TIDMAZN
RNS Number : 7385N
AstraZeneca PLC
22 May 2020
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(R) 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
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