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 – Columvi – in patients with relapsed or refractory diffuse large B-cell lymphoma, or r/r DLBCL. The updated data reflects the 49 efficacy-evaluable patients with a minimum of 6 months of follow-up from treatment initiation. Best overall response rate was 89.8% as assessed by Lugano criteria; complete response rate was 77.6%; strong efficacy in both the relapsed and primary refractory populations across both dose levels; in the 24 relapsed patients ORR was 100% and CR rate was 91.7%; in the 25 primary refractory patients ORR was 80% and CR rate was 64%; 14 patients converted from stable disease or partial response to CR over time. Of the 8 patients previously treated with CAR-T, 6 achieved a CR. The combination was generally well tolerated with a manageable safety profile. Grade 3 or higher treatment emergent adverse events observed in greater than 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% -. Cytokine release syndrome of all grades across dose levels was 36.7%. The company plans to share full data at a medical meeting and submit for publication by the end of 2026. In addition, the company plans to assess regulatory and compendia strategies.
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