Nuvalent Shared Topline Data From ALKOVE-1 Phase 1/2 Trial For Neladalkibin Pre-treated Patients With Advanced ALK-positive Non-small Cell Lung Cancer. Additionally, The Company Shared The First Report Of Preliminary Data From Phase 2 Exploratory Cohort

Author: Benzinga Newsdesk | November 17, 2025 06:34am

• In 253 ALK TKI pre-treated patients, ORR by BICR was 31% (95% CI: 26, 37), with initial estimated durability of response of 64% and 53% at the 12-month and 18-month landmarks, respectively.
• In the subset of 63 TKI pre-treated patients who were lorlatinib-naïve, ORR by BICR was 46% (95% CI: 33, 59), with initial estimated durability of response of 80% and 60% at the 12- and 18-month landmarks, respectively.
• Neladalkib demonstrated intracranial responses, ability to address key drivers of disease progression, and a generally well-tolerated safety profile with low rates of dose discontinuation (5%) and dose reduction (17%) due to TEAEs, consistent with its ALK-selective, TRK-sparing design.
• The Company plans to discuss pivotal data for the TKI pre-treated ALK-positive NSCLC population with the FDA at a pre-NDA meeting; detailed study results are planned for presentation at a future medical meeting

Posted In: NUVL