Sandoz announced data from the ASSIST-FL trial which shows GP 2013 met its primary endpoint of overall response rate (ORR), demonstrating equivalence with the reference product, MabThera/Rituxan.

Sandoz, has announced data from the ASSIST-FL trial. The confirmatory safety and efficacy study shows GP 2013 met its primary endpoint of overall response rate (ORR), demonstrating equivalence with the reference product, MabThera/Rituxan, in 629 patients. Results were presented at the 58th Annual Meeting of the American Society of Hematology (ASH). The combination treatment phase of the ASSIST-FL study - the first of a three-phase protocol - confirms that, for patients with previously untreated advanced follicular lymphoma, the ORR of GP 2013 (87.1%) and the reference product (87.5%) were equivalent. Consistent with clinical practice, patients received cyclophosphamide, vincristine and prednisone (CVP) in addition to reference product or GP 2013. The final results of the ASSIST-FL study are expected in 2018 after study completion.

The data demonstrated equivalent safety between Sandoz GP 2013 and the reference product, with adverse events being consistent with those observed in previous clinical trials. Pharmacokinetics (PK) and pharmacodynamics (PD) were also found to be equivalent. Secondary endpoints of median progression-free survival and overall survival are not yet reported as the study is still blinded and data are evolving.

The study is a prospective, multi-center, randomized, double-blind, active-controlled, parallel-group, confirmatory Phase III trial comparing the efficacy, safety, PK and PD of GP 2013 plus CVP versus MabThera/Rituxan plus CVP. 629 patients were recruited across 159 centers in 26 countries, all with previously untreated advanced stage follicular lymphoma. The study is comprised of a combination treatment phase (six months), a maintenance phase (two years), and follow-up until three years after randomization. Having completed the combination phase, Sandoz is now reporting these data with results from the maintenance phase of the study expected in 2018.

Comment: In May 2013 Sandoz announced that the EMA has accepted its MAA for rituximab biosimilar to Roche's EU-licensed MabThera (rituximab).The Rituximab patent expired on 22 September 2016 in the US and in the EU the patents expired on 12 November 2013.