Bifalgorithm post · ASCO 2026: Studies Aim to Expand Treatment Options for Lung Cancer · CROWN: 7-Year Update for Lorlatinib

Trial Efficacy

Trial Efficacy (ASCO 2026: Studies Aim to Expand Treatment Options for Lung Cancer · CROWN: 7-Year Update for Lorlatinib) — "After 7 years of follow-up, lorlat…

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  • Seven-year CROWN results show durable progression-free survival with lorlatinib in ALK-positive NSCLC.
  • Lorlatinib is a third-generation ALK TKI designed to cross the blood-brain barrier.
  • CROWN was a randomized phase 3 trial in patients with stage IIIB/IV ALK-positive NSCLC.
  • The trial enrolled 296 patients without prior systemic treatment for metastatic disease.
  • Patients received lorlatinib 100 mg once daily or crizotinib 250 mg twice daily.
  • The treatment groups included 149 patients receiving lorlatinib and 147 receiving crizotinib.
  • Patients were stratified by brain metastases and by Asian or non-Asian ethnicity.
  • No crossover was permitted between the study groups.
  • After seven years, median PFS had not been reached with lorlatinib, and 55% remained progression-free versus 3% with crizotinib.
  • Patients without progression during the first 24 months on lorlatinib had a 79% probability of being alive and progression-free at seven years.
  • Lorlatinib was favored across subgroups, including patients with or without brain metastases and Asian or non-Asian patients.
  • The seven-year findings were reported by study coauthor Tony S.K. Mok, MD.
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Trial Efficacy

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ASCO 2026: Studies Aim to Expand Treatment Options for Lung Cancer

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"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."

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