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 July 2021
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 approved in China for extensive-stage SCLC
19 July
2021 07:00 BST
Imfinzi approved in China
for the treatment
of extensive-stage small cell lung cancer
Only PD-1/PD-L1 immunotherapy to demonstrate both a significant
survival benefit and improved response rate in combination with a
choice of chemotherapies
AstraZeneca’s
Imfinzi (durvalumab) has
been approved in China for the 1st-line treatment of adult patients
with extensive-stage small cell lung cancer (ES-SCLC), in
combination with standard of care platinum chemotherapy (etoposide
plus a choice of either carboplatin or cisplatin).
The
approval by China’s National Medical Products Administration
was based on positive results from the CASPIAN Phase III trial. The
trial showed that Imfinzi
plus chemotherapy demonstrated a statistically significant and
clinically meaningful improvement in overall survival (OS) versus
chemotherapy alone. In addition, results from the China cohort of
patients were consistent with the global results.
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.1,2 Prognosis is
particularly poor, as only 7% of all SCLC patients and 3% of those
with extensive-stage disease will be alive five years after
diagnosis.3
Dave
Fredrickson, Executive Vice President, Oncology Business Unit,
said: “Today’s approval of Imfinzi plus chemotherapy brings an
important global standard of care to patients with extensive-stage
small cell lung cancer in China, who have had few treatment options
and a dire prognosis. Physicians can now offer these patients a
well-tolerated immunotherapy regimen with sustained overall
survival and prolonged treatment response, as well as convenient
dosing. This is also the first time physicians have had the choice
to combine immunotherapy with cisplatin, a preferred chemotherapy
in this setting in China.”
The
CASPIAN Phase III trial met the primary endpoint of OS for
Imfinzi plus chemotherapy
in June 2019, reducing the risk of death by 27% versus chemotherapy
alone (based on a hazard ratio [HR] of 0.73; 95% confidence
interval [CI] 0.59-0.91; p=0.0047), with a median OS of 13.0 months
versus 10.3 months for chemotherapy alone. These results were
published in The
Lancet in October 2019.4 Results also showed
an increased confirmed objective response rate for Imfinzi plus chemotherapy (68% versus
58% for chemotherapy alone). Imfinzi added to chemotherapy delayed
the time for disease symptoms to worsen.4
An updated analysis showed sustained efficacy for
Imfinzi plus chemotherapy
after a median follow up of more than two years (OS HR of 0.75; 95%
CI 0.62-0.91; nominal p=0.0032), with median OS of 12.9 months
versus 10.5 months for chemotherapy alone. An estimated 22.2% of
patients treated with Imfinzi plus chemotherapy were alive at
24 months versus 14.4% for chemotherapy alone. The safety and
tolerability for Imfinzi
and chemotherapy were consistent with the known safety profiles of
these medicines. No patients tested positive for treatment-emergent
anti-drug antibodies to Imfinzi.
Safety
and efficacy results in the China cohort of patients were
consistent with results in the overall global trial population.
Detailed results from this cohort will be presented at a
forthcoming medical meeting.
The
CASPIAN Phase III trial used a fixed dose of Imfinzi (1500mg) administered
every three weeks for four cycles while in combination with
chemotherapy and then every four weeks as a monotherapy until
disease progression. Based on the trial results, Imfinzi, in combination with etoposide and
either carboplatin or cisplatin, is approved in the 1st-line
setting of ES-SCLC in more than 55 countries, including the US,
Japan and across the EU.
Imfinzi is also being tested following concurrent
chemoradiation therapy in patients with limited-stage SCLC in the
ADRIATIC Phase III trial as part of a broad development programme.
In addition, Imfinzi is
also approved to treat non-small cell lung cancer (NSCLC) in the
curative-intent setting of unresectable, Stage III disease after
chemoradiation therapy in the US, Japan, China, across the EU and
in many other countries, based on results from the PACIFIC Phase
III trial.
