Nuvalent presents preliminary data for neladalkib from ALKOVE-1 Phase 1/2 trial

Nuvalent (NUVL) announced preliminary data from the ongoing ALKOVE-1 Phase 1/2 clinical trial of neladalkib, an investigational ALK-selective inhibitor, in patients with advanced ALK-positive solid tumors outside of non-small cell lung cancer, NSCLC. These data will be presented during a poster session at the European Society for Medical Oncology, ESMO, Congress 2025, taking place October 17-21, 2025, in Berlin, Germany. Among all patients with advanced ALK-positive solid tumors treated with neladalkib, an objective response rate of 44% was observed, including 9/13 patients who were ALK TKI-naive and 6/21 who were ALK TKI pre-treated. 80% of responders remained on treatment without disease progression as of the data cutoff date. Three case studies support neladalkib’s potential to induce deep and durable responses in a range of treatment settings: Treatment ongoing for approximately 12 months with partial response in a TKI-naive patient with an inflammatory myofibroblastic tumor previously treated with standard of care chemotherapy; Treatment ongoing for approximately 16 months with partial response in a TKI and chemotherapy pre-treated patient with peritoneal mesothelioma; and, Treatment ongoing for approximately 10 months with confirmed intracranial complete response in a TKI pre-treated patient with adenocarcinoma of unknown origin with baseline brain metastasis and ALK V1180L resistance mutation.