Table 2.
Efficacy and cellular kinetic variables | Patient A | Patient B | Patient C | Patient D | Patient E | Patient F | Patient G | Patient H | Patient I |
---|---|---|---|---|---|---|---|---|---|
Best overall response | CR | PD | CR | PR | PR | CR | CR | PD | CR |
Time to response, days | 28 | – | 28 | 31 | 28 | 30 | 90 | – | 91 |
Duration of response, days | 523+ | – | 51+ | 55 | 52+ | 148+ | 1+ | – | 1+ |
Progression-free survival, days | 550+ | 29 | 78+ | 85 | 79+ | 177+ | 90+ | 36 | 91+ |
Event-free survival, days | 550+ | 29 | 78+ | 85 | 126 | 207 | 90+ | 36 | 91+ |
Overall survival, days | 710+ | 231 | 144+ | 86+ | 183+ | 207+ | 160+ | 45 | 91+ |
AUC0–28d, copies/µg × days | 83,800 | 35,400 | 21,700 | 34,200 | 57,600 | 7290 | 189,000 | 1,740,000 | 2730 |
Cmax, copies/µg | 9410 | 6120 | 2470 | 4420 | 5840 | 846 | 11,900 | 137,000 | 149 |
Tmax, days | 5.82 | 5.85 | 8.78 | 12.9 | 5.73 | 6.96 | 11.0 | 26.7 | 19.8 |
T1/2, days | 408 | 7.53 | 26.6 | 1.18 | 32.4 | 4.16 | 77.9 | 2.72 | - |
AUC0-28d area under the concentration–time curve from time 0 to day 28, Cmax maximum concentration, CR complete response, PD progressive disease, PR partial response, T1/2 half-life, Tmax time to maximum expansion, + flags censored observations