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 August 2024
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
approved in US for resectable lung cancer
16 August 2024
Imfinzi approved
in the US for the treatment of resectable
non-small cell lung cancer before and after surgery
Based on AEGEAN Phase III trial results which showed Imfinzi-based
regimen reduced the risk of recurrence, progression or death by 32%
vs. neoadjuvant chemotherapy alone
AstraZeneca's Imfinzi (durvalumab) in combination with
chemotherapy has been approved in the US for the treatment of adult
patients with resectable early-stage (IIA-IIIB) non-small cell lung
cancer (NSCLC) and no known epidermal growth factor receptor (EGFR)
mutations or anaplastic lymphoma kinase (ALK) rearrangements. In
this regimen, patients are treated with Imfinzi in combination with neoadjuvant chemotherapy
before surgery and as adjuvant monotherapy after
surgery.
The approval by the Food and Drug Administration (FDA) was based on
positive results from the pivotal AEGEAN
trial, which were published
in The
New England Journal of Medicine in
October 2023. Results
from a planned interim analysis of event-free survival (EFS) showed
a statistically significant and clinically meaningful 32% reduction
in the risk of recurrence, progression events or death versus
chemotherapy alone in patients treated with
the Imfinzi-based regimen before and after surgery (32% data
maturity; EFS hazard ratio of 0.68; 95% confidence interval [CI]
0.53-0.88; p=0.003902).
In a final analysis of pathologic complete response (pCR),
treatment with Imfinzi plus neoadjuvant chemotherapy before surgery
resulted in a pCR rate of 17.2% versus 4.3% for patients treated
with neoadjuvant chemotherapy alone (difference in pCR 13.0%; 95%
CI 8.7-17.6).
Each year, there are an estimated 2.4 million people diagnosed with
lung cancer globally, with approximately 235,000 new diagnoses
expected in the US in 2024.1-2 Around
25-30% of all patients with NSCLC, the most common form of lung
cancer, are diagnosed early enough to have surgery with curative
intent.3-4 However,
the majority of patients with resectable disease will develop
recurrence and only 36-46% of patients with Stage II disease will
survive for five years.5-6 This
decreases to 24% for patients with Stage IIIA disease and 9% for
patients with Stage IIIB disease, reflecting a high unmet medical
need.6
John V. Heymach, MD, PhD, Professor and Chair
Thoracic/Head and Neck Medical Oncology, The University of Texas MD
Anderson Cancer Center in Houston, Texas, said: "This approval
brings an important new treatment option that should become a
backbone combination approach for patients with resectable
non-small cell lung cancer, who have historically faced high rates
of recurrence even after chemotherapy and surgery. When added both
before and after surgery, durvalumab delivered a significant and
meaningful improvement in outcomes in this curative-intent
setting."
Dave Fredrickson, Executive Vice President, Oncology Business Unit,
AstraZeneca, said: "Today's approval of Imfinzi in resectable early-stage lung cancer builds
on its strong foundation of changing clinical practice in
unresectable Stage III disease. We remain committed to bringing
novel approaches like AEGEAN to early lung cancer settings where
cure is the goal of treatment."
Imfinzi was
generally well tolerated, and no new safety signals were observed
in the neoadjuvant and adjuvant settings. Further,
adding Imfinzi to
neoadjuvant chemotherapy was consistent with the known profile for
this combination and did not compromise patients' ability to
complete surgery versus chemotherapy alone.
Imfinzi is
also approved in the UK, Switzerland and Taiwan
(China) in this setting based on the AEGEAN results. Regulatory
applications are also currently under review in the EU, China and
several other countries in this indication.
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 chemoradiotherapy
based on the PACIFIC Phase III trial.
Notes
Lung cancer
Lung cancer is the leading cause of cancer death among both men and
women, accounting for about one-fifth of all cancer
deaths.1,7 Lung
cancer is broadly split into NSCLC and small cell lung cancer
(SCLC), with 80-85% of patients diagnosed with
NSCLC.8-9
Early-stage lung cancer diagnoses are often only made when the
cancer is found on imaging for an unrelated
condition.10-11 The
majority of patients with resectable disease eventually develop
recurrence despite complete tumour resection and adjuvant
chemotherapy.5
AEGEAN
AEGEAN is a randomised, double-blind, multi-centre,
placebo-controlled global Phase III trial
evaluating Imfinzi as perioperative treatment for patients with
resectable Stage IIA-IIIB (Eighth Edition AJCC Cancer Staging
Manual) NSCLC, irrespective of PD-L1 expression. Perioperative
therapy includes treatment before and after surgery, also known as
neoadjuvant/adjuvant therapy. In the trial, 802 patients were
randomised to receive a 1500mg fixed dose
of Imfinzi plus chemotherapy or placebo plus
chemotherapy every three weeks for four cycles prior to surgery,
followed by Imfinzi or placebo every four weeks (for up to 12
cycles) after surgery. Patients with known EGFR or ALK genomic
tumour aberrations were excluded from the primary efficacy
analyses.
