Daiichi Sankyo (TSE: 4568) and Merck (NYSE: MRK), known as MSD
outside of the United States and Canada, today announced that the
first patient has been dosed in the IDeate-Lung02 phase 3 trial
evaluating the efficacy and safety of investigational ifinatamab
deruxtecan (I-DXd) in patients with relapsed small cell lung cancer
(SCLC) versus treatment of physician’s choice of chemotherapy.
Ifinatamab deruxtecan is a specifically engineered potential
first-in-class B7-H3 directed DXd antibody drug conjugate (ADC)
discovered by Daiichi Sankyo and being jointly developed by
Merck.
Small cell lung cancer is the second most common type of lung
cancer, accounting for about 15% of cases.1 SCLC is aggressive and
progresses rapidly to the metastatic stage, which has a five-year
survival rate of only 3%.2,3 Approximately 65% of all SCLC tumors
have a moderate-to-high expression of the protein B7-H3, which is
associated with disease progression and poor prognosis.4,5
“Patients living with small cell lung cancer face poor outcomes
with currently available treatments,” said Mark Rutstein, MD,
Global Head, Oncology Clinical Development, Daiichi Sankyo. “The
IDeate-Lung02 trial is an important next step as we look to better
understand the role of ifinatamab deruxtecan as a potential new
medicine for patients with certain types of small cell lung
cancer.”
“The initiation of the IDeate-Lung02 trial for ifinatamab
deruxtecan marks the second pivotal study since the start of our
collaboration with Daiichi Sankyo and follows the recent initiation
of the REJOICE-Ovarian01 phase 2/3 study for raludotatug
deruxtecan,” said Marjorie Green, MD, Senior Vice President and
Head of Oncology, Global Clinical Development, Merck Research
Laboratories. “This is a significant milestone as we work together
to evaluate an innovative medicine that may have the potential to
make a meaningful difference in the lives of people facing small
cell lung cancer, a difficult-to-treat cancer.”
The initiation of IDeate-Lung02 is based on updated results from
a subgroup analysis of the IDeate-PanTumor01 phase 1/2 trial of
ifinatamab deruxtecan presented at the 2023 World Conference on
Lung Cancer hosted by the International Association for the Study
of Lung Cancer.
About the IDeate-Lung02 Trial IDeate-Lung02 is a global,
multicenter, randomized, open-label phase 3 trial evaluating the
efficacy and safety of ifinatamab deruxtecan (I-DXd) versus
treatment of physician’s choice of chemotherapy (amrubicin,
lurbinectedin or topotecan) in patients with relapsed SCLC
following disease progression with only one prior line of
platinum-based chemotherapy. Eligible patients will be randomized
to receive ifinatamab deruxtecan (12 mg/kg) or physician’s choice
of chemotherapy.
The dual primary endpoints are objective response rate (ORR) as
assessed by blinded independent central review (BICR) and overall
survival. Secondary endpoints include ORR as assessed by
investigator, and progression-free survival, duration of response,
disease control rate and time to response – all assessed by both
BICR and investigator.
IDeate-Lung02 is expected to enroll approximately 460 patients
across Asia, Europe, Oceania, North America and South America. For
more information, please visit ClinicalTrials.gov.
About Small Cell Lung Cancer More than 2.48 million lung
cancer cases were diagnosed globally in 2022.6 Small cell lung
cancer is the second most common type of lung cancer, accounting
for about 15% of cases.1 SCLC is aggressive and progresses rapidly
to the metastatic stage, which has a five-year survival rate of
only 3%.2,3 While conventional first-line therapy for patients with
advanced SCLC may help some patients live longer, the current
second-line standard of care offers limited clinical benefit and
new treatment approaches are needed.7,8,9,10
About B7-H3 B7-H3 is a transmembrane protein that belongs
to the B7 family of proteins which bind to the CD28 family of
receptors that includes PD-1.11,12 B7-H3 is overexpressed in a wide
range of cancer types, including small cell lung cancer, and its
overexpression has been shown to correlate with poor prognosis,
making B7-H3 a promising therapeutic target.4,12,13,14,15 There are
currently no B7-H3 directed medicines approved for the treatment of
any cancer.
About Ifinatamab Deruxtecan Ifinatamab deruxtecan (I-DXd)
is an investigational, potential first-in-class B7-H3 directed ADC.
Designed using Daiichi Sankyo’s proprietary DXd ADC Technology,
ifinatamab deruxtecan is comprised of a humanized anti-B7-H3 IgG1
monoclonal antibody attached to a number of topoisomerase I
inhibitor payloads (an exatecan derivative, DXd) via
tetrapeptide-based cleavable linkers.
Ifinatamab deruxtecan is being evaluated in a global development
program, which includes IDeate-Lung02, a phase 3 trial in patients
with relapsed SCLC versus investigator’s choice of chemotherapy,
IDeate-Lung01, a phase 2 monotherapy trial in patients with
previously treated extensive-stage SCLC and IDeate-PanTumor01, a
phase 1/2 first-in-human trial in collaboration with Sarah Cannon
Research Institute (SCRI) with study operational oversight and
delivery provided through SCRI’s early phase oncology clinical
research organization, SCRI Development Innovations in Nashville,
TN. Ifinatamab deruxtecan was granted orphan drug designation by
the U.S. Food and Drug Administration in April 2023 and by the
European Commission in February 2024 for the treatment of SCLC.
