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 study investigated both extracranial and intracranial outcomes.1,3
The primary endpoints of the Phase II portion of the study were:1,3
The key secondary endpoints of the Phase II portion of the study were:1,3
| Endpoint | Primary interim analysis (data cutoff: March 15, 2017)*1 |
Follow-up analysis (data cutoff: May 14, 2019)†3 |
||
|---|---|---|---|---|
| Patients who received one prior-second generation ALK TKI‡ with or without prior chemotherapy (EXP3B; n=28) | Patients who received two or more prior ALK TKIs§ with or without prior chemotherapy (EXP4-5; n=111) | Patients who received one prior-second generation ALK TKI‡ with or without prior chemotherapy (EXP3B; n=28) | Patients who received two or more prior ALK TKIs§ with or without prior chemotherapy (EXP4-5; n=111) | |
| Overall objective response rate (ORR) | 32.1% (95 CI: 15.9-52.4) | 38.7% (95% CI: 29.6-48.5) | 42.9% (95% CI: 24.5-62.8) | 38.7% (95% CI: 29.6-48.5) |
| Intracranial objective response rate (IC-ORR) |
Evaluated in 9/28 patients: 55.6% (95% CI: 21.2-86.3) | Evaluated in 49/111 patients: 53.1% (95% CI: 38.3-67.5) | Evaluated in 9/28 patients: 66.7% (95% CI: 29.9-92.5) | Evaluated in 48/111 patients: 54.2% (95% CI: 39.2-68.6) |
*Median duration of follow-up for response: EXP3B: 7.0 months (IQR: 5.6-8.3); EXP4-5: 7.2 months (IQR: 5.6-9.8).1
†Median duration of treatment: EXP3B: 8.7 months (range 0.3-39.9); EXP4-5: 10.1 months (range: 0.2-43.2).3
‡Patients mostly received alectinib (46.4%) or ceritinib (46.4%) as first-line ALK TKI.1,3
§Patients mostly received alectinib (44.1%) or ceritinib (30.6%) as their last prior ALK TKI before LORVIQUA®.1,3
| Endpoint | Primary interim analysis (data cutoff: March 15, 2017)*1 |
Follow-up analysis (data cutoff: May 14, 2019)†3 |
||
|---|---|---|---|---|
| Patients who received one prior-second generation ALK TKI‡ with or without prior chemotherapy (EXP3B; n=28) | Patients who received two or more prior ALK TKIs§ with or without prior chemotherapy (EXP4-5; n=111) | Patients who received one prior-second generation ALK TKI‡ with or without prior chemotherapy (EXP3B; n=28) | Patients who received two or more prior ALK TKIs§ with or without prior chemotherapy (EXP4-5; n=111) | |
| Median overall DoR | NR (95% CI: 4.1 months-NR) | NR (95 CI: 5.5 months-NR) | Evaluated in 12/28 patients: 6.2 months (95% CI: 4.2-35.3 months) | Evaluated in 43/111 patients: 9.9 months (95% CI: 5.7-16.7 months) |
| Median IC-DoR | Evaluated in 9/28 patients: Not reached (95% CI: 4.1 months-NR) | Evaluated in 49/111 patients: 14.5 months (95% CI: 6.9-14.5 months) | Evaluated in 9/28 patients: 20.7 months (95% CI: 4.1-37.1 months) | Evaluated in 48/111 patients: 12.4 months (95% CI: 6.0-16.7 months) |
| Median PFS | 5.5 months (95% CI: 2.7-9.0 months) | 6.9 months (95% CI: 5.4-9.5 months) | 5.5 months (95% CI: 2.9-8.2 months) | 6.9 months (95% CI: 4.2-8.3 months) |
| Median OS | NR | NR | 38.5 months (95% CI: 12.3 months-NE) | 19.2 months (95% CI: 15.4-30.2 months) |
| Header | Header | Header | Header | Header |
|---|---|---|---|---|
| Content | Content | Content | Content | Content |
| Content | Content | Content | Content | Content |
| Content | Content | Content | Content | Content |
| Content | Content | Content | Content | Content |
| Content | Content | Content | Content | Content |
*Median duration of follow-up for response: EXP3B: 7.0 months (IQR: 5.6-8.3); EXP4-5: 7.2 months (IQR: 5.6-9.8).1
†Median duration of treatment: EXP3B: 8.7 months (range 0.3-39.9); EXP4-5: 10.1 months (range: 0.2-43.2).3
‡Patients mostly received alectinib (46.4%) or ceritinib (46.4%) as first-line ALK TKI.1,3
§Patients mostly received alectinib (44.1%) or ceritinib (30.6%) as their last prior ALK TKI before LORVIQUA®.1,3
Adapted from Felip E, et al. Annals of Oncology. 2021.3
Data cutoff: May 14, 2019.
