Table 2.
Key safety and efficacy data from the Phase 1b arm of clinical trial NCT01740297 (investigating ipilimumab in combination with talimogene laherparepvec in melanoma), the Phase 1b arm of clinical trial NCT02263508 (investigating pembrolizumab in combination with talimogene laherparepvec in melanoma), and historical data for talimogene laherparepvec monotherapy from the Phase III OPTiM clinical trial in melanoma*
| Talimogene laherparepvec + ipilimumab [44] | Talimogene laherparepvec + pembrolizumab [45] | Talimogene laherparepvec monotherapy [HISTORICAL DATA FROM OPTiM] [6, 30, 46] | |
|---|---|---|---|
| Baseline characteristics | |||
| Disease stage | |||
| IIIB | 1 (5) | 1 (5) | 22 (8) |
| IIIC | 3 (16) | 7 (33) | 66 (22) |
| IVM1a | 4 (21) | 2 (10) | 75 (25) |
| IVM1b | 5 (26) | 3 (14) | 64 (22) |
| IVM1c | 6 (32) | 8 (38) | 67 (23) |
| Unknown | 0 (0) | 0 (0) | 1 (<1) |
| ECOG performance status | |||
| 0 | 14 (74) | 19 (91) | 209 (71) |
| 1 | 5 (26) | 2 (10) | 82 (28) |
| Unknown | 0 (0) | 0 (0) | 4 (1) |
| LDH | |||
| ≤ULN | 15 (79) | 16 (76) | 266 (90) |
| >ULN | 1 (5) | 5 (24) | 15 (5) |
| Unknown | 3 (16) | 0 (0) | 14 (5) |
| Safety findings | |||
| Grade 3/4 TRAE, N (%) | |||
| Any event | 5 (26) | 7 (33)† | 33 (11) |
| Any attributed to talimogene laherparepvec | 3 (16) | 4 (19) | 33 (11) |
| Any attributed to checkpoint inhibitor | 4 (21) | 6 (29)† | NA |
| Efficacy findings | |||
| ORR, n (%) | 9 (50) | 12 (57) | 78 (26) |
| CR, n (%) | 4 (22) | 5 (24) | 32 (11) |
| PR, n (%) | 5 (28) | 7 (33) | 46 (16) |
| SD, n (%) | 4 (22) | 3 (14) | 134 (45) |
| PD, n (%) | 5 (28) | 6 (29) | 62 (21) |
| DRR, n (%)‡ | 8 (44) | NR | 48 (16) |
| DCR, N (%) | NR | 15 (71) | 225 (76) |
| 12-month PFS, % | 50 | 71 | NR |
| 12-month OS, % | 72 | NR | 74 |
| Tumor response at the lesion level, %# | |||
| Injected lesions | 74 | 80 | 64 |
| Non-injected lesions | 52 | 35 | NR |
| Non-visceral | 54 | 45 | 34 |
| Visceral | 50 | 28 | 15 |
CR complete response, DCR disease control rate, DRR durable response rate, ECOG Eastern Cooperative Oncology Group, LDH lactate dehydrogenase, NA not applicable, NR not reported, ORR overall response rate, OS overall survival, PD progressive disease, PFS progression-free survival, PR partial response, SD stable disease, TRAE treatment-related adverse event, ULN upper limit of normal
*The data are derived from three independent clinical trials; comparisons across trials should be interpreted with caution. †Data are for grade 3 TREAs only; one grade 4 TRAE (pneumonitis, pembrolizumab related) was reported. ‡In of clinical trial NCT01740297, DRR is defined as a duration of response (DOR) lasting ≥6 months, where DOR is the interval from a first confirmed objective response to confirmed PD. In OPTiM, DRR was defined as an objective response lasting continuously ≥6 months. #Tumor response defined as ≥50% regression