Table 1

Patient demographics and baseline characteristics of Cohorts 2, 4, and pooled Cohorts 2 and 4 (Full Analysis Set)

CharacteristicCohort 2 (n=66)Cohort 4 (n=87)Cohort 2+4 (N=153)
Median age, years (range)55.0 (20–79)58.0 (25–74)56.0 (20–79)
Sex, n (%)
 Male39 (59.1)44 (50.6)83 (54.2)
 Female27 (40.9)43 (49.4)70 (45.8)
Screening ECOG performance status, n (%)
 042 (63.6)62 (71.3)104 (68.0)
 124 (36.4)25 (28.7)49 (32.0)
Melanoma subtype,* n (%)
 Cutaneous39 (59.1)44 (50.6)83 (54.2)
 Mucosal4 (6.1)8 (9.2)12 (7.8)
 Acral4 (6.1)6 (6.9)10 (6.5)
BRAF V600-mutated, n (%)17 (25.8)24 (27.6)41 (26.8)
PD-L1 status,† n (%)
 TPS ≥1%37 (56.1)39 (44.8)76 (49.7)
 TPS <1%12 (18.2)20 (23.0)32 (20.9)
Melanoma stage at study entry, n (%)
 IIIC9 (13.6)1 (1.1)10 (6.5)
 IV57 (86.4)86 (98.9)143 (93.5)
Liver and/or brain lesions by IRC, n (%)28 (42.4)44 (50.6)72 (47.1)
Median target lesion SOD (range), mm95.8 (13.5–271.3)99.5 (15.7–552.9)97.8 (13.5–552.9)
Baseline lesions in ≥3 anatomic sites, n (%)44 (66.7)65 (74.7)109 (71.2)
Baseline target and non-target lesions,‡ n (%)
 ≤322 (33.3)14 (16.1)36 (23.5)
 >343 (65.2)73 (83.9)116 (75.8)
LDH, n (%)
 ≤ULN39 (59.1)31 (35.6)70 (45.8)
 1–2×ULN19 (28.8)35 (40.2)54 (35.3)
 >2×ULN8 (12.1)21 (24.1)29 (19.0)
Prior systemic therapies, n (%)
 Median number of therapies (range)3.0 (1–9)3.0 (1–8)3.0 (1–9)
 Anti-PD-1/PD-L166 (100)87 (100)153 (100)
 Anti-CTLA-453 (80.3)72 (82.8)125 (81.7)
 Anti-PD-1 plus anti-CTLA-4 combination34 (51.5)48 (55.2)82 (53.6)
 BRAF±MEK inhibitor15 (22.7)24 (27.6)39 (25.5)
 IL-27 (10.6)6 (6.9)13 (8.5)
Primary refractory to anti-PD-1/PD-L1,§ n (%)42 (63.6)41 (47.1)83 (54.2)
Median cumulative duration of anti-PD-1/PD-L1 therapy before lifileucel (range), months5.1 (1.4–51.1)10.0 (0.7–75.8)7.0 (0.7–75.8)
Anatomic site of resection
 Lymph node/skin/subcutaneous28 (42.4)43 (49.4)71 (46.4)
 Visceral organ12 (18.2)30 (34.5)42 (27.5)
 Other¶26 (39.4)14 (16.1)40 (26.1)
  • *Forty-seven patients (30.7%) had melanoma of other subtypes (including unknown primary subtype or insufficient information).

  • †Forty-five patients (29.4%) in the pooled cohorts had missing PD-L1 status.

  • ‡One patient in Cohort 2 had missing data on the number of baseline target and non-target lesions.

  • §Primary refractory to anti-PD-1/PD-L1 was defined as patients who had best response of progressive disease to prior anti-PD-1/PD-L1; the first anti-PD-1/PD-L1 with documented response was considered if multiple anti-PD-1/PD-L1 therapies were received.

  • ¶Other sites of resection included muscle, soft tissue, bone, limb/extremity, and others.

  • CTLA-4, cytotoxic T-lymphocyte–associated protein 4; ECOG, Eastern Cooperative Oncology Group; IL-2, interleukin 2; IRC, independent review committee; LDH, lactate dehydrogenase; PD-1, programmed cell death protein 1; PD-L1, programmed death ligand 1; SOD, sum of diameters; TPS, tumor proportion score; ULN, upper limit of normal.