Table 2.
Patient demographics and baseline characteristics
|
Number (%) of Patients |
||||||||
|---|---|---|---|---|---|---|---|---|
|
Part 1: 3 + 3 Dose Escalation |
Part 2: Patient Expansion |
Total (N = 79) | ||||||
|
Cohort 1 109 vg dose of LV305 (N = 3) |
Cohort 2 1010 vg dose of LV305 (N = 3) |
Arm A CMB305 expansion (N = 35) |
Arm B SC admin of CMB305 (N = 9) |
Arm C CMB305 + mCPA (N = 10) |
Arm D CMB305 + GLA-SE (N = 10) |
Arm E CMB305 escalation (N = 9) |
||
| Age (years), mean (SD) | 62.3 (19.5) | 34.0 (7.0) | 53.8 (15.3) | 41.8 (13.7) | 48.0 (14.2) | 51.6 (14.9) | 48.4 (14.8) | 50.4 (15.3) |
| Female | 2 (66.7) | 1 (33.3) | 18 (51.4) | 5 (55.6) | 4 (40.0) | 6 (60.0) | 4 (44.4) | 40 (50.6) |
| Race | ||||||||
| White | 3 (100) | 1 (33.3) | 30 (85.7) | 7 (77.8) | 6 (60.0) | 9 (90.0) | 6 (66.7) | 62 (78.5) |
| Asian | 0 | 1 (33.3) | 1 (2.9) | 0 | 1 (10.0) | 0 | 2 (22.2) | 5 (6.3) |
| Black or African American | 0 | 1 (33.3) | 2 (5.7) | 0 | 1 (10.0) | 1 (10.0) | 0 | 5 (6.3) |
| Not Reported/Other | 0 | 0 | 2 (5.7) | 2 (22.2) | 2 (20.0) | 0 | 1 (11.1) | 7 (8.9) |
| Ethnicity | ||||||||
| Not Hispanic or Latino | 2 (66.7) | 3 (100) | 32 (91.4) | 6 (66.7) | 7 (70.0) | 9 (90.0) | 6 (66.7) | 65 (82.3) |
| Hispanic or Latino | 1 (33.3) | 0 | 2 (5.7) | 1 (11.1) | 2 (20.0) | 1 (10.0) | 2 (22.2) | 9 (11.4) |
| Not reported | 0 | 0 | 1 (2.9) | 2 (22.2) | 1 (10.0) | 0 | 1 (11.1) | 5 (6.3) |
| ECOG Performance Status | ||||||||
| 0 | 1 (33.3) | 0 | 20 (57.1) | 3 (33.3) | 0 | 7 (70.0) | 5 (55.6) | 36 (45.6) |
| 1 | 2 (66.7) | 3 (100) | 15 (42.9) | 6 (66.7) | 10 (100) | 3 (30.0) | 4 (44.4) | 43 (54.4) |
| Disease typea | ||||||||
| NSCLC | 0 | 0 | 4 (11.4) | 0 | 0 | 0 | 0 | 4 (5.1) |
| Ovarian | 0 | 0 | 11 (31.4) | 0 | 0 | 0 | 0 | 11 (13.9) |
| Sarcoma | 3 (100) | 3 (100) | 20 (57.1) | 9 (100) | 10 (100) | 10 (100) | 9 (100) | 64 (81.0) |
| MRCL | 0 | 0 | 9 (25.7) | 2 (22.2) | 4 (40.0) | 8 (80.0) | 4 (44.4) | 27 (34.2) |
| SS | 2 (66.7) | 1 (33.3) | 11 (31.4) | 7 (77.8) | 6 (60.0) | 2 (20.0) | 4 (44.4) | 33 (41.8) |
| Other sarcoma | 1 (33.3) | 2 (66.7) | 0 | 0 | 0 | 0 | 1 (11.1) | 4 (5.1) |
| Disease status | ||||||||
| Metastatic | 2 (66.7) | 3 (100) | 27 (77.1) | 9 (100) | 10 (100) | 9 (90.0) | 8 (88.9) | 68 (86.1) |
| Locally advanced | 1 (33.3) | 0 | 8 (22.9) | 0 | 0 | 1 (10.0) | 1 (11.1) | 11 (13.9) |
| Progression status based on physician assessment | ||||||||
