Table II.
Summary of LCL161 Activity In Vivo
| Xenograft Line | Histology | Median Time to Event | P-value | EFS T/C | Median Final RTV | T/C | P-value | T/C Activity | EFS Activity | Response Activity |
|---|---|---|---|---|---|---|---|---|---|---|
| 30 mg/kg | ||||||||||
| BT-29 | Rhabdoid | 12.5 | 0.379 | 1.0 | >4 | 0.94 | 0.481 | Low | Low | Low |
| KT-14 | Rhabdoid | 31.7 | 0.578 | 1.0 | >4 | 1.04 | 0.684 | Low | Low | Low |
| KT-12 | Rhabdoid | 10.0 | 0.465 | 1.1 | >4 | 0.79 | 0.353 | Low | Low | Low |
| KT-10 | Wilms | 14.3 | 0.701 | 0.9 | >4 | 1.09 | 0.796 | Low | Low | Low |
| KT-11 | Wilms | 11.5 | 0.518 | 1.0 | >4 | 1.16 | 0.631 | Low | Low | Low |
| KT-13 | Wilms | 10.9 | 0.093 | 1.1 | >4 | 1.07 | 0.796 | Low | Low | Low |
| SK-NEP-1 | Ewing | 9.0 | 0.310 | 1.0 | >4 | 0.81 | 0.143 | Low | Low | Low |
| EW5 | Ewing | 14.4 | <0.001 | 1.5 | >4 | 0.74 | 0.009 | Low | Low | Int |
| EW8 | Ewing | 11.7 | 0.073 | 1.8 | >4 | 0.46 | 0.165 | Low | Low | Int |
| TC-71 | Ewing | 9.7 | 0.971 | 1.0 | >4 | 1.23 | 0.853 | Low | Low | Low |
| CHLA258 | Ewing | 8.3 | 0.758 | 1.2 | >4 | 1.18 | 0.971 | Low | Low | Low |
| Rh10 | ALV RMS | 25.1 | 0.932 | 1.3 | >4 | 0.95 | 0.965 | Low | Low | Low |
| Rh28 | ALV RMS | 13.1 | 0.342 | 0.7 | >4 | 1.43 | 0.052 | Low | Low | Low |
| Rh30 | ALV RMS | 15.3 | 0.186 | 1.4 | >4 | 0.80 | 0.315 | Low | Low | Low |
| Rh30R | ALV RMS | 12.2 | 0.271 | 1.2 | >4 | 0.66 | 0.002 | Low | Low | Low |
| Rh41 | ALV RMS | 15.4 | 0.586 | 1.0 | >4 | 1.00 | 1.000 | Low | Low | Low |
| Rh18 | EMB RMS | 13.5 | <0.001 | 1.2 | >4 | 0.63 | 0.002 | Low | Low | Low |
| BT-28 | Medulloblastoma | > EP | 0.002 | >10.9 | >4 | 0.42 | 0.009 | Int | Int | High |
| BT-45 | Medulloblastoma | 21.3 | 0.051 | 1.3 | >4 | 0.66 | 0.165 | Low | Low | Low |
| BT-50 | Medulloblastoma | > EP | 0.204 | > 1.3 | 2.8 | 0.79 | 0.014 | Low | NE | Int |
| BT-41 | Ependymoma | > EP | 1.000 | . | 2.0 | 0.57 | 0.123 | Low | NE | Int |
| BT-44 | Ependymoma | 9.6 | 0.707 | 0.9 | >4 | 1.31 | 0.842 | Low | Low | Low |
| GBM2 | Glioblastoma | 9.7 | 0.709 | 0.9 | >4 | 0.97 | 0.009 | Low | Low | Low |
| BT-39 | Glioblastoma | 11.9 | 0.003 | 1.8 | >4 | 0.65 | 0.123 | Low | Low | Int |
| D645 | Glioblastoma | 9.7 | 0.120 | 0.8 | >4 | 1.19 | 0.165 | Low | Low | Low |
| D456 | Glioblastoma | 11.8 | 0.045 | 1.5 | >4 | 0.82 | 0.481 | Low | Low | Low |
