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The content of this webpage has been produced in line with the LORVIQUA®▼ (lorlatinib) Summary of Product Characteristics for Great Britain.
If you are an HCP in Northern Ireland click here.
LORVIQUA®▼ (lorlatinib) Prescribing Information for Great Britain and Northern Ireland click here. XALKORI® (crizotinib) Prescribing Information for Great Britain and Northern Ireland click here. Adverse event reporting information can be found at the bottom of the page.
The CROWN study is a global, open-label, randomised, multicentre Phase 3 trial comparing the efficacy and safety of LORVIQUA® against crizotinib in treatment-naïve ALK+ advanced NSCLC patients.1,2
An interim analysis of efficacy was conducted after 75% of 177 expected events of progression or death had occurred (data cutoff: March 20, 2020).1 A longer-term follow-up analysis was conducted with 36.7 months (IQR: 31.3-41.9) of follow-up in the LORVIQUA® arm and 29.3 months (IQR: 10.8-35.0) in the crizotinib arm (data cutoff: September 20, 2021).2
The updated analysis was not pre-specified, therefore results are descriptive and exploratory in nature, and formal statistical comparisons between the treatment groups are not available.2
Adapted from Solomon BJ, et al. Presented at the AACR Annual Meeting 2022, 8-13 April.3
* ALK status determined by means of the Ventana ALK (D5F3) CDx IHC assay.1
† Including recent (within the past year) or active suicidal ideation or behaviour.4
‡ 5 crizotinib patients did not receive treatment but were included in the ITT population.1
§ Defined as the time from randomisation to RECIST-defined progression or death due to any cause.1
¶ Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.1
The baseline patient characteristics for the intention-to-treat population of the CROWN study (N=296) were as follows:1,5
| LORVIQUA® (n=149) |
Crizotinib (n=147) |
|
| Age (years) | ||
| Median | 61 | 56 |
| Interquartile range | 51-69 | 45-66 |
| Sex (%) | ||
| Female | 56 | 62 |
| Male | 44 | 38 |
| Race or ethnic group (%)* | ||
| White | 48 | 49 |
| Asian | 44 | 44 |
| Black or African American | 0 | 1 |
| Missing |
8
|
6
|
| ECOG PS (%)✝ | ||
| 0 | 45 | 39 |
| 1 | 53 | 55 |
| 2 | 2 | 6 |
| Smoking status (%)‡ | ||
| Never smoked | 54 | 64 |
| Previous smoker | 37 | 29 |
| Current smoker | 9 | 6 |
| Current stage of disease (%) | ||
| IIIA | 1 | 0 |
| IIIB | 8 | 5 |
| IV | 91 | 95 |
| Other§ | 1 | 0 |
| Previous systemic anticancer drug therapy (%)# | ||
| Yes | 8 | 6 |
| Previous radiotherapy (%) | ||
| Yes | 13 | 14 |
| Previous surgery (%) | ||
| Yes | 18 | 16 |
| Brain metastases (%) | ||
| Present at baseline | 25 | 27 |
Adapted from Shaw AT, et al. NEJM. 2020. and Solomon BJ, et al. Lancet Respir Med. 2022. Supplementary Appendix.1,5
*Race or ethnic group was reported by the investigator.1
†ECOG scores range from 0 to 5, with higher scores indicating greater disability.1
‡Smoking status was not reported for one patient in the crizotinib group.1
§The disease stage in one patient who had locally advanced disease at trial entry was defined according to the AJCC, version 8.0, instead of AJCC, version 7.0, as required by the protocol. This stage was therefore classified as “other”.1
#According to the protocol, previous adjuvant or neoadjuvant anticancer therapy was allowed if it had been completed more than 12 months before randomisation. One patient who had received previous chemotherapy for metastatic disease was reported as having a protocol violation.1
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.
ALK: anaplastic lymphoma kinase, AJCC: American Joint Committee on Cancer, BICR: blinded independent central review, BD: twice daily, CDx IHC: companion diagnostic immunohistochemistry, CNS: central nervous system, DOR: duration of response,
ECOG PS: Eastern Cooperative Oncology Group Performance Score, IC: intracranial, IQR: interquartile range, ITT: intention-to-treat, NSCLC: non-small cell lung cancer, ORR: objective response rate, OS: overall survival, PFS: progression-free survival, QD: once daily, QoL: quality of life, RECIST: Response Evaluation Criteria in Solid Tumors, TTP: time to progression
References
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