Table 1.
Baseline patient demographics and clinical characteristics
| Arm 1: tebentafusp +durvalumab (N=43) | Arm 2: tebentafusp +tremelimumab (N=13) | Arm 3: tebentafusp +durvalumab +tremelimumab (N=29) | All patients (N=85) | Efficacy population*(N=72) | Sensitivity population†(N=58) | |
| Median age (range), years | 59 (28–79) | 52 (30–74) | 58 (30–79) | 58 (28–79) | 59 (28–79) | 58 (29–79) |
| ECOG performance status, n (%) | ||||||
| 0 | 34 (79) | 5 (38) | 26 (90) | 65 (76) | 60 (83) | 47 (81) |
| 1 | 9 (21) | 8 (62) | 3 (10) | 20 (24) | 12 (17) | 11 (19) |
| Lactate dehydrogenase, n (%) | ||||||
| ≤ULN | 16 (37) | 5 (38) | 13 (45) | 34 (40) | 29 (40) | 24 (41) |
| >ULN | 18 (42) | 3 (23) | 11 (38) | 32 (38) | 29 (40) | 23 (40) |
| Missing | 9 (21) | 5 (38) | 5 (17) | 19 (22) | 14 (19) | 11 (19) |
| BRAFm, n (%) | 19 (44) | 6 (46) | 8 (28) | 33 (39) | 27 (38) | 22 (38) |
| BRAFm pts who received inhibitors | 13 (68) | 6 (100) | 6 (75) | 25 (76) | 19 (70) | 16 (73) |
| Prior lines of metastatic therapy, n (%) | ||||||
| 1L | 11 (26) | 1 (8) | 5 (17) | 17 (20) | 16 (22) | 10 (17) |
| 2L | 9 (21) | 1 (8) | 7 (24) | 17 (20) | 16 (22) | 16 (28) |
| 3L | 5 (12) | 5 (38) | 8 (28) | 18 (21) | 13 (18) | 12 (21) |
| 4L+ | 13 (30) | 6 (46) | 6 (21) | 25 (30) | 19 (26) | 18 (31) |
| Prior immunotherapy | ||||||
| Checkpoint inhibitors | ||||||
| Anti-PD(L)1 | 36 (84) | 13 (100) | 27 (93) | 76 (89) | 63 (88) | 58 (100) |
| Anti-CTLA4 | 32 (74) | 13 (100) | 19 (66) | 64 (75) | 51 (71) | 44 (76) |
| TIL therapy | 1 (2) | 2 (15) | 3 (10) | 6 (7) | 4 (6) | 4 (7) |
| Tebentafusp | 0 | 0 | 1 (3) | 1 (1) | 1 (1) | 1 (2) |
| Other | 18 (42) | 3 (23) | 8 (28) | 29 (34) | 26 (36) | 22 (38) |
| BOR to prior anti-PD(L)1 therapy, n (%) | ||||||
| CR/PR/SD (ie, relapsed) | 21 (46) | 10 (77) | 16 (55) | 47 (55) | 37 (51) | 34 (59) |
| PD (ie, refractory) | 11 (26) | 3 (23) | 10 (34) | 24 (28) | 21 (29) | 19 (33) |
| Missing | 4 (9) | 0 | 1 (3) | 5 (6) | 5 (7) | 5 (9) |
*The efficacy analysis population consists of patients treated with tebentafusp and durvalumab±tremelimumab (Arms 1 and 3).
†The sensitivity analysis population consists of patients treated with tebentafusp and durvalumab±tremelimumab who discontinued prior anti-PD(L)1 due to disease progression.
BOR, best overall response; BRAFm, BRAF mutation; CR, complete response; CTLA4, cytotoxic T-lymphocyte-associated antigen 4; ECOG, Eastern Cooperative Oncology Group; 1L, first line; 2L, second line; 3L, third line; 4L+, fourth line and beyond; PD, progressive disease; PD(L)1, programmed death (ligand) 1; PD(L)1, programmed death (ligand) 1; PR, partial response; SD, stable disease; TIL, tumor infiltrating lymphocyte; ULN, upper limit of normal.