Table 2.
Objective Response by BICR in All Patients and Intracranial Objective Response by BICR in Patients With Brain Metastases at Baseline (Asian Population)
| Outcome | Asian Population |
|
|---|---|---|
| Lorlatinib (n = 59) | Crizotinib (n = 61) | |
| Best overall response, n (%) | ||
| Complete response | 1 (2) | 0 |
| Partial response | 45 (76) | 35 (57) |
| Stable disease | 6 (10) | 15 (25) |
| Neither complete response nor progressive disease | 1 (2) | 2 (3) |
| Progressive disease | 5 (9) | 3 (5) |
| Not evaluable | 1 (2) | 6 (10) |
| Confirmed objective response rate, n (% [95% CI])a | 46 (78 [65–88]) | 35 (57 [44–70]) |
| OR (95% CI) | 2.63 (1.11–6.38) | |
| Median duration of response (95% CI), mob | NR (NR–NR) | 12.8 (9.3–NR) |
| Median time to tumor response (IQR), mo | 1.8 (1.7–1.9) | 1.8 (1.7–1.9) |
| Patients with measurable or nonmeasurable brain metastases at baseline | ||
| n | 11 | 15 |
| Confirmed CNS response, % (95% CI)a,c | 73 (39–94) | 20 (4–48) |
| CNS complete response, n (%) | 8 (73) | 2 (13) |
| Median duration of response (95% CI), mob | NR (NR–NR) | 17 (11–NR) |
BICR, blinded independent central review; CI, confidence interval; CNS, central nervous system; IQR, interquartile range; NR, not reached; OR, odds ratio.
a
Clopper-Pearson method.
b
Brookmeyer and Crowley method.
c
Intracranial assessment was performed by independent central neuroradiological review.