REG - AstraZeneca PLC - Imfinzi approved in EU for AEGEAN

AstraZenecaAnnouncement

04/04/2025 07:05

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RNS Number : 5490D  AstraZeneca PLC  04 April 2025

04 April 2025

 

Imfinzi-based perioperative regimen approved in the EU for

resectable non-small cell lung cancer

 

 Approval based on AEGEAN Phase III trial results which showed a 32%
reduction in the risk of recurrence, progression or death vs. neoadjuvant
chemotherapy alone

 

AstraZeneca's Imfinzi (durvalumab) in combination with chemotherapy has been
approved in the European Union (EU) for the treatment of adults with
resectable non-small cell lung cancer (NSCLC) at high risk of recurrence and
no epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma
kinase (ALK) rearrangements. In this regimen, patients are treated with
Imfinzi in combination with neoadjuvant chemotherapy before surgery and as
adjuvant monotherapy after surgery.

 

The approval by the European Commission follows the positive opinion
(https://www.astrazeneca.com/media-centre/press-releases/2025/imfinzi-recommended-for-eu-approval-for-aegean.html)
of the Committee for Medicinal Products for Human Use and is based on results
from the pivotal AEGEAN
(https://www.astrazeneca.com/media-centre/press-releases/2023/imfinzi-based-treatment-before-and-after-surgery-reduced-the-risk-of-disease-recurrence-progression-events-or-death-in-resectable-non-small-cell-lung-cancer.html)
trial, which were published in The New England Journal of Medicine
(https://www.nejm.org/) .

 

Each year in Europe, there are more than 450,000 people diagnosed with lung
cancer.(1) Around 25-30% of all patients with NSCLC, the most common form of
lung cancer, are diagnosed at an early stage to have surgery with curative
intent.(2-3) However, the majority of patients with resectable disease will
develop recurrence and only 36-46% of patients with Stage II disease will
survive for five years.(4-5) This decreases to 24% for patients with Stage
IIIA disease and 9% for patients with Stage IIIB disease, reflecting a high
unmet medical need.(4)

 

Professor Martin Reck, Head of the Department of Thoracic Oncology at the Lung
Clinic Grosshansdorf, Germany, member of the AEGEAN Steering Committee and
investigator in the trial, said: "Today's approval provides an important new
treatment option that should become a backbone combination approach for
patients in Europe with resectable non-small cell lung cancer, who have
historically faced high rates of recurrence and a poor prognosis. When added
to neoadjuvant chemotherapy, perioperative durvalumab meaningfully improved
outcomes in this curative-intent setting, significantly extending the time
patients lived without their cancer returning."

 

Dave Fredrickson, Executive Vice President, Oncology Haematology Business
Unit, AstraZeneca, said: "Today's approval marks an important step towards
improving outcomes for patients in Europe with resectable non-small cell lung
cancer, enabling more patients to access this important immunotherapy-based
regimen. This new indication builds on the established role of Imfinzi in
unresectable disease and underscores our commitment to transforming care in
the early stages of lung cancer where there is the greatest potential for
cure."

 

Results from a planned interim analysis of event-free survival (EFS) showed a
statistically significant and clinically meaningful 32% reduction in the risk
of recurrence, progression events or death versus neoadjuvant chemotherapy
alone in patients treated with the Imfinzi-based perioperative regimen (32%
data maturity; EFS hazard ratio  HR  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).

 

Additionally, interim overall survival (OS) results presented at the 2024
World Conference on Lung Cancer showed a favourable trend with the
Imfinzi-based perioperative regimen (35% data maturity; median OS: not reached
 NR  versus 53.2 months; HR=0.89; 95% CI 0.70-1.14). The OS data were not
tested for statistical significance at this interim analysis and will continue
to be assessed as a key secondary endpoint at final analysis.

 

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.

 

Imfinzi is approved in the US, China and several other countries in this
setting based on the AEGEAN results. Regulatory applications are currently
under review in Japan and additional countries in this indication.

 

Imfinzi is the global standard of care based on OS in the curative-intent
setting of unresectable, Stage III NSCLC in patients whose disease as not
progressed after chemoradiotherapy (CRT) based on the PACIFIC Phase III trial.

 

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.(6-7) Lung cancer is
broadly split into NSCLC and small cell lung cancer (SCLC), with 80-85% of
patients diagnosed with NSCLC.(8-9) An estimated 28,000 people are treated for
resectable NSCLC across the five major European countries each year.(10)

 

Early-stage lung cancer diagnoses are often only made when the cancer is found
on imaging for an unrelated condition.(11-12) The majority of patients with
resectable disease eventually develop recurrence despite complete tumour
resection and adjuvant chemotherapy.(5)

 

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, 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
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.

