LORVIQUA in first-line treatment of ALK+ advanced NSCLC1

LORVIQUA was evaluated as a first-line treatment option in the CROWN study. CROWN was a global, randomised, open-label, multicentre, Phase 3 trial of LORVIQUA vs crizotinib in patients with previously untreated, ALK-positive, locally advanced or metastatic NSCLC (N=296).1,2

Crizotinib was selected for the comparator arm because it was the standard-of-care first-line treatment at the time of trial initiation.2

Studied in a broad range of patients2

Approximately 26% of patients in both the LORVIQUA and crizotinib treatment arms had brain metastases at baseline.2

Baseline demographics (ITT population, N=296)2
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Characteristic LORVIQUA
(n=149)
Crizotinib
(n=147)
Age, years
Mean (SD)d 59.1 (±13.1) 55.6 (±13.5)
Median (IQR) 61 (51-69) 56 (45-66)
Sex, n (%)
Female 84 (56) 91 (62)
Male 65 (44) 56 (38)
Race or ethnic group, n (%)e
White 72 (48) 72 (49)
Asian 65 (44) 65 (44)
Black 0 1 (1)
Missing 12 (8) 9 (6)
Smoking status, n (%)f
Never smoked 81 (54) 94 (64)
Previous smoker 55 (37) 43 (29)
Current smoker 13 (9) 9 (6)
ECOG PS, n (%)g
0 67 (45) 57 (39)
1 79 (53) 81 (55)
2 3 (2) 9 (6)
Baseline disease characteristics (ITT population, N=296)2
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Characteristic LORVIQUA
(n=149)
Crizotinib
(n=147)
Current stage of disease, n (%)
IIIA 1 (1) 0
IIIB 12 (8) 8 (5)
IV 135 (91) 139 (95)
Otherh 1 (1) 0
Histologic type, n (%)
Adenocarcinoma 140 (94) 140 (95)
Adenosquamous carcinoma 6 (4) 5 (3)
Large cell carcinoma 0 1 (1)
Squamous cell carcinoma 3 (2) 1 (1)
Use of previous anticancer drug therapy, n (%)i
  12 (8) 9 (6)
Previous brain radiotherapy, n (%)
  9 (6) 10 (7)
Brain metastases at baseline, n (%)
  38 (26) 40 (27)
ReferencesaTreatment for both arms was continued until disease progression or unacceptable toxicity.1bFive patients in the crizotinib group did not receive treatment but were included in the ITT population.2cObjective response (defined as complete response or partial response), as assessed by BICR.1,2dPlus-minus values are means ±SD. Percentages may not total 100 because of rounding.2eRace or ethnic group was reported by the investigator.2fSmoking status was not reported for 1 patient in the crizotinib group.2gECOG scores range from 0 to 5, with higher scores indicating greater disability.2hThe disease stage in 1 patient who had locally advanced disease at trial entry was defined according to the AJCC, v.8.0, instead of AJCC, v.7.0, as required by the protocol. This stage was therefore classified as "other."2iAccording 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.2AJCC=American Joint Committee on Cancer; ALK=anaplastic lymphoma kinase; BICR=blinded independent central review; CDx=companion diagnostic; CNS=central nervous system; DoR=duration of response; ECOG PS=Eastern Cooperative Oncology Group performance status; IC-DoR=intracranial duration of response; IC-ORR=intracranial objective response rate;
IC-TTP=intracranial time-to-progression; IQR=interquartile range; ITT=intention to treat; NSCLC=non-small cell lung cancer; ORR=objective response rate; OS=overall survival; PFS=progression-free survival; RECIST=Response Evaluation Criteria in Solid Tumours; SD=standard deviation.
References:

Pfizer. LORVIQUA (lorlatinib) Summary of Product Characteristics. 

Shaw AT, Bauer TM, de Marinis F, et al; CROWN Trial Investigators. First-line lorlatinib or crizotinib in advanced ALK-positive lung cancer. N Engl J Med. 2020;383(21):2018-2029.
Study Design 
LORVIQUA 1L efficacy
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LORVIQUA 1L CNS efficacy
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PP-LOR-IRL-0066 February 2024 Legal Category S1A Further information available on request
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