ADC Therapeutics nosedives on 27 deaths in confirmatory trial for lymphoma drug
BioSpace • • business
Key Points:
- ADC Therapeutics reported three times as many deaths in patients treated with its lymphoma drug Zynlonta compared to those receiving standard immunotherapy, causing the company's share price to drop over 50% to $1.44.
- The Phase 3 LOTIS-5 trial enrolled 440 patients with diffuse large B cell lymphoma (DLBCL) and showed 27 deaths in the Zynlonta arm versus 9 in the control group, with most deaths occurring in patients aged 75 and older.
- While the trial met its primary endpoint by demonstrating a 27% reduction in risk of death or disease progression (progression-free survival), there was no overall survival benefit observed with Zynlonta treatment.
- ADC Therapeutics noted that the increased deaths were treatment-emergent adverse events and highlighted longer observation time in the experimental arm, but did not confirm a direct causal link to Zynlonta.
- The company plans to discuss the LOTIS-5 data with the FDA and aims to submit a supplemental application for full approval of Zynlonta plus rituximab in the fourth quarter.