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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 May 2020
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
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to the Commission pursuant to Rule 12g3-2(b) under the Securities
Exchange Act of 1934.
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assigned to the Registrant in connection with Rule 12g3-2(b):
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Enhertu granted Orphan
Drug Designation in the US for gastric
cancer
22 May 2020 07:00 BST
Enhertu granted Orphan Drug
Designation in the US for gastric
cancer
Designation follows recent US Breakthrough Therapy Designations for
Enhertu for HER2-positive metastatic gastric cancer and HER2-mutant
metastatic non-small cell lung cancer
AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi
Sankyo)'s Enhertu (trastuzumab deruxtecan) has been granted
Orphan Drug Designation (ODD) in the US for the treatment of
patients with gastric cancer, including gastroesophageal junction
cancer.
An estimated 27,600 new cases of gastric cancer will be diagnosed
this year and the disease could lead to more than 11,000 deaths in
the US in 2020.1
The Food and Drug Administration (FDA) grants ODD to medicines
intended for the treatment, diagnosis or prevention of rare
diseases or disorders that affect fewer than 200,000 people in the
US.
In the Phase II DESTINY-Gastric01
trial, patients with
HER2-positive metastatic gastric or gastroesophageal cancer who
were treated with Enhertu, a HER2-directed antibody drug conjugate (ADC),
demonstrated a statistically significant and clinically meaningful
improvement in objective response rate (ORR), the primary endpoint,
and overall survival (OS), a key secondary endpoint, versus
patients treated with investigator's choice of chemotherapy
(irinotecan or paclitaxel monotherapy).
The overall safety and tolerability profile
of Enhertu (6.4mg/kg) in DESTINY-Gastric01 was
consistent with that seen in the Phase I gastric cancer trial. The
most common adverse events were haematologic and gastrointestinal
including neutrophil count decrease, anaemia, nausea and decreased
appetite. There were cases of drug-related interstitial lung
disease (ILD) and pneumonitis, the majority of which were Grade 1
and 2, with two Grade 3 and one Grade 4. No Grade 5 events
(ILD-related deaths) occurred in patients with gastric cancer in
the Phase I trial or in the Phase II DESTINY-Gastric01
trial.
The full results of DESTINY-Gastric-01 will be presented during
the 2020 American Society of Clinical Oncology ASCO20 Virtual
Scientific Program, 29 to 31 May 2020.
Earlier this month, Enhertu received two Breakthrough Therapy
Designations for its potential use in HER2-positive unresectable or
metastatic gastric
cancer and HER2-mutant
metastatic non-small cell lung
cancer. Enhertu also
received SAKIGAKE designation from Japan's Ministry of Health
Labour and Welfare (MHLW) for potential use in HER2-positive
gastric cancer in March 2018. A supplemental New Drug Application
was recently submitted to the MHLW.
Gastric cancer
Gastric (stomach) cancer is the fifth most common cancer worldwide
and the third leading cause of cancer mortality with a five-year
survival rate of 5% for metastatic disease. There were
approximately one million new cases reported in 2018 and 783,000
deaths.2,3 In
the US, it is estimated that 27,600 new cases of gastric cancer
will be diagnosed in 2020 and more than 11,000 people will die from
the disease.1
Approximately one in five gastric cancers are HER2
positive.4,5 HER2
is a tyrosine kinase receptor growth-promoting protein expressed on
the surface of many types of tumours including gastric, breast and
lung cancers. Gastric cancer is usually diagnosed in the advanced
stage in the US, but even when diagnosed in earlier stages of the
disease the survival rate remains modest.6 Recommended
1st-line treatment for HER2-positive advanced or metastatic gastric
cancer is combination chemotherapy plus trastuzumab, an anti-HER2
medicine, which has been shown to improve survival outcomes when
added to chemotherapy. For gastric cancer that progresses on
1st-line treatment, there are no other approved HER2-targeted
medicines.7
