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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 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.
NVL-655 is currently being evaluated in the Phase 2 portion of the ALKOVE-1
Phase 1/2 clinical trial, a first-in-human study of NVL-655 in patients with advanced
ALK-positive NSCLC and other solid tumors (NCT05384626). The completed Phase 1 portion enrolled ALK-positive NSCLC patients who previously received at least one
ALK TKI and patients with other ALK-positive solid tumors who had been previously treated with at least one prior systemic anticancer therapy. The primary objectives were to determine the recommended Phase 2
dose (RP2D) and if applicable, the maximum tolerated dose (MTD) of NVL-655 in patients with ALK-positive solid tumors. Additional objectives included characterization of
the overall safety, tolerability, and pharmacokinetic profile, and evaluation of the preliminary anti-tumor activity of NVL-655. The ongoing global, single arm, open label Phase 2 portion is designed with
registrational intent for TKI pre-treated patients with ALK-positive NSCLC and to enable preliminary investigation for patients with
ALK-positive NSCLC who are TKI naïve.
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 Nuvalents strategy, business plans, and focus; the clinical development programs for zidesamtinib and NVL-655; the
expected timing of reporting data readouts from Nuvalents clinical trials of zidesamtinib and NVL-655; the design and timing of the ALKAZAR trial, including alignment with the FDA regarding the design of
the trial; the potential clinical effects of zidesamtinib and NVL-655; the potential of Nuvalents pipeline programs, including zidesamtinib and NVL-655; the
implications of data readouts and presentations; Nuvalents 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.
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