ADC Therapeutics SA (the “Company”) announced updated data from the ongoing LOTIS-7 Phase 1b open-label clinical trial evaluating the safety and efficacy of ZYNLONTA

On December 3, 2025, ADC Therapeutics SA (the "Company") reported updated data from the ongoing 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).

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As of the November 17, 2025 cutoff date, a total of 49 patients were efficacy evaluable with a minimum of 6 months of follow-up from treatment initiation. Key highlights of the data are as follows:

· Best overall response rate (ORR) was 89.8% (44/49 patients), as assessed by Lugano criteria
o ORR was 95.2% at the 120 µg/kg dose and was 85.7% at the selected 150 µg/kg dose
· Complete response (CR) rate was 77.6% (38/49 patients)
o Of these, 33/38 patients achieving CR remain in CR as of the data cutoff; the 5 patients who did not remain in CR included 2 patients with progressive disease, 2 patients with Grade 5 AEs which occurred during CR, and one censored patient
o CR rate was 81.0% at the 120 µg/kg dose and was 75.0% at the selected 150 µg/kg dose
· Strong efficacy in both the relapsed and primary refractory populations across both dose levels
o In the 24 relapsed patients, ORR was 100% and CR rate was 91.7%
o In the 25 primary refractory patients, ORR was 80% and CR rate was 64%
· 14 patients converted from stable disease (SD) or partial response (PR) to CR over time (1 and 13 patients, respectively)
· Of the 8 patients previously treated with CAR-T, 6 achieved a CR
· The combination was generally well tolerated with a manageable safety profile
o Grade 3 or higher treatment emergent adverse events (TEAEs) observed in > 5% of patients included neutropenia (32.7%), GGT increased (16.3%), anemia (10.2%), WBC decreased (8.2%), generalized oedema (8.2%), ALT increased (8.2%), AST increased (6.1%), and thrombocytopenia (6.1%)
o Grade 5 AEs occurred in 2 (4.1%) patients, one at each dose level; the one at the 120 µg/kg dose was treatment-related per the investigator
o Cytokine release syndrome (CRS) of all grades across dose levels was 36.7%
§ CRS all grades was 25.0% at the selected 150 µg/kg dose and 52.4% at the 120 µg/kg dose, with all but one were low Grade
o Immune effector cell-associated neurotoxicity syndrome (ICANS) was 4.1% across dose levels, with only Grade 1/2

(Press release, ADC Therapeutics, DEC 3, 2025, View Source [SID1234661192])