PR Newswire·Apr 21, 2026, 10:32 AM ET

Nuvalent to Present Pivotal Data from ALKOVE-1 Trial of Neladalkib in TKI Pre-treated Advanced ALK-positive NSCLC at the 2026 American Society of Clinical Oncology Annual Meeting

Nuvalent, Inc. will present pivotal efficacy & safety data for neladalkib in TKI pre-treated patients with advanced ALK-positive NSCLC from the ALKOVE-1 trial during an oral session at the 2026 ASCO Annual Meeting on May 29, 2026.
Preliminary data for neladalkib in TKI-naïve patients with advanced ALK-positive NSCLC will also be included in the ALKOVE-1 oral presentation.
Preliminary data for zidesamtinib in patients with advanced ROS1-positive solid tumors outside of NSCLC from the ARROS-1 trial will be presented in a poster session on May 30, 2026.
Neladalkib is an investigational brain-penetrant ALK-selective inhibitor designed to overcome resistance to first-, second-, & third-generation ALK inhibitors, including G1202R mutations, while avoiding TRK family inhibition.
Zidesamtinib is an investigational brain-penetrant ROS1-selective inhibitor designed to remain active against resistance mutations like G2032R & avoid TRK-related CNS adverse events.
The FDA has accepted Nuvalent's New Drug Application (NDA) for zidesamtinib for ROS1-positive NSCLC patients who received at least 1 prior ROS1 TKI, with a PDUFA target action date of September 18, 2026.
Both neladalkib & zidesamtinib have received breakthrough therapy designation & orphan drug designation from the FDA for their respective indications.