Overland ADCT BioPharma, a joint venture between China’s Overland Pharmaceuticals and Switzerland’s ADC Therapeutics SA (NYSE: ADCT), announced the initiation and first patient dosing of the global Phase III LOTIS-5 trial for Zynlonta (loncastuximab tesirine), an anti-CD19 antibody-drug conjugate (ADC). The study will evaluate Zynlonta in combination with rituximab as a second-line or later treatment for diffuse large B-cell lymphoma (DLBCL) patients ineligible for transplantation.
Trial Details
The LOTIS-5 trial will compare Zynlonta plus rituximab against standard immunochemotherapy in patients with relapsed or refractory DLBCL. The study aims to support regulatory filings for second-line treatment in this underserved patient population. DLBCL, an aggressive non-Hodgkin’s lymphoma, affects over half of Chinese patients who are ineligible for hematopoietic stem-cell transplantation.
Drug Profile
Zynlonta, a first-in-class ADC, combines a humanized anti-CD19 antibody with a pyrrolobenzodiazepine (PBD) dimer cytotoxin. The drug was approved in the US in April 2021 for third-line or later treatment of relapsed/refractory DLBCL. The Overland ADCT JV, established in December 2020, holds rights to develop and commercialize Zynlonta and three other ADCs in Greater China and Singapore.
Pipeline Expansion
Beyond DLBCL, Zynlonta is being developed for mantle cell lymphoma and follicular lymphoma. The JV’s pipeline includes ADCT-601 (AXL-targeted), ADCT-602 (anti-CD22), and ADCT-901 (KAAG1-targeted) ADCs.-Fineline Info & Tech
