TIDMAZN
RNS Number : 3664S
AstraZeneca PLC
09 March 2023
9 March 2023 07:00 GMT
Imfinzi significantly improved event-free survival in AEGEAN
Phase III trial for patients with resectable non-small cell lung
cancer
Results showed that Imfinzi-based treatment before and after
surgery significantly increased the time patients live without
recurrence or progression events
Positive high-level results from a planned interim analysis of
the AEGEAN Phase III, placebo- controlled trial showed that
treatment with AstraZeneca's Imfinzi (durvalumab) in combination
with neoadjuvant chemotherapy before surgery and as adjuvant
monotherapy after surgery demonstrated a statistically significant
and clinically meaningful improvement in event-free survival (EFS)
versus neoadjuvant chemotherapy alone followed by surgery for
patients with resectable early-stage (IIA-IIIB) non-small cell lung
cancer (NSCLC).
Results from the final pathologic complete response (pCR) and
major pathologic response (mPR) analyses were consistent with
previously announced positive results. The trial will continue as
planned to assess key secondary endpoints including disease-free
survival (DFS) and overall survival (OS).
Each year there are an estimated 2.2 million people diagnosed
with lung cancer globally with 80-85% of patients diagnosed with
NSCLC, the most common form of lung cancer .(1-3) Approximately
25-30% of all patients with NSCLC are diagnosed early enough to
have surgery with curative intent.(4-5) However, only around 56-65%
of patients with Stage II disease will survive for five years.(6)
This decreases to 41% for patients with Stage IIIA and 24% for
patients with Stage IIIB disease, reflecting a high unmet medical
need .(6)
John V. Heymach, MD, PhD. Professor and Chair Thoracic/Head and
Neck Medical Oncology, The University of Texas MD Anderson Cancer
Center, said: " Treating patients early with durvalumab both before
and after surgery delivers a significant and clinically meaningful
benefit in resectable non-small cell lung cancer, where new options
are urgently needed to offer patients the best chance of long-term
survival. The AEGEAN results provide compelling evidence that this
novel durvalumab regimen can drive improved outcomes in this
curative-intent setting."
Susan Galbraith, Executive Vice President, Oncology R&D,
AstraZeneca, said: "Patients with resectable non-small cell lung
cancer face unacceptably high rates of recurrence, despite
treatment with chemotherapy and surgery. We have shown that adding
Imfinzi both before and after surgery significantly increased the
time patients live without recurrence or progression events. We
will continue to follow patients for overall survival."
Imfinzi was well tolerated and no new safety concerns 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 increase complications or
adverse events, or compromise patients' ability to undergo surgery
versus chemotherapy alone.
These data will be presented at a forthcoming medical meeting
and shared with global health authorities.
AstraZeneca has a comprehensive portfolio of approved and
potential new medicines in development for patients with lung
cancer. In addition to these results, the Company is also
announcing today that Tagrisso (osimertinib) met a secondary
endpoint of OS in the ADAURA Phase III trial in early-stage (IB, II
and IIIA) epidermal growth factor receptor-mutated (EGFRm) NSCLC
after complete tumour resection with curative intent.
Notes
Lung cancer
Lung cancer is the leading cause of cancer death among both men
and women, accounting for about one-fifth of all cancer deaths.(1)
Lung cancer is broadly split into NSCLC and small cell lung cancer
(SCLC).(2) The majority of NSCLC patients are diagnosed with
advanced disease while approximately 25-30% present with resectable
disease at diagnosis.(4-5) 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 eventually
develop recurrence despite complete tumour resection and adjuvant
chemotherapy.(9)
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 mPR, defined as residual viable tumour of less than or equal
to 10% in the resected primary tumour following neoadjuvant
therapy, DFS, 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 in 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.
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
chemoradiation therapy 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. In an
exploratory analysis in 2021, updated results from the CASPIAN
trial showed Imfinzi plus chemotherapy tripled patient survival at
three years versus chemotherapy alone. Additionally, Imfinzi is
approved in combination with a short course of Imjudo
(tremelimumab) and chemotherapy for the treatment of metastatic
NSCLC in the US, EU and Japan based on the POSEIDON Phase III
trial.
In addition to its indications in lung cancer, Imfinzi is also
approved in combination with chemotherapy in locally advanced or
metastatic biliary tract cancer in the US, EU, Japan and several
other countries; in combination with Imjudo in unresectable
hepatocellular carcinoma in the US, EU and Japan; and in previously
treated patients with advanced bladder cancer in several
countries.
Since the first approval in May 2017, more than 150,000 patients
have been treated with Imfinzi.
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 SCLC
(ADRIATIC).
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 gastrointestinal (GI) cancers, ovarian cancer,
endometrial cancer 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 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 aims to reimagine cancer care and help transform
outcomes for patients with Imfinzi as a single treatment and in
combination with Imjudo as well as other novel immunotherapies and
modalities. The Company is also exploring next-generation
immunotherapies like bispecific antibodies and therapeutics that
harness different aspects of immunity to target cancer.
AstraZeneca is boldly 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. 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 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
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please click here . For Media contacts, click here .
References
1. World Health Organisation. 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 March 2023.
2. LUNGevity Foundation. Types of Lung Cancer. Available at: https://lungevity.org/for-patients-caregivers/lung-cancer-101/types-of-lung-cancer . Accessed March 2023.
3. 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.
4. Cagle PT, et al. Lung Cancer Biomarkers: Present Status and
Future Developments. Arch Pathol Lab Med.
2013;137(9):1191-1198.
5. Le Chevalier T. Adjuvant Chemotherapy for Resectable
Non-Small-Cell Lung Cancer: Where is it Going? Ann Oncol.
2010;21:vii196-198.
6. 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.
7. Sethi S, et al. Incidental Nodule Management - Should There Be a Formal Process? J 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 March 2023.
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.
Adrian Kemp
Company Secretary
AstraZeneca PLC
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