In the AEGEAN trial, the primary endpoints were pCR, defined as no
viable tumour in the resection specimen (including lymph nodes)
following neoadjuvant therapy, and EFS, defined as the time from
randomisation to an event like tumour recurrence, progression
precluding definitive surgery, or death. Key secondary endpoints
were major pathologic response, defined as residual viable tumour
of less than or equal to 10% in the resected primary tumour
following neoadjuvant therapy, disease-free survival, overall
survival (OS), safety and quality of life. The final pathologic
response analyses were performed after all patients had the
opportunity for surgery and pathology assessment per the trial
protocol. The trial enrolled participants from 264 centres in more
than 25 countries including in the US, Canada, Europe, South
America and Asia.
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.
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
chemoradiotherapy. Imfinzi in combination with chemotherapy (etoposide
and either carboplatin or cisplatin) is also approved for the
treatment of extensive-stage SCLC and in combination with a short
course of Imjudo (tremelimumab) and chemotherapy for the
treatment of metastatic NSCLC.
In limited-stage SCLC, Imfinzi demonstrated statistically significant and
clinically meaningful improvements in the dual primary endpoints of
OS and progression-free survival compared to placebo in patients
who had not progressed following standard-of-care concurrent
chemoradiotherapy in the ADRIATIC Phase III
trial.
In addition to its indications in lung
cancers, Imfinzi is approved in combination with chemotherapy
(gemcitabine plus cisplatin) in locally advanced or metastatic
biliary tract cancer and in combination
with Imjudo in unresectable hepatocellular carcinoma
(HCC). Imfinzi is also approved as a monotherapy in
unresectable HCC in Japan and the EU and in combination with
chemotherapy (carboplatin plus paclitaxel) followed
by Imfinzi monotherapy in primary advanced or recurrent
endometrial cancer that is mismatch repair deficient in the
US.
Since the first approval in May 2017, more than 220,000 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
SCLC, NSCLC, breast cancer, bladder cancer, several
gastrointestinal and gynaecologic cancers, 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 and Imjudo; 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 is a pioneer in introducing the concept of
immunotherapy into dedicated clinical areas of high unmet medical
need. The Company 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 strives to redefine cancer care and help transform
outcomes for patients with Imfinzi as a monotherapy and in combination
with Imjudo as well as other novel immunotherapies and
modalities. The Company is also investigating next-generation
immunotherapies like bispecific antibodies and therapeutics that
harness different aspects of immunity to target cancer, including
cell therapy and T cell engagers.
AstraZeneca is 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. The Company is focused on
exploring novel combination approaches to help prevent treatment
resistance and drive longer immune responses. 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's innovative
medicines are sold in more than 125 countries and used by millions
of patients worldwide. Please visit astrazeneca.com and
follow the Company on social media @AstraZeneca.
Contacts
For details on how to contact the Investor Relations Team, please
click here.
For Media contacts, click here.
References
1. World
Health Organization. International Agency for Research on Cancer.
Lung Fact Sheet. Available at: https://gco.iarc.who.int/media/globocan/factsheets/cancers/15-trachea-bronchus-and-lung-fact-sheet.pdf.
Accessed August 2024.
2. American
Cancer Society. Key Statistics for Lung Cancer. Available
at: https://www.cancer.org/cancer/types/lung-cancer/about/key-statistics.html.
Accessed August 2024.
3. Cagle
PT, et al. Lung Cancer Biomarkers: Present Status and Future
Developments. Arch Pathol
Lab Med.
2013;137(9):1191-1198.
4. Le
Chevalier T. Adjuvant Chemotherapy for Resectable Non-Small-Cell
Lung Cancer: Where is it Going? Ann
Oncol.
2010;21(suppl 7):vii196-198.
5. Pignon JP,
et al. Lung
Adjuvant Cisplatin Evaluation: A Pooled Analysis by the LACE
Collaborative Group. J
Clin Oncol. 2008;26(21):3552-3559.
6. Goldstraw
P, et al. The IASLC Lung Cancer Staging Project: proposals
for the revision of the TNM stage groupings in the forthcoming
(seventh) edition of the TNM Classification of malignant
tumours. J Thorac
Oncol. 2007;2(8):706-14.
7. World
Health Organization. International Agency for Research on Cancer.
World Fact Sheet. Available at: https://gco.iarc.who.int/media/globocan/factsheets/populations/900-world-fact-sheet.pdf.
Accessed August 2024.
8. LUNGevity
Foundation. Types of Lung Cancer. Available at: https://www.lungevity.org/for-patients-caregivers/lung-cancer-101/types-of-lung-cancer.
Accessed August 2024.
9. 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.
10. Sethi S, et al. Incidental Nodule
Management - Should There Be a Formal
Process? J Thorac
Dis. 2016:8(Suppl
6);S494-S497.
11. LUNGevity
Foundation. Screening and Early Detection. Available
at: https://lungevity.org/for-patients-caregivers/lung-cancer-101/screening-early-detection.
Accessed August 2024.
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.
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AstraZeneca
PLC
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Date:
16 August 2024
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By: /s/
Adrian Kemp
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Name:
Adrian Kemp
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Title:
Company Secretary
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