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 February
2024
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.
FDA accepts Dato-DXd BLA for nonsquamous NSCLC
19 February 2024
Datopotamab deruxtecan Biologics License Application accepted in
the US for patients with previously treated advanced nonsquamous
non-small cell lung cancer
Application based on results from the TROPION-Lung01 Phase III
trial
If approved, AstraZeneca and Daiichi Sankyo's datopotamab
deruxtecan may be
the first TROP2-directed antibody drug conjugate for patients with
lung cancer
AstraZeneca and Daiichi Sankyo's Biologics License Application
(BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted in
the US for the treatment of adult patients with locally advanced or
metastatic nonsquamous non-small cell lung cancer (NSCLC) who have
received prior systemic therapy. The Prescription Drug User Fee Act
date, the Food and Drug Administration (FDA) action date for its
regulatory decision, is during the fourth quarter of
2024.
The BLA is based on results from the pivotal TROPION-Lung01 Phase
III trial in which datopotamab deruxtecan demonstrated a
statistically significant improvement for the dual primary endpoint
of progression-free survival (PFS) compared to docetaxel, the
current standard of care, in patients with locally advanced or
metastatic NSCLC treated with at least one prior line of therapy.
For the dual primary endpoint of overall survival (OS), interim
results numerically favoured datopotamab deruxtecan over docetaxel
in the overall population; however, results did not reach
statistical significance at the time of data cut-off. In patients
with nonsquamous NSCLC, datopotamab deruxtecan showed a clinically
meaningful PFS benefit and a numerically favourable OS trend. The
trial is ongoing and OS will be assessed at final
analysis.
Datopotamab deruxtecan is a specifically engineered TROP2-directed
DXd antibody drug conjugate (ADC) being jointly developed by
AstraZeneca and Daiichi Sankyo.
Susan Galbraith, Executive Vice President, Oncology R&D,
AstraZeneca, said: "Datopotamab deruxtecan has the potential to
offer patients with previously treated advanced nonsquamous
non-small cell lung cancer an effective and tolerable alternative
to conventional chemotherapy. With regulatory discussions ongoing
around the world and a parallel submission underway in the US in
breast cancer, this is only the beginning of our efforts to make
this novel treatment available to patients as quickly as
possible."
Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo, said:
"Today's news is an important step forward in our goal of creating
new standards of care that have the potential to transform the
treatment of patients with non-small cell lung cancer. We are
encouraged by the FDA's acceptance of the BLA as we endeavour to
make datopotamab deruxtecan the first TROP2-directed antibody drug
conjugate approved to treat patients with nonsquamous non-small
cell lung cancer after disease progression on prior systemic
therapy. We look forward to working closely with the FDA to bring
datopotamab deruxtecan to patients."
Results from TROPION-Lung01 were
presented during a Presidential Symposium at the 2023 European
Society for Medical Oncology Congress.
The safety profile of datopotamab deruxtecan was consistent with
that observed in other ongoing trials with no new safety concerns
identified.
A parallel BLA for datopotamab deruxtecan based on results from the
pivotal TROPION-Breast01 Phase III trial is pending acceptance in
the US for the treatment of adult patients with metastatic hormone
receptor (HR)-positive, HER2-negative (IHC 0, IHC 1+ or IHC
2+/ISH-) breast cancer. Additional regulatory submissions for
datopotamab deruxtecan in lung and breast cancer are underway
globally.
Notes
Advanced non-small cell lung cancer
Nearly 250,000 lung cancer cases were diagnosed in the US in
2023.1 NSCLC
is the most common type of lung cancer accounting for about 80% of
cases.1 Approximately
70% and 30% of NSCLC tumours are of nonsquamous or squamous
histology, respectively.2 While
immunotherapy and targeted therapies have improved outcomes in the
1st-line setting, most patients eventually experience disease
progression and receive chemotherapy.3-5 For
decades, chemotherapy has been the last treatment available for
patients with advanced NSCLC, despite limited effectiveness and
known side effects.3-5
TROP2 is a protein broadly expressed in the majority of NSCLC
tumours.6 There
is currently no TROP2-directed ADC approved for the treatment of
lung cancer.7,8
TROPION-Lung01
TROPION-Lung01 is an ongoing global, randomised, multicentre,
open-label Phase III trial evaluating the efficacy and safety of
datopotamab deruxtecan versus docetaxel in patients with locally
advanced or metastatic NSCLC with and without actionable genomic
alterations previously treated with at least one prior line of
therapy. Patients with actionable genomic alterations were
previously treated with platinum-based chemotherapy and an approved
targeted therapy. Patients without known actionable genomic
alterations were previously treated, concurrently or sequentially,
with platinum-based chemotherapy and a PD-1 or PD-L1
inhibitor.
