LORVIQUA® (Lorlatinib)| 2L efficacy

Second-line & later efficacy

LORVIQUA showed substantial overall and intracranial activity both in treatment-naïve patients with ALK-positive Advanced NSCLC, and in those who had progressed on Crizotinib, second-generation ALK tyrosine kinase inhibitors, or after up to three previous ALK tyrosine kinase inhibitors^1,2

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Efficacy parameter	1 prior 2^nd-generation ALK TKI^a ± CT (EXP3B) (n=28)	≥2 prior ALK TKIs ± CT (EXP4–5) (n=111)
ORR^b	42.9%	39.6%
95% CI	24.5-62.8%	30.5-49.4%
CR (n)	1	2
PR (n)	11	42
Median DoR	5.6 months	9.9 months
95% CI	4.2 months-NR	5.7-24.4 months
Median PFS	5.5 months	6.9 months
95% CI	2.9-8.2 months	5.4-9.5 months

Adapted from LORVIQUA SmPC
Data cutoff: 2 February 2018.²

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^1,c

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Efficacy parameter	1 prior 2^nd-generation ALK TKI^a ± CT (EXP3B) (n=9)	≥2 prior ALK TKIs ± CT (EXP4–5) (n=48)
IC-ORR^b	66.7%	52.1%
95% CI	29.9%-92.5%	37.2%-66.7%
CR (n)	2	10
PR (n)	4	15
Median duration of IC response	NR	12.4 months
95% CI	4.1 months-NR	6.0 months-NR

Adapted from LORVIQUA SmPC
Data cutoff: 2 February 2018.²

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

Consistent responses were observed irrespective of previous 2^nd-generation ALK TKI received³

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Efficacy parameter	Alectinib (n=62)	Ceritinib (n=47)	Brigatinib (n=8)
Confirmed ORR	37.1%	40.4%	37.5%
95% CI	25·2%–50·3%	26·4%–55·7%	8·5%–75·5%
Confirmed Intracranial ORR	43.2%	54.1%	^40.0% 5.3%-85.3%
95% CI	27.1% - 60.5%	36.9%-70.5%	^40.0% 5.3%-85.3%

References:

Adapted from Supplement to: Solomon BJ, Besse B, Bauer TM, et al. Lorlatinib in patients with ALK-positive non-small-cell lung cancer: results from a global phase 2 study. Lancet Oncol 2018; published online Nov 6. http://dx.doi.org/10.1016/S1470-2045(18)30649-1
Data cutoff: 2 February 2018.²

^a Alectinib, brigatinib, or ceritinib.¹
^b Per ICR.¹
^c In patients with at least one measurable brain metastasis at baseline.¹
^d Kaplan-Meier estimate.²
^e Estimates 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.

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

References:

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

2. Besse B, Bauer M, et al. Lorlatinib in patients with ALK-positive non-small-cell lung
cancer: results from a global phase 2 study. Lancet Oncol 2018; 19: 1654–67
3. Supplement to: Solomon BJ, Besse B, Bauer TM, et al. Lorlatinib in patients with ALK-positive non-small-cell lung cancer: results from a global phase 2 study. Lancet Oncol 2018; published online Nov 6. http://dx.doi.org/10.1016/S1470-2045(18)30649-1

Efficacy

LORVIQUA safety profile

Review the safety

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