TABLE 2.
Tumor Response
| Outcome | Cohort 6—Anti–PD-(L)1–Naïve (n = 40) | Cohort 15—Systemic Therapy–Naïve (n = 40) | Cohort 16—Previous Neo/Adjuvant Therapy (n = 18) | No Previous Anti–PD-1 Therapy for Advanced Melanoma (n = 98) |
|---|---|---|---|---|
| Median follow-up (IQR), months | 20.8 (11.2-30.8) | 11.5 (8.9-13.9) | 9.7 (4.8-14.1) | 12.6 (8.6-19.0) |
| Treatment exposure, median (IQR), weeks | 37.1 (19.5-81.0) | 35.1 (15.1-51.2) | 22.9 (12.0-37.1) | 32.9 (15.0-53.7) |
| ORR, No. (%) | 25 (62.5) | 25 (62.5) | 10 (55.6) | 60 (61.2) |
| 95% CI for ORR | 45.8 to 77.3 | 45.8 to 77.3 | 30.8 to 78.5 | 50.8 to 70.9 |
| KM estimated duration of response, median (95% CI), months | NR (11.9 to NE) | NR (NE to NE) | NR (6.2 to NE) | NR (22.6 to NE) |
| DCR, No. (%) | 32 (80.0) | 32 (80.0) | 12 (66.7) | 76 (77.6) |
| 95% CI for DCR | 64.4 to 90.9 | 64.4 to 90.9 | 41.0 to 86.7 | 68.0 to 85.4 |
| Best overall response | ||||
| Complete response, No. (%) | 6 (15.0) | 5 (12.5) | 1 (5.6) | 12 (12.2) |
| Partial response, No. (%) | 19 (47.5) | 20 (50.0) | 9 (50.0) | 48 (49.0) |
| Stable disease, No. (%) | 7 (17.5) | 7 (17.5) | 2 (11.1) | 16 (16.3) |
| Progressive disease, No. (%) | 6 (15.0) | 6 (15.0) | 5 (27.8) | 17 (17.3) |
| Not evaluated,a No. (%) | 2 (5.0) | 2 (5.0) | 1 (5.6) | 5 (5.1) |
| KM estimated progression free survival, median (95% CI), months | 24.0 (4.2 to NE) | 15.3 (6.6 to NE) | 11.8 (1.4 to NE) | 13.3 (7.5 to NE) |
| Liver metastases, N1/N2 (%), ORR | ||||
| Yes | 6/14 (42.9) | 2/4 (50.0) | 0/2 (0) | 8/20 (40.0) |
| No | 19/26 (73.1) | 23/36 (63.9) | 10/16 (62.5) | 52/78 (66.7) |
| Baseline LDH >ULN, N1/N2 (%), ORR | ||||
| Yes | 10/17 (58.8) | 6/12 (50.0) | 1/3 (33.3) | 17/32 (53.1) |
| No | 15/23 (65.2) | 19/27 (70.4) | 9/15 (60.0) | 43/65 (66.2) |
NOTE. Five patients had acral melanoma and one patient had mucosal melanoma. Two of the five patients with acral melanoma had their best response as PR, and one as SD. The one patient with mucosal melanoma had their best response as SD.
Abbreviations: DCR, disease control rate; KM, Kaplan-Meier; LDH, lactate dehydrogenase; n, number; NE, not estimated; NR, not reached; N1, number of patients with the listed status who had complete or partial responses; N2, number of patients with the listed status; ORR, objective response rate; SD, standard deviation; ULN, upper limit of normal.
a
There was no overall response assessment in the received data for the five subjects.