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
2022
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
Imfinzi
+ Imjudo approved in US for lung cancer
11
November 2022 07:00 GMT
Imfinzi and Imjudo with
chemotherapy approved in the US
for patients with metastatic non-small cell lung
cancer
Approval based on POSEIDON Phase III trial results, which showed
significant survival benefit with a limited course of Imjudo added
to Imfinzi and chemotherapy
AstraZeneca's Imfinzi (durvalumab) in combination
with Imjudo (tremelimumab) plus platinum-based
chemotherapy has been approved in the US for the treatment of adult
patients with Stage IV (metastatic) non-small cell lung cancer
(NSCLC).
The
approval by the Food and Drug Administration (FDA) was based on the
results from the POSEIDON Phase III
trial. Patients treated with a limited course of five cycles
of the anti-CTLA-4 antibody Imjudo added to Imfinzi plus four cycles of
platinum-based chemotherapy experienced a 23% reduction in the risk
of death versus a range of chemotherapy options (based on a hazard
ratio [HR] of 0.77; 95% CI 0.65-0.92; p=0.00304). An estimated 33%
of patients were alive at two years versus 22% for chemotherapy.
This treatment combination also reduced the risk of disease
progression or death by 28% compared to chemotherapy alone (HR
0.72; 95% CI 0.60-0.86; p=0.00031).
Updated results from the POSEIDON Phase III trial after
approximately four years of follow-up presented at the European
Society of Medical Oncology (ESMO) Congress 2022 and published in
the Journal
of Clinical Oncology demonstrated sustained survival
benefit, improving overall survival (OS) by 25% compared to
chemotherapy alone (HR 0.75; 95% CI 0.63-0.88). An estimated 25% of
patients treated with the combination were alive at three years
versus 13.6% for those treated with chemotherapy alone. The safety
profile for Imjudo plus Imfinzi and chemotherapy was
consistent with the known profiles of each medicine, and no new
safety signals were identified.
In the
US, lung cancer is the second most commonly diagnosed cancer, with
more than 236,000 patients expected to be diagnosed in
2022.1 For patients
with metastatic NSCLC, prognosis is particularly poor, as only
approximately 8% will live beyond five years after
diagnosis.2
Melissa
Johnson, MD, Director of Lung Cancer Research, Sarah Cannon
Research Institute at Tennessee Oncology in Nashville, Tennessee,
and a lead investigator in the POSEIDON Phase III trial,
said: "Metastatic non-small cell
lung cancer remains a significant treatment challenge because many
patients' tumours do not respond well to standard therapies,
including checkpoint inhibitors. The approval of this dual
immunotherapy regimen with chemotherapy introduces a new, generally
well-tolerated treatment option for patients with this devastating
disease and gives them the chance to benefit from the long-term
survival advantage seen with CTLA-4 inhibition.
Dave Fredrickson, Executive Vice President, Oncology Business Unit,
AstraZeneca, said: "This approval underscores the importance of
delivering novel treatment combinations that extend survival in
metastatic non-small cell lung cancer, a complex setting where many
patients still face a dismal prognosis. This marks the second
indication for Imjudo added to Imfinzi in just a few weeks following its approval
in unresectable liver cancer, reinforcing the benefits of this new
medicine and our commitment to improving patient outcomes in cancer
settings with continued unmet need."
Regulatory
applications are also currently under review in Europe, Japan and several other
countries for this indication based on the POSEIDON
results.
Imfinzi is the only approved immunotherapy and the global
standard of care in the curative-intent setting of unresectable,
Stage III NSCLC in patients whose disease has not progressed after
chemoradiation therapy based on the PACIFIC Phase III
trial. Imfinzi is also approved in the US, the EU, Japan,
China and many other countries around the world for the treatment
of extensive-stage small cell lung cancer (ES-SCLC) based on the
CASPIAN Phase III trial. Imfinzi is approved in the US and several other
countries in combination with chemotherapy for the treatment of
locally advanced or metastatic biliary tract cancer based on the
TOPAZ-1 Phase III trial, and it is approved
with Imjudo in the US for the treatment of unresectable
hepatocellular carcinoma based on the HIMALAYA Phase III
trial.
Notes
Stage IV NSCLC
Lung
cancer is the second most common form of cancer globally, with more
than two million patients diagnosed in 2020.3 Lung cancer is
broadly split into NSCLC and SCLC, with 80-85% classified as NSCLC.
Within NSCLC, patients are classified as squamous, representing
25-30% of patients, or non-squamous, in approximately 70-75% of
patients.4-6
POSEIDON
The POSEIDON trial
was a randomised, open-label, multi-centre, global, Phase III trial
of Imfinzi plus
platinum-based chemotherapy, or Imfinzi, Imjudo and chemotherapy,
versus chemotherapy alone in the 1st-line treatment of 1,013
patients with metastatic NSCLC. The trial population included
patients with either non-squamous or squamous disease, and the full
range of PD-L1 expression levels. POSEIDON excluded patients with
certain epidermal growth factor receptor (EGFR) mutations or
anaplastic lymphoma kinase (ALK) fusions.
