Kinetics and management of adverse events associated with lorlatinib after 5 years of follow-up in the CROWN study.

ABSTRACT:

Objective

With 5 years of follow-up in the phase 3 CROWN study, lorlatinib showed unprecedented improvement in progression-free survival coupled with prolonged intracranial efficacy in patients with ALK-positive metastatic non-small cell lung cancer (mNSCLC). Here, we report kinetics and mitigation practices of select adverse events (AEs) to inform therapy management strategies.

Design

Post hoc safety analyses from the CROWN study assessed the incidence, prevalence, time to onset, duration, management, and resolution of hyperlipidemia, edema, weight gain, central nervous system (CNS) AEs, and peripheral neuropathy in the lorlatinib group (n = 149).

Results

After 5 years of follow-up, no new safety signals were observed. All-cause any-grade and grade 3/4 AEs occurred i

SUBMITTER: Liu G 

PROVIDER: S-EPMC12557321 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature