ADC Therapeutics announces updated data from LOTIS-7 trial

ADC Therapeutics (ADCT) announced updated data from the LOTIS-7 Phase 1b open-label clinical trial evaluating the safety and efficacy of Zynlonta in combination with the bispecific antibody glofitamab in patients with relapsed or refractory diffuse large B-cell lymphoma to be presented at the European Hematology Association 2025 Congress in Milan, Italy. The presentation highlights updated data as of April 14, in which r/r LBCL patients received dose levels of 120 microgram/kg or 150 microgram/kg of Zynlonta plus the bispecific antibody glofitamab, with 41 patients evaluable for safety and 30 patients evaluable for efficacy. Key highlights of the LOTIS-7 data presentation are as follows: best overall response data among the 30 efficacy evaluable patients shows overall response rate of 93.3% as assessed by Lugano Criteria; complete response rate of 86.7%; of these, 25/26 patients achieving CR remain in CR as of the data cut-off; median time to CR in 120 microgram/kg of 80 days; median time to CR in 150 microgram/kg of 42 days; 12 patients converted from stable disease or partial response to CR over time; of the 6 patients previously treated with CAR-T and undergoing response assessment, 5 achieved a CR. Among the 41 safety evaluable patients, the combination was generally well tolerated with a manageable safety profile and no DLTs across dose levels. Grade 3 or higher treatment emergent adverse events were observed in greater than 5% of patients included neutropenia, anemia, AST increased, GGT increased and thrombocytopenia. In the 150 microgram/kg dose, cytokine release syndrome, all of which were Grade 1, and immune effector cell-associated neurotoxicity syndrome, with one case of Grade 2, were observed. In the 120 microgram/kg dose, CRS all grades, all of which were Grade 1/2 except one case of Grade 3, and ICANS, with one case of Grade 1 and one case of Grade 2, were observed. TEAEs leading to discontinuation included three each for Zynlonta and glofitamab. There were no Grade 5 TEAEs observed.