LORVIQUA® (Lorlatinib) | 1L Safety data| PfizerPro Ireland

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Generally manageable safety profile with largely mild-to-moderate adverse reactions^1,2

The Safety profile for LORVIQUA® in the 5-year follow-up analysis was consistent with that in the prior analyses. No new safety signals emerged ^1,2

Data described here are reflective of the 149 adult patients treated with LORVIQUA® during the Phase 3 CROWN trial after 60 months of follow-up.¹ The most common adverse reactions (ARs) are reported below:

ARs (any grade) occurring in ≥20% of patients treated with LORVIQUA® (N=149)¹

Adverse reaction	Any grade	Grade 3 and 4
Hypercholesterolaemia^a	72%	21%
hypertriglyceridaemia^b	66%	25%
Oedema^c	57%	4%
Peripheral neuropathy^d	44%	1%
Weight increased	44%	23%
Fatigue^e	30%	1%
Arthralgia	28%	1%
Cognitive effects^f	28%	3%
Hypertension^h	26%	12%
Anaemia	25%	4%
Diarrhoea	23%	2%
Dyspnea^h	23%	3%
Headache^h	22%	0%
Mood effects^g	21%	1%
Cough^h	20%	0%
Pyrexia^h	20%	1%

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Adapted from Solomon BJ et al. Journal of Clinical Oncology 42, 3400-3409 (2024)

Refer to the LORVIQUA®Summary of Product Characteristicsfor the most up-to-date safety profile.
Learn more about Therapy Management

^aHypercholesterolaemia (including blood cholesterol increased, hypercholesterolaemia).^2
bHypertriglyceridaemia (including blood triglycerides increased, hypertriglyceridaemia).²
^cOedema (including generalised oedema, oedema, oedema peripheral, peripheral swelling, swelling).²
^dPeripheral neuropathy (including burning sensation, dysaesthesia, formication, gait disturbance, hypoaesthesia, motor dysfunction, muscular weakness, neuralgia, neuropathy peripheral, neurotoxicity, paraesthesia, peripheral motor neuropathy, peripheral sensory neuropathy, peroneal nerve palsy, sensory disturbance).²
^eFatigue (including asthenia, fatigue).²
^fCognitive effects (including events from SOC Nervous system disorders: amnesia, cognitive disorder, dementia, disturbance in attention, memory impairment, mental impairment; and also including events from SOC Psychiatric disorders: attention deficit/hyperactivity disorder, confusional state, delirium, disorientation, reading disorder). Within these effects, terms from SOC Nervous system disorders were more frequently reported than terms from SOC Psychiatric disorder.²
^gMood effects (including affective disorder, affect lability, aggression, agitation, anger, anxiety, bipolar I disorder, depressed mood, depression, depressive symptom, euphoric mood, irritability, mania, mood altered, mood swings, panic attack, personality change, stress).²
^hAdverse reaction was not included in the pooled safety analysis.²

In the CROWN study, treatment related adverse reactions (ARs) led to permanent discontinuations and dose reductions in 5% and 21% of patients with Lorviqua® and 6% and 13% of patients with crizotinib¹

CNS ARs occurred in 42% of patients in the Lorviqua® group, the majority of which (86%) were of grade 1/2 severity. Only 3 patients who experienced treatment related CNS ARs (two had confusional state and one had nightmares) permanently discontinued Lorviqua®¹

The safety profile of Lorviqua® was consistent with that in the prior analyses with no new safety signals detected after additional treatment exposure and longer follow up. ARs with Lorviqua® were manageable with dose reduction without affecting systemic or intracranial efficacy¹.

Data cutoff: 31 October 2023.¹

Based on data from 60-month follow-up of 149 patients who received LORVIQUA® 100 mg once daily in the Phase 3 CROWN trial.¹

1L=first-line; 2L=second-line; AR=adverse reaction; SOC=system organ class.

References:

Solomon BJ, Liu G, Felip E, et al. Lorlatinib versus crizotinib in patients with advanced ALK-positive non-small cell lung cancer: 5-year outcomes from the phase III CROWN study. Journal of Clinical Oncology (2024) 42,3400-3409

Pfizer. LORVIQUA® (lorlatinib) Summary of Product Characteristics.

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PP-LOR-IRL-0177 | AUG2025

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The Safety profile for LORVIQUA® in the 5-year follow-up analysis was consistent with that in the prior analyses. No new safety signals emerged 1,2

ARs (any grade) occurring in ≥20% of patients treated with LORVIQUA® (N=149)1

The Safety profile for LORVIQUA® in the 5-year follow-up analysis was consistent with that in the prior analyses. No new safety signals emerged ^1,2

ARs (any grade) occurring in ≥20% of patients treated with LORVIQUA® (N=149)¹