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The primary endpoint of PFS was met in the CROWN trial BICR-assessed primary analysis (median follow-up for PFS: 18.3 months for patients receiving LORVIQUA and 14.8 months for patients receiving crizotinib); median PFS was not estimable for the LORVIQUA arm. An unplanned INV-assessed follow-up analysis was performed at a median follow-up for PFS of approximately 83 months for patients on LORVIQUA (77.2 months for patients on crizotinib) to confirm the effect of LORVIQUA relative to crizotinib with longer follow-up. All tumour-related endpoints reported in the 7-year analysis are INV-assessed.1,2
LIMITATIONS: The results of this unplanned, INV-assessed analysis are descriptive. No formal hypothesis testing was performed given that the PFS endpoint was previously met in the CROWN trial primary analysis; results are presented descriptively. 1
Lorviqua as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)‑positive advanced non‑small cell lung cancer (aNSCLC) previously not treated with an ALK inhibitor or whose disease has progressed after prior treatment with an ALK inhibitor.
CROWN study design: LORVIQUA in 1L ALK +ve aNSCLC3
† The primary endpoint of PFS was met in the CROWN trial BICR-assessed primary analysis (median follow-up for PFS: 18.3 months for patients receiving LORVIQUA and 14.8 months for
patients receiving crizotinib); median PFS was not estimable for the LORVIQUA arm. An unplanned INV-assessed follow-up analysis was performed at a median follow-up for PFS of approximately 83 months for patients on LORVIQUA (77.2 months for patients on crizotinib) to confirm the effect of LORVIQUA relative to crizotinib with longer follow-up. All tumour-related endpoints reported in the 7-year analysis are INV-assessed.1,2
‡ LIMITATIONS: The results of this unplanned, INV-assessed analysis are descriptive. No formal hypothesis testing was performed given that the PFS endpoint was previously met in the CROWN trial primary analysis; results are presented descriptively.1
† The primary endpoint of PFS was met in the CROWN trial BICR-assessed primary analysis (median follow-up for PFS: 18.3 months for patients receiving LORVIQUA and 14.8 months for
patients receiving crizotinib); median PFS was not estimable for the LORVIQUA arm. An unplanned INV-assessed follow-up analysis was performed at a median follow-up for PFS of approximately 83 months for patients on LORVIQUA (77.2 months for patients on crizotinib) to confirm the effect of LORVIQUA relative to crizotinib with longer follow-up. All tumour-related endpoints reported in the 7-year analysis are INV-assessed.1,2
‡ LIMITATIONS: The results of this unplanned, INV-assessed analysis are descriptive. No formal hypothesis testing was performed given that the PFS endpoint was previously met in the CROWN trial primary analysis; results are presented descriptively.1
SAFETY SUMMARY
THERAPY MANAGEMENT CONSIDERATIONS
The safety profile for LORVIQUA in the 7-year follow-up analysis was consistent with that in the primary analysis. No new safety signals emerged1
• There was no new increase frequency of Grade 3 or 4 AEs in the 7-year follow-up analysis since the 5-year data update.1
• 5% (n=8) of patients discontinued LORVIQUA due to TRAEs.1
• No new treatment discontinuations due to TRAEs after the first 26 months.1
Most ARs occurred within the first 6 months and can be managed with appropriate mitigation strategies6
The below timeline is adapted from: Liu G, et al. Lung Cancer. 2024
For full safety information, please refer to the LOVIQUA SmPC3:
¶ The values listed here represent median time to first occurrence for each AE. There is a distribution in which some may occur earlier or later than these median values.3
a Hypercholesterolaemia (including blood cholesterol increased, hypercholesterolaemia).3
b Hypertriglyceridaemia (including blood triglycerides increased, hypertriglyceridaemia).3
c Oedema (including generalised oedema, oedema, oedema peripheral, peripheral swelling, swelling). there were no Grade 4 events in the 7-year follow-up analysis.1,3
d Peripheral 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). There were no Grade 4 events in the 7-year follow-up analysis.1,3
e Weight gain classification ranges from Grade 1 to Grade 3; there were no Grade 4 events in the 7-year follow-up analysis.3,6
f Fatigue (including asthenia, fatigue). There were no Grade 4 events for fatigue.1,3
g Cognitive 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 disorders. There were no Grade 4 events for cognitive effects.1,3
h Mood 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).3
** CNS effects included cognitive, mood, speech and psychotic effects.1
†† CNS AEs leading to permanent treatment discontinuation included cognitive effects defined as any event from High-Level Group Term cognitive and attention disorder or disturbances or deliria (including confusion) or mental impairment disorders; and psychotic effects defined as any event from Standardized MedDRA Queries narrow psychosis and psychotic disorders or psychological trauma of psychotic symptom.1
DOSE MODIFICATIONS
Some LORVIQUA AEs can be effectively managed with dose modifications
‡‡ Based on data from 84-month follow-up of 149 patients who received LORVIQUA 100 mg once daily in the Phase 3 CROWN trial.1
# Tumour assessments were performed at screening, then repeated every 8 weeks (±1 week) while on treatment and during follow-up until PD. To reduce patient burden and cumulative radiation exposure, the protocol was amended after the 5-year follow up to extend the interval between tumour assessments from every 8 to 16 weeks. Bone scans were performed (or bone MRI if preferred by Investigator) at baseline and on study only if bony metastases were suspected. Patients with positive results on the bone scans (or bone MRI) had these repeated every 16 weeks (±1 week).5
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Shaw AT, et al. Ann Oncol. 2026; doi: https://doi.org/10.1016/j.annonc.2026.05.692
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