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 August 2020
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.
Imfinzi granted FDA
Priority Review for less-frequent, fixed-dose
use
18 August 2020 07:00 BST
Imfinzi granted FDA Priority Review for
less-frequent, fixed-dose use
Option would extend dosing to four weeks in non-small cell
lung
and bladder cancer reducing medical visits by half
AstraZeneca's Imfinzi (durvalumab) has received acceptance for its
supplemental Biologics License Application (sBLA) and has also been
granted Priority Review in the US for a new four-week, fixed-dose
regimen for treatment in the approved indications of non-small cell
lung cancer (NSCLC) and bladder cancer.
If approved, Imfinzi could be administered intravenously every
four weeks at a fixed dose of 1500mg in unresectable Stage III
NSCLC after chemoradiation therapy and previously treated advanced
bladder cancer, consistent with the approved dosing in
extensive-stage small cell lung cancer
(ES-SCLC).
The Food and Drug Administration (FDA) grants Priority Review to
applications for medicines that offer significant advances over
available options by demonstrating safety or efficacy improvements,
preventing serious conditions, or enhancing patient compliance. The
Prescription Drug User Fee Act date, the FDA action date for their
regulatory decision, is during the fourth quarter of
2020.
If approved, the new dosing will be available as an alternative to
the approved weight-based dosing of 10mg/kg every two weeks. The
sBLA was based on data from several Imfinzi clinical trials, including results from the
Phase III CASPIAN trial in ES-SCLC which used the four-week,
fixed-dose regimen during maintenance.
Dave Fredrickson, Executive Vice President, Oncology Business Unit,
said: "The new less-frequent dosing option for non-small cell lung
cancer and bladder cancer will simplify and improve treatment by
enabling continuity of care while minimising the risk of exposure
to infection in the healthcare setting. This takes on
particular urgency during the current pandemic, as doctors care for
patients at high risk of COVID-19 complications. We are working
with health authorities in the US and other countries to bring the
option of four-week, fixed dosing for Imfinzi to patients around the world as soon as we
can."
Imfinzi is approved in the
curative-intent setting of unresectable, Stage III NSCLC after
chemoradiation therapy in the US, Japan, China, across the EU and
in many other countries, based on the Phase III PACIFIC
trial. Imfinzi is also approved for previously treated
patients with advanced bladder cancer in the US and several other
countries. Additionally, it is approved in the US and under review
in Japan and other countries for ES-SCLC. Imfinzi was also recently recommended for marketing
authorisation in the EU for this indication.
Stage III NSCLC
Stage III (locally-advanced) NSCLC is commonly divided into three
sub-categories (IIIA, IIIB and IIIC), defined by how much the
cancer has spread locally and the possibility of
surgery.1 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.1,2
Stage III NSCLC represents approximately one-third of NSCLC
incidence and in 2015 was estimated to affect nearly 200,000
patients in the following eight key countries: China, France,
Germany, Italy, Japan, Spain, UK, and the US, with approximately
43,000 cases in the US alone.3,4 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
chemoradiation therapy had been available to patients for
decades.6-9
Bladder cancer
In 2018, approximately 550,000 people were diagnosed with bladder
cancer around the world and 200,000 died from the
disease.10 Locally
advanced and metastatic bladder cancer remains an area of unmet
medical need and typically only one in seven patients are alive
five years after diagnosis.11 Urothelial
cancer (UC) is the most common form of bladder
cancer.12 UC
is the 10th most common cancer worldwide and the 13th most common
cause of cancer death.10,13 PD-L1
is widely expressed in tumour and immune cells in patients with
bladder cancer and helps tumours evade detection from the immune
system.14
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.
As part of a broad development programme, Imfinzi is also being tested as a monotherapy and in
combination 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, cervical 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.
AstraZeneca aims to address the unmet needs of patients with
EGFR-mutated tumours as a genetic driver of disease, which occur in
10-15% of NSCLC patients in the US and EU and 30-40% of NSCLC
patients in Asia, with the approved
medicines Iressa (gefitinib) and Tagrisso (osimertinib) and its ongoing Phase III
trials LAURA, NeoADAURA and FLAURA2.15-17
AstraZeneca is committed to addressing tumour mechanisms of
resistance through the ongoing Phase II trials SAVANNAH and ORCHARD
which test Tagrisso in combination with savolitinib, a selective
inhibitor of c-MET receptor tyrosine kinase, along with other
potential new medicines. Enhertu (trastuzumab deruxtecan), a HER2-directed
antibody drug conjugate, is in development for metastatic
non-squamous HER2-overexpressing or HER2-mutated NSCLC including
trials in combination with other anticancer treatments. In
addition, DS-1062, a trophoblast cell-surface antigen 2
(TROP2)-directed ADC, is in early development for advanced NSCLC
where TROP2 is overexpressed in the majority of
tumours.18
An extensive Immuno-Oncology development programme focuses on lung
cancer patients without a targetable genetic mutation which
represents up to three-quarters of all patients with lung
cancer.19 Imfinzi,
an anti-PDL1 antibody, is in development for patients with advanced
disease (Phase III trials POSEIDON and PEARL) and for patients in
earlier stages of disease including potentially-curative settings
(Phase III trials MERMAID-1, AEGEAN, ADJUVANT BR.31, PACIFIC-2,
PACIFIC-4, PACIFIC-5, and ADRIATIC) both as monotherapy and in
combination with tremelimumab and/or
chemotherapy. Imfinzi is also in development in the Phase II
trials NeoCOAST, COAST and HUDSON in combination with potential new
medicines from the early-stage pipeline
including Enhertu.
