Strategy prioritizes most accelerated path to
first potential approval
Initial NDA submission expected by mid-year
for zidesamtinib in TKI pre-treated ROS1-positive NSCLC population,
with topline pivotal data anticipated in the first half of
2025
Topline pivotal data for neladalkib (NVL-655)
in TKI pre-treated ALK-positive NSCLC population anticipated by
year-end 2025
Company to present at 43rd Annual
J.P. Morgan Healthcare Conference on Tuesday, January 14th at 9:00 a.m. PT
CAMBRIDGE, Mass., Jan. 13,
2025 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a
clinical-stage biopharmaceutical company focused on
creating precisely targeted therapies for
clinically proven kinase targets in cancer, today highlighted
pipeline progress and outlined key anticipated milestones towards
its first potential U.S. Food and Drug Administration (FDA)
approval under its "OnTarget 2026" operating plan.
As part of this plan, Nuvalent anticipates the following 2025
milestones:
- Report pivotal data for tyrosine kinase inhibitor (TKI)
pre-treated patients with advanced ROS1-positive non-small cell
lung cancer (NSCLC) from its ARROS-1 Phase 1/2 trial of
zidesamtinib in the first half of 2025;
- Submit a New Drug Application (NDA) for zidesamtinib with
initial target indication of TKI pre-treated patients with
advanced ROS1-positive NSCLC by mid-year 2025;
- Report pivotal data for TKI pre-treated patients with
advanced ALK-positive NSCLC from its ALKOVE-1 Phase 1/2 trial of
neladalkib (NVL-655) by year-end 2025;
- Initiate the ALKAZAR Phase 3 randomized, controlled trial
of neladalkib for TKI-naïve patients with ALK-positive NSCLC in the
first half of 2025; and
- Progress the HEROEX-1 Phase 1a/1b
trial of NVL-330 for patients with advanced
HER2-altered NSCLC.
With the achievement of these milestones, the company
anticipates that the first potential approval from its pipeline of
novel kinase inhibitors will be for zidesamtinib for the treatment
of TKI pre-treated ROS1-positive NSCLC in 2026.
"2025 marks our opportunity to
transition to becoming a fully integrated commercial-stage
biopharmaceutical company. Throughout this period of growth and
evolution, our strategy remains rooted in our commitment to our
core value of Patient Impact, and our responsibility to the
patients and treating physicians who continue to support our
clinical trials," said James
Porter, Ph.D., Chief Executive Officer at Nuvalent.
"Enrollment momentum in the Phase 2 portions of our ARROS-1 and
ALKOVE-1 clinical trials has further accelerated following our
presentation of updated Phase 1 data at ESMO 2024, reinforcing our
plan to report pivotal data from both programs this year. We
believe this enthusiasm is a clear demonstration of the medical
need for patients with ROS1- and ALK-positive NSCLC, and of our
responsibility to bring new treatment options to TKI pre-treated
patients as quickly as possible."
"Parallel development paths are in place towards our ultimate
goal to provide new, potential best-in-class treatment options to
all patients with ROS1- or ALK-positive NSCLC," said
Darlene Noci, A.L.M., Chief
Development Officer at Nuvalent. "For zidesamtinib, we plan to
submit an NDA this year with an initial target indication for TKI
pre-treated patients with ROS1-positive NSCLC, where we believe
zidesamtinib has demonstrated the potential to address a medical
need. We expect to report topline pivotal data from this population
in the first half of 2025. In parallel, we continue a collaborative
dialogue with the FDA on accelerated opportunities towards a
potential line-agnostic indication supported by our ongoing
TKI-naïve cohort in the Phase 2 portion of our ARROS-1 trial."
Ms. Noci continued, "Similarly for neladalkib, we expect
our initial NDA submission to be for TKI pre-treated patients with
ALK-positive NSCLC, supported by topline pivotal data from the
ALKOVE-1 trial that we expect to report by year-end 2025.
Additionally, we remain on-track to initiate the Phase 3
randomized, controlled ALKAZAR trial for TKI-naïve patients in the
first half of this year, a critical step towards our ultimate goal
of moving neladalkib up the treatment paradigm."
"We believe we have the right team in place and are well
resourced with cash runway into 2028 to support the advancement of
our clinical programs and ongoing buildout of a commercial
infrastructure," said Alexandra
Balcom, Chief Financial Officer at Nuvalent. "Beyond our
parallel-lead programs, we remain committed to advancement of our
HEROEX-1 Phase 1a/1b trial and robust
discovery pipeline for sustainable long-term growth."