About the Daiichi Sankyo and Merck Collaboration Daiichi
Sankyo and Merck (known as MSD outside of the United States and
Canada) entered into a global collaboration in October 2023 to
jointly develop and commercialize patritumab deruxtecan (HER3-DXd),
ifinatamab deruxtecan (I-DXd) and raludotatug deruxtecan (R-DXd),
except in Japan where Daiichi Sankyo will maintain exclusive
rights. Daiichi Sankyo will be solely responsible for manufacturing
and supply.
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 (Dato-DXd), 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. 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 needs. For more information,
please visit www.daiichisankyo.com.
Merck’s Focus on Cancer Every day, we follow the science
as we work to discover innovations that can help patients, no
matter what stage of cancer they have. As a leading oncology
company, we are pursuing research where scientific opportunity and
medical need converge, underpinned by our diverse pipeline of more
than 25 novel mechanisms. With one of the largest clinical
development programs across more than 30 tumor types, we strive to
advance breakthrough science that will shape the future of
oncology. By addressing barriers to clinical trial participation,
screening and treatment, we work with urgency to reduce disparities
and help ensure patients have access to high-quality cancer care.
Our unwavering commitment is what will bring us closer to our goal
of bringing life to more patients with cancer. For more
information, visit https://www.merck.com/research/oncology/.
About Merck At Merck, known as MSD outside of the United States
and Canada, we are unified around our purpose: We use the power of
leading-edge science to save and improve lives around the world.
For more than 130 years, we have brought hope to humanity through
the development of important medicines and vaccines. We aspire to
be the premier research-intensive biopharmaceutical company in the
world – and today, we are at the forefront of research to deliver
innovative health solutions that advance the prevention and
treatment of diseases in people and animals. We foster a diverse
and inclusive global workforce and operate responsibly every day to
enable a safe, sustainable and healthy future for all people and
communities. For more information, visit www.merck.com and connect
with us on X (formerly Twitter), Facebook, Instagram, YouTube and
LinkedIn.
Forward-Looking Statement of Merck & Co., Inc., Rahway,
N.J., USA This news release of Merck & Co., Inc., Rahway,
N.J., USA (the “company”) includes “forward-looking statements”
within the meaning of the safe harbor provisions of the U.S.
Private Securities Litigation Reform Act of 1995. These statements
are based upon the current beliefs and expectations of the
company’s management and are subject to significant risks and
uncertainties. There can be no guarantees with respect to pipeline
candidates that the candidates will receive the necessary
regulatory approvals or that they will prove to be commercially
successful. If underlying assumptions prove inaccurate or risks or
uncertainties materialize, actual results may differ materially
from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general
industry conditions and competition; general economic factors,
including interest rate and currency exchange rate fluctuations;
the impact of pharmaceutical industry regulation and health care
legislation in the United States and internationally; global trends
toward health care cost containment; technological advances, new
products and patents attained by competitors; challenges inherent
in new product development, including obtaining regulatory
approval; the company’s ability to accurately predict future market
conditions; manufacturing difficulties or delays; financial
instability of international economies and sovereign risk;
dependence on the effectiveness of the company’s patents and other
protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory
actions.
The company undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise. Additional factors that could cause
results to differ materially from those described in the
forward-looking statements can be found in the company’s Annual
Report on Form 10-K for the year ended December 31, 2023 and the
company’s other filings with the Securities and Exchange Commission
(SEC) available at the SEC’s Internet site (www.sec.gov).
References:
1 Schabath MB, et al. Cancer Epidemiol Biomarkers Prev. 2019
Oct;28(10):1563-1579. 2 Rudin CM, et al. Nat Rev Dis Primers.
2021;7(1):3. 3 Cancer.net. Lung Cancer - Small Cell: Statistics.
Accessed May 2024. 4 Qiu M-j, et al. Front. Oncol. 2021;11:600238.
5 Dong P, et al. Front Oncol. 2018;8:264 6 World Health
Organization. International Agency for Research on Cancer. U.S.
Cancer Fact Sheet. Accessed May 2024. 7 American Cancer Society.
Treatment Choices for Small Cell Lung Cancer, by Stage. Accessed
May 2024. 8 Liu SV, et al. J Clin Oncol. 2021;39(6):619-30. 9
Paz-Ares L, et al. ESMO Open. 2022;7(2):100408. 10 von Pawel J, et
al. J Clin Oncol. 2014; 32:4012-4019. 11 Zhao B, et al. J Hematol
Oncol. 2022;15(1):153. 12 Janakiram M, et al. Immunol Rev.
2017;276(1):26-39. 13 Picarda E, et al. Clin Cancer Res.
2016;22(14):3425-3431. 14 Bendell JC, et al. J Clin Oncol.
2020;39(15 suppl 1). Abstract TPS3646. 15 Kontos F, et al. Clin
Cancer Res. 2021;27(5):1227-1235.
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version on businesswire.com: https://www.businesswire.com/news/home/20240731774917/en/
Global/US Media: Jennifer Brennan Daiichi Sankyo, Inc.
jennifer.brennan@daiichisankyo.com (908) 900-3183 (mobile)
Japan Media: DS-PR@daiichisankyo.co.jp
Investor Relations Contact:
DaiichiSankyoIR@daiichisankyo.co.jp
Merck Media: Julie
Cunningham (617) 519-6264 julie.cunningham@merck.com
Carly Myar (917) 227-5957 carly.myar@merck.com
Investors: Peter Dannenbaum (732) 594-1579
peter.dannenbaum@merck.com
Damini Chokshi (732) 594-1577 damini_chokshi@merck.com
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