REG - AstraZeneca PLC - Enhertu DESTINY-PanTumor02 shows positive results

AstraZenecaAnnouncement

06/03/2023 07:00

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RNS Number : 9262R  AstraZeneca PLC  06 March 2023

06 March 2023 07:00 GMT

 

Enhertu showed clinically meaningful and durable responses across multiple
HER2-expressing tumour types in DESTINY-PanTumor02 Phase II trial

 

AstraZeneca and Daiichi Sankyo's Enhertu met prespecified criteria for
objective response rate and duration of response

 

Positive high-level results from an analysis of the ongoing DESTINY-PanTumor02
Phase II trial showed AstraZeneca and Daiichi Sankyo's Enhertu (trastuzumab
deruxtecan) met the prespecified target for objective response rate (ORR) and
demonstrated durable response across multiple HER2-expressing advanced solid
tumours in heavily pretreated patients.

 

Enhertu is a specifically engineered HER2-directed antibody drug conjugate
(ADC) being jointly developed and commercialised by AstraZeneca and Daiichi
Sankyo.

 

The DESTINY-PanTumor02 Phase II trial is evaluating the efficacy and safety of
Enhertu in patients with locally advanced, unresectable, or metastatic
previously treated, HER2-expressing solid tumours not eligible for curative
therapy, including biliary tract, bladder, cervical, endometrial, ovarian,
pancreatic, and rare cancers. The primary endpoint of the trial is
investigator-assessed confirmed ORR and investigator-assessed duration of
response (DoR) is a key secondary endpoint.

 

The data will be presented at an upcoming medical meeting and shared with
global regulatory authorities.

 

HER2 is a tyrosine kinase receptor protein expressed on the surface of various
tissue cells throughout the body and is involved in normal cell growth.(1,2)
In some cancer cells, HER2 expression is amplified or the cells have
activating mutations.(1,3) While HER2-directed therapies have been used to
treat breast, gastric and lung cancers, more research is needed evaluating
their potential role in treating other HER2-expressing tumour types.(2,4-6)

 

Cristian Massacesi, Chief Medical Officer and Oncology Chief Development
Officer, AstraZeneca, said, "Enhertu has already demonstrated its potential to
improve outcomes for patients with HER2-targetable breast, gastric and lung
cancers, and these positive initial results in other tumour settings with
significant unmet need are very encouraging. The DESTINY-PanTumor02 results
mark an important step forward in our understanding of the potential role of
Enhertu across multiple HER2-expressing tumour types."

 

Ken Takeshita, Global Head, R&D, Daiichi Sankyo, said, "The clinically
meaningful responses seen in the DESTINY-PanTumor02 trial reaffirm our belief
in the potential of Enhertu across multiple HER2-expressing cancers. The
results seen so far across multiple cohorts of the trial will inform next
steps of our broad development programme as we look to bring this important
medicine to as many patients as quickly as possible."

 

The safety profile observed in patients treated with Enhertu in the
DESTINY-PanTumor02 trial was consistent with that seen in other trials of
Enhertu with no new safety signals identified.

 

Notes

 

DESTINY-PanTumor02

DESTINY-PanTumor02 is a global, multicentre, multi-cohort, open-label Phase II
trial evaluating the efficacy and safety of Enhertu (5.4mg/kg) for the
treatment of HER2-expressing tumours, including biliary tract cancer, bladder
cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer
and rare tumours.

 

The primary efficacy endpoint of DESTINY-PanTumor02 is confirmed ORR as
assessed by investigator. Secondary endpoints include DoR, disease control
rate, progression-free survival, overall survival, safety, tolerability and
pharmacokinetics.

 

DESTINY-PanTumor02 has enrolled 268 patients at multiple sites in Asia, Europe
and North America. For more information about the trial, visit
ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT04482309) .

 

Enhertu

Enhertu is a HER2-directed ADC. Designed using Daiichi Sankyo's proprietary
DXd ADC technology, Enhertu is the lead ADC in the oncology portfolio of
Daiichi Sankyo and the most advanced programme in AstraZeneca's ADC scientific
platform. Enhertu consists of a HER2 monoclonal antibody attached to a
topoisomerase I inhibitor payload, an exatecan derivative, via a stable
tetrapeptide-based cleavable linker.

 

Enhertu (5.4mg/kg) is approved in more than 40 countries for the treatment of
adult patients with unresectable or metastatic HER2-positive breast cancer who
have received a (or one or more) prior anti-HER2-based regimen, either in the
metastatic setting or in the neoadjuvant or adjuvant setting, and have
developed disease recurrence during or within six months of completing therapy
based on the results from the DESTINY-Breast03 trial.

