ADC Therapeutics announces completion of enrollment of Phase 3 confirmatory clinical trial of ZYNLONTA® in combination with rituximab in 2L+ DLBCL

CAR-T Digest - August 2020

Weekly Digest - January 2025

30 Dec 2024: ADC Therapeutics announces completion of enrollment of Phase 3 confirmatory clinical trial of ZYNLONTA® in combination with rituximab in 2L+ DLBCL

ADC Therapeutics has completed enrollment in the Phase 3 LOTIS-5 trial, which is evaluating the combination of ZYNLONTA® (Loncastuximab tesirine-lpyl) and rituximab (Lonca-R) in patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL)
ZYNLONTA received accelerated approval from the FDA in 2021 for treating r/r DLBCL after two or more lines of systemic therapy. The LOTIS-5 trial is designed to confirm this approval and may support label expansion for 2L+ DLBCL in combination with rituximab
The randomized, open‐label, two‐part, two‐arm, multicenter study is designed to confirm accelerated approval and may support potential label expansion into 2L+ in combination with rituximab. Twenty patients were enrolled in part 1 of a non-randomized safety run‐in. As previously reported, the results showed an ORR of 80% with a CR rate of 50% and no new safety signals
ADC Therapeutics expects to share topline results from the primary endpoint analysis by the end of 2025 and potentially submit a supplemental Biologics License Application (BLA) to the FDA in Q1 2026, with possible approval by late 2026