Generally manageable safety profile with largely mild-to-moderate adverse reactions1

Data described here are reflective of the CROWN trial, a Phase 3 study of LORVIQUA vs crizotinib in patients with previously untreated, ALK-positive, locally advanced or metastatic NSCLC.

The most common adverse reactions are reported below.

ARs (any grade) occurring in ≥10% of patients treated with LORVIQUA (N=149)1,a
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Adverse reaction Any grade Grades 3 and 4
Hypercholesterolaemiab 70.5% 16.1%
Hypertriglyceridaemiab 63.8% 20.1%
Oedemab 55.0% 4.0%
Weight increased 38.3% 16.8%
Peripheral neuropathyb 33.6% 2.0%
Cognitive effectsb,c 21.5% 2.0%
Diarrhoea 21.5% 1.3%
Anemia 19.5% 2.7%
Fatigueb 19.5% 1.3%
Hypertension 18.1% 10.1%
Vision disorderb 18.1% 0.0%
Increased ALT level 17.4% 2.7%
Constipation 17.4% 0.0%
Mood effectsb,d 16.1% 1.3%
Nausea 14.8% 0.7%
Increased AST level 14.1% 2.0%
Vomiting 12.8% 0.7%
Hyperlipidemia 10.7% 2.0%
Adapted from Shaw AT, et al. N Engl J Med. 2020.
  • In the CROWN study, permanent discontinuations and dose reductions associated with adverse reactions occurred in 7.0% and 21.0% of patients with LORVIQUA and 9.0% and 15.0% with crizotinib, respectively1,a 
  • 35.0% of patients receiving LORVIQUA in the CROWN study reported CNS adverse events, but by time of analysis 56.0% had resolved and most required no intervention (33.0% resolved without intervention, 17.0% with dose modification)2,a 
  • Adverse reactions can be effectively managed with dose modifications and/or standard supportive medical therapy, without affecting the efficacy of LORVIQUA2,3 

Learn more about therapy management

ALT=alanine aminotransferase; AST=aspartate aminotransferase; AR=adverse reaction.aBased on data from 18-month median follow-up of 149 patients who received LORVIQUA 100 mg once daily in the Phase 3 CROWN trial.1bThis category comprised a cluster of adverse events that may represent similar clinical symptoms or syndromes. cCognitive effects with a frequency of at least 1% included memory impairment, disturbance in attention, confusion, amnesia, cognitive disorder, and delirium.dMood effects with a frequency of at least 1% included anxiety, depression, affect lability, affective disorder, agitation, irritability, and altered mood.References:Shaw AT, Bauer TM, de Marinis F, et al; CROWN Trial Investigators. First-line lorlatinib or crizotinib in advanced ALK-positive lung cancer. N Engl J Med. 2020;383(21):2018-2029.Solomon BJ, Bauer TM, Ou SHI, et al. Post hoc analysis of lorlatinib efficacy and safety in patients with ALK-positive advanced non-small-cell lung cancer from the Phase III CROWN study. J Clin Oncol. Published online May 23, 2022. doi: 10.1200/JCO.21.02278.Bauer TM, Felip E, Solomon BJ, et al. Clinical management of adverse events associated with lorlatinib. Oncologist. 2019;24(8):1103-1110.
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