Trial Efficacy

"After 7 years of follow-up, lorlatinib monotherapy’s median PFS still had not been met, and the 7-year PFS was 55%, reported study coauthor Tony S.K. Mok, MD, of the Chinese University of Hong Kong.2\n\nLorlatinib is a third-generation ALK TKI designed to cross the blood-brain barrier. CROWN (NCT03052608) is a randomized phase 3 trial that enrolled 296 patients with stage IIIB/IV ALK-positive NSCLC with no prior history of systemic treatment for metastatic disease.\n\nThe patients were randomly assigned to receive lorlatinib (100 mg once daily; n=149) or crizotinib (250 mg twice daily; n=147). Patients were stratified by the presence or absence of brain metastases, and by ethnicity (Asian or non-Asian). No crossover was permitted between the study groups.\n\nAt 7 years, median PFS in the intention-to-treat population had still not been reached for patients in the lorlatinib group, with 55% of patients still progression-free compared to 3% in the crizotinib group. Patients without progression events in the first 24 months on lorlatinib had a 79% probability of remaining alive and progression-free at 7 years, Dr Mok reported. Lorlatinib was favored across all patient subgroups, including patients with and without brain metastases, and Asian and non-Asian patients."