On April 23, 2025 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported two "Trial in Progress" poster presentations for its novel ALK-selective inhibitor, neladalkib, and novel HER2-selective inhibitor, NVL-330, at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from May 30 – June 5, 2025, in Chicago (Press release, Nuvalent, APR 23, 2025, View Source [SID1234652070]). Posters will be archived on the Nuvalent website at www.nuvalent.com.
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The first "Trial in Progress" poster will include background and study design for ALKAZAR (NCT06765109), a global, randomized, controlled Phase 3 trial designed to evaluate neladalkib versus the current standard of care for the treatment of patients with TKI-naïve ALK-positive non-small cell lung cancer (NSCLC). Patients will be randomized 1:1 to receive neladalkib monotherapy or ALECENSA (alectinib) monotherapy. The company plans to initiate the ALKAZAR trial in the first half of 2025.
The second poster will include background and study design for the ongoing HEROEX-1 Phase 1a/1b clinical trial (NCT06521554) evaluating the overall safety and tolerability of NVL-330 for pre-treated patients with HER2-altered NSCLC. Additional objectives include determination of the recommended Phase 2 dose, characterization of NVL-330’s pharmacokinetic profile, and preliminary evaluation of anti-tumor activity.
Details of the poster presentations are as follows:
Title: Neladalkib (NVL-655), a highly selective anaplastic lymphoma kinase (ALK) inhibitor, compared to alectinib in first-line treatment of patients with ALK-positive advanced non-small cell lung cancer: The Phase 3 ALKAZAR study
Authors: Sanjay Popat*1, Benjamin J. Solomon2, Thomas E. Stinchcombe3, Geoffrey Liu4, Gilberto Lopes5, Melissa Johnson6, Misako Nagasaka7, Ece Cali Daylan8, Christina Baik9, James D’Olimpio10, Tzu-Chuan Huang11, Alexander Spira12, Daniel Haggstrom13, Benjamin Creelan14, Tina Kehrig15, Junwu Shen15, Rachel DeLaRosa15, Viola W. Zhu15, Alexander Drilon16, Alice T. Shaw17
Abstract Number: TPS8666
Session Title: Lung Cancer—Non-Small Cell Metastatic
Session Date and Time: May 31, 2025, from 1:30 p.m.– 4:30 p.m. CDT
Poster Board Number: 136b
*Presenter, corresponding author; 1Royal Marsden Hospital NHS Foundation Trust and The Institute of Cancer Research, London, UK; 2Peter MacCallum Cancer Centre, Melbourne, Australia; 3Duke Cancer Center, Durham, NC, USA; 4Princess Margaret Hospital, Toronto, ON, Canada; 5Sylvester Comprehensive Cancer Center, Miami, FL, USA; 6Sarah Cannon Research Institute Oncology Partners, Nashville, TN, USA; 7University of California Irvine School of Medicine, Orange, CA, USA; 8Washington University School of Medicine, St. Louis, MO, USA; 9Fred Hutchinson Cancer Center, Seattle, WA, USA; 10Clinical Research Alliance Inc., Westbury, NY, USA; 11University Cancer and Blood Center, LLC, Athens, GA, USA; 12Virginia Cancer Specialists (Fairfax) – USOR, Fairfax, VA, USA; 13Carolinas Medical Center, Charlotte, NC, USA; 14H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA; 15Nuvalent, Inc., Cambridge, MA, USA; 16Memorial Sloan Kettering Cancer Center, New York, NY, USA; 17Dana-Farber Cancer Institute, Boston, MA, USA
Title: NVL-330, a selective HER2 tyrosine kinase inhibitor, in patients with advanced or metastatic HER2-altered non-small cell lung cancer: The Phase 1 HEROEX-1 study
Authors: Xiuning Le*1, Zofia Piotrowska2, Alexander Spira3, Christina Baik4, Maria Q. Baggstrom5, Gerald Falchook6, Joel Neal7, Shirish Gadgeel8, Gilberto Lopes9, Melissa Johnson10, Jonathan W. Riess11, Danny Nguyen12, Lisa Morelli13, Danieska Sandino13, Steven Margossian13, Vivek Upadhyay13, Fernando C. Santini14
Abstract Number: TPS8665
Session Title: Lung Cancer—Non-Small Cell Metastatic
Session Date and Time: May 31, 2025, from 1:30 p.m.– 4:30 p.m. CDT
Poster Board Number: 136a
*Presenter, corresponding author; 1University of Texas MD Anderson Cancer Center, Houston, TX, USA; 2Massachusetts General Hospital, Boston, MA, USA; 3NEXT Oncology, Fairfax, VA, USA; 4Fred Hutchinson Cancer Center, Seattle, WA, USA; 5Washington University School of Medicine, St. Louis, MO, USA; 6Sarah Cannon Research Institute at HealthONE, Denver, CO, USA; 7Stanford Cancer Institute, Stanford, CA, USA; 8Henry Ford Cancer Institute, Detroit, MI, USA; 9Sylvester Comprehensive Cancer Center, Miami, FL, USA; 10Sarah Cannon Research Institute Oncology Partners, Nashville, TN, USA; 11University of California Davis, Davis Comprehensive Cancer Center, Sacramento CA, USA; 12City of Hope-Lennar, Irvine, CA, USA; 13Nuvalent, Inc., Cambridge, MA, USA; 14Memorial Sloan Kettering Cancer Center, New York, NY, USA
About Neladalkib
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.