In the
experimental arms, patients were treated with a flat dose of
1,500mg of Imfinzi,
or Imfinzi and
75mg of Imjudo with up to four cycles of
chemotherapy every three weeks, followed by maintenance treatment
with Imfinzi once
every four weeks, or Imfinzi and a fifth dose of 75mg
of Imjudo given
at week 16. In comparison, the control arm allowed up to six cycles
of chemotherapy. Pemetrexed maintenance treatment was allowed in
all arms in patients with non-squamous disease if given during the
induction phase. Nearly all patients with non-squamous disease
(95.5%) had pemetrexed and platinum, while the majority of patients
with squamous disease receiving chemotherapy (88.3%) received
gemcitabine and platinum.
Primary
endpoints included progression-free survival (PFS) and OS for
the Imfinzi plus
chemotherapy arm. Key secondary endpoints included PFS and OS in
the Imfinzi plus Imjudo and chemotherapy arm. As
both PFS endpoints were met for Imfinzi plus chemotherapy
and Imfinzi,
Imjudo and chemotherapy, the prespecified statistical
analysis plan allowed for testing OS in the Imfinzi plus Imjudo and chemotherapy arm. The
trial was conducted in more than 150 centres across 18 countries,
including the US, Europe, South America, Asia and South
Africa.
Imfinzi
Imfinzi (durvalumab) is a human
monoclonal antibody that binds to the PD-L1 protein and blocks the
interaction of PD-L1 with the PD-1 and CD80 proteins, countering
the tumour's immune-evading tactics and releasing the inhibition of
immune responses.
In
addition to its approved indications in lung
cancer, Imfinzi is also the only approved
immunotherapy in unresectable or metastatic biliary tract cancer
and hepatocellular carcinoma (in combination with Imjudo), and is also approved for
previously treated patients with advanced bladder cancer in several
countries.
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 SCLC, NSCLC, bladder cancer, several
gastrointestinal (GI) cancers, ovarian cancer, endometrial cancer
and other solid tumours.
Imjudo
Imjudo (tremelimumab) is a human
monoclonal antibody that targets the activity of cytotoxic
T-lymphocyte-associated protein 4 (CTLA-4). Imjudo blocks the activity of
CTLA-4, contributing to T-cell activation, priming the immune
response to cancer and fostering cancer cell death.
Imjudo is also approved in combination
with Imfinzi for
the treatment of unresectable hepatocellular carcinoma (HCC) and is
being tested in combination with Imfinzi across
multiple tumour types including locoregional HCC (EMERALD-3), SCLC
(ADRIATIC) and bladder cancer (VOLGA and NILE).
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 Imjudo (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 immuno-oncology (IO)
AstraZeneca has a
comprehensive and diverse IO portfolio and pipeline anchored in
immunotherapies designed to overcome evasion of the anti-tumour
immune response and stimulate the body's immune system to attack
tumours.
AstraZeneca aims to
reimagine cancer care and help transform outcomes for patients
with Imfinzi as a
single treatment and in combination with Imjudo as well as other novel
immunotherapies and modalities. The Company is also exploring
next-generation immunotherapies like bispecific antibodies and
therapeutics that harness different aspects of immunity to target
cancer.
AstraZeneca
is boldly pursuing an innovative clinical strategy to bring
IO-based therapies that deliver long-term survival to new settings
across a wide range of cancer types. With an extensive clinical
programme, the Company also champions the use of IO treatment in
earlier disease stages, where there is the greatest potential for
cure.
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, Rare
Diseases, 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.
Lungevity. Lung Cancer Statistics. Available at: https://www.lungevity.org/for-supporters-advocates/lung-cancer-awareness/lung-cancer-statistics#1.
Accessed November 2022.
2.
American Cancer Society. Lung Cancer Survival Rates. Available at:
https://www.cancer.org/cancer/lung-cancer/detection-diagnosis-staging/survival-rates.html.
Accessed November 2022.
3. WHO.
International Agency of Cancer Research. Lung Fact Sheet. Available
at: https://gco.iarc.fr/today/data/factsheets/cancers/15-Lung-fact-sheet.pdf.
Accessed November 2022.
4.
Abernethy AP, et al.
Real-world first-line treatment and overall survival in non-small
cell lung cancer without known EGFR mutations or ALK rearrangements
in US community oncology setting. PLoS ONE.
2017;12(6):e0178420.
5.
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.
6.
Cancer.net. Lung Cancer - Non-Small Cell: Introduction. Available
at: https://www.cancer.net/cancer-types/lung-cancer-non-small-cell/introduction.
Accessed November 2022.
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:
11 November
2022
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By: /s/
Adrian Kemp
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|
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Name:
Adrian Kemp
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Title:
Company Secretary
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