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
Indicate by check
mark whether the registrant files or will file annual reports under
cover of Form 20-F or Form 40-F.
Form
20-F X Form 40-F __
Indicate by check
mark if the registrant is submitting the Form 6-K in paper as
permitted by Regulation S-T Rule 101(b)(1):
Indicate by check
mark if the registrant is submitting the Form 6-K in paper as
permitted by Regulation S-T Rule 101(b)(7): ______
Indicate by check
mark whether the registrant by furnishing the information contained
in this Form is also thereby furnishing the information to the
Commission pursuant to Rule 12g3-2(b) under the Securities Exchange
Act of 1934.
Yes __
No X
If
“Yes” is marked, indicate below the file number assigned to the
Registrant in connection with Rule 12g3-2(b):
82-_____________
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
|
AstraZeneca (NYSE:AZN)
Historical Stock Chart
From Dec 2020 to Jan 2021
AstraZeneca (NYSE:AZN)
Historical Stock Chart
From Jan 2020 to Jan 2021
