REG - AstraZeneca PLC - Imfinzi improved pCR in resectable lung cancer

AstraZenecaAnnouncement

30/06/2022 07:16

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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 (http://www.astrazeneca.com/)  and follow the
Company on Twitter @AstraZeneca (https://twitter.com/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.   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
(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
(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
(https://lungevity.org/for-patients-caregivers/lung-cancer-101/screening-early-detection)
. Accessed June 2022.

 

Adrian Kemp

Company Secretary

AstraZeneca PLC

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