Joint venture Overland ADCT BioPharma (CY) Ltd, a partnership between China’s Overland Pharmaceuticals and Swiss firm ADC Therapeutics SA (NYSE: ADCT), announced that the primary endpoint has been reached in a Phase II regulatory study. The study assessed the efficacy and safety of Zynlonta (loncastuximab tesirine), an antibody-drug conjugate (ADC) targeting CD19, for the treatment of recurrent/refractory diffuse large B-cell lymphoma (R/R DLBCL). The results are in line with those of the global pivotal ADCT-402-201 study and will support a market approval filing for the drug in China.
Zynlonta’s Ongoing Phase III Study and Potential for NMPA Approval
Zynlonta is also the subject of the confirmatory Phase III ADCT-402-311 study in R/R DLBCL in China. This study is a global Phase III trial assessing the efficacy and safety of the drug in combination with rituximab compared to rituximab combined with chemotherapy. If Zynlonta obtains conditional approval from the National Medical Products Administration (NMPA), the study will provide scientific evidence for full approval in the R/R DLBCL indication. The first indication for the drug in China is anticipated to be in the second-line setting for R/R DLBCL as a combination therapy.
Global Recognition of Loncastuximab Tesirine
Loncastuximab tesirine was granted fast-track designation in the US in April 2021 for use in adults with r/r DLBCL who have received at least two lines of systemic therapy. It remains the first and only CD19-targeted ADC globally. A conditional approval was also awarded in the European Union in December 2022, highlighting the drug’s potential impact on the treatment landscape for R/R DLBCL patients worldwide.-Fineline Info & Tech
