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The information on this website is based on data from adult patients with ALK-positive advanced NSCLC (anaplastic lymphoma kinase positive advanced non small cell lung cancer) treated with LORVIQUA▼(lorlatinib), produced in line with the LORVIQUA (lorlatinib) Summary of Product Characteristics.
LORVIQUA (lorlatinib) Prescribing Information click here.
▼LORVIQUA is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. Adverse event reporting information can also be found at the bottom of the page.
Efficacy parameter | 1 prior 2nd-generation ALK TKIa ± CT (EXP3B) (n=28) |
≥2 prior ALK TKIs ± CT (EXP4–5) (n=111) |
---|---|---|
ORRb | 42.9% | 39.6% |
95% CI | 24.5-62.8% | 30.5-49.4% |
CR (n) | 1 | 2 |
PR (n) | 11 | 42 |
Median DoR | 5.6 months | 9.9 months |
95% CI | 4.2 months-NR | 5.7-24.4 months |
Median PFS | 5.5 months | 6.9 months |
95% CI | 2.9-8.2 months | 5.4-9.5 months |
Adapted from LORVIQUA SmPC, 2022.
Data cutoff: 2 February 2018.2
Efficacy parameter | 1 prior 2nd-generation ALK TKIa ± CT (EXP3B) (n=9) |
≥2 prior ALK TKIs ± CT (EXP4–5) (n=48) |
---|---|---|
IC-ORRb | 66.7% | 52.1% |
95% CI | 29.9%-92.5% | 37.2%-66.7% |
CR (n) | 2 | 10 |
PR (n) | 4 | 15 |
Median duration of IC response | NR | 12.4 months |
95% CI | 4.1 months-NR | 6.0 months-NR |
Adapted from LORVIQUA SmPC, 2022.
Data cutoff: 2 February 2018.2
Efficacy parameter | Alectinib (n=62) | Ceritinib (n=47) | Brigatinib (n=8) |
---|---|---|---|
Confirmed ORR | 37.1% | 40.4% | 37.5% |
95% CI | 25·2%–50·3% | 26·4%–55·7% | 8·5%–75·5% |
Confirmed Intracranial ORR | 43.2% | 54.1% |
40.0% 5.3%-85.3% |
95% CI | 27.1% - 60.5% | 36.9%-70.5% |
Adapted from Besse B, et al. ASCO 2018.
Data cutoff: 2 February 2018.2
aAlectinib, brigatinib, or ceritinib.1
bPer ICR.1
cIn patients with at least one measurable brain metastasis at baseline.1
dKaplan-Meier estimate.2
eEstimates for progression-free survival duration of response and duration of IC response are not calculated due to the small number of patients who received brigatinib as the last second-generation ALK TKI before lorlatinib.2
ALK=anaplastic lymphoma kinase; CNS=central nervous system; CR=complete response; CT=chemotherapy;
DoR=duration of response; EXP=expansion cohort; ICR=independent central review; NC=not calculated; NR=not reached; ORR=objective response rate; PFS=progression-free survival; PR=partial response; TKI=tyrosine kinase inhibitor.
Adverse events should be reported. Report an adverse event to your national reporting system (HPRA Pharmacovigilance)
Adverse events should also be reported to Pfizer Medical Information on 1800 633 363
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PP-UNP-IRL-0784. June 2024