Baseline Demographics and Clinical Characteristics for Patients Treated with Talimogene Laherparepvec and GM-CSF

CharacteristicsAll Patientsa(N = 436)Patients with Durable Response (N = 51)
Median age (range), years63 (22–94)70 (36–91)
Sex, n (%)
 Men250 (57)31 (61)
 Women186 (43)20 (39)
Disease substage, n (%)b
 IIIB34 (8)10 (20)
 IIIC97 (22)19 (37)
 IVM1a118 (27)13 (26)
 IVM1b90 (21)3 (6)
 IVM1c96 (22)6 (12)
 Missing1 (<1)0 (0)
LDH, n (%)a
 ≤ ULN390 (89)47 (92)
 > ULN20 (5)0 (0)
Line of therapy, n (%)
 First-line203 (47)33 (65)
 Second or greater233 (53)18 (35)
ECOG performance status, n (%)a
 0306 (70)41 (80)
 1114 (26)10 (20)
 Missing16 (4)0 (0)
HSV serostatus, n (%)a
 Positive142 (33)34 (67)
 Negative253 (58)13 (26)
 Unknown/missing41 (9)4 (8)
BRAF status, n (%)
 Mutation69 (16)5 (10)
 Wild-type68 (16)6 (12)
 Unknown/missing299 (68)40 (78)
Treatment assignment, n (%)
 Talimogene laherparepvecc295 (68)48 (94)
 GM-CSFd141 (32)3 (6)

DRR durable response rate, ECOG Eastern Cooperative Oncology Group, GM-CSF granulocyte macrophage-colony stimulating factor, HSV herpes simplex virus, LDH lactate dehydrogenase, ULN upper limit of normal

aIntent-to-treat population

bIncludes one patient with unknown disease stage

c4 patients in the talimogene laherparepvec arm were not treated with talimogene laherparepvec

d11 patients in the GM-CSF arm were not treated with GM-CSF