Adapted from Solomon BJ, et al. Lancet Respir Med. 2022.1
Data cutoff: September 20, 2021.1
*The higher incidence of grade 3-4 AEs in patients in the LORVIQUA® arm was largely due to frequent recurrence of altered lipid concentration, including hypertriglyceridaemia (23% in the LORVIQUA® arm vs. 0% in the crizotinib arm) and hypercholesterolaemia (19% in the LORVIQUA® arm vs. 0% in the crizotinib arm), as well as weight gain (20% in the LORVIQUA® arm vs. 2% in the crizotinib arm) and hypertension (11% in the LORVIQUA® arm vs 1% in the crizotinib arm).1
| Event* Data are n (%) |
LORVIQUA® (n=149) | Crizotinib (n=142) | ||||
| Any Grade | Grade 3 | Grade 4 | Any Grade | Grade 3 | Grade 4 | |
| Any adverse event | 149 (100) | 94 (63) | 19 (13) | 140 (99) | 69 (49) | 12 (8) |
| Hypercholesterolaemia† | 108 (72) | 27 (18) | 2 (1) | 5 (4) | 0 | 0 |
| Hypertriglyceridaemia† | 99 (66) | 23 (15) | 11 (7) | 8 (6) | 0 | 0 |
| Oedema† | 83 (56) | 6 (4) | 0 | 61 (43) | 2 (1) | 0 |
| Weight Increased | 65 (44) | 30 (20) | 0 | 18 (13) | 3 (2) | 0 |
| Peripheral neuropathy† | 60 (40) | 2 (1) | 0 | 21 (15) | 1 (1) | 0 |
| Arthralgia | 39 (26) | 1 (1) | 0 | 20 (14) | 0 | 0 |
| Cognitive effects† | 38 (26) | 5 (3) | 0 | 9 (6) | 0 | 0 |
| Anaemia | 33(22) | 5 (3) | 0 | 13 (9) | 4 (3) | 0 |
| Diarrhoea | 33 (22) | 2 (1) | 0 | 75 (53) | 1 (1) | 0 |
| Vision disorder† | 28 (19) | 0 | 0 | 56 (39) | 1 (1) | 0 |
| ALT increased† | 27 (18) | 4 (3) | 0 | 49 (35) | 5 (4) | 1 (1) |
| Constipation | 29 (19) | 0 | 0 | 43 (30) | 1 (1) | 0 |
| Nausea | 23 (15) | 1 (1) | 0 | 75 (53) | 3 (2) | 0 |
| AST increased† | 22 (15) | 3 (2) | 0 | 39 (27) | 5 (4) | 0 |
| Vomiting | 20 (13) | 1 (1) | 0 | 56 (39) | 2 (1) | 0 |
| Decreased appetite | 6 (4) | 0 | 0 | 35 (25) | 4 (3) | 0 |
Adapted from Solomon BJ, et al. Lancet Respir Med. 2022. Supplementary Appendix.2
Data cutoff: September 20, 2021.2
*Patients were only counted once per event.2
†This category comprised a cluster of AEs that may represent similar clinical symptoms or syndromes.2
|
Event Data are n (%) |
LORVIQUA (n=149) | ||||
| Any grade | Grade 1 | Grade 2 | Grade 3 | Grade 4 | |
| Any CNS AE | 58 (39) | 34 (23) | 16 (11) | 8 (5) | 0 |
| Cognitive effects* | 38 (26) | 23 (15) | 10 (7) | 5 (3) | 0 |
| Mood effects† | 26 (17) | 14 (9) | 10 (7) | 2 (1) | 0 |
| Speech effects‡ | 8 (5) | 6 (4) | 1 (1) | 1 (1) | 0 |
| Psychotic effects§ | 7 (5) | 5 (3) | 1 (1) | 1 (1) | 0 |
Adapted from Solomon BJ, et al. Lancet Respir Med. 2022. Supplementary Appendix.2
Data cutoff: September 20, 2021.2
*Cognitive disorders were any event from cognitive and attention disorders and disturbances, or deliria (including confusion), or mental impairment disorders.2
†Mood effects were any event from anxiety disorders and symptoms, or depressed mood disorders and disturbances, or manic and bipolar mood disorders and disturbances, or mood disorders and disturbances NEC, or personality disorders and disturbances in behaviour.2
‡Speech effects were any event from speech and language abnormalities.
§Psychotic effects were any event from narrow psychosis and psychotic disorders or PT of psychotic symptom.2
|
Patients with event* Data are n (%) |
Time Interval | ||||
| <6 months (n=149) | 6 months-1 year (n=129) | 1-2 years (n=177) | 2-3 years (n=98) | >3 years (n=92) | |
| Any CNS AE | 37 (25) | 14 (11) | 18 (15) | 10 (10) | 2 (2) |
Adapted from Bearz A, et al. Poster 979P presented at ESMO 2022, 9-13 Sept.3
Data cutoff: September 20, 2021.3
* Patients were only counted once per time interval within each cluster. n was the number of patients at risk during the specified time period.3
For the most up-to-date safety information, please refer to the full LORVIQUA® Summary of Product Characteristics.4
Outcomes for the primary endpoint of progression-free survival (assessed by BICR) and key secondary endpoints.
Outcomes for the secondary endpoint of patient-reported quality of life.
AE: adverse event, ALT: alanine aminotransferase, AST: aspartate aminotransferase, CNS: central nervous system, NEC: not elsewhere classified, PT: preferred term
References
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