LORVIQUA® (lorlatinib) as monotherapy is indicated for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) or for patients with ALK-positive metastatic NSCLC whose disease has progressed after alectinib or ceritinib as the first ALK tyrosine kinase inhibitor (TKI) therapy, or crizotinib and at least one other ALK TKI1

Study Overview
The LORVIQUA® global registrational study design

  • This is a single arm, multicenter, Phase II study of 100 mg LORVIQUA®  in previously treated patients  with ALK+ advanced NSCLC1,2 ​​​​​​​
  • The study included several cohorts, of which EXP3B,  EXP4 and EXP5  are covered by the LORVIQUA ® indication1,
  • Patients with brain metastases were induded across cohorts2

     - EXP3B 46% (n=13); EXP4-5 75% (n=83)

Trial design for cohorts EXP3B, 4, 52

Adapted from Solomon BJ, et al.  lancet Oncol. 2018.
The LORVIQUA® global registrational study: Baseline characteristics2

         Adapted from Solomon BJ, et al  2018.

*Treatment  continued  until  investigator-assessed  progressive  disease,  unacceptable toxicity, withdrawal  of consent,  or death
. Treatment beyond objective progression  was allowed  if the patient derived  clinical   benefit  (according to the investigator’s discretion).2
Objective  tumor response (defined as complete response or partial response) according to RECIST version 1.1, as assessed by  ICR,2
intracranial tumor response (defined as complete response or partial response) according  to modified RECIST version 1.1, which allowed  for up to 5 CNS target lesions, as assessed  by ICR.2
 §Patients  predominantly received   either alectinib  or ceritinib as the last ALK TKI ± CI before LORVIQUA®2
Lines of therapy (if the same TKI  was given twice, this was counted as two prior lines of treatment).2
ǁ In some countries, race was  not allowed to be collected per local regulations.2
# By independent central  review and includes measurable and non measurable baseline  central nervous  system lesions.2

For Healthcare Professionals only

Abbreviations: ALK+, Anaplastic lymphoma kinase positive; CI, confidence interval; CNS, central nervous system; CT, chemotherapy; DoR, duration of response: ECOG PS, Eastern Cooperative Oncology Group  performance status: EORTC, European Organisation for Research and Treatment of Cancer; FISH, fluorescence in situ hybridization; IQR, interquartile range; NSCLC, non-small cell lung  cancer; PFS, progression-free survival: PRO, patient-reported outcome; QLQ-C30, Quality of Life Questionnaire-Core 30; QLQ-LC13, Quality of Life Questionnaire- lung cancer 13;  RECIST, Response Evaluation Criteria in Solid Tumours; SD, standard deviation; TKI, tyrosine kinase inhibitor; TTR, time to response.

1. Pfizer. LORVIQUA® (lorlatinib) Prescribing Information, Available from: http://labeling.pfizer.com/ShowLabeling.aspx?id=12540 Accessed September 23,2021. 
2. Solomon 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(12)1654-1667.

The use of lorlatinib has been associated with increases in serum cholesterol and triglycerides. Serum cholesterol and triglycerides should be monitored before the initiation of lorlatinib; 2, 4, and 8 weeks after initiating lorlatinib, and periodically thereafter. Initiation, or increase in the dose, of lipid-lowering agents is required.
Central nervous system (CNS) effects have been observed in patients receiving lorlatinib including seizures, psychotic effects, changes in cognitive function, mood (including suicidal ideation), mental status, sleep, and speech. Dose modification or discontinuation may be required for those patients who develop CNS effects.
PR interval prolongation and atrioventricular (AV) block events have been reported in patients receiving lorlatinib. Monitor electrocardiogram (ECG) prior to initiating lorlatinib and monthly thereafter, particularly in patients with predisposing conditions to the occurrence of clinically significant cardiac events. Dose modification may be required for those patients who develop AV block.
Elevations of lipase and/or amylase have occurred in patients receiving lorlatinib. Median time of occurrence of increase in serum lipase and amylase is 70 days (range: 7 days to 696 days) and 41 days (range: 7 days to 489 days), respectively. Risk of pancreatitis should be considered in patients receiving lorlatinib due to concomitant hypertriglyceridemia and/or a potential intrinsic mechanism. Patients should be monitored for lipase and amylase elevations prior to the start of lorlatinib treatment and regularly thereafter as clinically indicated.
Severe or life threatening pulmonary adverse drug reactions consistent with ILD/pneumonitis have occurred with lorlatinib. Any patient who presents with worsening of respiratory symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough and fever) should be promptly evaluated for ILD/pneumonitis. Lorlatinib should be withheld and/or permanently discontinued based on severity.
Hypertension has been reported in patients receiving lorlatinib. Blood pressure should be controlled prior to the initiation of lorlatinib. Blood pressure should be monitored after 2 weeks and at least monthly thereafter during treatment with lorlatinib. Lorlatinib should be withheld and resumed at a reduced dose or permanently discontinued based on severity.
Hyperglycemia has occurred in patients receiving lorlatinib. Fasting serum glucose should be assessed prior to the initiation of lorlatinib and monitored periodically thereafter. Lorlatinib should be withheld and resumed at a reduced dose or permanently discontinued based on severity.
Concomitant use of any strong CYP3A inducer is contraindicated. Any strong CYP3A inducers have to be discontinued for at least 3 plasma half-lives of the strong CYP3A inducer before lorlatinib treatment is started. No clinically meaningful changes in liver function tests were seen in healthy subjects after receiving a combination of lorlatinib with the moderate CYP3A inducer modafinil.
Women of childbearing potential should be advised to avoid getting pregnant while receiving lorlatinib. Male fertility may be compromised during treatment with lorlatinib. Men should seek advice on effective fertility preservation before treatment.

​​​​​​​LORVIQUA® Efficacy

® Safety Profile
LORVIQUA® Dosing and Therapy
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