TABLE 1.

Summary of Overall and Intracranial Response by Investigator Assessment

Response/Duration	Lorlatinib	Crizotinib
Intention-to-treat population, No.	149	147
Confirmed ORR, % (95% CI)	81 (73 to 87)	63 (54 to 70)
Best overall response, No. (%)
Complete response	15 (10)	3 (2)
Partial response	105 (70)	89 (61)
Stable disease	16 (11)	38 (26)
Progressive disease	8 (5)	7 (5)
Not evaluable	5 (3)	10 (7)
ORR for lorlatinib v crizotinib, OR (95% CI)	2.43 (1.43 to 4.43)
Duration of response, months, median (95% CI)	NR (NR to NR)	9.2 (7.5 to 11.1)
Duration of response ≥2 years, n/N (%)	89/120 (74)	14/92 (15)
Patients with measurable and/or nonmeasurable baseline brain metastases, No.	35	38
Confirmed intracranial ORR, % (95% CI)	60 (42 to 76)	11 (3 to 25)
Best overall response, No. (%)
Complete response	17 (49)	2 (5)
Partial response	4 (11)	2 (5)
Stable disease	0	4 (11)
Noncomplete response or nonprogressive disease	13 (37)	22 (58)
Progressive disease	1 (3)	5 (13)
Not evaluable	0	3 (8)
ORR for lorlatinib v crizotinib, OR (95% CI)	12.02 (3.23 to 54.92)
Duration of intracranial response, months, median (95% CI)	NR (NR to NR)	12.8 (7.5 to NR)
Duration of intracranial response ≥2 years, n/N (%)	17/21 (81)	0
Patients with measurable baseline brain metastases, No.	12	6
Confirmed intracranial ORR, % (95% CI)	92 (62 to 100)	33 (4 to 78)
Best overall response, No. (%)
Complete response	7 (58)	0
Partial response	4 (33)	2 (33)
Stable disease	0	4 (67)
Progressive disease	1 (8)	0
Not evaluable	0	0
ORR for lorlatinib v crizotinib, OR (95% CI)	15.00 (0.99 to 786.47)
Duration of intracranial response, months, median (95% CI)	NR (NR to NR)	10.2 (7.5 to NR)
Duration of intracranial response ≥2 years, n/N (%)	8/11 (73)	0

Abbreviations: NR, not reached; OR, odds ratio; ORR, objective response rate.