ADCT News & Events

ADC Therapeutics announced the completion of enrollment in 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, or r/r DLBCL. LOTIS-7 trial enrollment is now complete with 100 r/r DLBCL patients dosed at the selected 150 microgram/kg dose of ZYNLONTA plus glofitamab. Primary endpoints of the study include safety and tolerability. Secondary endpoints include overall response rate, duration of response, complete response, relapse free survival, progression-free survival, and overall survival, as well as pharmacokinetics and immunogenicity. The company plans to share full data from LOTIS-7 at a medical meeting and submit the results for publication by the end of 2026.

ADC Therapeutics announced a strategic reorganization to focus resources behind key value-driving initiatives in support of the ZYNLONTA, or loncastuximab tesirine-lpyl, franchise. As part of the reorganization, ADC Therapeutics plans to reduce its workforce globally by approximately 17%. The reduction is driven by the expected completion of the LOTIS-5 and LOTIS-7 trials this year, as well as operational efficiencies. With these changes, the Company is resourced to deliver on its key clinical, regulatory and manufacturing activities while maintaining the full externally facing medical affairs and commercial footprint to support ZYNLONTA. The Company is preparing for a scheduled pre-sBLA meeting with the FDA in August 2026 to discuss the potential regulatory path forward for ZYNLONTA in combination with rituximab to treat relapsed or refractory diffuse large B-cell lymphoma following the recent topline data results from the Phase 3 LOTIS-5 trial. ADC Therapeutics expects to submit an sBLA in the fourth quarter of 2026. In addition, the Company continues to advance the ZYNLONTA franchise through the ongoing Phase 1b LOTIS-7 trial evaluating ZYNLONTA in combination with glofitamab in 2L+ DLBCL. ADC Therapeutics expects the reorganization to generate annualized estimated cost savings of approximately $10M. ADC Therapeutics estimates that it will incur one-time pre-tax charges of approximately $3M for employee severance, benefits and related termination costs, the majority of which will be recognized in the Q2. The Company has an expected cash runway at least into 2028.