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 2022
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 improved pCR in resectable lung cancer
30 June 2022 07:00 BST
Imfinzi plus
chemotherapy significantly improved pathologic complete response in
AEGEAN Phase III trial in resectable non-small cell lung
cancer
Trial will continue to assess additional primary endpoint of
event-free survival
Positive high-level results from a planned interim analysis of the
AEGEAN Phase III trial showed treatment with
AstraZeneca's Imfinzi (durvalumab) in combination with neoadjuvant
chemotherapy before surgery demonstrated a statistically
significant and meaningful improvement in pathologic complete
response (pCR) compared
to neoadjuvant chemotherapy alone for patients with resectable
non-small cell lung cancer (NSCLC).
A statistically significant improvement in major pathologic
response (MPR) was also observed. The
trial will continue as planned to assess the additional primary
endpoint of event-free survival (EFS) to which the Company,
investigators and participants remain blinded.
The safety and tolerability of adding Imfinzi to neoadjuvant chemotherapy was consistent
with the known profile for this combination and did not decrease
the number of patients able to undergo successful surgery versus
chemotherapy alone.
Up to 30% of all patients globally with NSCLC are diagnosed early
enough to have surgery with curative intent.1-3 However,
only around 56-65% of patients with Stage II disease will survive
for five-years. This decreases to 24-41% for patients with
Stage III disease.4
Susan Galbraith, Executive Vice President, Oncology R&D,
said: ''Treating
resectable lung cancer early provides the best chance for a cure,
yet lung cancer will still recur within five years for the majority
of patients despite chemotherapy and successful surgery. Engaging
the immune response with Imfinzi both before and after surgery is an exciting
new strategy, and we hope these early findings from AEGEAN will
lead to improved survival for lung cancer patients in this
potentially curative setting."
These pCR data will be shared with global health authorities and
presented at a forthcoming medical meeting when EFS results are
available.
AstraZeneca has several ongoing registrational trials focused on
testing Imfinzi in earlier stages of lung cancer, including
in resectable NSCLC (ADJUVANT BR.31) and unresectable NSCLC
(PACIFIC-2, 4, 5, 8 and 9), and in limited-stage small cell lung
cancer (SCLC) (ADRIATIC).
Imfinzi is
approved in the curative-intent setting of unresectable Stage III
NSCLC in patients whose disease has not progressed after
chemoradiotherapy in
the US, Japan, China, across the EU and many other countries, and
is the global standard of care in this setting based on the PACIFIC
Phase III trial. Imfinzi is
also approved in the US, EU, Japan, China and many other countries
around the world for the treatment of extensive-stage SCLC based on
the CASPIAN Phase III trial.
Notes
Lung cancer
In 2020, an estimated 2.2 million people were diagnosed with lung
cancer worldwide.5 Lung
cancer is the leading cause of cancer mortality among men and women
and accounts for about one-fifth of all cancer-related
deaths.5 Lung
cancer is broadly split into NSCLC and SCLC, with 80-85% classified
as NSCLC.6 The
majority of NSCLC patients are diagnosed with advanced disease
while approximately 25-30% present with
resectable disease at diagnosis. 1-2 Early-stage
lung cancer diagnoses are often only made when the cancer is found
on imaging for an unrelated condition.7-8
For patients with resectable tumours, the majority of patients
eventually develop recurrence despite complete tumour resection and
adjuvant chemotherapy.
AEGEAN
AEGEAN is a randomised, double-blind, multi-centre, global Phase
III trial evaluating Imfinzi as perioperative treatment for patients with
resectable Stage IIA-IIIB (tumours greater
than or equal to 4cm
or node positive) NSCLC with no EGFR or ALK genomic tumour
aberrations, 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 every three weeks plus chemotherapy or
placebo plus chemotherapy for four cycles prior to surgery,
followed by Imfinzi or placebo every four weeks (for up to 12
cycles) after surgery.
In the AEGEAN trial, the primary endpoints are pCR, defined as no
viable tumour following neoadjuvant therapy, and EFS, defined as
the time from randomisation to an event like tumour recurrence or
progression. At this interim analysis EFS was not assessed. Key
secondary endpoints are MPR, defined as residual viable tumour of
less than or equal to ten percent following neoadjuvant therapy,
disease-free survival, overall survival, safety and quality of
life. The trial is being conducted across 264 centres in more than
25 countries 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.
As well as global approvals in lung
cancer, Imfinzi is
approved for previously treated patients with advanced bladder
cancer in several countries.
Since the first approval in May 2017, more than 100,000 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, bladder cancer, several GI cancers, ovarian cancer,
endometrial cancer and other solid tumours.
In the past year, Imfinzi combinations
have resulted in positive Phase III trials in multiple additional
cancer settings including; unresectable advanced liver cancer
(HIMALAYA), biliary tract cancer (TOPAZ-1) and metastatic NSCLC
(POSEIDON) and the data are under review with global health
authorities.
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
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 immunotherapy
Immunotherapy is a therapeutic approach designed to stimulate the
body's immune system to attack tumours. The Company's
Immuno-Oncology (IO) portfolio is anchored in immunotherapies that
have been designed to overcome evasion of the anti-tumour immune
response. AstraZeneca is invested in using IO approaches that
deliver long-term survival for new groups of patients across tumour
types.
The Company is pursuing a comprehensive clinical-trial programme
that includes Imfinzi as a single treatment and in combination
with tremelimumab and other novel antibodies in multiple tumour
types, stages of disease, and lines of treatment, and where
relevant using the PD-L1 biomarker as a decision-making tool to
define the best potential treatment path for a
patient.
In addition, the ability to combine the IO portfolio with
radiation, chemotherapy, and targeted small molecules from across
AstraZeneca's oncology pipeline, and from research partners, may
provide new treatment options across a broad range of
tumours.
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 Twitter @AstraZeneca.
Contacts
For details on how to contact the Investor Relations Team, please
click here.
For Media contacts, click here.
References
1. Cagle
PT, et
al. Lung Cancer
Biomarkers: Present Status and Future
Developments. Arch Pathol Lab
Med. 2013;137:1191-1198.
2. Le
Chevalier T. Adjuvant Chemotherapy for Resectable Non-Small-Cell
Lung Cancer: Where is it Going? Ann Oncol. 2010;21:vii196-198.
3. Pignon
JP, et
al. Lung Adjuvant
Cisplatin Evaluation: A Pooled Analysis by the LACE Collaborative
Group. J Clin
Oncol. 2008;26:3552-3559.
4. Goldstraw
P, et
al. The IASLC Lung Cancer
Staging Project: Proposals for Revision of the TNM Stage Groupings
in the Forthcoming (Eighth) Edition of the TNM Classification for
Lung Cancer. J Thorac
Oncol. 2016;11(1):39-51.
doi:10.1016/j.jtho.2015.09.009
5. World
Health Organization. International Agency for Research on Cancer.
Lung Fact Sheet. Available at https://gco.iarc.fr/today/data/factsheets/cancers/15-Lung-fact-sheet.pdf Accessed
June 2022.
6. LUNGevity
Foundation. Types of Lung Cancer. Available at https://lungevity.org/for-patients-caregivers/lung-cancer-101/types-of-lung-cancer.
Accessed June 2022.
7. Sethi
S, et
al. Incidental Nodule
Management - Should There Be a Formal
Process?. Journal of Thorac
Onc.
2016:8;S494-S497.
8. LUNGevity
Foundation. Screening and Early Detection. Available
at https://lungevity.org/for-patients-caregivers/lung-cancer-101/screening-early-detection.
Accessed June 2022.
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:
30 June 2022
|
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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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