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Table 1 Baseline Demographics and Clinical Characteristics for Patients Treated with Talimogene Laherparepvec and GM-CSF

From: Durable response rate as an endpoint in cancer immunotherapy: insights from oncolytic virus clinical trials

Characteristics All Patientsa(N = 436) Patients with Durable Response (N = 51)
Median age (range), years 63 (22–94) 70 (36–91)
Sex, n (%)
 Men 250 (57) 31 (61)
 Women 186 (43) 20 (39)
Disease substage, n (%)b
 IIIB 34 (8) 10 (20)
 IIIC 97 (22) 19 (37)
 IVM1a 118 (27) 13 (26)
 IVM1b 90 (21) 3 (6)
 IVM1c 96 (22) 6 (12)
 Missing 1 (<1) 0 (0)
LDH, n (%)a
 ≤ ULN 390 (89) 47 (92)
 > ULN 20 (5) 0 (0)
Line of therapy, n (%)
 First-line 203 (47) 33 (65)
 Second or greater 233 (53) 18 (35)
ECOG performance status, n (%)a
 0 306 (70) 41 (80)
 1 114 (26) 10 (20)
 Missing 16 (4) 0 (0)
HSV serostatus, n (%)a
 Positive 142 (33) 34 (67)
 Negative 253 (58) 13 (26)
 Unknown/missing 41 (9) 4 (8)
BRAF status, n (%)
 Mutation 69 (16) 5 (10)
 Wild-type 68 (16) 6 (12)
 Unknown/missing 299 (68) 40 (78)
Treatment assignment, n (%)
 Talimogene laherparepvecc 295 (68) 48 (94)
 GM-CSFd 141 (32) 3 (6)
  1. 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
  2. aIntent-to-treat population
  3. bIncludes one patient with unknown disease stage
  4. c4 patients in the talimogene laherparepvec arm were not treated with talimogene laherparepvec
  5. d11 patients in the GM-CSF arm were not treated with GM-CSF