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 June 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 the US for endometrial
cancer
17 June 2024
Imfinzi plus
chemotherapy approved in the US for
mismatch repair deficient advanced or recurrent endometrial
cancer
Approval based on DUO-E trial results, which showed Imfinzi reduced
the
risk of disease progression or death by 58% vs.
chemotherapy
AstraZeneca's Imfinzi (durvalumab) in combination with carboplatin
and paclitaxel followed by Imfinzi monotherapy has been approved in the US as
treatment for adult patients with primary advanced or recurrent
endometrial cancer that is mismatch repair deficient
(dMMR).1
The approval by the Food and Drug Administration (FDA) was based on
the results of a prespecified exploratory subgroup analysis by MMR
status in the DUO-E Phase
III trial. Results from
DUO-E were published in the Journal
of Clinical Oncology.
In the trial, Imfinzi plus carboplatin and paclitaxel followed
by Imfinzi monotherapy (Imfinzi arm) reduced the risk of disease progression
or death by 58% in patients with dMMR endometrial cancer versus
chemotherapy alone (hazard ratio 0.42; 95% confidence interval
0.22-0.80).2
In the US, endometrial cancer is the fourth most common cancer in
women, with more than 66,000 patients diagnosed and almost 12,000
deaths in 2022.3,4 Patients
diagnosed at an early stage of disease have a five-year survival
rate of approximately 80-90%, but there is a significant need for
new treatment options for people with advanced disease, where the
survival rate falls to less than 20%.5,6
Shannon N. Westin, Professor of Gynecologic Oncology and
Reproductive Medicine at The University of Texas MD Anderson Cancer
Center, and principal investigator of the trial, said, "With the
incidence and mortality of endometrial cancer expected to continue
to increase significantly in the coming decades, it is more
important than ever that we bring new treatment options to patients
at the earliest possible moment in their care. This approval
underlines clear evidence that durvalumab plus chemotherapy
followed by durvalumab monotherapy delivers important clinical
benefits for patients with mismatch repair deficient endometrial
cancer."
Dave Fredrickson, Executive Vice President, Oncology Business
Unit, AstraZeneca, said: "There have been limited advances in the
treatment of endometrial cancer in the last few decades, and
continued innovation is critical as the burden of this cancer is
expected to grow in the future. Immunotherapy in combination with
chemotherapy is emerging as a new standard of care in this setting,
and the approval of Imfinzi offers an important new option for patients
with mismatch repair deficient disease."
The safety and tolerability profile of the Imfinzi and chemotherapy regimen was generally
manageable, well tolerated and broadly consistent with prior
clinical trials with no new safety signals.1,2
The Lynparza (olaparib) and Imfinzi arm, which
investigated Imfinzi plus chemotherapy followed
by Imfinzi plus Lynparza as maintenance therapy, also met the primary
endpoint of progression-free survival (PFS). The trial
continues to assess OS as a key secondary endpoint for both arms.
Regulatory applications for both Imfinzi as well as Imfinzi and Lynparza regimens are currently under review in
the EU, Japan and several other countries based on the DUO-E
results.
Notes
Endometrial cancer
Endometrial cancer is a highly heterogeneous disease that
originates in the tissue lining of the uterus and is most common in
women who have already been through menopause, with the average age
at diagnosis being over 60 years old.7-10 It
is the sixth most common cancer in women
worldwide.11,12 Incidence
and mortality of endometrial cancer are expected to increase by
approximately 61% and 87% respectively (from 420,400 cases and
97,700 deaths in 2022 to 676,300 cases and 183,100 deaths) in
2050.13
The majority of patients with endometrial cancer are diagnosed at
an early stage of disease, where the cancer is confined to the
uterus.9,10 They
are typically treated with surgery and/or radiation, and the
five-year survival rate is high (approximately
80-90%).5,6 Patients
with advanced disease (Stage III-IV) usually have a much poorer
prognosis, with the five-year survival rate falling to less than
20%.5,6 Immunotherapy
combined with chemotherapy is emerging as a new standard of care
for advanced endometrial cancer, particularly for patients with
dMMR disease, who make up approximately 20-30% of all patients with
this type of cancer.6,14,15,16 There
remains a high unmet need for treatments for the remaining 70-80%
of endometrial cancer patients with pMMR
disease.15,16
DUO-E
The DUO-E trial (GOG 3041/ENGOT-EN10) is a three-arm, randomised,
double-blind, placebo-controlled, multicentre Phase III trial of
1st-line Imfinzi (durvalumab)
plus platinum-based chemotherapy (carboplatin and paclitaxel)
followed by either Imfinzi monotherapy or Imfinzi plus Lynparza (olaparib) as maintenance therapy versus
platinum-based chemotherapy alone as a treatment for patients with
newly diagnosed advanced or recurrent endometrial
cancer.
The DUO-E trial randomised 699 patients with newly diagnosed
advanced or recurrent epithelial endometrial carcinoma to receive
either Imfinzi (1120mg) or placebo, given every three weeks
in addition to standard-of-care platinum-based chemotherapy. After
4-6 cycles of chemotherapy, patients (whose disease had not
progressed) then received either Imfinzi (1500mg) or placebo every four weeks as
maintenance, plus 300mg Lynparza (300mg BID [2x150mg tablets, twice a day])
or placebo until disease progression.
