Efficacy results with lurbinectedin plus doxorubicin in patients with endometrial cancer
| Dose escalation phase (n=15)* | Expanded cohort (n=19)† | |
| Objective response per RECIST v1.1. | ||
| CR, n (%) | 2 (13.3) | – |
| PR, n (%) | 2 (13.3) | 8 (42.1) |
| SD ≥4 months, n (%) | 5 (33.3) | 4 (21.1) |
| SD <4 months, n (%) | 3 (20.0) | 3 (15.8) |
| PD, n (%) | 3 (20.0) | 4 (21.1) |
| ORR, % (95% CI) | 26.7 (7.8 to 55.1) | 42.1 (20.3 to 66.5) |
| Disease control rate (95% CI) ‡ | 80.0 (51.9 to 95.7) | 78.9 (54.4 to 93.9) |
| Clinical benefit rate (95% CI) § | 60.0 (32.3 to 83.7) | 63.2 (38.4 to 83.7) |
| Median DoR (months) (95% CI) | 19.5 (8.2 to NR) | 7.5 (6.4 to NR) |
| Median PFS (months) (95% CI) | 7.3 (2.5 to 10.1) | 7.7 (2.0 to 16.7) |
| Median OS (months) (95% CI) | NA | 14.2 (4.5 to NR) |
*Patients treated at fixed doxorubicin dose (50 mg/m2) and escalating lurbinectedin doses (ranging from 3.0 to 5.0 mg flat dose) on day 1 every 3 weeks.
†Patients treated at the recommended dose of doxorubicin 40 mg/m2 plus lurbinectedin 2.0 mg/m2 on day 1 every 3 weeks.
‡Objective response plus stable disease.
§Objective response plus stable disease ≥4 months.
CR, complete response; DoR, duration of response; NA, not available; NR, not reached; ORR, overall response rate; OS, overall survival; PD, disease progression; PFS, progression-free survival; PR, partial response; SD, stable disease.