Table 1.
Clinical trials of farletuzumab (MORAb-003) in ovarian cancer
| Study, year, reference | Phase | Patient population (n, cancer type) | Chemotherapy status | Dosing schedule | Disease status, n (%) | PFS | Toxicities (grade 3–4); n (%) |
|---|---|---|---|---|---|---|---|
| Konner et al, 201060 Markman et al, 200464 |
I | 25, OC | PL-refractory/resistant | Farletuzumab (12.5–400.0 mg/m2; D1, 8, 15, 22; 5 W) | SD, 9 (36%) PD, 15 (60%) NA, 1 (4%) |
NA* | Fatigue; Two (8%) |
| Armstrong et al, 201310 NCT00849667, 201365 |
II† | 54, OPFC | PL-sensitive recurrent | Arm A: single-agent farletuzumab Arm B: combination therapy (six cycles CP (AUC5–6) iv + TX (paclitaxel 175 mg/m2 or docetaxel 75 mg/m2) iv every 3 W for six cycles + farletuzumab 2.5 mg/kg iv) Arm C: maintenance therapy (single-agent farletuzumab weekly) |
(Combination therapy) (n=47) CR, 3 (7%) PR, 30 (68%) SD, 9 (21%) PD, 2 (5%) NA, 3 (6.8%) |
Arm A: 10.3 M Arm B: 8.8 M Arm C: NA |
Not observed |
| Vergote et al, 201367 | III | 1,100, OPFC | PL-sensitive recurrent | Arm 1: CP + TXL + placebo Arm 2: CP + TXL + MORAb-003 (1.25 mg/kg) Arm 3: CP + TXL + MORAb-003 (2.5 mg/kg) |
NA | Arm 1: 9.0 M (median) Arm 2: 9.5 M (median) Arm 3: 9.7 M (median) |
Not observed |
| NCT00738699, 201368 | III‡ | 417, OC | PL-resistant recurrent | Arm 1: TXL + farletuzumab Arm 2:TXL + placebo |
NA | NA | NA |
| NCT01004380, 201469 | I | 15, OC | PL-sensitive | 6 cycles CP (AUC5–6) iv + PLD (30 mg/m2) iv on D1 of every W + weekly farletuzumab 2.5 mg/kg iv Maintenance: farletuzumab |
NA | NA | NA |
Notes:
*
Efficacy analysis was not an endpoint of this study;
†
second remission greater than or equal to first remission in 21% of subjects;
‡
prematurely closed.
Abbreviations: CP, carboplatin; CR, complete response; D, day; iv, intravenous; M, months; NA, not available; OC, ovarian cancer; OPFC, primary peritoneal, fallopian tube cancer; PD, progressive disease; PFS, progression-free survival; PL, platinum; PLD, pegylated liposomal doxorubicin; PR, partial response; SD, stable disease; TX, taxane; TXL, taxol; W, week.