The dual primary endpoint was PFS of each treatment arm versus
standard of care. Key secondary endpoints included overall survival
(OS), safety and tolerability. The trial continues to assess OS for
both Imfinzi monotherapy and Imfinzi plus Lynparza as maintenance therapy in the overall trial
population. Mismatch repair (MMR) status, recurrence status and
geographic location were stratification factors. The trial was
sponsored independently by AstraZeneca and conducted in 253 study
locations across 22 countries including the US, Europe, South
America and Asia.
For more information about the trial, please
visit ClinicalTrials.gov.
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 indications in unresectable, Stage III NSCLC and
ES-SCLC, Imfinzi is currently approved in a number of
countries in combination with a short course of
tremelimumab (Imjudo) and chemotherapy for the treatment of metastatic
NSCLC.
Imfinzi is also approved
in a number of countries in combination with chemotherapy 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.
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, bladder cancer, breast cancer, several
gastrointestinal cancers and other solid
tumours.
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 aims to reimagine cancer care and help
transform outcomes for patients with Imfinzi as monotherapy 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'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. Imfinzi (durvalumab) US prescribing information; Jun
2024.
2. Shannon
N. Westin et al. Durvalumab Plus Carboplatin/Paclitaxel
Followed by Maintenance Durvalumab With or Without Olaparib as
First-Line Treatment for Advanced Endometrial Cancer: The Phase III
DUO-E Trial. JCO 42, 283-299(2024).
3. World Health Organization. IARC.
Absolute numbers, Incidence, Females, in 2022. United States of
America. Available at: https://gco.iarc.fr/today/en/dataviz/pie?mode=cancer&cancers=24&sexes=2&group_populations=1&populations=840.
Accessed Jun 2024.
4. World Health Organization. IARC.
Corpus Uteri. Estimated numbers from 2022 to 2050, United States,
Females, age [0-85+]. Available at: https://gco.iarc.who.int/tomorrow/en/dataviz/trends?multiple_populations=1&cancers=24&populations=840.
Accessed Jun 2024.
5.
Cao SY, et al. Recurrence and survival of patients with stage III
endometrial cancer after radical surgery followed by adjuvant
chemo- or chemoradiotherapy: a systematic review and meta-analysis.
BMC Cancer. 2023 Jan 9;23(1):31.
6. Haj
Hamoud B, et al. The Evolving Landscape Of Immunotherapy In
Uterine Cancer: A Comprehensive Review. Life.
2023;13(7):1502.
7.
Dork T, et al. Genetic Susceptibility to Endometrial Cancer: Risk
Factors and Clinical Management. Cancers (Basel).
2020;12(9):2407.
8. American Cancer Society. What is
Endometrial Cancer? Available at https://www.cancer.org/cancer/endometrial-cancer/about/what-is-endometrial-cancer.html.
Accessed Jun 2024.
9. Oakin
A, et al. ESMO Guidelines. Endometrial Cancer: ESMO Clinical
Practice Guidelines for Diagnosis, Treatment and Follow-Up. Ann
Oncol. 2022;33(9):860-877.
10.
Cancer.Net. Uterine Cancer: Statistics. Available at:
https://www.cancer.net/cancer-types/uterine-cancer/statistics.
Accessed Jun 2024.
11.
World Cancer Research Fund International. Endometrial Cancer
Statistics. Available at
https://www.wcrf.org/cancer-trends/endometrial-cancer-statistics/.
Accessed Jun 2024.
12. World Health Organisation. IARC. Corpus
Uteri. Absolute numbers, Incidence, Females in 2022. Available
at: https://gco.iarc.who.int/today/en/dataviz/pie?mode=cancer&group_populations=1&populations=900&sexes=2.
Accessed Jun 2024.
13. World Health Organization. IARC. Corpus
Uteri. Estimated Numbers From 2022 To 2050, Females, Age [0-85+]
World. Available at https://gco.iarc.who.int/tomorrow/en/dataviz/trends?multiple_populations=1&cancers=24.
Accessed Jun 2024.
14. Gov.uk. MHRA Authorises Monoclonal
Antibody Treatment, Jemperli, To Be Used With Chemotherapy For
Endometrial Cancer. Available at https://www.gov.uk/government/news/mhra-authorises-monoclonal-antibody-treatment-jemperli-to-be-used-with-chemotherapy-for-endometrial-cancer.
Accessed Jun 2024.
15.
Yang Y, et al. Molecular Subtypes Of Endometrial Cancer:
Implications For Adjuvant Treatment Strategies. International
Journal of Gynecology & Obstetrics. 2023;00:1-24.
16.
Kelkar SS, et al. Treatment Patterns And Real-World Clinical
Outcomes In Patients With Advanced Endometrial Cancer That Are
Non-Microsatellite Instability High (Non-MSI-High) Or Mismatch
Repair Proficient (Pmmr) In The United States. Gynecologic Oncology
Reports. 2022;42:101026.
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:
17 June 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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