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 December 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 new dose receives positive EU CHMP opinion
15 December 2020 07:00
GMT
Imfinzi recommended for approval in the EU by CHMP
for less-
frequent, fixed-dose use in unresectable non-small cell lung
cancer
Option would extend dosing from two to four weeks,
reducing medical visits and improving patient
convenience
AstraZeneca's Imfinzi (durvalumab) has been recommended for
marketing authorisation in the European Union (EU) for an
additional dosing option, 1,500mg fixed dose every four weeks, in
the approved indication of 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).
This new dosing option is consistent with the
approved Imfinzi dosing in extensive-stage small cell lung
cancer (ES-SCLC) and once approved, will be available to patients
with locally advanced, unresectable NSCLC weighing more than
30kg.
Following review of the application under its accelerated
assessment procedure, the Committee for Medicinal Products for
Human Use (CHMP) of the European Medicines Agency based its
positive opinion on data from several Imfinzi clinical trials, including the PACIFIC Phase
III trial which supported the two-week, weight-based dosing of
10mg/kg every two weeks already approved in locally advanced,
unresectable NSCLC, and the CASPIAN Phase III trial which used
fixed dosing every four weeks during maintenance treatment in
ES-SCLC.
José Baselga, Executive Vice President, Oncology R&D,
said: "The four-week dosing regimen will decrease the risk of
exposure to infection in the healthcare setting, furthering our
efforts to ensure continuity of care for cancer patients at high
risk of complications during the pandemic. We look forward to
offering non-small cell lung cancer patients in Europe an option
that would reduce medical visits by extending dosing from two to
four weeks."
Imfinzi was
recently approved in the
US for this dosing
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.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 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
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 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 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.12 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'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. Accessed September
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 September 2020.
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. 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 December
2020
|
By: /s/
Adrian Kemp
|
|
Name:
Adrian Kemp
|
|
Title:
Company Secretary
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