 

Enhertu (5.4mg/kg) is approved in more than 30 countries for the treatment of
adult patients with unresectable or metastatic HER2-low (immunohistochemistry
 IHC  1+ or IHC 2+/in-situ hybridisation  ISH -) breast cancer who have
received a prior systemic therapy in the metastatic setting or developed
disease recurrence during or within six months of completing adjuvant
chemotherapy based on the results from the DESTINY-Breast04 trial.

 

Enhertu (5.4mg/kg) is approved under accelerated approval in the US for the
treatment of adult patients with unresectable or metastatic non-small cell
lung cancer whose tumours have activating HER2 (ERBB2) mutations, as detected
by an FDA-approved test, and who have received a prior systemic therapy based
on the results from the DESTINY-Lung02 trial. Continued approval for this
indication may be contingent upon verification and description of clinical
benefit in a confirmatory trial.

 

Enhertu (6.4mg/kg) is approved in more than 30 countries for the treatment of
adult patients with locally advanced or metastatic HER2-positive gastric or
gastroesophageal junction adenocarcinoma who have received a prior
trastuzumab-based regimen based on the results from the DESTINY-Gastric01
trial and/or DESTINY-Gastric02 trial.

 

Enhertu development programme

A comprehensive global development programme is underway evaluating the
efficacy and safety of Enhertu monotherapy across multiple HER2-targetable
cancers. Trials in combination with other anticancer treatments, such as
immunotherapy, are also underway.

 

Daiichi Sankyo collaboration

Daiichi Sankyo Company, Limited (TSE: 4568) [referred to as Daiichi Sankyo]
and AstraZeneca entered into a global collaboration to jointly develop and
commercialise Enhertu (a HER2-directed ADC) in March 2019
(https://www.astrazeneca.com/media-centre/press-releases/2019/astrazeneca-and-daiichi-sankyo-enter-collaboration-for-novel-her-2-targeting-antibody-drug-conjugate.html)
, and datopotamab deruxtecan (DS-1062; a TROP2-directed ADC) in July 2020
(https://www.astrazeneca.com/media-centre/press-releases/2020/astrazeneca-and-daiichi-sankyo-enter-collaboration-to-develop-and-commercialise-new-antibody-drug-conjugate.html)
, except in Japan where Daiichi Sankyo maintains exclusive rights. Daiichi
Sankyo is responsible for the manufacturing and supply of Enhertu and
datopotamab deruxtecan.

 

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 operates in over 100 countries
and its innovative medicines are used by millions of patients worldwide.
Please visit astrazeneca.com (http://www.astrazeneca.com/)  and follow the
Company on Twitter @AstraZeneca (https://twitter.com/AstraZeneca) .

 

Contacts
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.

 

References

1.   ASCO. Breast Cancer. Available at:
https://www.cancer.net/sites/cancer.net/files/asco_answers_guide_breast.pdf
(https://www.cancer.net/sites/cancer.net/files/asco_answers_guide_breast.pdf)
. Accessed March 2023.

2.   Iqbal N, et al. Human Epidermal Growth Factor Receptor 2 (HER2) in
Cancers: Overexpression and Therapeutic Implications Mol Biol Int.
2014;852748.

3.   Omar N, et al. HER2-an emerging biomarker in non-breast and non-gastric
cancers. Pathogenesis. 2015;2(3):1-9.

4.   Wu VS, et al. From bench to bedside: What do we know about hormone
receptor-positive and human epidermal growth factor receptor 2-positive breast
cancer? J Steroid Biochem Mol Biol. 2015;153;45-53.

5.   American Cancer Society. Targeted Drug Therapy for Stomach Cancer.
Available at:
https://www.cancer.org/cancer/stomach-cancer/treating/targeted-therapies.html
(https://www.cancer.org/cancer/stomach-cancer/treating/targeted-therapies.html)
. Accessed March 2023.

6.   National Cancer Institute. Enhertu Marks First Targeted Therapy for
HER2-Mutant Lung Cancer. Available
at: https://www.cancer.gov/news-events/cancer-currents-blog/2022/fda-lung-cancer-enhertu-her2
(https://protect-de.mimecast.com/s/6CDdCz6rEAC48WmGpuXqeTP?domain=cancer.gov)
. Accessed March 2023.

 

Adrian Kemp

Company Secretary

AstraZeneca PLC

 

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