ADC Therapeutics SA (NYSE:ADCT) stock is trading lower on Thursday after the company indicated that LOTIS-5 showed elevated serious and Grade 5 adverse events, and it will discuss the benefit-risk profile with the FDA.

LOTIS-5 Meets Primary Endpoint

ADC Therapeutics shared topline results from its Phase 3 LOTIS-5 confirmatory study, with ZYNLONTA in combination with rituximab meeting the trial’s primary endpoint of progression-free survival in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

The combination also showed no detrimental impact on overall survival while delivering higher complete response rates and longer durations of complete response compared with the control regimen.

Patients treated with ZYNLONTA plus rituximab recorded a median progression-free survival of 6.1 months, compared with 4.7 months for those receiving R-GemOx.