- Application based on results from the TROPION-Breast01 phase 3
trial
- Additional BLA under review in the U.S. for Daiichi Sankyo and
AstraZeneca’s datopotamab deruxtecan for patients with advanced
nonsquamous non-small cell lung cancer
Daiichi Sankyo (TSE: 4568) and AstraZeneca’s (LSE/STO/Nasdaq:
AZN) Biologics License Application (BLA) for datopotamab deruxtecan
(Dato-DXd) has been accepted in the U.S. for the treatment of adult
patients with unresectable or metastatic hormone receptor (HR)
positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast
cancer who have received prior systemic therapy for unresectable or
metastatic disease.
Datopotamab deruxtecan is a specifically engineered TROP2
directed DXd antibody drug conjugate (ADC) discovered by Daiichi
Sankyo and being jointly developed by Daiichi Sankyo and
AstraZeneca.
The Prescription Drug User Fee Act (PDUFA) date, the U.S. Food
and Drug Administration (FDA) action date for its regulatory
decision, is January 29, 2025.
The BLA is based on results from the pivotal TROPION-Breast01
phase 3 trial, which were presented at a Presidential Symposium at
the European Society for Medical Oncology (#ESMO23) 2023 Congress
and in an oral presentation at the 2023 San Antonio Breast Cancer
Symposium (#SABCS23). In the trial, datopotamab deruxtecan
demonstrated a statistically significant and clinically meaningful
improvement for the dual primary endpoint of progression-free
survival (PFS) compared to investigator’s choice of chemotherapy in
patients with unresectable or metastatic HR positive, HER2 negative
breast cancer previously treated with endocrine-based therapy and
at least one systemic therapy. For the dual primary endpoint of
overall survival (OS), interim results numerically favored
datopotamab deruxtecan over chemotherapy but were not mature at the
time of data cut-off. The trial is ongoing and OS will be assessed
at future analyses. The safety profile of datopotamab deruxtecan
was consistent with that observed in other ongoing trials with no
new safety concerns identified. The most common grade 3 or higher
treatment-related adverse events in the datopotamab deruxtecan and
chemotherapy arms, respectively, were neutropenia (1% vs. 31%),
stomatitis (6% vs. 3%), fatigue (2% vs. 2%) and anemia (1% vs.
2%).
“The FDA’s acceptance of the BLA brings us closer to providing
patients with previously treated HR positive, HER2 negative breast
cancer an alternative option to conventional chemotherapy earlier
in the metastatic setting,” said Ken Takeshita, MD, Global Head,
R&D, Daiichi Sankyo. “Following our recently accepted
application for advanced nonsquamous non-small cell lung cancer in
the U.S., along with additional regulatory reviews underway in
China, the EU, Japan and other regions, we are working swiftly to
bring datopotamab deruxtecan as a potential new treatment option to
patients around the world.”
“Despite marked progress in the treatment of HR positive, HER2
negative breast cancer, most patients with advanced disease develop
endocrine resistance and face the prospect of one or several lines
of chemotherapy,” said Susan Galbraith, MBBChir, PhD, Executive
Vice President, Oncology R&D, AstraZeneca. “If approved,
datopotamab deruxtecan has the potential to provide these patients
an efficacious and better tolerated alternative to conventional
chemotherapy.”
An additional BLA for datopotamab deruxtecan based on results
from the pivotal TROPION-Lung01 phase 3 trial is under review in
the U.S. for the treatment of adult patients with locally advanced
or metastatic nonsquamous non-small cell lung cancer (NSCLC) who
have received prior systemic therapy. Additional regulatory
submissions for datopotamab deruxtecan in lung and breast cancer
are underway globally.
About TROPION-Breast01 TROPION-Breast01 is a global,
randomized, multicenter, open-label phase 3 trial evaluating the
efficacy and safety of datopotamab deruxtecan versus investigator’s
choice of single-agent chemotherapy (eribulin, capecitabine,
vinorelbine or gemcitabine) in patients with unresectable or
metastatic HR positive, HER2 negative (IHC 0, IHC 1+ or IHC
2+/ISH-) breast cancer who have progressed on and are not suitable
for endocrine therapy per investigator assessment and have received
at least one additional systemic therapy for unresectable or
metastatic disease.
The dual primary endpoints of TROPION-Breast01 are PFS as
assessed by blinded independent central review and OS. Key
secondary endpoints include objective response rate, duration of
response, investigator-assessed PFS, disease control rate, time to
first subsequent therapy and safety. TROPION-Breast01 enrolled more
than 700 patients in Africa, Asia, Europe, North America and South
America. For more information visit ClinicalTrials.gov.
