LORVIQUA® (Lorlatinib)| 2L efficacy

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Overview

Starting Strong in 1L

About LORVIQUA®

Study Design

1L study design

2L+ study design

Efficacy

1L overall efficacy

1L CNS efficacy

1L 5-Year overall efficacy

1L 5-Year CNS efficacy

2L+ efficacy

Safety

Pooled Safety: all lines

1L safety

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Second-line & later efficacy

LORVIQUA® achieved frequent and durable responses in patients previously treated with 2^nd-generation ALK TKIs¹

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Efficacy parameter	One prior ALK TKI^awith or without prior chemotherapy (N=99)^b	Two or more prior ALK TKIs with or without prior chemotherapy (N=111)^c
Objective response rate^d (95% CI) Complete response, n Partial response, n	42.4% (32.5, 52.8) 5 37	39.6% (30.5, 49.4) 2 42
Duration of response Median, months (95% CI)	NE (7.8, NE)	9.9 (5.7, 24.4)
Progression-free survival Median, months (95% CI)	8.3 (6.3, 16.5)	6.9 (5.4, 9.5)

Adapted from LORVIQUA® SmPC¹

Adapted from LORVIQUA SmPC, 2022.
Data cutoff: 2 February 2018.²

In patients who received at least one prior ALK TKI, Lorviqua® demonstrated compelling intracranial efficacy

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Efficacy parameter	One prior ALK TKI^a with or without prior chemotherapy (N = 19)^b	Two or more prior ALK TKIs with or without prior chemotherapy (N=48)^c
Objective response rate^d (95% CI) Complete response, n Partial response, n	63.2% (38.4, 83.7) 4 8	52.1% (37.2, 66.7) 10 15
Duration of intra-cranial response Median, months (95% CI)	NE (4.2, NE)	12.4 (6.0, NE)

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Adapted from LORVIQUA SmPC, 2022.
Data cutoff: 2 February 2018.²

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References:

Adapted from LORVIQUA® SmPC.¹

^aAlectinib, brigatinib, or ceritinib.
^bPooled efficacy results from Study A and B*
^cEfficacy results from Study A only*
^dPer ICR

*Study A was a single-arm, multicentre Phase 1/2 study to investigate the use of Lorviqua® in the treatment of ALK-positive advanced NSCLC after treatment with at least one second-generation ALK TKI. Study B was a single-arm, multicentre Phase 4 study in patients with ALK-positive advanced NSCLC after one prior ALK TKI treatment (alectinib or ceritinib).'

Abbreviations: ALK= Anaplastic lymphoma kinase; CI=confidence interval; ICR=Independent Central Review; N/n=number of patients; NE=not estimable; TKI=tyrosine kinase inhibitor.

Adapted from Besse B, et al. ASCO 2018.
Data cutoff: 2 February 2018.²

^aAlectinib, brigatinib, or ceritinib.¹

^bPer ICR.¹

^cIn patients with at least one measurable brain metastasis at baseline.¹

^dKaplan-Meier estimate.²

^eEstimates for progression-free survival duration of response and duration of IC response are not calculated due to the small number of patients who received brigatinib as the last second-generation ALK TKI before lorlatinib.²

ALK=anaplastic lymphoma kinase; CNS=central nervous system; CR=complete response; CT=chemotherapy;
DoR=duration of response; EXP=expansion cohort; ICR=independent central review; NC=not calculated; NR=not reached; ORR=objective response rate; PFS=progression-free survival; PR=partial response; TKI=tyrosine kinase inhibitor.

References:

1. Pfizer. LORVIQUA® (lorlatinib) Summary of Product Characteristics.

Efficacy

LORVIQUA® safety profile

Review the safety

PP-LOR-IRL-0172 | JUL2025

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