Lorlatinib approved for the first-line treatment of adult patients with metastatic anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC).
Lorbrena trade name.
Radomized, open-label, parallel 2-arm phase 3 CROWN trial, designed to evaluate lorlatinib compared with crizotinib in previously untreated patients.
Treatment with lorlatinib demonstrated a 72% reduction in the risk for progression or death.
The intracranial objective response rate was 82% compared with 23% with crizotinib.
The intracranial duration of response was 12 months or longer in 79% of patients treated with lorlatinib compared with 0% of those who received crizotinib.
Adverse events: edema (56%), weight gain (38%), peripheral neuropathy (35%), cognitive effects (21%), diarrhea (21%), dyspnea (20%), and hypertriglyceridemia (22%).
Serious AEs occurred in 34% of patients: pneumonia (4.7%), dyspnea (2.7%), respiratory failure (2.7%), cognitive effects (2.0%), and pyrexia (2.0%).
Fatal AEs occurred in 3.4% of the lorlatinib arm, and included pneumonia (0.7%), respiratory failure (0.7%), cardiac failure acute (0.7%), pulmonary embolism (0.7%), and sudden death (0.7%).