About Hormone Receptor Positive, HER2 Negative Breast
Cancer More than 275,000 breast cancer cases were diagnosed in
the U.S. in 2022.1 HR positive, HER2 negative breast cancer is the
most common subtype, accounting for more than 65% of diagnosed
cases.2 Breast cancer is considered HR positive, HER2 negative when
tumors test positive for estrogen and/or progesterone hormone
receptors and negative for HER2 (measured as HER2 score of IHC 0,
IHC 1+ or IHC 2+/ISH-).2,3 Standard initial treatment for this
subtype of breast cancer is endocrine therapy but most patients
with advanced disease will develop resistance, underscoring the
need for additional options.4,5
TROP2 is a protein broadly expressed in HR positive, HER2
negative breast cancer and is associated with increased tumor
progression and poor survival.6,7
About Datopotamab Deruxtecan (Dato-DXd) Datopotamab
deruxtecan (Dato-DXd) is an investigational TROP2 directed ADC.
Designed using Daiichi Sankyo’s proprietary DXd ADC Technology,
datopotamab deruxtecan is one of six DXd ADCs in the oncology
pipeline of Daiichi Sankyo, and one of the most advanced programs
in AstraZeneca’s ADC scientific platform. Datopotamab deruxtecan is
comprised of a humanized anti-TROP2 IgG1 monoclonal antibody,
developed in collaboration with Sapporo Medical University,
attached to a number of topoisomerase I inhibitor payloads (an
exatecan derivative, DXd) via tetrapeptide-based cleavable
linkers.
A comprehensive global clinical development program is underway
with more than 20 trials evaluating the efficacy and safety of
datopotamab deruxtecan across multiple cancers, including NSCLC,
triple negative breast cancer and HR positive, HER2 negative breast
cancer.
About the Daiichi Sankyo and AstraZeneca Collaboration
Daiichi Sankyo and AstraZeneca entered into a global collaboration
to jointly develop and commercialize ENHERTU in March 2019 and
datopotamab deruxtecan in July 2020, except in Japan where Daiichi
Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is
responsible for the manufacturing and supply of ENHERTU and
datopotamab deruxtecan.
About the DXd ADC Portfolio of Daiichi Sankyo The DXd ADC
portfolio of Daiichi Sankyo currently consists of six ADCs in
clinical development across multiple types of cancer. ENHERTU, a
HER2 directed ADC, and datopotamab deruxtecan, a TROP2 directed
ADC, are being jointly developed and commercialized globally with
AstraZeneca. Patritumab deruxtecan (HER3-DXd), a HER3 directed ADC,
ifinatamab deruxtecan (I-DXd), a B7-H3 directed ADC, and
raludotatug deruxtecan (R-DXd), a CDH6 directed ADC, are being
jointly developed and commercialized globally with Merck & Co.,
Inc., Rahway, N.J. USA. DS-3939, a TA-MUC1 directed ADC, is being
developed by Daiichi Sankyo.
Designed using Daiichi Sankyo’s proprietary DXd ADC Technology
to target and deliver a cytotoxic payload inside cancer cells that
express a specific cell surface antigen, each ADC consists of a
monoclonal antibody attached to a number of topoisomerase I
inhibitor payloads (an exatecan derivative, DXd) via
tetrapeptide-based cleavable linkers.
Datopotamab deruxtecan, ifinatamab deruxtecan, patritumab
deruxtecan, raludotatug deruxtecan and DS-3939 are investigational
medicines that have not been approved for any indication in any
country. Safety and efficacy have not been established.
About Daiichi Sankyo Daiichi Sankyo is an innovative
global healthcare company contributing to the sustainable
development of society that discovers, develops and delivers new
standards of care to enrich the quality of life around the world.
With more than 120 years of experience, Daiichi Sankyo leverages
its world-class science and technology to create new modalities and
innovative medicines for people with cancer, cardiovascular and
other diseases with high unmet medical need. For more information,
please visit www.daiichisankyo.com.
References: 1 World Health Organization. Global Cancer
Observatory: United States of America. Accessed April 2024. 2
National Cancer Institute. SEER cancer stat facts: female breast
cancer subtypes. Accessed April 2024. 3 Iqbal N, et al. Mol Biol
Int. 2014;852748. 4 Lin M, et al. J Cancer. 2020;
10.7150/jca.48944. 5 Lloyd MR, et al. Clin Cancer Res.
2022;28(5):821-30. 6 Goldenberg D, et al. Oncotarget. 2018;9(48):
28989-29006. 7 Vidula N, et al. Breast Cancer Res Treat. 2022
Aug;194(3):569-575.
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version on businesswire.com: https://www.businesswire.com/news/home/20240329281783/en/
Media:
Global/US: Jennifer Brennan Daiichi Sankyo, Inc.
jbrennan2@dsi.com +1 908 900 3183 (mobile)
Japan: Daiichi Sankyo Co., Ltd.
DS-PR@daiichisankyo.co.jp
Investor Relations:
DaiichiSankyoIR@daiichisankyo.co.jp
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