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 November 2020
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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by check mark whether the registrant files or will file annual
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Imfinzi new dosing approved in the US
20 November 2020 07:00 GMT
Imfinzi approved in the US for less-frequent,
fixed-dose use
Four-week dosing now approved in all Imfinzi indications, reducing
medical visits and improving patient convenience
AstraZeneca's Imfinzi (durvalumab) has been approved in the US for an
additional dosing option, a 1,500mg fixed dose every four weeks, in
the approved indications of unresectable Stage III non-small cell
lung cancer (NSCLC) after chemoradiation therapy (CRT) and
previously treated advanced bladder cancer. This new option is
consistent with the approved Imfinzi dosing in extensive-stage small cell lung
cancer (ES-SCLC) and will be available to patients weighing more
than 30kg as an alternative to the approved weight-based dosing of
10mg/kg every two weeks.
The approval by the Food and Drug Administration (FDA)
was based on data from several Imfinzi clinical trials, including the PACIFIC Phase
III trial which supported the two-week, weight-based dosing in
unresectable Stage III NSCLC, and the CASPIAN Phase III trial which
used four-week, fixed-dosing during maintenance treatment in
ES-SCLC. The decision follows the Priority
Review granted
by the FDA in August 2020.
Victoria M. Villaflor, MD, Clinical Professor in the Department of
Medical Oncology and Therapeutics Research at City of Hope Cancer
Center, Los Angeles, California, said: "This new four-week dosing
option gives doctors the choice to cut the number of visits for
critical cancer treatment in half and offers a regimen that is more
convenient for patients. Additionally, it limits potential exposure
to infection in the healthcare environment for a population that is
especially vulnerable to complications from COVID-19."
Dave Fredrickson, Executive Vice President, Oncology Business Unit,
said: "The approval of this new dosing option across indications
reflects our ongoing commitment to improve the patient experience
and ensure continuity of care - a priority at all times, but
especially during the pandemic. Cancer won't wait, and it is our
job to provide patients with treatment options that acknowledge the
challenges the pandemic poses to cancer care, enabling them to
visit their physician when truly needed and avoid preventable
exposure to healthcare-associated infections."
The four-week 1,500mg fixed-dosing option
for Imfinzi is also under regulatory review in several
other countries, including in the EU where the new dosing option
was granted accelerated assessment.
Imfinzi is approved in the
curative-intent setting of unresectable, Stage III NSCLC after CRT
in the US, in the EU, in Japan, in China and in many other
countries, based on the PACIFIC Phase III
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, the EU, Japan
and several other countries around the world for the treatment of
ES-SCLC based on the CASPIAN Phase III trial.
Stage III NSCLC
Stage III NSCLC (locally advanced) 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, where 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 large 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
CRT had been available to patients for decades.6-8
Small cell lung cancer
SCLC is a highly aggressive, fast-growing form of lung cancer that
typically recurs and progresses rapidly, despite initial response
to chemotherapy.9,10 About
two thirds of SCLC patients are diagnosed with extensive-stage
disease, in which the cancer has spread widely through the lung or
to other parts of the body.11 Prognosis
is particularly poor, as only 6% of all SCLC patients will be alive
five years after diagnosis.11
Bladder cancer
In 2018, approximately 550,000 people were diagnosed with bladder
cancer around the world and 200,000 died from the
disease.12 Locally
advanced and metastatic bladder cancer remains an area of unmet
medical need and typically only one in seven patients is alive five
years after diagnosis.13 Urothelial
cancer (UC) is the most common form of bladder
cancer.14 UC
is the 10th most common cancer worldwide and the 13th most common
cause of cancer death.12,15 PD-L1
is widely expressed in tumour and immune cells in patients with
bladder cancer and helps tumours evade detection from the immune
system.16
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
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 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
represent up to three-quarters of all patients with lung
cancer.17 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, 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 Phase II trials NeoCOAST, COAST and HUDSON in
combination with potential new medicines from the early-stage
pipeline, including Enhertu (trastuzumab
deruxtecan).
AstraZeneca's approach to IO
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 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. ASCO. Cancer.net. Lung Cancer - Non-Small Cell. Available
at: https://www.cancer.net/cancer-types/lung-cancer/view-all.
Accessed September 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.
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.
6. 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.
7. NCCN. 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.
Accessed September 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.
9. Kalemkerian GP, et al. Treatment Options for Relapsed Small-Cell
Lung Cancer: What Progress Have We Made? J Oncol
Pract.
2018;14(6):369-370.
10. National Cancer Institute. NCI Dictionary - Small Cell Lung
Cancer. Available at https://www.cancer.gov/publications/dictionaries/cancer-terms/def/small-cell-lung-cancer.
Accessed November 2020.
11. Cancer.Net. Lung Cancer - Small Cell. Available
at https://www.cancer.net/cancer-types/lung-cancer-small-cell.
Accessed November 2020.
12. 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 September 2020.
13. 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.
14. American Society of Clinical Oncology. Bladder Cancer:
Introduction. Available at https://www.cancer.net/cancer-types/bladder-cancer/introduction.
Accessed September 2020.
15. World Cancer Research Fund. Bladder Cancer Statistics.
Available at https://www.wcrf.org/dietandcancer/cancer-trends/bladder-cancer-statistics.
Accessed September 2020.
16. Magdalene J, et al. Immune Responses in Bladder Cancer-Role of
Immune Cell Populations, Prognostic Factors and Therapeutic
Implications. Front
Oncol. 2019;9:1270.
17. 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:
20 November
2020
|
By: /s/
Adrian Kemp
|
|
Name:
Adrian Kemp
|
|
Title:
Company Secretary
|
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