The dual primary endpoints of TROPION-Lung01 are PFS as assessed by
blinded independent central review (BICR) and OS. Key secondary
endpoints include investigator-assessed PFS, objective response
rate, duration of response, time to response, disease control rate
as assessed by both BICR and investigator, and
safety. TROPION-Lung01 enrolled approximately 600 patients in
Asia, Europe, North America and South America. For more information
visit ClinicalTrials.gov.
Datopotamab deruxtecan (Dato-DXd)
Datopotamab deruxtecan (Dato-DXd) is an investigational
TROP2-directed ADC. Designed using Daiichi Sankyo's proprietary DXd
ADC Technology, datopotamab deruxtecan is one of six ADCs in the
oncology pipeline of Daiichi Sankyo, and one of the most advanced
programmes in AstraZeneca's ADC scientific platform. Datopotamab
deruxtecan is comprised of a humanized 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.
A comprehensive development programme called TROPION is underway
globally with more than 14 trials evaluating the efficacy and
safety of datopotamab deruxtecan across multiple cancers, including
NSCLC, triple-negative breast cancer and HR-positive, HER2-negative
breast cancer. Beyond the TROPION programme, datopotamab deruxtecan
also is being evaluated in novel combinations in several ongoing
trials.
Daiichi Sankyo collaboration
AstraZeneca and Daiichi Sankyo entered into a global collaboration
to jointly develop and commercialise Enhertu in March
2019 and datopotamab
deruxtecan 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 datopotamab
deruxtecan.
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 (durvalumab) and Imjudo (tremelimumab); Enhertu (trastuzumab deruxtecan) and 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 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/Nasdaq: 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 operates in over
100 countries and its innovative medicines are 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.
Cancer.net, Lung Cancer - Non-Small Cell: Statistics. Available
at: https://www.cancer.net/cancer-types/lung-cancer-non-small-cell/statistics.
Accessed February 2024.
2.
National Cancer Institute. SEER Cancer Statistics Factsheets: Lung
and Bronchus Cancer, 2015. Available at: SEER
Cancer Statistics Factsheets: Lung and Bronchus Cancer,
2015. Accessed
February 2024.
3. Chen
R, et
al.
Emerging therapeutic agents for advanced non-small cell lung
cancer. J
Hematol Oncol.
2020;13(1):58.
4. Majeed
U, et
al.
Targeted therapy in advanced non-small cell lung cancer: current
advances and future trends. J
Hematol Oncol.
2021;14(1):108.
5. Pircher,
A, et
al. Docetaxel in the Treatment
of Non-small Cell Lung Cancer (NSCLC) - An Observational Study
Focusing on Symptom Improvement. Anticancer
Research.
2013;33(9):3831-3836.
6. Mito
R, et
al. Clinical impact of TROP2 in
non‐small
lung cancers and its correlation with abnormal p53 nuclear
accumulation. Pathol Int. 2020;70(5):287-294.
7. Rodríguez-Abreau
D et
al. Pemetrexed plus platinum with or
without pembrolizumab in patients with previously untreated
metastatic nonsquamous NSCLC: protocol-specified final analysis
from KEYNOTE-189. Ann
Onc. 2021
Jul;32(7): 881-895.
8.
American Cancer Society. Targeted Drug Therapy for Non-Small Cell
Lung Cancer. Available at: https://www.cancer.org/cancer/types/lung-cancer/treating-non-small-cell/targeted-therapies.html. Accessed
February 2024.
Adrian Kemp
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:
19 February
2024
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By: /s/
Adrian Kemp
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Name:
Adrian Kemp
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Title:
Company Secretary
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