Table 1.
Demographics and Key Baseline Characteristics
Characteristics | AMG 102 10 mg/kg n = 40 | AMG 102 20 mg/kg n = 20 | All Enrolled Patients N = 60a |
---|---|---|---|
Sex, n (%) | |||
Women | 15 (38) | 7 (35) | 22 (37) |
Men | 25 (63) | 13 (65) | 38 (63) |
Race, n (%) | |||
White | 36 (90) | 18 (90) | 54 (90) |
Black | 3 (8) | 0 (0) | 3 (5) |
Hispanic | 1 (3) | 1 (5) | 2 (3) |
Asian | 0 (0) | 1 (5) | 1 (2) |
Age, median (range) | 54 (19–71) | 54 (26–71) | 54 (19–71) |
Karnofsky performance status, n (%) | |||
100 | 1 (3) | 1 (5) | 2 (3) |
90 | 18 (45) | 7 (35) | 25 (42) |
80 | 14 (35) | 7 (35) | 21 (35) |
70 | 4 (10) | 3 (15) | 7 (12) |
60 | 3 (8) | 2 (10) | 5 (8) |
Histologic type for primary tumor, n (%) | |||
Glioblastoma multiforme | 38 (95) | 20 (100) | 58 (97) |
Low-grade gliomab | 1 (3) | 0 (0) | 1 (2) |
Other | 1 (3) | 0 (0) | 1 (2) |
Months since initial diagnosis,c | |||
median (range) | 16 (3.9–78) | 14 (1–40) | 16 (1–78) |
Prior therapies,dn (%) | |||
0 | 0 (0) | 0 (0) | 0 (0) |
1 | 11 (28) | 3 (15) | 14 (23) |
2 | 13 (33) | 9 (45) | 22 (37) |
≥3 | 16 (40) | 8 (40) | 24 (40) |
Prior radiotherapy, n (%) | |||
0 | 1 (3) | 0 (0) | 1 (2) |
1 | 33 (85) | 19 (95) | 52 (87) |
2 | 5 (13) | 1 (5) | 6 (10) |
≥3 | 1 (3) | 0 (0) | 1 (2) |
Prior VEGF pathway inhibitors, n (%) | |||
Bevacizumab | 19 (48) | 10 (50) | 29 (48) |
Aflibercept | 3 (8) | 1 (5) | 4 (7) |
Sorafenib | 0 (0) | 2 (10) | 2 (3) |
Pazopanib | 1 (3) | 0 (0) | 1 (2) |
Vandetanib | 1 (3) | 0 (0) | 1 (2) |
Vatalanib | 1 (3) | 0 (0) | 1 (2) |
Prior surgery,en (%) | 40 (100) | 20 (100) | 60 (100) |
aPatients who received ≥1 dose of AMG 102.
bEnrollment of the patient with low-grade disease was a protocol violation.
cDate of enrollment minus date of primary diagnosis.
dIncludes chemotherapy, immunotherapy, hormonal therapy, targeted biologics, small-molecule inhibitors, vaccines, and others.
ePrior surgery includes biopsy and resection procedures.