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About LORVIQUA®

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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

LORVIQUA® was 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)
Other^h	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)

^{Adapted from Shaw AT, et al. N Engl J Med Suppl. 2020}

References

^aTreatment for both arms was continued until disease progression or unacceptable toxicity.¹

^bFive patients in the crizotinib group did not receive treatment but were included in the ITT population.²

^cObjective response (defined as complete response or partial response), as assessed by BICR.^1,2

^dPlus-minus values are means ±SD. Percentages may not total 100 because of rounding.²

^eRace or ethnic group was reported by the investigator.²

^fSmoking status was not reported for 1 patient in the crizotinib group.²

^gECOG scores range from 0 to 5, with higher scores indicating greater disability.²

^hThe 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."²

ⁱAccording 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.²

1L=first-line; 2L=second-line; AJCC=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 overall efficacy

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LORVIQUA® 1L CNS efficacy

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PP-LOR-IRL-0169 | JUL2025

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