09:07 AM EST, 11/17/2025 (MT Newswires) -- Nuvalent ( NUVL ) said Monday its investigational treatment neladalkib showed intracranial responses and ability to address key drivers of disease progression in a phase 1/2 trial in tyrosine kinase inhibitor pre-treated patients with advanced ALK-positive non-small cell lung cancer.

The company said neladalkib achieved an objective response rate by blinded independent central review of 31% in 253 TKI pre-treated patients, with initial estimated durability of response of 64% at 12 months and 53% at 18 months.

Among 63 TKI pre-treated patients who were lorlatinib-naive, ORR by BICR was 46% and durability of response was 80% at 12 months and 60% and 18 months, Nuvalent ( NUVL ) added.

The investigational treatment also demonstrated a generally well-tolerated safety profile with low rates of dose discontinuation and dose reduction, the company said.

Nuvalent ( NUVL ) said it plans to discuss the topline pivotal data for the drug with the US Food and Drug Administration at a meeting prior to submitting a new drug application.

Shares of Nuvalent ( NUVL ) were down more than 2% in recent premarket activity Monday.