ADC Therapeutics Says LOTIS-5 Met Primary Endpoint in Phase 3 ZYNLONTA Trial

ADC Therapeutics said its Phase 3 LOTIS-5 confirmatory trial of ZYNLONTA in combination with rituximab met its primary endpoint in relapsed or refractory diffuse large B-cell lymphoma, or DLBCL.

The company said the study showed a progression-free survival benefit and no detrimental effect on overall survival at the topline stage. It also said the treatment arm had higher complete response rates and longer duration of complete response than the control arm.

Safety profile

The topline data also showed a mixed safety picture. ADC Therapeutics said serious adverse events, treatment withdrawals and grade 5 events were higher in the ZYNLONTA arm.

The company said it plans to discuss the benefit-risk profile with the FDA before filing a supplemental biologics license application.

The announcement follows prior guidance from ADC Therapeutics that LOTIS-5 topline results were expected in the second quarter of 2026. The company said on May 4 that it would pursue an sBLA if the data were positive.

Independent and syndication coverage on June 4 reiterated the efficacy result while highlighting the safety concerns in the readout.