CAMBRIDGE, Mass., May 16, 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-655 for
the treatment of patients with locally advanced or metastatic
ALK-positive non-small cell lung cancer (NSCLC) who have been
previously treated with two or more ALK tyrosine kinase inhibitors
(TKIs).
ALK rearrangements occur in up to approximately 5% of metastatic
NSCLCs. At the time of diagnosis, up to 40% of these patients
present with accompanying brain metastases, and approximately 50%
of patients develop resistance mutations following treatment with
currently available first- or second-generation ALK TKIs. There
remains no clear standard of care for patients who have been
previously treated with two or more ALK TKIs.
NVL-655 is a novel brain-penetrant ALK-selective 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.
"Today's announcement of FDA breakthrough therapy designation
for NVL-655 marks another important milestone for our ALK program
and the second breakthrough designation granted to our pipeline of
novel kinase inhibitors this year," said Darlene Noci, A.L.M., Chief Development Officer
at Nuvalent. "Our team is committed to expeditiously advancing
NVL-655 in recognition of the continued need for innovation for
patients with ALK-positive NSCLC who have exhausted available
therapies. We expect to provide an update from the ALKOVE-1 trial
of NVL-655 at a medical meeting in the second half of 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-655 is based on the preliminary safety and
activity of NVL-655 in heavily pretreated patients with advanced
ALK-positive NSCLC in the Phase 1 portion of the Phase 1/2 ALKOVE-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 the second half of 2024.
About NVL-655
NVL-655 is a novel brain-penetrant
ALK-selective inhibitor created with the aim to overcome
limitations observed with currently available ALK inhibitors.
NVL-655 is designed to remain active in tumors that have developed
resistance to first-, second-, and third-generation ALK inhibitors,
including tumors with single or compound treatment-emergent ALK
mutations such as G1202R. In addition, NVL-655 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/ALK inhibitors
and to drive deep, durable responses for patients across all lines
of therapy. NVL-655 has received orphan drug designation for
ALK-positive non-small cell lung cancer (NSCLC) and is currently
being investigated in the ALKOVE-1 clinical trial (NCT05384626), a
first-in-human Phase 1/2 clinical trial for patients with advanced
ALK-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-altered
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; the clinical development program for
NVL-655; the potential clinical effect of NVL-655; the design and
enrollment of the ALKOVE-1 trial, including its intended pivotal
registration-directed design; the potential of Nuvalent's pipeline
programs, including NVL-655; 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," "continue," "target"
or the negative of these terms and similar words or expressions are
intended to identify forward-looking 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 ALKOVE-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 ALKOVE-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 March 31,
2024, 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.