AstraZeneca in immuno-oncology (IO)
AstraZeneca is a pioneer in introducing the concept of
immunotherapy into dedicated clinical areas of high unmet medical
need. The Company has a comprehensive and diverse IO portfolio and
pipeline anchored in immunotherapies designed to overcome evasion
of the anti-tumour immune response and stimulate the body's immune
system to attack tumours.
AstraZeneca strives to redefine cancer care and help transform
outcomes for patients with Imfinzi as a monotherapy and in combination
with Imjudo as well as other novel immunotherapies and
modalities. The Company is also investigating next-generation
immunotherapies like bispecific antibodies and therapeutics that
harness different aspects of immunity to target cancer, including
cell therapy and T-cell engagers.
AstraZeneca is pursuing an innovative clinical strategy to bring
IO-based therapies that deliver long-term survival to new settings
across a wide range of cancer types. The Company is focused on
exploring novel combination approaches to help prevent treatment
resistance and drive longer immune responses. With an extensive
clinical programme, the Company also champions the use of IO
treatment in earlier disease stages, where there is the greatest
potential for cure.
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 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 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.
AstraZeneca PLC. Investor relations epidemiology spreadsheet.
Available at: https://www.astrazeneca.com/investor-relations.html.
Accessed September 2026.
2. Cao W, et al. Incidence, Risk
Factors, and Impact of Immunotherapy on Brain Metastasis in
Extensive-Stage Small Cell Lung Cancer Without Baseline Brain
Involvement. JCO Oncol
Pract. Published online 12
May 2026.
3. Shalata W, et al. Current and
Emerging Therapeutic Strategies for Limited- and Extensive-Stage
Small-Cell Lung Cancer. Med Sci
(Basel). 2025;13(3):142.
4.
World Health Organization. International Agency for Research on
Cancer. Lung Fact Sheet. Available at:
https://gco.iarc.who.int/media/globocan/factsheets/cancers/15-trachea-bronchus-and-lung-fact-sheet.pdf.
Accessed September 2026.
5.
World Health Organization. International Agency for Research on
Cancer. World Fact Sheet. Available at:
https://gco.iarc.who.int/media/globocan/factsheets/populations/900-world-fact-sheet.pdf.
Accessed September 2026.
6.
LUNGevity Foundation. Types of Lung Cancer. Available at:
https://www.lungevity.org/for-patients-caregivers/lung-cancer-101/types-of-lung-cancer.
Accessed September 2026.
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: 08 September 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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