ADC Therapeutics Releases Phase 3 Data for Zynlonta
ADC Therapeutics announced topline data from its Phase 3 LOTIS-5 confirmatory trial evaluating Zynlonta - loncastuximab tesirine-lpyl - in combination with rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma, or r/r DLBCL. Zynlonta plus rituximab achieved statistical significance on the trial's primary endpoint of progression-free survival and demonstrated no detrimental effect on the key secondary efficacy endpoint of overall survival. In addition, a higher complete response rate and duration of CRs were observed with Zynlonta plus rituximab. Overall, treatment emergent adverse event, or TEAE, rates were similar between arms, with hematologic TEAEs higher in the control arm and infection, hepatotoxicity, and edema/effusion higher in the test arm. Serious adverse events, TEAEs leading to study drug withdrawal, and Grade 5 events were higher in the test arm, with the majority of Grade 5 TEAEs in the test arm occurring in patients aged 75 years or older. ADC plans to discuss the benefit-risk profile of this combination with the FDA as it prepares for the planned supplemental Biologics License Application filing. ADBC intend to conduct a pre-sBLA meeting in August and is preparing for a planned sBLA submission in Q4. In addition, the company will continue to evaluate a broad range of value maximizing alternatives, including but not limited to near-term cost reduction initiatives.