*Median duration of treatment: EXP3B: 8.7 months (range: 0.3-39.9); EXP4-5: 10.1 months (range: 0.2-43.2).3
†Patients predominantly received alectinib (46.4%) or ceritinib (46.4%) as first-line ALK TKI.1,3
‡ Patients mostly received alectinib (44.1%) or ceritinib (30.6%) as their last prior ALK TKI before LORVIQUA®.1,3
§Objective tumour response (defined as complete response or partial response) according to RECIST version 1.1, as assessed by ICR.1,3
x Kaplan-Meier estimates; CIs were derived using the Brookmeyer Crowley method.3
Adapted from Solomon et al. Lancet Oncol. 20181
Data cutoff: March 15, 2017.
*Median duration of follow-up for response: EXP3B: 7.0 months (IQR: 5.6-8.3); EXP4-5: 7.2 months (IQR:5.6-9.8).1
†Patients predominantly received alectinib (46.4%) or ceritinib (46.4%) as first-line ALK TKI.1,3
‡ Patients mostly received alectinib (44.1%) or ceritinib (30.6%) as their last prior ALK TKI before LORVIQUA®.1,3
§Objective tumour response (defined as complete response or partial response) according to RECIST version 1.1, as assessed by ICR.1,3
x Using the Brookmeyer and Crowley method.1
Adapted from Felip E, et al. Annals of Oncology. 2021.3
Data cutoff: May 14, 2019.
*Median duration of treatment: EXP3B: 8.7 months (range: 0.3-39.9); EXP4-5: 10.1 months (range: 0.2-43.2).3
†Patients predominantly received alectinib (46.4%) or ceritinib (46.4%) as first-line ALK TKI.1,3
‡ Patients mostly received alectinib (44.1%) or ceritinib (30.6%) as their last prior ALK TKI before LORVIQUA®.1,3
§IC-ORR (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.1,3
x Kaplan-Meier estimates; CIs were derived using the Brookmeyer Crowley method.3
Adapted from Solomon BJ, et al. Lancet Oncol. 2018.1
Data cut off March 15, 2017.
*Median duration of follow-up for respnse: EXP3B: 7.0 months (IQR: 5.6-8.3); EXP4-5: 7.2 months (IQR:5.6-9.8).1
†Patients predominantly received alectinib (46.4%) or ceritinib (46.4%) as first-line ALK TKI.1,3
‡ Patients mostly received alectinib (44.1%) or ceritinib (30.6%) as their last prior ALK TKI before LORVIQUA®.1,3
§IC-ORR (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.1,3
x Using the Brookmeyer and Crowley method.1
Patient-reported outcomes assessed using the EORTC Quality of Life Questionnaire Core 30 (QLQ-C30) and corresponding Lung Cancer Module (QLQ-LC13).
Safety profile of LORVIQUA® in the Phase I/II Study.
ALK: anaplastic lymphoma kinase, NSCLC: non-small cell lung cancer, TKI: tyrosine kinase inhibitor, ORR: overall response rate, PR: partial response, CR: complete response, IC-ORR: intracranial-overall response rate, CNS: central nervous system, ICR: independent central radiology, DOR: duration of response, IC-DOR: intracranial duration of response, PFS: progression-free survival, OS: overall survival, EXP: expansion cohorts, CI: confidence interval, IQR: interquartile range, NR: not reached, NE: not estimable
References
Use interactive hypothetical Patient case studies to understand the Patient pathway, from diagnosis to treatment, including monitoring Adverse Events
These pages are not intended for patients or for members of the general public. The healthcare professional web pages contain promotional content.
I confirm that I am a healthcare professional* resident in the United Kingdom.
If you select 'No', you will be redirected to Pfizer.co.uk where you will be able to access reference information on Pfizer's prescription medicines.
*The ABPI Code definition for healthcare professional is members of the medical, dental, pharmacy and nursing professionals and any other persons who in the course of their professional activities may administer, prescribe, purchase, recommend or supply a medicine.
PP-UNP-GBR-7812. January 2024