REG - AstraZeneca PLC - Update on Imfinzi PEARL trial

AstraZenecaAnnouncement

19/12/2022 07:15

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RNS Number : 0760K  AstraZeneca PLC  19 December 2022

19 December 2022 07:05 GMT

 

Update on PEARL Phase III trial of Imfinzi monotherapy

in Stage IV non-small cell lung cancer

 

The PEARL Phase III trial for AstraZeneca's Imfinzi (durvalumab) did not
achieve statistical significance for the primary endpoints of improving
overall survival (OS) versus platinum-based chemotherapy as a monotherapy
treatment of patients with Stage IV (metastatic) non-small cell lung cancer
(NSCLC) whose tumour cells express high levels (25% or more) of PD-L1, or in a
subgroup of patients at low risk of early mortality. There was an improvement
in OS with Imfinzi monotherapy, which was clinically meaningful in the subset
of patients with PD-L1 tumour expression greater than 50%, a secondary
endpoint. The trial was conducted primarily in Asia.

 

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca,
said: "With PEARL, we set out to answer important scientific questions in the
treatment of metastatic non-small cell lung cancer at a time when patient
selection for immune checkpoint inhibitors was still evolving. We are
encouraged to see patients in the metastatic setting at a higher level of
PD-L1 tumour expression demonstrate the most benefit with Imfinzi monotherapy
treatment, as is commonly seen in this class. We remain steadfast in our
dedication to developing new and improved medicines and regimens for patients
with lung cancer across our diverse portfolio."

 

The safety and tolerability profile for Imfinzi was broadly consistent with
the known profile of the medicine, and no new safety signals were
identified. The data will be shared in due course.

 

Notes

 

Stage IV NSCLC

Lung cancer is the second most common form of cancer globally, with more than
two million patients diagnosed in 2020.(1) Lung cancer is broadly split into
NSCLC and small-cell lung cancer (SCLC), with 80-85% classified as NSCLC.(2,3)
Within NSCLC, patients are classified as squamous, representing 25-30% of
patients, or non-squamous, representing approximately 70-75% of patients.(3-5)

 

PEARL

PEARL was a randomised, open-label, multicentre, global Phase III trial of
Imfinzi monotherapy versus platinum-based chemotherapy (investigator's choice)
as a 1st-line treatment in patients with metastatic NSCLC.

 

Eligible patients had tumours expressing high levels of PD-L1, defined as
≥25% of tumour cells (TC). The predominantly Asian trial population included
both smokers and non-smokers and patients of squamous and non-squamous
histology. PEARL excluded patients with certain epidermal growth factor
receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) fusions.

 

The two primary endpoints were OS in patients whose tumours expressed high
levels of PD-L1 (TC≥25%) and OS in a subgroup of patients identified as
being at low risk of early mortality using a model developed by AstraZeneca
that evaluates various clinical parameters prior to treatment. The trial
included centres in Asia, Europe and Australia.

 

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 in combination with Imjudo (tremelimumab) plus platinum-based
chemotherapy is approved in the US for the treatment of Stage IV (metastatic)
NSCLC based on the POSEIDON Phase III trial. Additionally, 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, the EU, Japan, China and many other
countries around the world for the treatment of extensive-stage small cell
lung cancer based on the CASPIAN Phase III trial.

 

In addition to its approved indications in lung cancer, Imfinzi is the only
approved immunotherapy in unresectable or metastatic biliary tract cancer and
is also approved in unresectable hepatocellular carcinoma in combination with
Imjudo. It is also approved for previously treated patients with advanced
bladder cancer in several countries.

 

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 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 (osimertinib) and Iressa
(gefitinib); Imfinzi (durvalumab) and Imjudo (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 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 (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.   WHO. International Agency of Cancer Research. 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 December 2022.

2.   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.

3.   Abernethy AP, et al. Real-world first-line treatment and overall
survival in non-small cell lung cancer without known EGFR mutations or ALK
rearrangements in US community oncology setting. PLoS ONE.
2017;12(6):e0178420.

4.   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.

5.   Cancer.net. Lung Cancer - Non-Small Cell: Introduction. Available
at: https://www.cancer.net/cancer-types/lung-cancer-non-small-cell/introduction
(https://www.cancer.net/cancer-types/lung-cancer-non-small-cell/introduction)
. Accessed December 2022.

Adrian Kemp

Company Secretary

AstraZeneca PLC

 

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