- Submission based on HERTHENA-Lung01 results showing patritumab
deruxtecan demonstrated clinically meaningful and durable responses
in patients with advanced EGFR-mutated non-small cell lung cancer
previously treated with two or more systemic therapies
- Application being evaluated under FDA Real-Time Oncology
Review
- If approved, patritumab deruxtecan would be a first-in-class
HER3 directed DXd antibody drug conjugate for these patients
Daiichi Sankyo (TSE: 4568) and Merck (known as MSD outside of
the United States and Canada) (NYSE: MRK) announced today that the
U.S. Food and Drug Administration (FDA) has accepted and granted
Priority Review to the Biologics License Application (BLA) for
patritumab deruxtecan (HER3-DXd) for the treatment of adult
patients with locally advanced or metastatic EGFR-mutated non-small
cell lung cancer (NSCLC) previously treated with two or more
systemic therapies.
The Prescription Drug User Fee Act (PDUFA) date, the FDA action
date for their regulatory decision, is June 26, 2024. The Priority
Review follows receipt of Breakthrough Therapy Designation granted
by the FDA in December 2021.
The FDA grants Priority Review to applications for medicines
that, if approved, would offer significant improvements over
available options by demonstrating safety or efficacy improvements,
preventing serious conditions or enhancing patient compliance. The
BLA is being reviewed under the Real-Time Oncology Review (RTOR)
program, an initiative of the FDA which is designed to bring safe
and effective cancer treatments to patients as early as possible.
RTOR allows the FDA to review components of an application before
submission of the complete application.
Patritumab deruxtecan is a specifically engineered potential
first-in-class HER3 directed DXd antibody drug conjugate (ADC)
discovered by Daiichi Sankyo and being jointly developed and
commercialized by Daiichi Sankyo and Merck.
The BLA is based on the primary results from the HERTHENA-Lung01
pivotal phase 2 trial and data results presented at the IASLC 2023
World Conference on Lung Cancer (#WCLC23), which were
simultaneously published in the Journal of Clinical Oncology.
In HERTHENA-Lung01, patritumab deruxtecan was studied in 225
patients with EGFR-mutated locally advanced or metastatic NSCLC
following disease progression with an EGFR TKI and platinum-based
chemotherapy, which demonstrated an objective response rate (ORR)
of 29.8% (95% CI: 23.9-36.2), including one complete response and
66 partial responses. The median duration of response was 6.4
months (95% CI: 4.9-7.8). The safety profile of patritumab
deruxtecan observed in HERTHENA-Lung01 was consistent with previous
phase 1 clinical trials in NSCLC with a treatment discontinuation
rate of 7.1% due to treatment-emergent adverse events (TEAEs).
Grade 3 or higher TEAEs occurred in 64.9% of patients. The most
common (≥5%) grade 3 or higher TEAEs were thrombocytopenia (21%),
neutropenia (19%), anemia (14%), leukopenia (10%), fatigue (6%),
hypokalemia (5%) and asthenia (5%). Twelve patients (5.3%) had
confirmed treatment-related interstitial lung disease (ILD) as
determined by an independent adjudication committee. One grade 5
ILD event was observed.
“The FDA’s prioritization of the BLA submission reflects the
strength of the data from HERTHENA-Lung01 and emphasizes the need
to provide new options to patients with locally advanced or
metastatic EGFR-mutated non-small cell lung cancer previously
treated with two or more systemic therapies,” said Ken Takeshita,
MD, Global Head, R&D, Daiichi Sankyo. “If approved, patritumab
deruxtecan could become the first HER3 directed medicine approved
in the US and the second DXd antibody drug conjugate approved from
Daiichi Sankyo’s oncology pipeline.”
“The acceptance of the BLA submission of patritumab deruxtecan
marks an important step in potentially bringing this new medicine
to previously treated patients with EGFR-mutated non-small cell
lung cancer who often experience recurrence and have few remaining
treatment options,” said Marjorie Green, MD, Senior Vice President
and Head of Late-Stage Oncology, Global Clinical Development, Merck
Research Laboratories. “Today is the first of many important
milestones from our collaboration with Daiichi Sankyo, as we work
together to bring new and potentially first-in-class antibody drug
conjugates to people living with cancer.”
