Full Efficacy & Safety Summary Table
| Indication | Relapsed DLBCL following at least 2 prior lines of therapy (incl. SCT eligible/ineligible and patients who received prior SCT or CART) |
| Registrational Trial | Accelerated Approval. Phase 2 (n=145), Single Arm LOTIS-2 trial (NCT03589469) |
| Regimen | Intravenous infusion administered over 30 minutes on Day 1 of each cycle (every 3 weeks). Administer intravenous infusion: 0.15 mg/kg every 3 weeks for 2 cycles. 0.075 mg/kg every 3 weeks for subsequent cycles |
| Efficacy Outcomes | ORR: 48.3% (24% CR) DOR: 10.3 months |
| Safety Outcomes | Gr 3+ AEs (≥10%): Neutropenia 26.2%, Thrombocytopenia 17.9%, Gamma-glutamyltransferase 17.2%, Anemia 10.3% |