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Table 1.

Baseline demographics and disease characteristics

Sarcoma patientsAll patients
(n = 24)(n = 39)
Median (range) age, years 47 (25–72) 56 (25–75) 
Male/female gender, n (%) 11 (46)/13 (54) 15 (38)/24 (62) 
Diagnosis, n (%) 
 SS 13 (54) 13 (33) 
 MRCL 6 (25) 6 (15) 
 Other sarcomaa 5 (21) 5 (13) 
 Ovarian N/A 8 (21) 
 Melanoma N/A 6 (15) 
 NSCLC N/A 1 (3) 
Stage at diagnosis, n (%) 
 II 1 (4) 1 (3) 
 III 2 (8) 4 (10) 
 IV 21 (88) 34 (87) 
NY-ESO-1 expressionb, n (%) 
 ≤5% 11 (28) 
 >5%–25%c 4 (17) 15 (38) 
 >25%–50% 2 (8) 2 (5) 
 >50%–75% 2 (8) 3 (8) 
 >75%–100% 16 (67) 19 (49) 
Median (range) time since diagnosis, years 3.4 (0.5–13.4) 2.9 (0.5–18.2) 
Median (range) time since last treatment, months 4.9 (0.7–66) 4.8 (0.7–66) 
Prior therapy, n (%) 
 Radiation 21 (88) 26 (68) 
 Systemic anticancer therapy 20 (83) 32 (84) 
Number of prior systemic anticancer therapies, n (%) 
 0 linesd 4 (17) 9 (23) 
 1 line 10 (42) 15 (38) 
 2 lines 3 (13) 4 (10) 
 ≥3 lines 7 (29) 11 (28) 
Tumor status at study entry, n (%) 
 NEDe 6 (25) 9 (23) 
 SD 5 (21) 9 (23) 
 Evidence of any tumor growth 13 (54) 21 (54) 
Mean tumor burden at study entryf, mm 45.3 (±18.9) 41.9 (±18.3) 
Sarcoma patientsAll patients
(n = 24)(n = 39)
Median (range) age, years 47 (25–72) 56 (25–75) 
Male/female gender, n (%) 11 (46)/13 (54) 15 (38)/24 (62) 
Diagnosis, n (%) 
 SS 13 (54) 13 (33) 
 MRCL 6 (25) 6 (15) 
 Other sarcomaa 5 (21) 5 (13) 
 Ovarian N/A 8 (21) 
 Melanoma N/A 6 (15) 
 NSCLC N/A 1 (3) 
Stage at diagnosis, n (%) 
 II 1 (4) 1 (3) 
 III 2 (8) 4 (10) 
 IV 21 (88) 34 (87) 
NY-ESO-1 expressionb, n (%) 
 ≤5% 11 (28) 
 >5%–25%c 4 (17) 15 (38) 
 >25%–50% 2 (8) 2 (5) 
 >50%–75% 2 (8) 3 (8) 
 >75%–100% 16 (67) 19 (49) 
Median (range) time since diagnosis, years 3.4 (0.5–13.4) 2.9 (0.5–18.2) 
Median (range) time since last treatment, months 4.9 (0.7–66) 4.8 (0.7–66) 
Prior therapy, n (%) 
 Radiation 21 (88) 26 (68) 
 Systemic anticancer therapy 20 (83) 32 (84) 
Number of prior systemic anticancer therapies, n (%) 
 0 linesd 4 (17) 9 (23) 
 1 line 10 (42) 15 (38) 
 2 lines 3 (13) 4 (10) 
 ≥3 lines 7 (29) 11 (28) 
Tumor status at study entry, n (%) 
 NEDe 6 (25) 9 (23) 
 SD 5 (21) 9 (23) 
 Evidence of any tumor growth 13 (54) 21 (54) 
Mean tumor burden at study entryf, mm 45.3 (±18.9) 41.9 (±18.3) 

Abbreviation: NA, not applicable.

aOther sarcoma subtypes included leiomyosarcoma (n = 2) and rhabdomyosarcoma (n = 1), solitary fibrous tumor (n = 1), and Ewing sarcoma (n = 1).

bAmong patients with nonsarcoma tumor types, high expression (≥50%) was detected in 50% of melanoma patients (3/6) and the only NSCLC patient; the remaining 3 melanoma patients had low (<1%) expression. All patients with ovarian cancer had NY-ESO-1 expression in ≤5% of tumor cells, including 5 with expression <1%.

cIncludes any tumor-specific positivity up to <25%.

dAll patients had prior therapy with at least one of the following: surgery, radiation, systemic anticancer therapy; patients with no prior systemic anticancer therapies had prior local radiation and/or surgery.

eNED was determined by investigator assessment of baseline imaging. If there were no measurable target lesions nor any evidence of nontarget lesions, investigators made assessment of NED.

fSum of target lesion diameters; 19 patients (11 with sarcoma) classified as NED or with only presence of nontarget lesions were excluded.

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