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AstraZeneca: Enhertu (trastuzumab deruxtecan) approved in the US for HER2-positive unresectable or metastatic breast cancer...

Accelerated Approval of AstraZeneca and Daiichi Sankyo's Enhertu based
on the DESTINY-Breast01 trial that showed clinically meaningful and
durable responses

AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo) today
announced that the US Food and Drug Administration (FDA) has approved
Enhertu (fam-trastuzumab deruxtecan-nxki) 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 in the
metastatic setting.

This indication is approved under Accelerated Approval based on tumour
response rate and duration of response. Continued approval for this
indication may be contingent upon verification and description of
clinical benefit in a confirmatory trial.

Enhertu is a HER2-directed antibody-drug conjugate (ADC) and the FDA
approval is based on the results of the registrational Phase II trial
DESTINY-Breast01 of Enhertu (5.4mg/kg) monotherapy in patients with
HER2-positive metastatic breast cancer. All patients received prior
trastuzumab, trastuzumab emtansine and 66% had prior pertuzumab.

The Phase II trial results showed a confirmed objective response rate
of 60.3% (n=111, 95% CI 52.9-67.4) including a 4.3% complete response
rate (n=8) and a 56.0% partial response rate (n=103). A median
duration of response of 14.8 months (95% CI 13.8-16.9) was
demonstrated as of 1 August 2019.[1] In addition, a median
progression-free survival of 16.4 months (95% CI 12.7-not estimable),
based upon a median duration of follow up of 11.1 months, was
recently presented at the San Antonio Breast Cancer Symposium and
published online in The New England Journal of Medicine

José Baselga, Executive Vice President, Oncology R&D, said: "Enhertu
has shown impressive results in women with HER2-positive metastatic
breast cancer, with the majority of women benefiting from treatment
and the median duration of the response exceeding 14 months. With
this first approval, we are proud to bring Enhertu to patients with
high unmet need and we look forward to further exploring its
potential in additional settings."

Antoine Yver, Executive Vice President and Global Head, Oncology R&D,
Daiichi Sankyo said: "The approval of Enhertu underscores that this
specifically engineered HER2-directed antibody-drug conjugate is
delivering on its intent to establish an important new treatment for
patients with HER2-positive metastatic breast cancer. Since the
beginning of our clinical trial programme four years ago, we have
focused on the opportunity to transform the treatment landscape for
patients with HER2-positive metastatic breast cancer, and we are
extremely proud of how quickly we delivered Enhertu to patients in
the US, as Enhertu represents one of the fastest-developed biologics
in oncology."

The safety of Enhertu has been evaluated in a pooled analysis from
both the Phase II trial DESTINY-Breast01 and the earlier Phase I
trial among a total of 234 patients with unresectable or metastatic
HER2-positive breast cancer who received at least one dose of Enhertu

The most common adverse reactions (greater than or equal to 20% of
patients) were nausea, fatigue, vomiting, alopecia and constipation.
Interstitial lung disease (ILD)/pneumonitis occurred in 9% of
patients. Fatal outcomes due to ILD/pneumonitis occurred in six
patients (2.6%) - two deaths previously reported in the Phase I trial
and four deaths previously reported in the Phase II trial
DESTINY-Breast01. Following an initial ILD management programme
already in place, a further monitoring, management and educational
campaign on ILD/pneumonitis was launched in 2019. Patients and
physicians should be aware of ILD/pneumonitis and patients should be
actively screened and monitored for potential signs and symptoms. If
ILD/pneumonitis is identified, it should be managed with dose
modification and steroid treatment according to management

A regulatory submission for the treatment of patients with
HER2-positive metastatic breast cancer has also been made to Japan's
Ministry of Health, Labour and Welfare based on the DESTINY-Breast01
and Phase I trials.

AstraZeneca and Daiichi Sankyo are exploring the further potential of
Enhertu in HER2-breast cancer with three ongoing Phase III trials.

Financial considerations

Following US approval, an amount of $125m is due from AstraZeneca to
Daiichi Sankyo as the first milestone payment in HER2-positive breast
cancer. Upon approval, this will be capitalised together with the
upfront payment already made earlier in the year 2019.

Future sales of Enhertu in the US will be recognised by Daiichi
Sankyo. AstraZeneca will report its share of gross profit margin from
the sales in the US as collaboration revenue in the Company's
financial statements. For further details on the financial
arrangements, please consult the announcement
of the collaboration agreement from March 2019.

About HER2-positive breast cancer

Approximately one in five breast cancers are HER2-positive.[3,4
]Despite recent improvements and approvals of new medicines, there
remains significant unmet needs for patients with HER2-positive
metastatic breast cancer.[5,6] This disease remains incurable with
patients eventually progressing after available treatments.[5,6 ]

About HER2

HER2 is a tyrosine kinase receptor growth-promoting protein found on
the surface of some cancer cells that is associated with aggressive
disease and poor prognosis in patients with breast cancer.7 To be
considered HER2-positive, tumour cancer cells are usually tested by
one of two methods: immunohistochemistry (IHC) or fluorescent in situ
hybridisation (FISH). IHC test results are reported as: 0, IHC 1+,
IHC 2+, or IHC 3+.[3] A finding of IHC 3+ and/or FISH amplification
is considered positive.[3]

About DESTINY-Breast01

DESTINY-Breast01 is a registrational Phase II, single-arm, open-label,
global, multicentre, two-part trial evaluating the safety and
efficacy of Enhertu in patients with HER2-positive unresectable
and/or metastatic breast cancer previously treated with trastuzumab
emtansine. The primary endpoint of the trial is objective response
rate, as determined by independent central review. Secondary
objectives include duration of response, disease control rate,
clinical benefit rate, progression-free survival and overall
survival. Enrolment into DESTINY-Breast01 was completed in September
2018 with 184 patients at more than 100 sites globally.

About Enhertu

Enhertu (fam-trastuzumab deruxtecan-nxki in the US only; trastuzumab
deruxtecan outside the US) is the lead product in the ADC Franchise
of the Daiichi Sankyo Cancer Enterprise 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.

About Enhertu clinical development

A comprehensive development programme is underway globally with five
registrational trials in HER2-expressing metastatic breast and
gastric cancers including a trial in patients with metastatic breast
cancer and low levels of HER2 expression. Phase II trials are
underway for HER2-expressing advanced colorectal cancer, as well as
metastatic non-squamous HER2-overexpressing or HER2-mutated non-small
cell lung cancer. Trials in combination with other anticancer
treatments, such as immunotherapy, are also underway.

About the 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.

About 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 at least six
new medicines to be launched between 2014 and 2020, and a broad
pipeline of small molecules and biologic medicines 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 investments 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 Antibody-Drug Conjugates - 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.

About 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 and Metabolism, and Respiratory. AstraZeneca
operates in over 100 countries and its innovative medicines are used
by millions of patients worldwide. Please visit
( and follow the Company on Twitter
@AstraZeneca (

Media Relations
Gonzalo Viña +44 203 749 5916
Rob Skelding Oncology +44 203 749 5821
Rebecca Einhorn Oncology +1 301 518 4122
Matt Kent BioPharmaceuticals +44 203 749 5906
Jennifer Hursit Other +44 203 749 5762
Christina Sweden +46 8 552 53 106
Michele Meixell US +1 302 885 2677

Thomas Kudsk +44 203 749 5712

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