DESTINY-Gastric01
DESTINY-Gastric01 is a Phase II, open-label, multi-centre trial
testing the safety and efficacy of Enhertu in a primary cohort of 188 patients from
Japan and South Korea with HER2-expressing, advanced gastric or
gastroesophageal junction adenocarcinoma (defined as IHC3+ or
IHC2+/ISH+) who have progressed on two or more prior treatment
regimens including fluoropyrimidine and platinum chemotherapy and
trastuzumab. Patients were randomised 2:1 to
receive Enhertu or investigator's choice of chemotherapy
(paclitaxel or irinotecan monotherapy). Patients were treated
with Enhertu 6.4mg/kg once every three weeks or
chemotherapy. The primary endpoint of the trial is ORR, as assessed
by an independent review committee. Secondary endpoints include OS,
progression-free survival, duration of response, disease control
rate and time to treatment failure as well as pharmacokinetic and
safety endpoints.8
Enhertu
Enhertu (trastuzumab
deruxtecan; fam-trastuzumab deruxtecan-nxki in the US) is a
HER2-directed ADC and is the lead ADC in the oncology
portfolio of Daiichi Sankyo and the most advanced programme in
AstraZeneca's ADC scientific platform. ADCs are targeted cancer
medicines that deliver cytotoxic chemotherapy ("payload") to cancer
cells via a linker attached to a monoclonal antibody that binds to
a specific target expressed on cancer cells.
Enhertu (5.4mg/kg) is
approved in the US and Japan for the treatment of adult patients
with unresectable or metastatic HER2-positive breast cancer who
have received two or more prior anti-HER2-based regimens based on
the DESTINY-Breast01 trial.
Enhertu clinical
development
A comprehensive development programme is underway globally with six
registrational trials evaluating the efficacy and safety
of Enhertu monotherapy across multiple HER2-targetable
cancers including breast, gastric and lung cancers. Trials in
combination with other anticancer treatments, such as
immunotherapy, are also underway.
Collaboration between AstraZeneca and Daiichi Sankyo
In March 2019, AstraZeneca and Daiichi Sankyo entered into a global
collaboration to jointly develop and
commercialise Enhertu worldwide, except in Japan where Daiichi
Sankyo maintains exclusive rights. Daiichi Sankyo is solely
responsible for manufacturing and supply.
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 six 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. In
addition to AstraZeneca's main capabilities, the Company is
actively pursuing innovative partnerships and investment that
accelerate the delivery of our strategy, as illustrated by the
investment in Acerta Pharma in haematology.
By harnessing the power of four scientific platforms -
Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response
and ADCs - 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/NYSE: 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. American Cancer
Society. Stomach Cancer: About Stomach Cancer. Available
at: https://www.cancer.org/cancer/stomach-cancer/about/key-statistics.html.
2. Bray F, et al. Global cancer
statistics 2018: GLOBOCAN estimates of incidence and mortality
worldwide for 36 cancers in 185 countries. CA Cancer J.
Clin. 2018;
68:394-424.
3. American Cancer
Society. Stomach Cancer: Early Detection, Diagnosis, and Staging.
Available at: https://www.cancer.org/cancer/stomach-cancer/detection-diagnosis-staging/survival-rates.html.
4.
American
Cancer Society. Stomach Cancer: Treating Stomach Cancer. Available
at: https://www.cancer.org/cancer/stomach-cancer/treating/targeted-therapies.html.
5. Iqbal N, Iqbal N. Human
Epidermal Growth Factor Receptor 2 (HER2) in Cancers:
Overexpression and Therapeutic
Implications. Mol Biol
Int. 2014;2014:852748.
doi:10.1155/2014/852748.
6. Curea F.G, et al. Current Targeted
Therapies in HER2-Positive Gastric
Adenocarcinoma. Cancer Biotherapy &
Radiopharmaceuticals. 2017;32
(10).
7.
NCCN Guidelines® Gastric Cancer. Version 4.2019. December 20,
2019: MS-22-36.
8.
ClinicalTrials.Gov. NCT03329690. Available
at: https://www.clinicaltrials.gov/ct2/show/NCT03329690.
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:
22 May 2020
|
By: /s/
Adrian Kemp
|
|
Name:
Adrian Kemp
|
|
Title:
Company Secretary
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