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 January 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.
Imfinziapproved in the EU for less-frequent, fixed-dose use in
unresectable non-small cell lung cancer
15 January 2021 07:00 GMT
Imfinzi approved in the EU for less-frequent,
fixed-
dose use in unresectable non-small cell lung cancer
New option extends dosing from two to four weeks,
reducing medical visits and improving patient
convenience
AstraZeneca's Imfinzi (durvalumab) has been approved in the
European Union and the UK for an additional dosing option, a
1,500mg fixed dose every four weeks, in locally advanced,
unresectable non-small cell lung cancer (NSCLC) in adults whose
tumours express PD-L1 on at least 1% of tumour cells and whose
disease has not progressed following platinum-based chemoradiation
therapy (CRT).
Lung cancer is the leading cause of cancer death and 80-85% of
patients with lung cancer have NSCLC.1-3 Approximately
one third of patients are diagnosed in the Stage III setting and
the majority of these have unresectable tumours and are treated
with curative intent.3-5
This new dosing option is consistent with the
approved Imfinzi dosing in extensive-stage small cell lung
cancer (ES-SCLC) and is available to patients with locally
advanced, unresectable NSCLC weighing more than
30kg.
The approval by the European Commission was based on data from
several Imfinzi clinical trials. These include the PACIFIC
Phase III trial which supported the two-week, weight-based dosing
of 10mg/kg already approved in locally advanced, unresectable
NSCLC, and the CASPIAN Phase III trial which used four-week, fixed
dosing during maintenance treatment in ES-SCLC.
The approval follows an accelerated assessment by the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines
Agency, which recommended
approval in December 2020.
This CHMP recommendation and approval also apply to the
UK.
Luis Paz-Ares, MD, PhD, Chair, Medical Oncology Department,
Hospital Universitario Doce de Octubre, Madrid, Spain and principal
investigator in the CASPIAN Phase III trial, said: "Less-frequent
dosing is important for cancer patients, and may be particularly
relevant right now for those suffering from lung cancer, who are
especially vulnerable to complications from COVID-19. Patients with
cancer should be able to focus on living their lives as much as
possible and doctors can now offer them a more convenient dosing
option that could reduce medical visits by half and help avoid
unnecessary risk of exposure to infection in the healthcare
setting."
Dave Fredrickson, Executive Vice President, Oncology Business Unit,
said: "We are pleased to offer a four-week dosing option to lung
cancer patients in Europe to meet an urgent need and help enable
continuity of care during the pandemic. Cancer won't wait, and it
is our job to provide patients with treatment options that address
the challenges the pandemic poses to their care."
Imfinzi was also
recently approved for
unresectable Stage III NSCLC after CRT in the US for the four-week, fixed-dose
regimen. Imfinzi is approved in the curative-intent setting
of unresectable, Stage III (locally advanced) NSCLC after CRT 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 around the world for the
treatment of ES-SCLC based on the CASPIAN Phase III
trial.
Stage III NSCLC
Stage III (locally advanced) NSCLC is commonly divided into
three subcategories (IIIA, IIIB and IIIC), defined by how much the
cancer has spread locally and the possibility of
surgery.2 Stage
III disease is different from Stage IV disease, when the cancer has
spread (metastasised), as the majority of Stage
III patients are currently treated with curative
intent.2,3
Stage III NSCLC represents approximately one third of NSCLC
incidence and in 2015 was estimated to affect nearly
200,000 patients in China, France, Germany, Italy, Japan, Spain,
UK, and the US, with approximately 43,000 cases in the US
alone.4,6 The
majority of Stage III NSCLC patients are diagnosed with
unresectable tumours.5 Prior
to approval of Imfinzi in this setting, no new treatments
beyond CRT had been available to patients for
decades.7-9
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 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
combinations including with tremelimumab, an anti-CTLA4
monoclonal antibody and potential new medicine, as a treatment for
patients with NSCLC, SCLC, bladder cancer, head and neck
cancer, liver cancer, biliary tract cancer, oesophageal
cancer, gastric and gastroesophageal cancer, cervical
cancer, ovarian cancer, endometrial cancer and other solid
tumours.
AstraZeneca in lung cancer
AstraZeneca has a comprehensive portfolio of approved and potential
new medicines in late-stage development for the treatment of
different forms of lung cancer spanning different histologies,
several stages of disease, lines of therapy and modes of
action.
An extensive Immuno-Oncology (IO) development programme
focuses on lung cancer patients without a targetable genetic
mutation which represents up to three-quarters of all patients with
lung cancer.10 Imfinzi,
an anti-PDL1 antibody, is in development for patients with advanced
disease (POSEIDON and PEARL Phase III trials) and for patients
in earlier stages of disease including potentially-curative
settings (MERMAID-1, MERMAID-2, AEGEAN, ADJUVANT BR.31,
PACIFIC-2, PACIFIC-4, PACIFIC-5, and ADRIATIC Phase III
trials) both as monotherapy and in combination
with tremelimumab and/or
chemotherapy.
Imfinzi is also in
development in the NeoCOAST, COAST and HUDSON Phase II
trials in combination with potential new medicines from the
early-stage pipeline including Enhertu (trastuzumab deruxtecan).
AstraZeneca in immunotherapy
Immunotherapy is a therapeutic approach designed to stimulate the
body's immune system to attack tumours. The Company's IO portfolio
is anchored in 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, small,
targeted 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 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. International Agency for
Research on Cancer. Lung Fact Sheet. Available
at http://gco.iarc.fr/today/data/factsheets/cancers/15-Lung-fact-sheet.pdf.
Accessed January 2021.
2. ASCO. Cancer.net. Lung Cancer - Non-Small Cell. Available
at: https://www.cancer.net/cancer-types/lung-cancer/view-all. Accessed January
2021.
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. Antonia SJ, et al. PACIFIC Investigators. Durvalumab After
Chemoradiotherapy In Stage III Non-Small-Cell Lung
Cancer. N
Engl J Med.
2017;377(20):1919-1929.
5. Provencio M, et al. Inoperable Stage III Non-Small Cell Lung
Cancer: Current
Treatment And Role Of Vinorelbine. J Thorac Dis. 2011;3:197-204.
6. EpiCast Report: NSCLC Epidemiology Forecast to
2025. GlobalData. 2016.
7. Curran WJ, et al. Sequential vs Concurrent Chemoradiation for
Stage III Non-Small Cell Lung Cancer: Randomized Phase III Trial
RTOG 9410. J Natl Cancer
Inst.
2011;103(19):1452-1460.
8. NCCN. NCCN Clinical Practice Guidelines in Oncology (NCCN
Guidelines) - Non-Small Cell Lung Cancer. Version
2.2021. https://www.nccn.org/professionals/physician_gls/pdf/nscl_blocks.pdf.
Accessed January 2021.
9. Hanna N, et al. Current Standards and Clinical Trials in
Systemic Therapy for Stage III Lung Cancer: What is
New? Am Soc Clin
Oncol Educ Book. 2015:e442-447.
10. Pakkala, S, et al. Personalized therapy for lung cancer:
striking a moving target. JCI
Insight. 2018;3(15):e120858.
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:
15 January
2021
|
By: /s/
Adrian Kemp
|
|
Name:
Adrian Kemp
|
|
Title:
Company Secretary
|
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