Small cell lung cancer
Lung cancer is the leading cause of cancer death among men and
women and accounts for about one-fifth of all cancer
deaths.5
Lung cancer
is broadly split into NSCLC and SCLC, with about 15% classified as
SCLC.6
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.3
CASPIAN
CASPIAN
was a randomised, open-label, multi-centre, global Phase III trial
in the 1st-line treatment of 805 patients with ES-SCLC. The trial
compared Imfinzi in
combination with etoposide and either carboplatin or cisplatin
platinum chemotherapy, or Imfinzi and chemotherapy with the
addition of a second immunotherapy, tremelimumab, versus
chemotherapy alone. In the two experimental arms, patients were
treated with four cycles of chemotherapy. In comparison, the
control arm allowed up to six cycles of chemotherapy and optional
prophylactic cranial irradiation.
The
trial was conducted in more than 200 centres across 23 countries,
including the US, Europe, South America, Asia and the Middle East.
The primary endpoint was OS in each of the two experimental arms.
In June 2019, AstraZeneca announced the CASPIAN Phase III trial had
met one primary endpoint of demonstrating OS for Imfinzi plus chemotherapy at a planned
interim analysis. In March 2020, however, it was announced that the
second experimental arm with tremelimumab did not meet its primary
endpoint of OS.
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.
In addition to approvals in
ES-SCLC and unresectable, Stage III NSCLC, Imfinzi is approved for previously
treated patients with advanced bladder cancer in several countries.
Since the first approval in May 2017, more than 100,000 patients
have been treated with Imfinzi.
As part
of a broad development programme, Imfinzi is being tested as a single
treatment and in combinations with other anti-cancer treatments for
patients with NSCLC, SCLC, bladder cancer, hepatocellular
carcinoma, biliary tract cancer (a form of liver cancer),
oesophageal cancer, gastric and gastroesophageal cancer, cervical
cancer, ovarian cancer, endometrial cancer, and other solid
tumours.
AstraZeneca in lung cancer
AstraZeneca
is working to bring patients with lung cancer closer to cure
through the detection and treatment of early-stage disease, while
also pushing the boundaries of science to improve outcomes in the
resistant and advanced settings. By defining new therapeutic
targets and investigating innovative approaches, the Company aims
to match medicines to the patients who can benefit
most.
The
Company’s comprehensive portfolio includes leading lung
cancer medicines and the next wave of innovations, including
Tagrisso (osimertinib) and
Iressa (gefitinib);
Imfinzi (durvalumab) and
tremelimumab; Enhertu
(trastuzumab deruxtecan) and datopotamab deruxtecan in
collaboration with Daiichi Sankyo; Orpathys (savolitinib) in collaboration
with HUTCHMED; as well as a pipeline of potential new medicines and
combinations across diverse mechanisms of action.
AstraZeneca
is a founding member of the Lung Ambition Alliance, a global
coalition working to accelerate innovation and deliver meaningful
improvements for people with lung cancer, including and beyond
treatment.
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
single treatment and in combination with tremelimumab and other
novel antibodies in multiple tumour types, stages of disease, and
lines of treatment, 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
is leading a revolution in oncology with the ambition to provide
cures for cancer in every form, following the science to understand
cancer and all its complexities to discover, develop and deliver
life-changing medicines to patients.
The
Company’s focus is on some of the most challenging cancers.
It is through persistent innovation that AstraZeneca has built one
of the most diverse portfolios and pipelines in the industry, with
the potential to catalyse changes in the practice of medicine and
transform the patient experience.
AstraZeneca
has the vision to redefine cancer care 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 in Oncology and
BioPharmaceuticals, including 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.
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 July 2021.
2.
Kalemkerian GP,
et al. Treatment Options
for Relapsed Small-Cell Lung Cancer: What Progress Have We Made?
J Oncol Pract,
2018:14;369-370.
3.
Cancer.Net. Lung Cancer
- Small Cell. Available at
https://www.cancer.net/cancer-types/33776/view-all.
Accessed July 2021.
4.
Paz-Ares L,
et
al. Durvalumab plus
platinum-etoposide versus platinum-etoposide in first-line
treatment of extensive-stage small cell lung cancer (CASPIAN): a
randomised, controlled, open-label, Phase III trial.
The
Lancet.
2019;394(10212):1929-1939.
5.
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 July 2021.
6.
LUNGevity Foundation.
Types of Lung Cancer. Available at https://lungevity.org/for-patients-caregivers/lung-cancer-101/types-of-lung-cancer.
Accessed July 2021.
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:
19 July
2021
|
By: /s/
Adrian Kemp
|
|
Name:
Adrian Kemp
|
|
Title:
Company Secretary
|