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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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Enhertu granted Breakthrough
Therapy Designation in the US for HER2-positive metastatic
gastric cancer
11 May 2020 07:00 BST
Enhertu granted Breakthrough
Therapy Designation
in the US for HER2-positive metastatic gastric
cancer
Second US
Breakthrough Therapy Designation for Enhertu
AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi
Sankyo)'s Enhertu (trastuzumab deruxtecan) has been granted
Breakthrough Therapy Designation (BTD) in the US for the treatment
of patients with HER2-positive unresectable or metastatic gastric
or gastroesophageal junction adenocarcinoma who have received two
or more prior regimens including trastuzumab.
Gastric cancer is the third leading cause of cancer
mortality with a five-year survival rate of 5% for metastatic
disease.1,2 Approximately
one in five gastric cancers are considered HER2
positive.3,4
The Food and Drug Administration's (FDA) BTD is designed to
accelerate the development and regulatory review of potential new
medicines that are intended to treat a serious condition and
address a significant unmet medical need. The new medicine needs to
have shown encouraging early clinical results that demonstrate
substantial improvement on a clinically significant endpoint over
available medicines.
José Baselga, Executive Vice President, R&D Oncology,
said: "Current therapy options are limited for patients with
HER2-positive metastatic gastric cancer and for those who relapse,
there are no approved HER2-targeted medicines. We look forward to
working with the FDA to further explore the potential
of Enhertu to become an important new treatment and the
first antibody drug conjugate for this devastating
disease."
Gilles Gallant, Senior Vice President, Global Head, Oncology
Development, Oncology R&D, Daiichi Sankyo, said:
"DESTINY-Gastric01 represents the first randomised trial
of Enhertu to demonstrate clinically meaningful and
statistically significant results, including objective response and
survival increases compared to physician's choice of chemotherapy.
We are thrilled that the FDA has granted Enhertu a second Breakthrough Therapy
Designation."
The FDA granted BTD based on data from the registrational Phase II
DESTINY-Gastric01 trial and data from the Phase I trial published
in The
Lancet Oncology.5,6 In
DESTINY-Gastric01, patients 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 (6.4 mg/kg) in DESTINY-Gastric01 was
consistent with that seen in the Phase I 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 ILD-related deaths (Grade 5) 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.
Enhertu received SAKIGAKE
designation in March 2018 by Japan's Ministry of Health, Labour and
Welfare (MHLW) for potential use in the same HER2-positive gastric
cancer patient population and was recently submitted to the MHLW
for approval. This is the second BTD
granted for Enhertu in the US. Enhertu received
BTD in 2017 for HER2-positive metastatic breast cancer and
received approval in
December 2019.
Gastric cancer
Gastric (stomach) cancer is the fifth most common cancer worldwide
and the third leading cause of cancer mortality; there were
approximately one million new cases reported in 2018 and 783,000
deaths.1 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.7
Approximately one in five gastric cancers are HER2
positive.2,4 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, but even when diagnosed in earlier stages of the disease the
survival rate remains modest.8 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-targeting
medicines.9
DESTINY-Gastric01
DESTINY-Gastric01 is a registrational 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 cancer
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 6.4 mg/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.5
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 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-driven
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. 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.
2. 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.
3.
American
Cancer Society. Stomach Cancer: Treating Stomach Cancer. Available
at: https://www.cancer.org/cancer/stomach-cancer/treating/targeted-therapies.html.
4. 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.
5.
ClinicalTrials.Gov. NCT03329690. Available
at: https://www.clinicaltrials.gov/ct2/show/NCT03329690?term=ds-8201&cond=Gastric+Cancer&draw=2&rank=1
6. Shitara, K, et al. Trastuzumab
deruxtecan (DS-8201a) in patients with advanced HER2-positive
gastric cancer: a dose-expansion, phase 1
study. Lancet
Oncol. 2019;
20:827-36.
7. American
Cancer Society. Stomach Cancer: About Stomach Cancer. Available
at: https://www.cancer.org/cancer/stomach-cancer/about/key-statistics.html.
8.
Curea F.G, et al. Current Targeted Therapies in
HER2-Positive.
9.
NCCN Guidelines® Gastric Cancer. Version 4.2019. December 20,
2019: MS-22-36.
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 May
2020
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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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