| Stable disease | 0 | 0 | 14 (40.0) | 2 (22.2) | 4 (40.0) | 2 (20.0) | 5 (55.6) | 27 (34.2) |
| Any tumor growth/PD | 1 (33.3) | 3 (100) | 17 (48.6) | 6 (66.7) | 6 (60.0) | 8 (80.0) | 4 (44.4) | 45 (57.0) |
| No evidence of disease | 2 (66.7) | 0 | 4 (11.4) | 1 (11.1) | 0 | 0 | 0 | 7 (8.9) |
| Current TNM stageb | ||||||||
| Stage IIIA | 1 (33.3) | 0 | 0 | 0 | 0 | 0 | 1 (11.1) | 2 (2.5) |
| Stage IIIC | 0 | 0 | 6 (17.1) | 0 | 0 | 0 | 0 | 6 (7.6) |
| Stage IV | 2 (66.7) | 3 (100) | 23 (65.7) | 9 (100) | 10 (100) | 9 (90.0) | 8 (88.9) | 64 (81.0) |
| Not staged/Missing | 0 | 0 | 6 (17.1) | 0 | 0 | 1 (10.0) | 0 | 7 (8.9) |
| NY-ESO-1 expression (% tumor cells positive) | ||||||||
| 1–25% | 1 (33.3) | 0 | 15 (42.9) | 1 (11.1) | 2 (20.0) | 2 (20.0) | 3 (33.3) | 24 (30.4) |
| >25–50% | 0 | 0 | 3 (8.6) | 0 | 0 | 0 | 1 (11.1) | 4 (5.1) |
| >50–75% | 0 | 2 (66.7) | 2 (5.7) | 1 (11.1) | 0 | 0 | 0 | 5 (6.3) |
| >75–100% | 2 (66.7) | 1 (33.3) | 15 (42.9) | 7 (77.8) | 8 (80.0) | 8 (80.0) | 5 (55.6) | 46 (58.2) |
| Number of lines of prior therapy (any type) | ||||||||
| 1 | 1 (33.3) | 1 (33.3) | 11 (31.4) | 6 (66.7) | 4 (40.0) | 2 (20.0) | 0 | 25 (31.6) |
| 2 | 0 | 0 | 8 (22.9) | 2 (22.2) | 3 (30.0) | 5 (50.0) | 4 (44.4) | 22 (27.8) |
| ≥3 | 2 (66.7) | 2 (66.7) | 14 (40.0) | 1 (11.1) | 3 (30.0) | 2 (20.0) | 4 (44.4) | 28 (35.4) |
| Missing | 0 | 0 | 2 (5.7) | 0 | 0 | 1 (10.0) | 1 (11.1) | 4 (5.1) |
| Type of prior therapy | ||||||||
| Radiotherapy | 3 (100) | 2 (66.7) | 19 (54.3) | 4 (44.4) | 8 (80.0) | 9 (90.0) | 8 (88.9) | 53 (67.1) |
| Immunotherapy | 1 (33.3) | 0 | 5 (14.3) | 0 | 1 (10.0) | 0 | 2 (22.2) | 9 (11.4) |
| Chemotherapy | 3 (100) | 3 (100) | 33 (94.3) | 9 (100) | 10 (100) | 9 (90.0) | 8 (88.9) | 75 (94.9) |
| Other therapy | 1 (33.3) | 1 (33.3) | 4 (11.4) | 1 (11.1) | 1 (10.0) | 1 (10.0) | 2 (22.2) | 11 (13.9) |
Abbreviations: ECOG = Eastern Cooperative Oncology Group; GLA-SE = glucopyranosyl lipid A-stable emulsion; mCPA = metronomic cyclophosphamide; MRCL = myxoid/round cell liposarcoma; NSCLC = non-small cell lung carcinoma; PD = progressive disease; SC = subcutaneous; SD = standard deviation; SS = synovial sarcoma; TNM = tumor node metastasis
aPatients with melanoma were eligible to participate, but no patients with melanoma enrolled in the study.
bNo patients had a current TNM stage of 0, I, II, IIB, or IIIB.