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 July 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.
ODAC reviewed Imfinzi in resectable lung cancer
26 July
2024
FDA Advisory Committee reviewed Imfinzi for treatment of
resectable non-small cell lung cancer based on AEGEAN Phase III
trial results
The
Food and Drug Administration's (FDA) Oncologic Drugs Advisory
Committee (ODAC) acknowledged that AstraZeneca's Imfinzi (durvalumab) met the
primary endpoint of event-free survival (EFS) in the treatment of
resectable non-small cell lung cancer (NSCLC) based on the AEGEAN
Phase III trial results with an overall tolerable safety profile.
In the trial, adult patients with resectable early-stage (IIA-IIIB)
NSCLC and no known epidermal growth factor receptor (EGFR)
mutations or anaplastic lymphoma kinase (ALK) rearrangements were
treated with Imfinzi in combination with
neoadjuvant chemotherapy before surgery and as adjuvant monotherapy
after surgery. The discussion noted that while the
contribution by phase of neoadjuvant and adjuvant components of the
perioperative regimen could not be clearly assigned based on the
trial design, this is an important potential regimen for
patients.
The FDA
accepted the supplemental Biologics License Application (sBLA) in
September 2023 for Imfinzi in this indication based
on positive results from the pivotal AEGEAN trial,
which were published in The
New England Journal of Medicine in October
2023.
John V.
Heymach, MD, PhD, Professor and Chair Thoracic/Head and Neck
Medical Oncology, The University of Texas MD Anderson Cancer Center
in Houston, Texas, said: "The majority of patients with resectable
lung cancer face recurrence of their disease even after surgery and
neoadjuvant chemotherapy. The Committee acknowledged the potential
to address this urgent unmet need with durvalumab both before and
after surgery, which can significantly increase the time patients
live without progression and recurrence events in this
curative-intent setting."
Susan
Galbraith, Executive Vice President, Oncology R&D, AstraZeneca,
said: "The Committee's discussion of the AEGEAN data highlighted
the significant benefit delivered by this Imfinzi-based regimen for patients with
resectable lung cancer. We are committed to working closely with
the FDA to bring this novel immunotherapy option to patients that
offers a flexible chemotherapy backbone."
Results
from a planned interim analysis of EFS from the AEGEAN trial showed
a statistically significant and clinically meaningful 32% reduction
in the risk of recurrence, progression events or death versus
chemotherapy alone in patients treated with the Imfinzi-based regimen before and after
surgery (32% data maturity; EFS hazard ratio of 0.68; 95%
confidence interval [CI] 0.53-0.88; p=0.003902). In a final
analysis of pathologic complete response (pCR), treatment
with Imfinzi plus
neoadjuvant chemotherapy before surgery resulted in a pCR rate of
17.2% versus 4.3% for patients treated with neoadjuvant
chemotherapy alone (difference in pCR 13.0%; 95% CI
8.7-17.6).
Imfinzi was generally well tolerated, and no new safety
signals were observed in the neoadjuvant and adjuvant
settings. Further, adding Imfinzi to neoadjuvant
chemotherapy was consistent with the known profile for this
combination and did not compromise patients' ability to complete
surgery versus chemotherapy alone.
The
ODAC provides the FDA with independent, expert advice and
recommendations on marketed and investigational medicines for use
in the treatment of cancer. The FDA will consider the feedback as
it reviews the submission and is not bound by the Committee's
recommendation.
Imfinzi is approved in
Switzerland and the UK for the treatment of adults with
resectable NSCLC in Stage II and III without known EGFR mutations
or ALK rearrangements, based on the AEGEAN results. Regulatory
applications for Imfinzi in this setting are also
currently under review in the EU, China and several other
countries.
Imfinzi is the only approved immunotherapy and the
global standard of care in the curative-intent setting of
unresectable, Stage III NSCLC in patients whose disease has not
progressed after chemoradiotherapy based on the PACIFIC Phase III
trial.
Notes
Lung cancer
Each
year, there are an estimated 2.4 million people diagnosed with lung
cancer globally.1 Lung cancer is
the leading cause of cancer death among both men and women,
accounting for about one-fifth of all cancer deaths.1-2 Lung cancer
is broadly split into NSCLC and small cell lung cancer (SCLC), with
80-85% of patients diagnosed with NSCLC.3-4
The
majority of NSCLC patients are diagnosed with advanced disease
while approximately 25-30% present with resectable disease at
diagnosis.5-6 Early-stage
lung cancer diagnoses are often only made when the cancer is found
on imaging for an unrelated condition.7-8
The
majority of patients with resectable disease eventually develop
recurrence despite complete tumour resection and adjuvant
chemotherapy.9 Only 36-46% of
patients with Stage II disease will survive for five
years.10 This decreases
to 24% for patients with Stage IIIA disease and 9% for patients
with Stage IIIB disease, reflecting a high unmet medical
need.10
AEGEAN
AEGEAN
is a randomised, double-blind, multi-centre, placebo-controlled
global Phase III trial evaluating Imfinzi as perioperative treatment
for patients with resectable Stage IIA-IIIB (Eighth Edition AJCC
Cancer Staging Manual) NSCLC, irrespective of PD-L1 expression.
