CAMBRIDGE, Mass., Feb. 27,
2024 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a
clinical-stage biopharmaceutical company focused on creating
precisely targeted therapies for clinically proven kinase
targets in cancer, today announced that the U.S. Food and Drug
Administration (FDA) has granted breakthrough therapy designation
(BTD) to NVL-520 for the treatment of patients with ROS1-positive
metastatic non-small cell lung cancer (NSCLC) who have been
previously treated with two or more ROS1 tyrosine kinase
inhibitors (TKIs).
ROS1 rearrangements occur in up to approximately 3% of
metastatic NSCLCs. At the time of diagnosis, up to 40% of these
patients present with accompanying brain metastases, and
approximately 40% of patients develop resistance mutations
following current front-line treatment. There remains no clear
standard of care for patients who have been previously treated with
two or more ROS1 TKIs.
NVL-520 is a novel brain-penetrant ROS1-selective tyrosine
kinase inhibitor (TKI) created with the aim to simultaneously
overcome the clinical challenges of emergent treatment resistance,
brain metastases, and off-target central nervous system (CNS)
adverse events associated with inhibition of the
structurally-related tropomyosin receptor kinase (TRK) family that
may limit the use of currently available ROS1 TKIs.
"In line with our commitment to bringing new potential
best-in-class medicines to patients with cancer as quickly as
possible, we are always looking for opportunities to further
accelerate our programs," said James
Porter, Ph.D., Chief Executive Officer at Nuvalent.
"We're very encouraged by today's announcement of FDA breakthrough
therapy designation for NVL-520, as it recognizes the continued
need for innovation for patients with ROS1-positive NSCLC who have
exhausted available therapies. We look forward to providing an
update from the ARROS-1 trial of NVL-520 at a medical meeting later
this year."
BTD is designed to expedite the development and review of
therapies intended to treat a serious or life-threatening condition
and whose preliminary clinical evidence indicates that the drug may
demonstrate substantial improvement on one or more clinically
significant endpoints over existing available therapies. Under the
designation, the FDA provides intensive guidance, organizational
commitment involving senior managers, and eligibility for rolling
review and other actions to expedite review.
The BTD for NVL-520 is based on the preliminary safety and
activity of NVL-520 in heavily pretreated patients with advanced
ROS1-positive NSCLC in the Phase 1 portion of the Phase 1/2 ARROS-1
clinical trial. Enrollment in the Phase 2 portion of the trial is
ongoing, and the company expects to share updated data from the
trial at a medical meeting in 2024.
About NVL-520
NVL-520 is a novel brain-penetrant
ROS1-selective inhibitor created with the aim to overcome
limitations observed with currently available ROS1 inhibitors.
NVL-520 is designed to remain active in tumors that have developed
resistance to currently available ROS1 inhibitors, including tumors
with treatment-emergent ROS1 mutations such as G2032R. In addition,
NVL-520 is designed for central nervous system (CNS) penetrance to
improve treatment options for patients with brain metastases, and
to avoid inhibition of the structurally-related tropomyosin
receptor kinase (TRK) family. Together, these characteristics have
the potential to avoid TRK-related CNS adverse events seen with
dual TRK/ROS1 inhibitors and to drive deep, durable responses for
patients across all lines of therapy. NVL-520 has received orphan
drug designation for ROS1-positive non-small cell lung cancer
(NSCLC) and is currently being investigated in the ARROS-1 trial
(NCT05118789), a first-in-human Phase 1/2 clinical trial for
patients with advanced ROS1-positive NSCLC and other solid
tumors.
About Nuvalent
Nuvalent, Inc. (Nasdaq: NUVL) is a
clinical-stage biopharmaceutical company focused on creating
precisely targeted therapies for patients with cancer, designed to
overcome the limitations of existing therapies for clinically
proven kinase targets. Leveraging deep expertise in chemistry and
structure-based drug design, we develop innovative small molecules
that have the potential to overcome resistance, minimize adverse
events, address brain metastases, and drive more durable responses.
Nuvalent is advancing a robust pipeline with investigational
candidates for ROS1-positive, ALK-positive, and HER2-positive
non-small cell lung cancer, and multiple discovery-stage research
programs.
Forward-Looking Statements
This press release contains
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995, as amended, including,
without limitation, implied and express statements regarding
Nuvalent's strategy, business plans, and focus; the expected timing
of data announcements and product approvals; the clinical
development program for NVL-520; the potential clinical effect of
NVL-520; the design and enrollment of the ARROS-1 trial, including
its intended pivotal registration-directed design; the potential of
Nuvalent's pipeline programs, including NVL-520; the implications
of data readouts and presentations; Nuvalent's research and
development programs for the treatment of cancer; and risks and
uncertainties associated with drug development. The words "may,"
"might," "could," "would," "should," "expect," "plan,"
"anticipate," "aim," "goal," "intend," "believe," "expect,"
"estimate," "seek," "predict," "future," "project," "potential,"
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statements, although not all forward-looking statements contain
these identifying words. Drug development and commercialization
involve a high degree of risk, and only a small number of research
and development programs result in commercialization of a product.
You should not place undue reliance on these statements or the
scientific data presented.
Any forward-looking statements in this press release are based
on management's current expectations and beliefs and are subject to
a number of risks, uncertainties, and important factors that may
cause actual events or results to differ materially from those
expressed or implied by any forward-looking statements contained in
this press release, including, without limitation: risks that
Nuvalent may not fully enroll the ARROS-1 trial or that enrollment
will take longer than expected; unexpected concerns that may arise
from additional data, analysis, or results obtained during
preclinical studies or clinical trials; the risk that results of
earlier clinical trials may not be predictive of the results of
later-stage clinical trials; the risk that data from our clinical
trials may not be sufficient to support registration and that
Nuvalent may be required to conduct one or more additional studies
or trials prior to seeking registration of our product candidates;
the occurrence of adverse safety events; risks that the FDA may not
approve our potential products on the timelines we expect, or at
all; risks of unexpected costs, delays, or other unexpected
hurdles; the direct or indirect impact of public health emergencies
or global geopolitical circumstances on the timing and anticipated
timing and results of Nuvalent's clinical trials, strategy, and
future operations, including the ARROS-1 trial; the timing and
outcome of Nuvalent's planned interactions with regulatory
authorities; risks related to obtaining, maintaining, and
protecting Nuvalent's intellectual property. These and other risks
and uncertainties are described in greater detail in the section
entitled "Risk Factors" in Nuvalent's Quarterly Report on Form 10-Q
for the quarterly period ended September 30,
2023, as well as any prior and subsequent filings with the
Securities and Exchange Commission. In addition, any
forward-looking statements represent Nuvalent's views only as of
today and should not be relied upon as representing its views as of
any subsequent date. Nuvalent explicitly disclaims any obligation
to update any forward-looking statements.
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SOURCE Nuvalent, Inc.