Table 2.
Comparison of Investigator-Assessed PFS Among Randomized Pivotal Trials of Brigatinib, Alectinib, and Lorlatinib
| ALTA 1-L (Asian Subgroup) | ALEX (Asian Subgroup) | ALESIA (5 Year Follow-Up) | CROWN (Asian Subgroup)* | |||||
|---|---|---|---|---|---|---|---|---|
| Brigatinib | Crizotinib | Alectinib | Crizotinib | Alectinib | Crizotinib | Lorlatinib | Crizotinib | |
| N | 59 | 49 | 69 | 69 | 125 | 62 | 59 | 61 |
| Dose | 180 mg QD | 250 mg BID | 600 mg BID | 250 mg BID | 600 mg BID | 250 mg BID | 100 mg QD | 250 mg BID |
| Median Follow-up time (months) | 40.7 (range: 0.7–49.9) | 13.6 (range: 0.1–47.0) | 27.8 (range: 0.5–38.7) | 22.8 (range: 0.3–36.7) | 61 | 51 | 36.7 (IQR: 31.3–41.9) | 29.3 (IQR: 10.8–35.0) |
| mPFS (months) (95% CI) | 26.7 (18.4 – not reached) | 11.0 (9.2–18.6) | 34.8 | 9.6 | 41.6 (33.1–58.9) | 11.1 (9.1–18.4) | NR (32.9 – NR) | 9.2 (7.2–12.7) |
| HR | 0.42 (95% CI: 0.25–0.73; p = 0.0024) | 0.43 (95% CI: 0.27–0.67) | 0.33 (95% CI: 0.23–0.49) | 0.24 (95% CI: 0.14–0.41) | ||||
Notes: *Asians from Japan, South Korea, Greater China (China, Hong Kong Taiwan), Singapore (N = 120). This analysis is different from the overall CROWN “Asian” subgroup analysis which included 131 “Asians” with a BIRC-assessed HR of 0.44 (0.26–0.75).
Abbreviations: BID, twice daily; CI, confidence interval; HR, hazard ratio; IQR, inter-quartile range; mPFS, median progression-free survival; NR, not reached; QD, once daily.