| NB-SD | Neuroblastoma | 14.9 | 0.714 | 1.4 | >4 | 0.83 | 0.008 | Low | Low | Low |
| NB-1771 | Neuroblastoma | 23.4 | 0.008 | 1.4 | >4 | 0.52 | 0.853 | Low | Low | Low |
| NB-1691 | Neuroblastoma | 10.6 | 0.454 | 1.1 | >4 | 0.90 | 0.696 | Low | Low | Low |
| NB-EBc1 | Neuroblastoma | 14.8 | 0.024 | 1.4 | >4 | 0.76 | 0.234 | Low | Low | Low |
| CHLA-79 | Neuroblastoma | 18.5 | 0.146 | 1.5 | >4 | 0.80 | 0.579 | Low | Low | Low |
| NB-1643 | Neuroblastoma | 8.6 | 0.748 | 1.0 | >4 | 1.04 | 0.035 | Low | Low | Low |
| OS-1 | Osteosarcoma | 38.8 | 0.017 | 1.3 | >4 | 0.76 | 0.001 | Low | Low | Low |
| OS-2 | Osteosarcoma | 23.6 | <0.001 | 1.3 | >4 | 0.76 | 0.278 | Low | Low | Low |
| OS-17 | Osteosarcoma | 20.8 | 0.500 | 1.0 | >4 | 0.91 | <0.001 | Low | Low | Low |
| OS-9 | Osteosarcoma | 28.6 | <0.001 | 1.8 | >4 | 0.57 | <0.001 | Low | Low | Int |
| OS-33 | Osteosarcoma | 26.1 | <0.001 | 1.4 | >4 | 0.61 | 0.133 | Low | Low | Low |
| OS-31 | Osteosarcoma | 23.5 | 0.044 | 1.1 | >4 | 0.81 | Low | Low | Low | |
| ALL-2 | ALL B-precursor | 10.4 | 0.531 | 1.0 | >25 | . | Low | Low | ||
| ALL-3 | ALL B-precursor | 9.3 | 0.363 | 1.2 | >25 | . | Low | Low | ||
| ALL-4 | ALL B-precursor | 9.0 | 0.819 | 1.5 | >25 | . | Low | Low | ||
| ALL-7 | ALL B-precursor | 6.0 | 1.000 | 1.0 | >25 | . | Low | Low | ||
| ALL-8 | ALL T-cell | 11.2 | 0.547 | 1.0 | >25 | . | Low | Low | ||
| ALL-16 | ALL T-cell | > EP | 0.103 | > 1.4 | >25 | . | NE | Int | ||
| ALL-17 | ALL B-precursor | 6.3 | 0.669 | 1.1 | >25 | . | Low | Low | ||
| ALL-19 | ALL B-precursor | 5.4 | 0.652 | 1.1 | >25 | . | Low | Low | ||
| 75 mg/kg (solid Tumors) | ||||||||||
| EW5 | Ewing | 11.5 | <0.001 | 1.7 | >4 | 0.68 | <0.001 | Low | Low | Low |
| BT-28 | Medulloblastoma | 5.7 | 0.3190 | 1.2 | >4 | 0.66 | 0'165 | Low | Low | Low |
| BT-39 | Glioblastoma | 18.1 | 0.0060 | 1.3 | >4 | 0.66 | Low | Low | Low | |
| Karpas-299 | ALCL | 13.3 | <0.001 | 1.6 | >4 | 0.65 | Low | Low | Low | |
| 100 mg/kg (ALL models) | ||||||||||
| ALL-7 | ALL B-precursor | 3.0 | 0.6880 | 1.0 | >25 | . | Low | Low | ||
| ALL-19 | ALL B-precursor | 10.2 | 0.5240 | 2.1 | >25 | . | Low | Low | ||
| ALL-31 | ALL T-cell | 5.8 | 0.4890 | 1.0 | >25 | . | Low | Low | ||
| MLL-7 | ALL B-precursor | 8.9 | 0.2150 | 1.7 | >25 | . | Low | Low | ||