Nuvalent to Present Data on Zidesamtinib and NVL-655 at ESMO Congress 2024

CAMBRIDGE, Mass., July 16, 2024 -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company, has announced that updated data from their ARROS-1 and ALKOVE-1 Phase 1/2 clinical trials will be presented at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain, from September 13-17, 2024.

Nuvalent's ARROS-1 trial focuses on their drug zidesamtinib (NVL-520) for ROS1 fusion-positive solid tumors, while the ALKOVE-1 trial centers on NVL-655 for ALK-positive solid tumors. Both studies aim to address the limitations of existing therapies for these specific kinase targets in cancer treatment.

The details for the presentations are as follows:
1. The ALKOVE-1 study, titled "Phase 1/2 ALKOVE-1 study of NVL-655 in ALK-positive (ALK+) solid tumors," will be presented by Dr. Alexander Drilon from Memorial Sloan Kettering Cancer Center, New York. This session falls under the "Proffered paper session" category and is scheduled for September 14, 2024, from 9:40 to 9:50 CEST at the Barcelona Auditorium – Hall 2. The presentation number is 1253O.

2. The ARROS-1 study, titled "Phase 1/2 ARROS-1 study of zidesamtinib (NVL-520) in ROS1 fusion-positive solid tumors," will be presented by Dr. Benjamin Besse from Institut Gustav Roussy, Villejuif, France. This mini oral session will take place on the same day from 10:30 to 10:35 CEST at the Santander Auditorium – Hall 5. The presentation number is 1256MO.

Additionally, new preclinical data on the intracranial activity of zidesamtinib will be presented during a poster session. The study is titled "Profiling of Zidesamtinib and Other ROS1 Inhibitors in an Intracranial CD74-ROS1 G2032R Preclinical Model," with the abstract number 4811. Anupong Tangpeerachaikul from Nuvalent, Inc. will present this data.

Zidesamtinib is a brain-penetrant ROS1-selective inhibitor designed to overcome the limitations of existing ROS1 inhibitors. It is intended to remain effective against tumors that have developed resistance to current ROS1 inhibitors and is designed to penetrate the central nervous system to offer better treatment options for patients with brain metastases. This drug also aims to avoid inhibiting the tropomyosin receptor kinase (TRK) family, potentially reducing related adverse events. Zidesamtinib has received breakthrough therapy designation for treating ROS1-positive metastatic non-small cell lung cancer (NSCLC) in patients previously treated with two or more ROS1 tyrosine kinase inhibitors and orphan drug designation for ROS1-positive NSCLC. The ARROS-1 trial (NCT05118789) is a first-in-human Phase 1/2 clinical trial for patients with advanced ROS1-positive NSCLC and other solid tumors.

NVL-655 is another brain-penetrant inhibitor, but it targets ALK-selective inhibitors. It aims to address tumors that have developed resistance to first-, second-, and third-generation ALK inhibitors. NVL-655 is designed to penetrate the central nervous system and avoid inhibiting the TRK family to reduce adverse events, aiming to provide lasting responses across all lines of therapy. NVL-655 has received orphan drug designation for ALK-positive NSCLC and is 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.

Nuvalent, Inc. is dedicated to developing targeted therapies for cancer patients, aiming to overcome the limitations of existing treatments for kinase targets. Their approach leverages expertise in chemistry and structure-based drug design to develop small molecules that potentially overcome resistance, minimize adverse events, address brain metastases, and provide durable responses. Nuvalent's pipeline includes investigational candidates for ROS1-positive, ALK-positive, and HER2-altered non-small cell lung cancer, along with multiple discovery-stage research programs.

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