Data keeps Nuvalent on track for rolling zidesamtinib NDA

Nuvalent (Nasdaq: NUVL), a US biopharma developing precisely targeted therapies for clinically-proven kinase targets in cancer, has announced positive pivotal data for zidesamtinib, a novel ROS1-selective inhibitor, in TKI (tyrosine kinase inhibitor) pre-treated patients with advanced ROS1-positive non-small cell lung cancer (NSCLC).

Alongside the data from the global ARROS-1 Phase I/II trial, Nuvalent announced progress on the front-line development strategies for its parallel lead programs in ROS1-positive and ALK-positive NSCLC.

These included the first report of preliminary data from the Phase II TKI-naïve cohort in its ARROS-I trial, progress in activities to support the global initiation of the ALKAZAR Phase III, randomized, controlled study designed to evaluate neladalkib, a novel ALK-selective inhibitor, versus alectinib, a front-line standard of care, in TKI-naïve ALK-positive NSCLC, for which enrolment is expected to begin early in the second half of 2025.