ADC Therapeutics Reports 93% Response Rate in Lymphoma Drug Trial, Including CAR-T Resistant Patients

ADC Therapeutics SA (NYSE:ADCT), a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), today 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 (COLUMVI®) in patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) to be presented at the European Hematology Association 2025 Congress (EHA2025) in Milan, Italy. The Company will host a conference call and webcast featuring LOTIS-7 trial principal investigator and EHA presenting author, Juan Alderuccio, MD, Clinical Site Disease Group Leader, Lymphoma Section, at Sylvester Comprehensive Cancer Center, part of the University of Miami Miller School of Medicine today at 8:00 a.m. ET to discuss the results. To access the conference call, please register here.

 

"The data seen in this study with the combination of ZYNLONTA and glofitamab has shown a manageable safety profile along with strong efficacy data from patients with relapsed or refractory DLBCL, with complete responses observed regardless of prior therapy, including CAR-T," said Mohamed Zaki, MD, PhD, Chief Medical Officer of ADC Therapeutics. "The combination of these two anti-cancer agents holds significant promise for advancing the treatment landscape and addressing unmet need in patients with these hard-to-treat lymphomas."

The presentation highlights updated data as of April 14, 2025, in which r/r LBCL patients received dose levels of 120 µg/kg or 150 µg/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 (ORR) of 93.3% (28/30 pts) as assessed by Lugano Criteria
• Complete response (CR) rate of 86.7% (26/30 pts)
  • Of these, 25/26 patients achieving CR remain in CR as of the data cut-off
    • Median time to CR in 120 µg/kg = 80 days
    • Median time to CR in 150 µg/kg = 42 days
• 12 patients converted from stable disease (SD) or partial response (PR) to CR over time (1 and 11 pts respectively)
• 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 (TEAEs) observed in > 5% of patients included neutropenia (24.4%), anemia (9.8%), AST increased (7.3%), GGT increased (7.3%), and thrombocytopenia (7.3%)
  • In the 150 µg/kg dose, cytokine release syndrome (CRS) (23.8%), all of which were Grade 1, and immune effector cell-associated neurotoxicity syndrome (ICANS) (4.8%), with one case of Grade 2, were observed
  • In the 120 µg/kg dose, CRS all grades (55%), all of which were Grade 1/2 except one case of Grade 3, and ICANS (10%), with one case of Grade 1 and one case of Grade 2, were observed
  • TEAEs leading to discontinuation included 3 each for ZYNLONTA and glofitamab
  • There were no Grade 5 TEAEs observed