Table 3.
Phase II studies of plitidepsin as single-agent or in combination
| Diagnosis | Schedule | N (evaluable) | Median survival (months) | Response | |
|---|---|---|---|---|---|
| Single agent studies | |||||
| APL-B-001-0141 | Renal or advanced colorectal cancer | Plitidepsin 5 mg/m2 (24-h IV) d1,15 q4wk | Renal cancer 19 | PFI =2.1; OS =7.0 | Renal cancer: 2 PR, 1 SD |
| APL-B-002-0240 | Medullary thyroid carcinoma | Plitidepsin 5 mg/m2 (3-h IV) d1,15 q4wk | 16 | TTP =5.3; PFS =5.5 | 11 SD |
| APL-B-004-0242 | Non-small-cell lung cancer | Plitidepsin 5 mg/m2 (3-h IV) d1,15 q4wk | 17 | TTP/PFS = 1.2; OS =4.3 | 3 SD |
| APL-B-005-0244 | Transitional cell carcinoma of the urothelium | Plitidepsin 5 mg/m2 (3-h IV) d1,15 q4wk | 18 | TTP/PFS = 1.4; OS =2.3 | 1 SD |
| APL-B-007-0239 | Melanoma | Plitidepsin 5 mg/m2 (3-h IV) d1,15 q4wk | 35 | TTP/PFS = 1.3; OS =3.5 | 2 PR, 3 SD |
| APL-B-011-02a | Prostate adenocarcinoma | Plitidepsin 5 mg/m2 (3-h IV) d1,15 q4wk | https://clinicaltrials.gov/ct2/show/results/NCT00780975 | ||
| APL-B-014-0337 | MM | Plitidepsin 5 mg/m2 (3-h IV) d1,15 q4wk | 47 | NA | 2 PR, 4 MR (IWG-MRT) |
| APL-B-020-1041 | Myelofibrosis (primary and secondary) | Plitidepsin 5 mg/m2 (3-h IV) d1,15 q4wk | 12 | PFS =4.6 | 1 clinical improvement |
| APLIPO45 | Liposarcoma | Plitidepsin 5 mg/m2 (3-h IV) d1,15 q4wk | 14 | PFS =1.6; OS =9.2 | 2 SD |
| APL-B-006-0243 | Small-cell lung cancer | Plitidepsin 3.2 mg/m2 (1-h IV) (d1,8,15 q4wk) | 17 | TTP/PFS = 1.3; OS =4.8 | 1 SD |
| APL-B-012-02a | Indolent NHL | Plitidepsin 3.2 mg/m2 (1-h IV) (d1,8,15 q4wk) | http://www.clinicaltrialsregister.eu/ctr-search/trial/2004-002692-16/ES | ||
| APL-B-013-0238 | Aggressive NHL | Plitidepsin 3.2 mg/m2 (1-h IV) (d1,8,15 q4wk) | PTCL: 29 Other: 30 | PTCL: TTP/PFS = 1.6; OS = 10.2 Other: TTP/PFS = 1.3; OS =4.5 |
PTCL: 2 CR, 4 PR Other: no responses |
| APL-B-015-04a | Acute lymphoblastic leukemia | Plitidepsin 3.2 mg/m2 (1-h IV) (d1,8,15 q4wk) | http://www.clinicaltrials.gov/ct2/show/NCT00780143 | ||
| APL-B-016-0532 | Melanoma | Plitidepsin 2.4 mg/m2 (1-h IV) (d1,8,15 q4wk) | 16 | TTP/PFS = 1.5; OS = 4.1 | 2 SD |
| Combination studies | |||||
| APL-B-001-0141 | Renal or advanced colorectal cancer | Plitidepsin 7 mg/m2 (24-h IV) + L-carnitine | Renal: 18 Colorectal: 18 |
Renal: PFI =2.1; OS =7.6 Colorectal: PFI =1.7; OS =8.2 | Renal: 2 SD Colorectal: no responses |
| APL-B-014-0336 | MM | Plitidepsin 5 mg/m2 (3-h IV) d1,15 q4wk + dexamethasone 20 mg po d1–4 q4wk | 18 | TTP =4.2; PFS =3.8 | 2 PR, 2 MR (IWG-MRT) |
| APL-B-016-0532 | Melanoma | Plitidepsin 2.4 mg/m2 (1-h IV) (d1,8,15 q4wk) + dacarbazine 800 mg/m2 d1 q4wk (1-h IV) | 28 | TTP/PFS =3.3 | 1 CR, 5 PR, 9 SD |
Note:
a
Ongoing clinical trials or unpublished results.
Abbreviations: d, day; CR, complete remission; IV, intravenous; IWG-MRT, International Working Group for Myelofibrosis Research and Treatment; MM, multiple myeloma; MR, minor response; NA, not available; NHL, non-Hodgkin lymphoma; OS, overall survival; PFI, progression-free interval; PFS, progression-free survival; PTCL, peripheral T-cell lymphoma; PR, partial response; TTP, time to progression; SD, stable disease; q4wk, every 4 weeks.