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
First Line Prior ALK TKI

Efficacy in Patients Who Received Prior ALK TKI Therapy

Study Design: Prior ALK TKI

LORVIQUA® is a third-generation ALK inhibitor that was studied in a subgroup of patients who progressed on second-generation ALK

Phase 1/2, single-arm, multicenter trial1
The demographic characteristics across the 197 patients were: 59% female, 49% White, 36% Asian; the mean age was 53 years (29 to 85 years) with 19% of patients ≥65 years. The ECOG performance status at baseline was 0 or 1 in 97% of patients. Brain metastases were present at baseline in 62% of patients. All 197 patients had received prior systemic therapy, 20% received 1, 28% received 2, 19% received 3, and 34% received 4 or more prior systemic therapies. Of the 197 patients, 44% received 1 prior ALK TKI, 33% received 2 prior ALK TKIs, and 23% received 3 or more prior ALK TKIs.1

*Alectinib, ceritinib, or brigatinib.2
According to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 and as assessed by Independent Central Review (ICR) committee.
​​​​​​​ECOG=Eastern Cooperative Oncology Group.

Prior Treatment​​​​​​​

Chemotherapy administered in the metastatic setting

Overall and Intracranial Response Rates

Adapted from local Prescribing Information (see Tables 5 and 6).1

In exploratory analyses conducted in subgroups defined by prior therapy, the response rates to LORVIQUA® were:1

•    ORR=69.5% (95% CI: 56.1–80.8) in 59 patients who received crizotinib
•    ORR=33.3% (95% CI: 16.5–54.0) in 27 patients who received 1 ALK inhibitor excluding crizotinib as the only TKI
•    ORR=38.7% (95% CI: 29.6–48.5) in 111 patients who received 2 or more ALK TKIs

§Assessed by Independent Central Review (ICR) per RECIST version 1.1.
Alectinib, ceritinib, or brigatinib.
NR=not reached; ORR=overall response rate; RECIST=Response Evaluation Criteria in Solid Tumours.

​​​​​​​LORVIQUA® Efficacy

® Safety Profile
LORVIQUA® Dosing and Therapy
1. Pfizer. LORVIQUA® (lorlatinib) Prescribing Information, Available from: http://labeling.pfizer.com/ShowLabeling.aspx?id=12540 
Accessed 6 January 2022.
2. Recondo G, Facchinetti F, Olaussen KA, Besse B, Friboulet L. Nat Rev Clin Oncol. 2018;15(11):694-708. 

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.
Click here for LORVIQUA® Prescribing Information

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