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
The aim of the Phase I portion of the study was to assess the safety, efficacy and pharmacokinetic properties of lorlatinib in 54 advanced ALK+ NSCLC patients at increasing doses to establish the maximum tolerated dose and select the recommended Phase II dose. The primary endpoint was dose-limiting toxicities during cycle 1 according to invesitgator assessment; secondary endpoints included safety, pharmacokinetics and overall response.1,2
The Phase II part of the study included six different expansion cohorts (EXP), of which EXP3B, EXP4 and EXP5 support the LORVIQUA® indication.1,2
Adapted from Solomon BJ, et al. Lancet Oncol. 2018
LORVIQUA® is not approved for the treatment of ROS1 positive advanced NSCLC.
*Asymptomatic untreated or treated CNS metastases were permitted.2
**Bone marrow (absolute neutrophil count ≥1·5 × 109/L, platelets ≥100 × 109/L, and haemoglobin ≥9 g/dL), pancreatic (serum amylase [pancreatic isoenzyme] ≤1·5 × upper limit of normal [ULN] and serum lipase ≤1·5 × ULN), renal (serum creatinine ≤1·5 × ULN or estimated creatinine clearance ≥60 mL/min as calculated using the method standard for for the institution), and liver (total serum bilirubin ≤1·5 × ULN, and aspartate aminotransferase and alanine aminotransferase ≤2·5 × ULN [≤5·0 × ULN in the event of liver metastases]) function.2
†Treatment continued until investigator-assessed PD, unacceptable toxicity, withdrawal of consent, or death. Treatment beyond objective progression was allowed if the patient derived clinical benefit (according to the investigator’s discretion).2
‡Objective tumour response (defined as complete response or partial response) according to RECIST version 1.1, as assessed by ICR.2
§Intracranial objective tumour response (defined as complete response or partial response) according to modified RECIST version 1.1, which allowed for up to five CNS target lesions, as assessed by ICR.2
| Characteristic | EXP3B (n=28) | EXP4-5 (n=111) |
|---|---|---|
| Prior therapy for NSCLC | 1 prior second-generation ALK TKI* + CT | ≥2 previous ALK TKIs*† with or without chemotherapy |
| Age (years) | ||
| Median (IQR) | 54.0 (46.5 - 64.0) | 51.0 (43.0 - 59.0) |
| Mean (SD) | 55.0 (11.6) | 51.9 (11.5) |
| Range | 33 - 77 | 29 - 83 |
| Sex | ||
| Female | 16 (57%) | 62 (56%) |
| Male | 12 (43%) | 49 (44%) |
| Race | ||
| White | 7 (25%) | 59 (53%) |
| Black | 1 (4%) | 0 |
| Asian | 16 (57%) | 37 (33%) |
| Other | 1 (4%) | 5 (5%) |
| Unspecified‡ | 3 (11%) | 10 (9%) |
| ECOG | ||
| 0 | 15 (54%) | 46 (41%) |
| 1 | 13 (46%) | 59 (53%) |
| 2 | 0 | 6 (5%) |
| Brain metastases | ||
| Present at baseline§ | 13 (46%) | 83 (75%) |
Adapted from Solomon BJ, et al. Lancet Oncol. 20182
*Patients predominantly received either alectinib or ceritinib as the last ALK TKI before LORVIQUA®.2
†Lines of therapy (if the same TKI was given twice, this was counted as two prior lines of treatment).2
‡In some countries, race was not allowed to be collected per local regulations.2
§By independent central review and includes measurable and non-measurable baseline central nervous system lesions.2
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Navigate to study design, efficacy outcomes, quality of life data and safety outcomes for the LORVIQUA® Phase I/II study.
Outcomes for the primary endpoints of overall and intracranial objective tumour response and key secondary endpoints.
ALK: Anaplastic Lymphoma Kinase, CI: Confidence Interval, CT: Chemotherapy, ECOG: Eastern Cooperative Oncology Group, ICR: Independent Central Radiography Review, IQR: Interquartile Range, NSCLC: Non-Small Cell Lung Cancer, ORR: Overall Response Rate, PD: Progressive Disease, SD: Standard Deviation, TKI: Tyrosine Kinase Inhibitor
References
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