Phase III trials of IBI 301 meet primary endpoints in non-Hodgkin lymphoma

Innovent Biologics and Eli Lilly announced that IBI 301, a recombinant human-mouse chimeric anti-cell surface protein (anti-CD20) monoclonal antibody being co-developed as a potential biosimilar to rituximab, which is sold under the brand name MabThera/Rituxan has met pre-defined primary endpoints in two randomized clinical trials comparing IBI301 to rituximab, namely: a phase III clinical trial (CIBI301A301) in patients with diffuse large B-cell lymphoma (DLBCL) and a pharmacokinetic (PK) study (CIBI301A201) in patients with CD20-positive B-cell lymphoma. The details of these studies will be disclosed in future publications in scientific journals and conferences.

CIBI301A201 is a randomized, double-blinded, parallel, positive-controlled single-dose clinical trial in China with an enrollment of 181 patients which compares the PK profile, safety, tolerability, and immunogenicity of IBI301 with those of rituximab in patients with CD20-positive B-cell lymphoma. The primary objective of the study is to compare the PK profile of these two agents.

CIBI301A301 is a multi-center, randomized, double-blinded, parallel, positive-controlled phase III clinical trial in China with an enrollment of 420 patients which evaluates the efficacy and safety of IBI301 and rituximab in the first-line treatment of patients with newly diagnosed DLBCL. The objective of the study is to compare the clinical activity and safety between IBI301 and rituximab when each is used in combination with standard chemotherapy (CHOP) in patients with diffuse DLBCL. The primary endpoint is objective response rate (ORR).