The safety and efficacy of LORVIQUA® was evaluated in a single-arm, multicentre, Phase I/II study of patients with ALK+ advanced NSCLC who were treatment naive in the advanced setting or had disease progression after at least one previous treatment with a TKI.1-4
In the Phase II portion of the Phase I/II Registrational Study, the most frequently reported (≥15% of patients) treatment-related adverse events with LORVIQUA® (n=295) were hypercholesterolaemia (84.4%), hypertriglyceridaemia (67.1%), oedema (45.8%), peripheral neuropathy (34.2%), cognitive effects (23.7%), weight increased (23.7%) and mood effects (15.6%).2
Dose reductions occured in 25.4% of patients, temporary dose interruptions occured in 81.7% of patients, and 3.4% of patients discontinued treatment due to a treatment-related AE.2
No treatment-related deaths were reported in the Phase II portion of the Phase I/II Study.2
No treatment-related deaths were reported in the Phase II portion of the Phase I/II Study.2
| AEs, n (%) | Total (N =295) | Grade 1-2 | Grade 3 | Grade 4 | Grade 5 |
|---|---|---|---|---|---|
| Any treatment-related AE | 281 (95.3) | 139 (47.1) | 119 (40.3) | 23 (7.8) | 0 |
| Hypercholesterolaemiab | 249 (84.4) | 197 (66.8) | 47 (15.9) | 5 (1.7) | 0 |
| Hypertriglyceridaemiab | 198 (67.1) | 143 (48.5) | 46 (15.6) | 9 (3.1) | 0 |
| Oedemab | 135 (45.8) | 129 (43.7) | 6 (2.0) | 0 | 0 |
| Peripheral neuropathyb | 101 (34.2) | 95 (32.2) | 6 (2.0) | 0 | 0 |
| Cognitive effectsb | 70 (23.7) | 65 (22.0) | 5 (1.7) | 0 | 0 |
| Weight increased | 70 (23.7) | 55 (18.6) | 15 (5.1) | 0 | 0 |
| Mood effectsb | 46 (15.6) | 43 (14.6) | 3 (1.0) | 0 | 0 |
| Aspartate aminotransferase increased | 38 (12.9) | 37 (12.5) | 1 (0.3) | 0 | 0 |
| Diarrhea | 37 (12.5) | 36 (12.2) | 1 (0.3) | 0 | 0 |
| Arthralgia | 35 (11.9) | 34 (11.5) | 1 (0.3) | 0 | 0 |
| Alanine aminotransferase increased | 34 (11.5) | 32 (10.8) | 2 (0.7) | 0 | 0 |
| Lipase increased | 31 (10.5) | 15 (5.1) | 12 (4.1) | 4 (1.4) | 0 |
| Fatigue | 30 (10.2) | 29 (9.8) | 1 (0.3) | 0 | 0 |
Adapted from Felip E, et al. Ann Oncol. 2021.2
a Based on all patients who received the recommended dose of LORVIQUA® (100 mg QD) in the Phase I/II Study.
b Refers to AE cluster terms of cognitive effects, oedema, hypercholesterolaemia, hypertriglyceridaemia, mood effects, peripheral neuropathy, psychotic effects, sleep effects, speech effects, vision disorder.2
For the most up-to-date safety information, please refer to the full LORVIQUA® Summary of Product Characteristics for Great Britain.
Outcomes for the primary endpoints of overall and intracranial objective tumour response and key secondary endpoints.
Patient-reported outcomes assessed using the EORTC Quality of Life Questionnaire Core 30 (QLQC30) and corresponding Lung Cancer Module (QLQ-LC13).
AE: Adverse Event, ALK: Anaplastic Lymphoma Kinase, NSCLC: Non-Small Cell Lung Cancer, TKI: Tyrosine Kinase Inhibitor
References
Use interactive hypothetical Patient case studies to understand the Patient pathway, from diagnosis to treatment, including monitoring Adverse Events
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