Perioperative therapy includes treatment before and after surgery,
also known as neoadjuvant/adjuvant therapy. In the trial, 802
patients were randomised to receive a 1500mg fixed dose
of Imfinzi plus
chemotherapy or placebo plus chemotherapy every three weeks for
four cycles prior to surgery, followed by Imfinzi or placebo every four
weeks (for up to 12 cycles) after surgery. Patients with known
EGFR or ALK genomic tumour aberrations were excluded from the
primary efficacy analyses.
In the
AEGEAN trial, the primary endpoints were pCR, defined as no
viable tumour in the resection specimen (including lymph nodes)
following neoadjuvant therapy, and EFS, defined as the time from
randomisation to an event like tumour recurrence, progression
precluding definitive surgery, or death. Key secondary endpoints
were major pathologic response, defined as residual viable tumour
of less than or equal to 10% in the resected primary tumour
following neoadjuvant therapy, disease-free survival, overall
survival (OS), safety and quality of life. The final pathologic
response analyses were performed after all patients had the
opportunity for surgery and pathology assessment per the trial
protocol. The trial enrolled participants from 264 centres in more
than 25 countries and regions including in the US,
Canada, Europe, South America and Asia.
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.
Imfinzi is the only approved immunotherapy and the
global standard of care in the curative-intent setting of
unresectable, Stage III NSCLC in patients whose disease has not
progressed after chemoradiotherapy. Imfinzi is also approved for the
treatment of extensive-stage SCLC and in combination with a short
course of Imjudo (tremelimumab) and
chemotherapy for the treatment of metastatic
NSCLC.
In
limited-stage SCLC, Imfinzi demonstrated statistically
significant and clinically meaningful improvements in the dual
primary endpoints of OS and progression-free survival compared to
placebo in patients who had not progressed following
standard-of-care concurrent chemoradiotherapy in the ADRIATIC Phase
III trial.
In
addition to its indications in lung cancers, Imfinzi is approved in combination
with chemotherapy (gemcitabine plus cisplatin) in locally advanced
or metastatic biliary tract cancer and in combination
with Imjudo in
unresectable hepatocellular carcinoma (HCC). Imfinzi is also approved as a
monotherapy in unresectable HCC in Japan and the EU and in
combination with chemotherapy (carboplatin plus paclitaxel)
followed by Imfinzi monotherapy in primary
advanced or recurrent endometrial cancer that is mismatch repair
deficient in the US.
Since
the first approval in May 2017, more than 220,000 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 SCLC, NSCLC, breast cancer, bladder
cancer, several gastrointestinal and gynaecologic cancers, and
other solid tumours.
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 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/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'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.
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
July 2024.
2.
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 July 2024.
3.
LUNGevity
Foundation. Types of Lung Cancer. Available at: https://www.lungevity.org/for-patients-caregivers/lung-cancer-101/types-of-lung-cancer.
Accessed July 2024.
4.
Cheema PK, et al.
Perspectives on treatment advances for stage III locally advanced
unresectable non-small-cell lung cancer. Curr Oncol.
2019;26(1):37-42.
5.
Cagle PT, et
al. Lung Cancer
Biomarkers: Present Status and Future
Developments. Arch Pathol Lab
Med. 2013;137(9):1191-1198.
6.
Le Chevalier T.
Adjuvant Chemotherapy for Resectable Non-Small-Cell Lung Cancer:
Where is it Going? Ann
Oncol. 2010;21(suppl 7):vii196-198.
7.
Sethi S, et al.
Incidental Nodule Management - Should There Be a Formal
Process? J Thorac Dis.
2016:8(Suppl 6);S494-S497.
8.
LUNGevity
Foundation. Screening and Early Detection. Available
at: https://lungevity.org/for-patients-caregivers/lung-cancer-101/screening-early-detection. Accessed
July 2024.
9.
Pignon JP, et
al. Lung Adjuvant
Cisplatin Evaluation: A Pooled Analysis by the LACE Collaborative
Group. J Clin
Oncol. 2008;26(21):3552-3559.
10.
Goldstraw P,
et al. The IASLC Lung Cancer Staging Project: proposals for
the revision of the TNM stage groupings in the forthcoming
(seventh) edition of the TNM Classification of malignant
tumours. J Thorac
Oncol. 2007;2(8):706-14.
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.
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AstraZeneca
PLC
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Date:
26 July 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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