Innovent and Eli Lilly's Rituximab Biosimilar Meets Primary End Points in PK and Phase 3 Studies

China-based biosimilar developer Innovent and Eli Lilly and Company announced this week that 2 studies of IBI301, a proposed rituximab biosimilar being jointly developed by the 2 drug makers, met their primary end points.

The first study, a randomized, double-blind, parallel, positive-controlled, single-dose study, assessed the pharmacokinetics (PK), safety, tolerability, and immunogenicity of the biosimilar versus the reference drug in 181 patients with CD20-positive B-cell lymphoma. Innovent and Lilly say that the PK study met its primary end point, area under the concentration—time curve from time zero to infinity, of the biosimilar versus the reference over a time frame of 91 days.

The second study was a multicenter, randomized, double-blind, parallel, positive-controlled phase 3 trial that enrolled 420 patients with diffuse large B-cell lymphoma who received either the biosimilar or the reference drug in combination with standard chemotherapy for 6 cycles as first-line treatment for newly diagnosed disease. The drug makers indicated that the trial met its primary end point of overall response rate over a time frame of 18 weeks.

“Malignant lymphoma is one of the top 10 malignancies in China, and incidences thereof are still rising and

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a heavy economic burden for the vast majority of patients. Anti-CD20 monoclonal antibodies are effective treatments for lymphoma. However, currently there is only 1 approved biosimilar in China,” said Michael Yu, founder, chairman, and chief executive officer of Innovent, in a statement announcing the topline results. “The results of clinical studies of IBI301, a potential biosimilar of rituximab, are encouraging. We hope that the launch of IBI301 in the China market will improve its affordability, so more patients with lymphoma can benefit from the drug,” he added.

Wang Li, senior vice president of Lilly China and head of Lilly China drug development and medical affairs, added, “The results of these studies have significant clinical value and show the outstanding research and development capabilities of Innovent. We hope that IBI301 can be approved soon in order to offer an affordable treatment option for lymphoma patients in China.”

These positive results are the latest in a line of biosimilar news for Innovent; the company in late 2018 applied for Chinese regulatory approval of its proposed adalimumab biosimilar, which was studied in a phase 3 clinical trial in patients with ankylosing spondylitis. Also in 2018, the company filed for Chinese approval of its proposed bevacizumab biosimilar, which was studied in patients with advanced nonsquamous non—small-cell lung cancer.