Table 2.
Tumor response: all patients, GBM patients, and AA patients (primary efficacy population)
Tumor response | Number of patients (%) |
||
---|---|---|---|
10 µM trabedersen | 80 µM trabedersen | Standard chemotherapy (TMZ/PCV) | |
All patients | n = 40 | n = 49 | n = 45 |
6 months | |||
Tumor control rate (CR + PR + SD) | 13 (33%) | 10 (20%) | 12 (27%) |
Overall response rate (CR + PR) | 2 (5%) | 3 (6%) | 3 (7%) |
Progressive disease | 19 (48%) | 34 (69%) | 23 (51%) |
Missing MRI data | 8 (20%) | 5 (10%) | 9 (20%) |
14 months | |||
Tumor control rate (CR + PR + SD) | 9 (23%) | 4 (8%) | 3 (7%) |
Overall response rate (CR + PR) | 6 (15%) | 3 (6%) | 2 (4%) |
Progressive disease | 22 (55%) | 31 (63%) | 32 (71%) |
Missing MRI data | 9 (23%) | 14 (29%) | 10 (22%) |
GBM patients | n = 28 | n = 34 | n = 33 |
6 months | |||
Tumor control rate (CR + PR + SD) | 4 (14%) | 4 (12%) | 5 (15%) |
Overall response rate (CR + PR) | 0 | 1 (3%) | 0 |
Progressive disease | 16 (57%) | 26 (77%) | 19 (58%) |
Missing MRI data | 8 (29%) | 4 (12%) | 8 (24%) |
14 months | |||
Tumor control rate (CR + PR + SD) | 2 (7%) | 1 (3%) | 3 (9%) |
Overall response rate (CR + PR) | 1 (4%) | 0 | 2 (6%) |
Progressive disease | 20 (71%) | 25 (74%) | 25 (76%) |
Missing MRI data | 6 (21%) | 8 (24%) | 5 (15%) |
AA patients | n = 12 | n = 15 | n = 12 |
6 months | |||
Tumor control rate (CR + PR + SD) | 9 (75%) | 6 (40%) | 7 (58%) |
Overall response rate (CR + PR) | 2 (17%) | 2 (13%) | 3 (25%) |
Progressive disease | 3 (25%) | 8 (53%) | 4 (33%) |
Missing MRI data | 0 | 1 (7%) | 1 (8%) |
14 months | |||
Tumor control rate (CR + PR + SD) | 7 (58%) | 3 (20%) | 0 |
Overall response rate (CR + PR) | 5 (42%) | 3 (20%) | 0 |
Progressive disease | 2 (17%) | 6 (40%) | 7 (58%) |
Missing MRI data | 3 (25%) | 6 (40%) | 5 (42%) |
AA, anaplastic astrocytoma; GBM, glioblastoma; PCV, procarbazine/CCNU (lomustine)/vincristine; TMZ, temozolomide; CR, complete response; PR, partial response; SD, stable disease.