Enrollment Updates for ARROS-1 and ALKOVE-1
ARROS-1 for ROS1-positive NSCLC
- As of December 31, 2024, a total
of 430 Phase 1 and Phase 2 patients had been enrolled in the
ongoing ARROS-1 Phase 1/2 trial of zidesamtinib for patients with
advanced ROS1-positive NSCLC and other solid tumors, which is
designed with registrational intent for TKI pre-treated and
TKI-naïve patients with advanced ROS1-positive NSCLC. Updated Phase
1 data were presented in September
2024 at the ESMO Congress.
ALKOVE-1 for ALK-positive NSCLC
- As of December 31, 2024, a total
of 596 Phase 1 and Phase 2 patients had been enrolled in the
ongoing ALKOVE-1 Phase 1/2 trial of neladalkib for patients
with advanced ALK-positive NSCLC and other solid tumors, which is
designed with registrational intent for TKI pre-treated patients.
Updated Phase 1 data were presented in September 2024 at the ESMO Congress.
Presentation at 43rd Annual J.P. Morgan Healthcare
Conference
Dr. Porter will present at the 43rd Annual J.P.
Morgan Healthcare Conference in San
Francisco on Tuesday, January 14,
2025 at 9:00 a.m. PT. A live
webcast will be available in the Investors section of Nuvalent's
website at www.nuvalent.com, and will be archived for 30 days
following the conference.
About Zidesamtinib
Zidesamtinib is a novel brain-penetrant ROS1-selective inhibitor
created with the aim to overcome limitations observed with
currently available ROS1 inhibitors. Zidesamtinib 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, zidesamtinib 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. Zidesamtinib has received breakthrough
therapy designation for the treatment of patients with
ROS1-positive metastatic non-small cell lung cancer (NSCLC) who
have been previously treated with 2 or more ROS1 tyrosine kinase
inhibitors and orphan drug designation for ROS1-positive NSCLC.
About Neladalkib (NVL-655)
Neladalkib is a novel brain-penetrant ALK-selective inhibitor
created with the aim to overcome limitations observed with
currently available ALK inhibitors. Neladalkib 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, neladalkib 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. Neladalkib has
received breakthrough therapy designation for the treatment of
patients with locally advanced or metastatic ALK-positive non-small
cell lung cancer (NSCLC) who have been previously treated with 2 or
more ALK tyrosine kinase inhibitors and orphan drug designation for
ALK-positive NSCLC.
About NVL-330
NVL-330 is a novel brain-penetrant HER2-selective tyrosine
kinase inhibitor designed to address the combined medical need of
treating HER2-mutant tumors, including those with HER2 exon 20
insertion mutations, avoiding treatment related adverse events due
to off-target inhibition of wild-type EGFR, and treating brain
metastases.
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; Nuvalent's estimated cash runway; the expected timing of
data announcements, clinical trial initiations, FDA submissions and
potential product approval, including the projections in our
OnTarget 2026 operating plan; the clinical development programs for
zidesamtinib, neladalkib and NVL-330; the timing of the ALKAZAR
trial; the potential clinical effects of Nuvalent's product
development candidates; the design and enrollment of Nuvalent's
clinical trials, including for ARROS-1 and ALKOVE-1 their intended
pivotal registration-directed design; the potential of Nuvalent's
pipeline programs, including zidesamtinib, neladalkib and NVL-330;
the implications of data readouts and presentations; timing and
content of potential discussions with FDA regarding potential
accelerated approval pathways; Nuvalent's potential buildout of a
commercial infrastructure; Nuvalent's research and development
programs for the treatment of cancer; and risks and uncertainties
associated with drug development. The words "may," "might," "will,"
"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 its clinical trials or that
enrollment will take longer than expected; unexpected concerns that
may arise from additional data, analysis, or results obtained
during preclinical studies and 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 zidesamtinib
or neladalkib product candidates; risks that Nuvalent may not
achieve the goals and milestones set forth in its OnTarget 2026
operating plan; 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; risks that Nuvalent may not be able to nominate
drug candidates from its discovery programs; 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, ALKOVE-1, ALKAZAR and HEROEX-1 trials; the
timing and outcome of Nuvalent's planned interactions with
regulatory authorities; and 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, 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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