Feng Roger Luo: Primary results from a Phase 2 clinical trial evaluating ZYNLONTA® in Chinese patients with relapsed or refractory DLBCL

Feng Roger Luo, Chief Development Officer, Head of Clinical and Preclinical Development at Overland Pharmaceuticals, made the following post on LinkedIn:

“Overland Pharmaceutics announced primary results from a Phase 2 clinical trial (NCT03589469) evaluating Lonca (loncastuximab tesirine-lpyl) monotherapy demonstrated a substantial single-agent efficacy and manageable safety profile in Chinese patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL). The data from the multi-institution bridging pivotal study were reported during a poster presentation on 11th Dec at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition by the investigator from China.

This is the first study evaluating ZYNLONTA® in Chinese patients with relapsed or refractory DLBCL, the overall response rate was 51.6% and complete response rate was 23.4%, similar activity was also observed in several high-risk subgroups including patients who are refractory to all prior lines of therapies, failed against CD-19 CAR-T therapies and primary refractory patients. The results were consistent with the ones generated from LOTIS-2, the global Phase 2 pivotal trial of Lonca monotherapy, which demonstrated Lonca’s the meaningful clinical efficacy and manageable safety profiles in both Chinese as well as Caucasian patients with R/R DLBCL.
Based on the primary results of trial, Overland Pharmaceutics has submitted the BLA filling of Lonca in June 2023 with the priority review status granted by China health authority. The review process is expected to be finished in the middle of 2024. Congratulations to o the entire study team for their strong commitment and outstanding accomplishment”

Source: Feng Roger Luo/LinkedIn