 

In addition to its indications in resectable, early-stage (IIA-IIIB) NSCLC and
unresectable, Stage III NSCLC, Imfinzi is also approved for use in
combination with a short course of Imjudo (tremelimumab) and chemotherapy for
the treatment of metastatic NSCLC. Imfinzi is also approved for limited-stage
SCLC in patients whose disease has not progressed following concurrent
platinum-based CRT; and in combination with chemotherapy (etoposide and either
carboplatin or cisplatin) for the treatment of extensive-stage SCLC.

 

Imfinzi is also 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.

 

In March 2025, perioperative Imfinzi added to standard-of-care chemotherapy
met the primary endpoint of EFS in the MATTERHORN Phase III trial in
resectable gastric and gastroesophageal junction cancers.

 

Imfinzi is also approved as a perioperative treatment in combination with
neoadjuvant chemotherapy for muscle-invasive bladder cancer in the US.

 

Imfinzi in combination with chemotherapy followed by Imfinzi monotherapy is
approved as a 1st-line treatment for primary advanced or recurrent endometrial
cancer (mismatch repair deficient disease only in US and EU). Imfinzi in
combination with chemotherapy followed by Lynparza (olaparib) and Imfinzi is
approved for patients with mismatch repair proficient advanced or recurrent
endometrial cancer in EU and Japan.

 

Since the first approval in May 2017, more than 374,000 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, breast 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 Datroway
(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 (http://www.astrazeneca.com/) and follow the
Company on social media @AstraZeneca
(https://www.linkedin.com/company/astrazeneca) .

 

Contacts

For details on how to contact the Investor Relations Team, please click here
(https://www.astrazeneca.com/investor-relations.html#Contacts) . For Media
contacts, click here (https://www.astrazeneca.com/media-centre/contacts.html)
.

 

References

1.   Ferlay J, et al. Cancer incidence and mortality patterns in Europe:
Estimates for 40 countries and 25 major cancers in 2018. Eur J Cancer.
2018;103:356-387.

2.   Cagle PT, et al. Lung Cancer Biomarkers: Present Status and Future
Developments. Arch Pathol Lab Med. 2013;137(9):1191-1198.

3.   Le Chevalier T. Adjuvant Chemotherapy for Resectable Non-Small-Cell
Lung Cancer: Where is it Going? Ann Oncol. 2010;21(suppl 7):vii196-198.

4.   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.

5.   Pignon JP, et al. Lung Adjuvant Cisplatin Evaluation: A Pooled Analysis
by the LACE Collaborative Group. J Clin Oncol. 2008;26(21):3552-3559.

6.   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
(https://gco.iarc.who.int/media/globocan/factsheets/cancers/15-trachea-bronchus-and-lung-fact-sheet.pdf)
. Accessed April 2025.

7.   World Health Organization. International Agency for Research on Cancer.
All Cancers Fact Sheet. Available at:
https://gco.iarc.who.int/media/globocan/factsheets/cancers/39-all-cancers-fact-sheet.pdf
(https://gco.iarc.who.int/media/globocan/factsheets/cancers/39-all-cancers-fact-sheet.pdf)
. Accessed April 2025.

8.   LUNGevity Foundation. Types of Lung Cancer. Available at:
https://www.lungevity.org/for-patients-caregivers/lung-cancer-101/types-of-lung-cancer
(https://www.lungevity.org/for-patients-caregivers/lung-cancer-101/types-of-lung-cancer)
. Accessed April 2025.

9.   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.

10.  AstraZeneca PLC. Investor Relations Epidemiology Spreadsheet. Available
at: https://www.astrazeneca.com/investor-relations.html
(https://www.astrazeneca.com/investor-relations.html) . Accessed April 2025.

11. Sethi S, et al. Incidental Nodule Management - Should There Be a Formal
Process? J Thorac Dis. 2016:8(Suppl 6);S494-S497.

12.  LUNGevity Foundation. Screening and Early Detection. Available at:
https://lungevity.org/for-patients-caregivers/lung-cancer-101/screening-early-detection
(https://lungevity.org/for-patients-caregivers/lung-cancer-101/screening-early-detection)
. Accessed April 2025.

 

 

Adrian Kemp

Company Secretary

AstraZeneca PLC

 

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