Table 1.
Response | Tebentafusp (N = 252) | Control (N = 126)* |
---|---|---|
Best overall response — no. of patients (%) | ||
Complete response | 1 (<1) | 0 |
Partial response | 27 (11) | 6 (5) |
Stable disease | 87 (35) | 28 (22) |
Progressive disease | 132 (52) | 82 (65) |
Not evaluable or not applicable | 5 (2) | 10 (8) |
Objective response — no. of patients (%) | 28 (11) | 6 (5) |
Stratified odds ratio for objective response, tebentafusp vs. control (95% CI)† | 2.46 (1.00–6.06) | Reference |
Disease control at 12 wk — no. of patients (%)‡ | 115 (46) | 34 (27) |
Stratified odds ratio for disease control, tebentafusp vs. control (95% CI)§ | 2.34 (1.45–3.76) | Reference |
Patients in the control group received the investigator’s choice of single-agent therapy with pembrolizumab, ipilimumab, or dacarbazine.
The 95% confidence intervals were calculated with the use of the exact Clopper–Pearson method.
Disease control was defined as a complete response, a partial response, or stable disease that persisted for at least 12 weeks.
The odds ratio and 95% confidence interval were calculated with a Stratified Cochran–Mantel–Haenszel test, with stratification according to lactate dehydrogenase (LDH) status (i.e., LDH level higher than the upper limit of the normal range or less than or equal to the upper limit of the normal range).