TIDMAZN
RNS Number : 7287Q
AstraZeneca PLC
30 June 2022
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
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
RNS may use your IP address to confirm compliance with the terms
and conditions, to analyse how you engage with the information
contained in this communication, and to share such analysis on an
anonymised basis with others as part of our commercial services.
For further information about how RNS and the London Stock Exchange
use the personal data you provide us, please see our Privacy
Policy.
END
MSCUKRARUNUNUUR
(END) Dow Jones Newswires
June 30, 2022 02:00 ET (06:00 GMT)
Astrazeneca (LSE:AZN)
Gráfica de Acción Histórica
De Feb 2024 a Mar 2024
Astrazeneca (LSE:AZN)
Gráfica de Acción Histórica
De Mar 2023 a Mar 2024