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FORM 6-K
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Report
of Foreign Issuer
Pursuant
to Rule 13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For the
month of February 2021
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Update on KESTREL Phase
III trial of Imfinzi with or without tremelimumab in the
1st-line treatment of recurrent or metastatic head and neck
cancer
5 February 2021 07:00 GMT
Update on KESTREL Phase III trial
of Imfinzi with or without tremelimumab in the 1st-line
treatment of recurrent or metastatic head and neck
cancer
The KESTREL Phase III trial for
AstraZeneca's Imfinzi (durvalumab) did not meet the primary
endpoint of improving overall survival (OS) versus the EXTREME
treatment regimen (chemotherapy plus cetuximab), a standard of
care, in the 1st-line treatment of patients with recurrent or
metastatic head and neck squamous cell carcinoma (HNSCC) whose
tumours expressed high levels of PD-L1. Also, the combination
of Imfinzi plus tremelimumab did not indicate an OS
benefit in 'all-comer' patients, a secondary
endpoint.
Dave Fredrickson, Executive Vice President, Oncology Business Unit,
said: "Metastatic head and neck cancer is a complex and challenging
disease with a poor prognosis. While we are disappointed by these
results, insights from the KESTREL Phase III trial will advance our
understanding and application of immunotherapy across our clinical
development programme. We will continue to build on the established
benefits of Imfinzi in early lung cancer and small cell lung
cancer, to bring immunotherapy treatment options to all patients
who may benefit."
The safety and tolerability profiles for Imfinzi as a monotherapy and in combination with
tremelimumab were consistent with previous trials. The data will be
shared in due course.
HNSCC
Nearly 750,000 patients were diagnosed with head and neck cancer
around the world in 2020.1 Two
thirds of these patients are diagnosed in advanced stages, and more
than half of those treated eventually relapse.2,3 Median
survival for a patient with an uncurable or metastatic relapse
remains under one year.3 More
than 90% of all head and neck cancers start in the squamous cells
that line the mouth, nose and throat and are called head and neck
squamous cell carcinomas.4
KESTREL
The KESTREL Phase III trial was a randomised, open-label,
multi-centre, global trial in the 1st-line treatment of recurrent
or metastatic HNSCC. The trial tested Imfinzi or Imfinzi plus a second immunotherapy, tremelimumab,
versus the EXTREME treatment regimen (cetuximab with
cisplatin or carboplatin plus 5-fluorouracil), a standard of
care treatment. High PD-L1 was defined as either 50% or more tumour
cells or 25% or more tumour-infiltrating immune cells expressing
PD-L1.
The trial was conducted in more than 200 centres across 23
countries, including centres in the US, Europe, South America and
Asia. The primary endpoint was OS in patients with high PD-L1
expression in the Imfinzi monotherapy arm. OS in 'all-comer' patients
treated with the combination of Imfinzi plus tremelimumab was being tested as a key
secondary endpoint.
Imfinzi
Imfinzi (durvalumab) is a
human monoclonal antibody that binds to PD-L1 and blocks the
interaction of PD-L1 with PD-1 and CD80, countering the tumour's
immune-evading tactics and releasing the inhibition of immune
responses.
Imfinzi is approved in the
curative-intent setting of unresectable, Stage III non-small cell
lung cancer (NSCLC) after chemoradiation therapy in the EU, US,
Japan, China and many other countries, based on the PACIFIC Phase
III trial. Additionally, it is approved in the EU, US, Japan and
many other countries for the treatment of extensive-stage small
cell lung cancer (SCLC) based on the CASPIAN Phase III
trial. Imfinzi is
also approved for previously treated patients with advanced bladder
cancer in the US and several other countries.
As part of a broad development programme, Imfinzi is being tested as a monotherapy and in
combination with other anti-cancer treatments for patients with
NSCLC, SCLC, bladder cancer, hepatocellular carcinoma (HCC),
biliary tract cancer, oesophageal cancer, gastric and
gastroesophageal cancer, cervical cancer, ovarian cancer,
endometrial cancer and other solid tumours.
Tremelimumab
Tremelimumab is a human monoclonal antibody and potential new
medicine that targets the activity of cytotoxic
T-lymphocyte-associated protein 4 (CTLA-4). Tremelimumab blocks the
activity of CTLA-4, contributing to T cell activation, priming the
immune response to cancer and fostering cancer cell death.
Tremelimumab is being tested in a clinical trial programme in
combination with Imfinzi in NSCLC, SCLC, bladder cancer and
HCC.
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 by immunotherapies that
have been designed to overcome anti-tumour immune suppression.
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 monotherapy and in combination with
tremelimumab in multiple tumour types, stages of disease, and lines
of therapy, 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 small, targeted molecules from
across AstraZeneca's oncology pipeline, and from research partners,
may provide new treatment options across a broad range of
tumours.
In head and neck cancer, the Company is also testing monalizumab, a
first-in-class humanised anti-NKG2A antibody, in combination with
cetuximab in the INTERLINK-1 Phase III trial in patients with
recurrent or metastatic HNSCC previously treated with IO and
chemotherapy. AstraZeneca obtained full oncology rights to
monalizumab from Innate Pharma in October 2018 through a
co-development and commercialisation agreement initiated in
2015.
AstraZeneca in oncology
AstraZeneca has a deep-rooted heritage in oncology and offers a
quickly growing portfolio of new medicines that has the potential
to transform patients' lives and the Company's future. With seven
new medicines launched between 2014 and 2020, and a broad pipeline
of small molecules and biologics in development, the Company is
committed to advance oncology as a key growth driver for
AstraZeneca focused on lung, ovarian, breast and blood
cancers.
By harnessing the power of six scientific platforms -
Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage
Response, Antibody Drug Conjugates, Epigenetics, and Cell Therapies
- and by championing the development of personalised combinations,
AstraZeneca has the vision to redefine cancer treatment 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,
primarily for the treatment of diseases in three therapy areas -
Oncology, 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. World Health Organization. World GLOBOCAN 2020. Available
at https://gco.iarc.fr/today/home.
Accessed January 2021.
2. Heriou A, et al. Multiple Cancers of the Head and Neck. MAEDICA -
a Journal of Clinical Medicine
2013;8(1):80-852.
3. Rothschild U, et al. Immunotherapy in head and neck cancer -
scientific rationale, current treatment options and future
directions. Swiss Med
Wkly.
2018;148:w14625.
4. Palka K, et al. Update in Molecular Diagnostic Tests in Head and
Neck Cancer. Semin Oncol. 2008 June;35(3):198-210.
Adrian Kemp
Company Secretary
AstraZeneca PLC
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
Date:
05 February 2021
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By: /s/
Adrian Kemp
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Name:
Adrian Kemp
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Title:
Company Secretary
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