Lymphoma Biosimilar Potentially Equivalent to Reference Product

Recent interim findings suggest that the biosimilar GP2013 is equivalent in safety and efficacy to its reference product, MabThera (ritixumab).

Results from an interim analysis of the phase 3 ASSIST-FL clinical trial were presented at the 58^th Annual Meeting of the American Society of Hematology, Sandoz reported in a press release.

The ASSIST-FL clinical study included 629 patients from 26 different countries. The trial consists of a 6-month long combination treatment phase, a 2-year maintenance phase, and a 3-year follow-up after randomization.

Since the combination treatment phase has been completed, Sandoz recently analyzed and presented the data.

In the combination treatment phase of the clinical trial, patients received treatment with cyclophosphamide, vincristine, and prednisone, in addition to GP2013 or the reference product.

Investigators found that the overall response rate for treatment-naïve patients with advanced follicular lymphoma was 87.1% in patients taking GP2013, and 87.5% in patients taking the reference product. These findings demonstrate the equivalency of the 2 drugs, according to Sandoz.

Additionally, adverse events seen with both the biosimilar and the reference product were consistent, as well as pharmacokinetic and pharmacodynamics. These findings suggest that GP2013 could potentially be used as an alternative to the reference product.

Secondary endpoints, including progression-free survival and overall survival, have yet to be reported due to the ongoing status of the trial. Additional results will be announced in 2018 after the study is completed, Sandoz reported.

GP2013 is being investigated in a global development program, which includes ASSIST-FL and other studies, to evaluate the drug in patients with rheumatoid arthritis (ASSIST-RA), and the impact of switching from the reference product to the biosimilar (ASSIST-RT).

The development program also includes analytical level evaluation and 5 pre-clinical studies to determine the full profile of the biosimilar.

Sandoz is committed to improving patient access to treatment through the creation of biosimilars, according to the press release. Currently, Sandoz is marketing 3 biosimilars around the world, and plans to launch 5 oncology and immunology biosimilars by 2020, they reported.

"Sandoz recognizes the access challenges that healthcare systems are facing, particularly in long-term cancer care," said Mark Levick, global head of Development, Sandoz Biopharmaceuticals. "If approved, our medicine will offer a high-quality biologic treatment option that could free up resources. Not only would this allow for greater investment in new, innovative treatments, it could also provide more patients with blood cancers, like follicular lymphoma, access to potentially life-saving medicine."