Table 4 Overall efficacy of lurbinectedin treatment assessed by IRC and the investigator in the dose-escalation stage.
Assessment | 2.5 mg/m2 (n = 3) | 3.2 mg/m2 (n = 7) | All patients (n = 10) | |||
|---|---|---|---|---|---|---|
IRC | Investigator | IRC | Investigator | IRC | Investigator | |
RECIST responses | ||||||
 Complete response | 0 | 0 | 0 | 0 | 0 | 0 |
 Partial response | 0 | 0 | 1 (14.3%) | 1 (14.3%) | 1 (10.0%) | 1 (10.0%) |
 Stable disease | 1 (33.3%) | 1 (33.3%) | 6 (85.7%) | 5 (71.4%) | 7 (70.0%) | 6 (60.0%) |
 Progressive disease | 2 (66.7%) | 2 (66.7%) | 0 | 1 (14.3%) | 2 (20.0%) | 3 (30.0%) |
 Not evaluable | 0 | 0 | 0 | 0 | 0 | 0 |
 Overall response, % (95% CI) | 0% (0–56.2) | 0% (0–56.2) | 14.3% (2.6- 51.3) | 14.3% (2.6–51.3) | 10.0% (1.8–40.4) | 10.0% (1.8–40.4) |
 Disease control, % (95% CI) | 33.3% (6.2–79.2) | 33.3% (6.2–79.2) | 100.0% (64.6–100.0) | 85.7% (48.7–97.4) | 80.0% (49.0–94.3) | 70.0% (39.7–89.2) |
Duration of response | ||||||
 Disease progression, relapse, or death events in responding patients, n/N (%) | 0 | 0 | 0 | 0 | 0 | 0 |
 Censored*, n/N (%) | 0 | 0 | 1/1(100.0%) | 1/1(100.0%) | 1/1(100.0%) | 1/1(100.0%) |
 Median duration of response, months (95% CI) | NR (inf–inf) | NR (inf–inf) | NR (inf–inf) | NR (inf–inf) | NR (inf–inf) | NR (inf–inf) |
Progression-free survival | ||||||
 Progression-free survival events, n (%) | 3 (100%) | 3 (100%) | 1 (14.3%) | 4 (57.1%) | 4 (40.0%) | 7 (70.0%) |
 Censored*, n (%) | 0 | 0 | 6 (85.7%) | 3 (42.9%) | 6 (60.0%) | 3 (30.0%) |
 Median progression-free survival, months (95% CI) | 1.6 (1.4–inf) | 1.6 (1.4–inf) | 12.2 (inf–inf) | 4.2 (1.3–inf) | 12.2 (1.4–inf) | 2.7 (1.3–inf) |
Overall survival | ||||||
 Deaths | 3 (100%) | 3 (42.9%) | 6 (60.0%) | |||
 Censored* | 0 | 4 (57.1%) | 4 (40.0%) | |||
 Median overall survival, months (95% CI) | 4.4 (3.8–inf) | 13.3 (1.4–inf) | 12.4 (1.4–inf) | |||
