Tumor burden and complete response rate at 6 months by blinded independent central review and investigator-reported responses
| End point . | Active treatment arm . | NKTR-255 combined cohorts . | Placebo . | ||
|---|---|---|---|---|---|
| NKTR-255 1.5 μg/kg . | NKTR-255 3.0 μg/kg . | NKTR-255 3.0/6.0 μg/kg . | |||
| Number of patients randomized to cohort | n = 5 | n = 3 | n = 3 | n = 11 | n = 4 |
| ITT CRR per BICR at 6 months | 4/5 (80%) | 2/3 (67%) | 2/3 (67%) | 8/11 (73%) | 2/4 (50%) |
| Efficacy evaluable population CRR per PI at 6 months | 4/4 (100%) | 2/3 (67%) | 2/3 (67%) | 8/10 (80%) | 2/4 (50%) |
| Number of patients that converted from SD or PR to CR per PI at 6 months | 1/5 (20%) SD to PR to CR | 1/3 (33%) PR to CR | 0 | 2/11 (18%) | 0 |
| Median tumor burden (SPD), mm2 | 1320 | 3121 | 1056 | 1408 | 939 |
| End point . | Active treatment arm . | NKTR-255 combined cohorts . | Placebo . | ||
|---|---|---|---|---|---|
| NKTR-255 1.5 μg/kg . | NKTR-255 3.0 μg/kg . | NKTR-255 3.0/6.0 μg/kg . | |||
| Number of patients randomized to cohort | n = 5 | n = 3 | n = 3 | n = 11 | n = 4 |
| ITT CRR per BICR at 6 months | 4/5 (80%) | 2/3 (67%) | 2/3 (67%) | 8/11 (73%) | 2/4 (50%) |
| Efficacy evaluable population CRR per PI at 6 months | 4/4 (100%) | 2/3 (67%) | 2/3 (67%) | 8/10 (80%) | 2/4 (50%) |
| Number of patients that converted from SD or PR to CR per PI at 6 months | 1/5 (20%) SD to PR to CR | 1/3 (33%) PR to CR | 0 | 2/11 (18%) | 0 |
| Median tumor burden (SPD), mm2 | 1320 | 3121 | 1056 | 1408 | 939 |
Tabular summary of the CRR between groups.
BICR, blinded independent central review; CRR, complete response rate; ITT, intention-to-treat; PI, principal investigator; PR, partial response; SD, stable disease; SPD, sum of the product of diameters.