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ADC Therapeutics Announces Updated Data from LOTIS-7 Phase 1b Clinical Trial of ZYNLONTA® in Combination with Bispecific Antibody Supporting Potential Best-in-Class Regimen in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma
Prnewswire· 2025-12-03 12:30
Core Insights - ADC Therapeutics announced updated data from the LOTIS-7 Phase 1b trial, showing ZYNLONTA® combined with glofitamab (COLUMVI®) achieved an 89.8% overall response rate (ORR) and a 77.6% complete response (CR) rate in patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) [1][2] Company Overview - ADC Therapeutics is a global leader in antibody drug conjugates (ADCs), focusing on innovative treatments for patients with hematological malignancies [2] - The company is headquartered in Lausanne, Switzerland, with operations in London and New Jersey [2] Clinical Trial Highlights - The LOTIS-7 trial is designed to evaluate the safety and efficacy of ZYNLONTA in combination with various agents, including glofitamab, in patients with B-cell non-Hodgkin lymphoma [1] - As of November 17, 2025, 49 patients were efficacy-evaluable, with a minimum of 6 months follow-up [1] - The trial aims to complete enrollment of approximately 100 patients by the first half of 2026, with full data expected to be shared at a medical meeting and submitted for publication by the end of 2026 [1] Efficacy Data - The best overall response rate (ORR) was 89.8%, with 44 out of 49 patients responding [1] - The complete response (CR) rate was 77.6%, with 33 of the 38 patients who achieved CR remaining in that state at the data cutoff [1] - In the subgroup of 24 relapsed patients, the ORR was 100% and the CR rate was 91.7% [1] - Among 25 primary refractory patients, the ORR was 80% and the CR rate was 64% [1] Safety Profile - The combination treatment was generally well tolerated, with a manageable safety profile [1] - Grade 3 or higher treatment-emergent adverse events (TEAEs) included neutropenia (32.7%), GGT increased (16.3%), and anemia (10.2%) [1] - Cytokine release syndrome (CRS) occurred in 36.7% of patients, with varying severity across dose levels [1] Future Plans - The company plans to assess regulatory and compendia strategies for ZYNLONTA and its combinations [1] - ADC Therapeutics is also advancing a next-generation PSMA-targeting ADC, leveraging its expertise in ADC development [2]
ADC Therapeutics Announces Updated Data from LOTIS-7 Clinical Trial Presented at the European Hematology Association 2025 Congress
Prnewswire· 2025-06-12 10:30
Core Insights - ADC Therapeutics announced promising results from the LOTIS-7 Phase 1b trial, showing a 93.3% overall response rate (ORR) and an 86.7% complete response (CR) rate in patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) treated with ZYNLONTA® and glofitamab [1][3][4] Efficacy Data - Among 30 efficacy evaluable patients, 28 achieved an overall response, with 26 achieving complete responses [3] - 25 out of 26 patients who achieved CR remained in CR at the data cut-off [1][3] - Median time to CR was 80 days for the 120 µg/kg dose and 42 days for the 150 µg/kg dose [3] - 12 patients converted from stable disease or partial response to CR over time [3] - Of 6 patients previously treated with CAR-T, 5 achieved CR [3] Safety Profile - The combination treatment was generally well tolerated, with no dose-limiting toxicities (DLTs) reported [3] - Among 41 safety evaluable patients, the most common grade 3 or higher treatment-emergent adverse events (TEAEs) included neutropenia (24.4%), anemia (9.8%), and increased liver enzymes [3] - Cytokine release syndrome (CRS) was observed in 23.8% of patients at the 150 µg/kg dose, all Grade 1, while 55% experienced CRS at the 120 µg/kg dose [3] Study Expansion - The company is expanding enrollment for the LOTIS-7 trial to 100 patients at the 150 µg/kg dose of ZYNLONTA [1][4] - The updated data will be presented at the European Hematology Association 2025 Congress and the 18th International Conference on Malignant Lymphoma [4] About ZYNLONTA - ZYNLONTA is a CD19-directed antibody drug conjugate (ADC) approved for treating adult patients with r/r large B-cell lymphoma after two or more lines of systemic therapy [9][13] - The drug works by binding to CD19-expressing cells and delivering a potent payload that leads to tumor cell death [8]
ADC Therapeutics Announces Presentation of LOTIS-7 Clinical Trial Data at the European Hematology Association 2025 Congress (EHA2025) and the 18th International Conference on Malignant Lymphoma (ICML)
Prnewswire· 2025-05-14 11:45
Core Insights - ADC Therapeutics announced promising results from the LOTIS-7 Phase 1b clinical trial, showing an overall response rate (ORR) of 95.5% and a complete response (CR) rate of 90.9% among 22 evaluable patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) [1][4] - The combination of ZYNLONTA and glofitamab demonstrated a manageable safety profile, with adverse events consistent with known profiles of the individual agents [2][4] - Updated data will be presented at the European Hematology Association 2025 Congress (EHA2025) and the International Conference on Malignant Lymphoma (ICML) [1][5] Efficacy and Safety Data - In the efficacy evaluable population, the ORR was 95.5% (21 out of 22 patients), and the CR rate was 90.9% (20 out of 22 patients) [4] - Among 31 patients treated, the most common Grade ≥3 treatment-emergent adverse event (TEAE) was neutropenia at 32.3% [4] - Other notable Grade 3/4 TEAEs included generalized edema, pericardial effusion, photosensitivity reaction, rash, sepsis, and pneumonia, each at 3.2% [4] Presentation Details - The LOTIS-7 data will be presented in a poster session at EHA2025 on June 14, 2025, with the presenting author being Juan Pablo Alderuccio, MD [3][5] - An oral encore presentation will take place at ICML on June 20, 2025, also featuring Juan Pablo Alderuccio as the presenting author [5] Study Overview - LOTIS-7 is a Phase 1b global multicenter study evaluating ZYNLONTA in combination with various agents, including glofitamab, in patients with relapsed or refractory B-cell non-Hodgkin lymphoma [6] - The study includes a dose escalation phase and a dose expansion phase, with primary endpoints focusing on safety and tolerability [6] About ZYNLONTA - ZYNLONTA is a CD19-directed antibody drug conjugate (ADC) approved for treating adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy [9][12] - The drug works by binding to CD19-expressing cells and delivering a potent payload that leads to tumor cell death [8]