TABLE 4.
Summary of progression‐free and overall survival outcomes
| Parameter | Safety Part Arm A + Expansion Part Zolbetuximab 800/600 mg/m2 (n = 15) | Safety Part Arm B Zolbetuximab 1000 mg/m2 (n = 3) |
|---|---|---|
| PFS events, n (%) | 14 (93.3) | 3 (100.0) |
| Duration of PFS (months) a | ||
| Median (95% CI) | 2.6 (0.9–2.8) | 1.7 (1.2–2.1) |
| Range | 0.10–11.07 | 1.18–2.10 |
| Duration of OS (months) a | ||
| Median (95% CI) | 4.4 (2.6–11.4) | 6.4 (2.9–6.8) |
| Range | 1.77–13.96 | 2.89–6.83 |
| Follow‐up time (months) b | ||
| Median (95% CI) | NE (2.5–NE) | NE (NE–NE) |
PFS was defined as the time from start of zolbetuximab treatment until death from any cause or radiographic disease progression per RECIST v1.1, whichever occurred first. For patients with none of these events, PFS was censored based on the rules defined in the statistical analysis plan.
Abbreviations: CI, confidence interval; NE, not estimable; OS, overall survival; PFS, progression‐free survival; RECIST v1.1, response evaluation criteria in solid tumors version 1.1.
a
Based on Kaplan–Meier estimate.
b
Based on reverse Kaplan–Meier estimate.