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

Data described here are reflective of the Phase 1/2 study of LORVIQUA in patients with previously treated ALK-positive, advanced or metastatic NSCLC.1

The most common adverse reactions are reported below. 

ARs (any grade) occurring in ≥10% of patients treated with LORVIQUA (N=275)1
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Adverse reaction Any grade Grades 3 and 4
Hypercholesterolaemiaa 81.5% 15.6%
Hypertriglyceridaemiaa 60.4% 15.6%
Oedemaa 43.3% 2.2%
Peripheral neuropathya 29.8% 1.8%
Weight increased 18.2% 1.8%
Cognitive effectsa 17.8% 1.1%
Mood effectsa 14.9% 0.7%
Fatiguea 13.1% 0.4%
Diarrhoea 10.5% 0.4%
Arthralgia 10.2% 0.0%
AST increased 10.2% 0.4%

Adapted from Solomon NJ, et al. Lancet Oncol. 2018.

  • In patients receiving LORVIQUA, permanent discontinuations and dose reductions associated with adverse reactions occurred in 3.0% and 22.0% of patients, respectively1
  • Of the 295 patients on LORVIQUA, only 8.0% required dose modification due to CNS adverse reactions and 62.5% of these patients experienced resolution of CNS adverse reactions after dose modification
  • Adverse reactions can be effectively managed with dose modifications and/or standard supportive medical therapy2

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AST=aspartate aminotransferase; AR=adverse reaction.aCluster term comprising adverse events that represent similar clinical symptoms or syndromes.ReferencesSolomon BJ, Besse B, Bauer TM, et al. Lorlatinib in patients with ALK-positive non-small-cell lung cancer: results from a global phase 2 study. Lancet Oncol. 2018;19:1654-1667.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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