Table 3.
Frequency of EML4::ALK Fusion Variants and TP53 Mutations and Response to Lorlatinib and Crizotinib (Asian Population)
| Biomarker | Lorlatinib (n = 59) | Crizotinib (n = 61) | ||||||
|---|---|---|---|---|---|---|---|---|
| ctDNA, n (%) | 44 (75) | 48 (79) | ||||||
| ALK fusion, n (%) | 26 (59) | 31 (65) | ||||||
| Lorlatinib | Crizotinib | |||||||
|---|---|---|---|---|---|---|---|---|
| n (%) | ORR, % (95% CI)a | PFS, median, mo (95% CI)b | DOR, median, mo (95% CI)b | n (%) | ORR, % (95% CI)a | PFS, median, mo (95% CI)b | DOR, median, mo (95% CI)b | |
| EML4::ALK variant 1 | 6 (14) | 100 (54–100) | NR (NR–NR) | NR (NR–NR) | 11 (23) | 36 (11–69) | 7.4 (5.5–12.9) | NR (5.5–NR) |
| PFS HR (95% CI) | 0.13 (0.015–1.051) | – | ||||||
| EML4::ALK variant 3 | 11 (25) | 82 (48–98) | NR (5.3–NR) | NR (12.8–NR) | 13 (27) | 77 (46–95) | 10.3 (5.4–12.8) | 9.6 (4.6–12.8) |
| PFS HR (95% CI) | 0.25 (0.064–0.944) | – | ||||||
| TP53 mutation positive | 16 (36) | 63 (35–85) | NR (5.3–NR) | NR (NR–NR) | 18 (38) | 56 (31–79) | 5.6 (3.7–12.9) | 8.5 (4.6–NR) |
| TP53 mutation negative | 28 (64) | 79 (59–92) | NR (18.4–NR) | NR (16.5–NR) | 30 (62) | 57 (37–75) | 11.4 (10.9–14.8) | 12.8 (9.4–NR) |
CI, confidence interval; ctDNA, circulating tumor DNA; DOR, duration of response; HR, hazard ratio; NR, not reached; ORR, objective response rate; PFS, progression-free survival.
a
Clopper-Pearson method.
b
Brookmeyer and Crowley method.