Swiss commercial-stage company focussed on antibody drug conjugates (ADCs) ADC Therapeutics SA (NYSE:ADCT) announced on Monday that it has completed enrolment for LOTIS-5, a Phase 3 trial evaluating ZYNLONTA (loncastuximab tesirine-lpyl) combined with rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL).

ZYNLONTA received FDA accelerated approval in 2021 for r/r DLBCL treatment after two or more systemic therapies. LOTIS-5 is a multicentre, randomized, open-label study aimed at confirming this approval and exploring label expansion to second-line and later (2L+) settings. Part 1, a non-randomized safety run-in, reported an 80% overall response rate and 50% complete response rate without new safety signals.

Part 2 randomizes 2L+ DLBCL patients to receive ZYNLONTA-rituximab or rituximab-gemcitabine-oxaliplatin (R-GemOx). Progression-free survival is the primary endpoint, with additional measures including overall survival, response rates, and adverse event profiles. Topline results are expected by late 2025, with FDA submission in Q1 2026 and potential approval by late 2026.