AstraZeneca's approach to Immuno-Oncology
Immuno-oncology (IO) is a therapeutic approach designed to
stimulate the body's immune system to attack tumours. The Company's
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, 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 four scientific platforms -
Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response
and Antibody Drug Conjugates - 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/NYSE: 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. ASCO. Cancer.net. Lung Cancer - Non-Small Cell. Available
at: https://www.cancer.net/cancer-types/lung-cancer/view-all.
Accessed June 2020.
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. doi:10.3747/co.25.4096.
Accessed June 2020.
3. 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.
4. EpiCast Report: NSCLC Epidemiology Forecast to 2025. GlobalData.
2016.
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.
Accessed June 2020.
6. Eberhardt WE, et al. Panel Members. 2nd ESMO Consensus Conference
in Lung Cancer: locally advanced Stage III non-small-cell lung
cancer. Ann Oncol. 2015;26(8):1573-1588. Accessed June
2020.
7. Gandara DR, et al. Long-Term Survival with Concurrent CRT
Followed by Consolidation Docetaxel in Stage IIIB Non-Small-Cell
Lung Cancer: A Phase II Southwest Oncology Group Study
(S9504). Clin Lung
Cancer. 2006;8(2):116-121.
Accessed June 2020.
8. 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. Accessed
June 2020.
9. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines).
Non-small cell lung cancer, version 8.
2017. https://www.nccn.org/professionals/physician_gls/pdf/nscl_blocks.pdf.
Published August 3, 2017. Accessed June 2020.
10. World Health Organization International Agency for Research on
Cancer. Cancer Fact Sheets - Bladder. Available
at http://gco.iarc.fr/today/data/factsheets/cancers/30-Bladder-fact-sheet.pdf.
Accessed June 2020.
11. Von der Maase H, et al. Long-Term Survival Results of a Randomized
Trial Comparing Gemcitabine Plus Cisplatin, With Methotrexate,
Vinblastine, Doxorubicin, Plus Cisplatin in Patients With Bladder
Cancer. J Clin
Oncol. 2005;23:4602-4608.
12. American Society of Clinical Oncology. Bladder Cancer:
Introduction. Available at https://www.cancer.net/cancer-types/bladder-cancer/introduction.
Accessed June 2020.
13. World Cancer Research Fund. Bladder cancer statistics.
Available at https://www.wcrf.org/dietandcancer/cancer-trends/bladder-cancer-statistics.
Accessed June 2020.
14. Magdalene J, et al. Joseph M, et al. Immune Responses in Bladder
Cancer-Role of Immune Cell Populations, Prognostic Factors and
Therapeutic Implications. Front
Oncol. 2019;9:1270.
15. Szumera-Ciećkiewicz A, et al. EGFR Mutation Testing on Cytological and
Histological Samples in Non-Small Cell Lung Cancer: a Polish,
Single Institution Study and Systematic Review of European
Incidence. Int J Clin Exp
Pathol.
2013:6;2800-12.
16. Keedy VL, et al. American Society of Clinical Oncology
Provisional Clinical Opinion: Epidermal Growth Factor Receptor
(EGFR) Mutation Testing for Patients with Advanced Non-Small-Cell
Lung Cancer Considering First-Line EGFR Tyrosine Kinase Inhibitor
Therapy. J Clin
Oncol.
2011:29;2121-27.
17. Ellison G, et al. EGFR Mutation Testing in Lung Cancer: a
Review of Available Methods and Their Use for Analysis of Tumour
Tissue and Cytology Samples. J Clin
Pathol. 2013:66;79-89.
18. Zaman S, et al. Targeting Trop-2 in solid tumors: future
prospects. Onco Targets
Ther. 2019; 12:
1781-1790.
19. 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:
18 August
2020
|
By: /s/
Adrian Kemp
|
|
Name:
Adrian Kemp
|
|
Title:
Company Secretary
|