NVL-655

Nuvalent appoints Grant Bogle to its Board of Directors, enhancing its transition from development to commercialization of novel kinase inhibitors, with pivotal data expected in 2025.

Nuvalent's NVL-655, a selective and brain-penetrant ALK inhibitor, is detailed in a Cancer Discovery manuscript, addressing limitations of current ALK TKIs in treating ALK-positive NSCLC. Preclinical and preliminary clinical data support NVL-655's potential to overcome resistance and improve tolerability, with ongoing ALKOVE-1 trial enrollment and planned ESMO Congress presentation.

Nuvalent presented updated Phase 1 data from ALKOVE-1 and ARROS-1 trials at ESMO 2024, showing durability of NVL-655 and zidesamtinib in treating heavily pre-treated cancer patients. The data supports ongoing Phase 2 studies, which could potentially support future marketing applications. Nuvalent also shared new preclinical data on zidesamtinib's intracranial activity, avoiding TRK inhibition-related neurological toxicities. The company plans to discuss these updates in a conference call on September 14, 2024, and aims to develop NVL-655 and zidesamtinib as front-line treatments for ALK- or ROS1-positive NSCLC.