- Application based on results from the TROPION-Lung01 phase 3
trial
- If approved, Daiichi Sankyo and AstraZeneca’s datopotamab
deruxtecan may be the first TROP2 directed antibody drug conjugate
for patients with 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 locally advanced or metastatic nonsquamous non-small
cell lung cancer (NSCLC) who have received prior systemic
therapy.
Datopotamab deruxtecan is a specifically engineered TROP2
directed DXd antibody drug conjugate (ADC) 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 December 20, 2024.
The BLA is based on results from the pivotal TROPION-Lung01
phase 3 trial presented at a Presidential Symposium at the European
Society for Medical Oncology (#ESMO23) 2023 Congress. In the trial,
datopotamab deruxtecan demonstrated a statistically significant
improvement for the dual primary endpoint of progression-free
survival (PFS) compared to docetaxel, the current standard of care,
in patients with locally advanced or metastatic NSCLC treated with
at least one prior line of therapy. For the dual primary endpoint
of overall survival (OS), interim results numerically favored
datopotamab deruxtecan over docetaxel in the overall population,
however, results did not reach statistical significance at the time
of data cut-off. In patients with nonsquamous NSCLC, datopotamab
deruxtecan showed a clinically meaningful PFS benefit and a
numerically favorable OS trend. The trial is ongoing and OS will be
assessed at final analysis. The safety profile of datopotamab
deruxtecan was consistent with that observed in other ongoing
trials with no new safety concerns identified.
“Today’s news is an important step forward in our goal of
creating new standards of care that have the potential to transform
the treatment of patients with non-small cell lung cancer,” said
Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “We are
encouraged by the FDA's acceptance of the BLA as we endeavor to
make datopotamab deruxtecan the first TROP2 directed antibody drug
conjugate approved to treat patients with nonsquamous non-small
cell lung cancer after disease progression on prior systemic
therapy. We look forward to working closely with the FDA to bring
datopotamab deruxtecan to patients.”
“Datopotamab deruxtecan has the potential to offer patients with
previously treated advanced nonsquamous non-small cell lung cancer
an effective and tolerable alternative to conventional
chemotherapy,” said Susan Galbraith, MBBChir, PhD, Executive Vice
President, Oncology R&D, AstraZeneca. “With regulatory
discussions ongoing around the world and a parallel submission
underway in the U.S. in breast cancer, this is only the beginning
of our efforts to make this novel treatment available to patients
as quickly as possible.”
A parallel BLA for datopotamab deruxtecan based on results from
the pivotal TROPION-Breast01 phase 3 trial is pending acceptance in
the U.S. for the treatment of adult patients with metastatic
hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC
2+/ISH-) breast cancer. Additional regulatory submissions for
datopotamab deruxtecan in lung and breast cancer are underway
globally.
About TROPION-Lung01 TROPION-Lung01 is an ongoing global,
randomized, multicenter, open-label phase 3 trial evaluating the
efficacy and safety of datopotamab deruxtecan versus docetaxel in
patients with locally advanced or metastatic NSCLC with and without
actionable genomic alterations previously treated with at least one
prior line of therapy. Patients with actionable genomic alterations
were previously treated with platinum-based chemotherapy and an
approved targeted therapy. Patients without known actionable
genomic alterations were previously treated, concurrently or
sequentially, with platinum-based chemotherapy and a PD-1 or PD-L1
inhibitor.
The dual primary endpoints of TROPION-Lung01 are PFS as assessed
by blinded independent central review (BICR) and OS. Key secondary
endpoints include investigator-assessed PFS, objective response
rate, duration of response, time to response, disease control rate
as assessed by both BICR and investigator, and safety.
TROPION-Lung01 enrolled approximately 600 patients in Asia, Europe,
North America and South America. For more information visit
ClinicalTrials.gov.
About Advanced Non-Small Cell Lung Cancer Nearly 250,000
lung cancer cases were diagnosed in the U.S. in 2023.1 NSCLC is the
most common type of lung cancer, accounting for about 80% of
cases.1 Approximately 70% and 30% of NSCLC tumors are of
nonsquamous or squamous histology, respectively.2 While
immunotherapy and targeted therapies have improved outcomes in the
first-line setting, most patients eventually experience disease
progression and receive chemotherapy.3,4,5 For decades,
chemotherapy has been the last treatment available for patients
with advanced NSCLC, despite limited effectiveness and known side
effects.3,4,5
TROP2 is a protein broadly expressed in the majority of NSCLC
tumors.6 There is currently no TROP2 directed ADC approved for the
treatment of lung cancer.7,8
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 development program called TROPION is underway
globally with more than 14 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. Beyond the TROPION program, datopotamab deruxtecan
also is being evaluated in novel combinations in several ongoing
trials.
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 (Dato-DXd) 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 Cancer.net. Lung Cancer – Non-Small Cell: Statistics. Accessed
February 2024. 2 National Cancer Institute. SEER Cancer Statistics
Factsheets: Lung and Bronchus Cancer, 2015. Accessed February 2024.
3 Chen R, et al. J Hemal Oncol. 2020;13(1):58. 4 Majeed U, et al. J
Hematol Oncol. 2021;14(1):108 5 Pircher A, et al. Anticancer
Research. 2020;70(5):287-294. 6 Mito R, et al. Pathol Int.
2020;70(5):287-294. 7 Rodríguez-Abreau D et al. Ann Onc. 2021
Jul;32(7): 881-895. 8 American Cancer Society. Targeted Drug
Therapy for Non-Small Cell Lung Cancer. Accessed February 2024.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240216552444/en/
Media Contacts: Global/US: Jennifer Brennan Daiichi
Sankyo, Inc. jbrennan2@dsi.com +1 908 900 3183 (mobile)
Japan: Koji Ogiwara Daiichi Sankyo Co., Ltd.
ogiwara.koji.ay@daiichisankyo.co.jp +81 3 6225 1126 (office)
Investor Relations Contact:
DaiichiSankyoIR@daiichisankyo.co.jp
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