About HERTHENA-Lung01
HERTHENA-Lung01 is a global, multicenter, open-label, two-arm
phase 2 trial evaluating the safety and efficacy of patritumab
deruxtecan in patients with EGFR-mutated locally advanced or
metastatic NSCLC following disease progression with an EGFR TKI and
platinum-based chemotherapy. Patients were randomized 1:1 to
receive 5.6 mg/kg (n=225) or an uptitration regimen (n=50). The
uptitration arm was discontinued as the dose of 5.6 mg/kg of
patritumab deruxtecan was selected following a risk-benefit
analysis conducted from the phase 1 trial assessing the doses in a
similar patient population.
The primary endpoint of HERTHENA-Lung01 was ORR as assessed by
blinded independent central review (BICR). Secondary endpoints
included duration of response, progression-free survival (PFS),
disease control rate, and time to response – all assessed by both
BICR and investigator assessment – as well as investigator-assessed
ORR, overall survival, safety and tolerability.
HERTHENA-Lung01 enrolled patients in Asia, Europe, North America
and Oceania. For more information about the trial, visit
ClinicalTrials.gov.
About EGFR-Mutated Non-Small Cell Lung Cancer
Lung cancer is the second most common cancer and the leading
cause of cancer-related deaths worldwide.1 NSCLC accounts for
approximately 85% of all lung cancers – 55% having distant spread
at diagnosis – with EGFR mutations occurring in 14% to 38% of all
NSCLC tumors worldwide.2,3,4
About HER3
HER3 is a member of the EGFR family of receptor tyrosine
kinases.5 It is estimated that about 83% of primary NSCLC tumors
and 90% of advanced EGFR-mutated tumors express HER3 after prior
EGFR TKI treatment.6,7 There is currently no HER3 directed therapy
approved for the treatment of any cancer.
About Patritumab Deruxtecan
Patritumab deruxtecan (HER3-DXd) is an investigational HER3
directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC
technology, patritumab deruxtecan is composed of a fully human
anti-HER3 IgG1 monoclonal antibody attached to a number of
topoisomerase I inhibitor payloads (an exatecan derivative, DXd)
via tetrapeptide-based cleavable linkers.
Patritumab deruxtecan was granted Breakthrough Therapy
Designation by the U.S. Food and Drug Administration in December
2021 for the treatment of patients with EGFR-mutated locally
advanced or metastatic NSCLC with disease progression on or after
treatment with a third-generation TKI and platinum-based
therapies.
Patritumab deruxtecan is currently being evaluated as both a
monotherapy and in combination with other therapies in a global
development program, which includes HERTHENA-Lung02, a phase 3
trial versus platinum-based chemotherapy in patients with
EGFR-mutated locally advanced or metastatic NSCLC following disease
progression on or after treatment with a third-generation EGFR TKI;
a phase 1 trial in combination with osimertinib in EGFR-mutated
locally advanced or metastatic NSCLC; and a phase 1 trial in
previously treated patients with advanced NSCLC. A phase 1/2 trial
in HER3 expressing metastatic breast cancer also has been
completed.
About the Daiichi Sankyo and Merck Collaboration
Daiichi Sankyo and Merck 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.
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 the global outbreak of novel coronavirus disease
(COVID-19); 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, 2022 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 World Health Organization. International Agency for Research
on Cancer. Lung Fact Sheet. Accessed September 2023. 2
Economopoulou P, et al. Ann Transl Med. 2018; 6(8):138. 3 Chen R,
et al. J Hematol Oncol. 2020; 13(1):58. 4 Zhang Y-L, et al.
Oncotarget. 2016; 7(48):78985-78993. 5 Mishra R, et al. Onco Rev.
2018; 12(355):45-62. 6 Scharpenseel H, et al. Scientific Reports.
2019; 9:7406. 7 Yonesaka K, et al. Clin Cancer Res. 2022;
15:28(2):390-403.
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Daiichi Sankyo Global/US
Media: Jennifer Brennan Daiichi Sankyo, Inc. jbrennan2@dsi.com
+1 908 900 3183 (mobile)
Japan Media: Koji Ogiwara Daiichi Sankyo Co., Ltd.
Ogiwara.koji.ay@daiichisankyo.co.jp +81 3 6225 1126 (office)
Investor Relations Contact:
DaiichiSankyoIR@daiichisankyo.co.jp
Merck Media: Robert
Josephson +1 203 914 2372 robert.josephson@merck.com
Investors: Peter Dannenbaum +1 732 594 1579
peter.dannenbaum@merck.com
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