Two biosimilars, CT-P10 and GP2013, offer comparable safety to rituximab for patients with previously untreated, advanced follicular lymphoma, according to 2 phase 3 clinical trials published in The Lancet Haematology.1,2
“I believe the potential of rituximab [biosimilars] to lower overall treatment costs will lessen the burden of financial toxicity for both patients and their families faced with a lymphoma diagnosis,” said Kristin Hennenfent, PharmD, MBA, BCOP, BCPS, associate director at Xcenda-AmerisourceBergen, a consultancy based in Philadelphia, Pennsylvania.
CT-P10 exhibited “non-inferior efficacy and pharmacokinetic equivalence” to rituximab, reported authors of a randomized, double-blind phase 3 clinical trial.1 The findings bolster previous phase 3 trial data among patients with rheumatoid arthritis, which found that CT-P10 is biosimilar to rituximab.
“Furthermore,” the authors wrote, “CT-P10 was well tolerated and the safety and immunogenicity profiles of CT-P10 were similar to that of rituximab.”
Overall response rates were 97% (64/66) among patients receiving CT-P10 and 93% (63/68) among patients receiving rituximab, they reported.
The randomized ASSIST_FL (ClinicalTrials.gov Identifier: NCT01419665) study offered similar evidence for comparable safety between GP2013 and rituximab among 629 patients with newly diagnosed advanced follicular lymphoma.2 At a median follow-up of 11.6 months, overall response equivalency between GP2013 and rituximab was achieved (87% vs 88%, respectively), with comparable safety, tolerability, pharmacokinetics, and immunogenicity.
The findings are one reason why it is “an extremely exciting time” for the burgeoning oncology biosimilars market, said Dave Picard, MBA, senior vice president of global generic pharmaceuticals at AmerisourceBergen.
Rituximab is a chimeric anti-CD20 monoclonal antibody; its US patent market-exclusivity period ended in 2016.3 Each study compared rituximab and the biosimilar with cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.1,2
In the CT-P10 trial, patients were randomly assigned 1:1 to receive CVP plus 375 mg/m2 infusions of CT-P10 or rituximab every 21 days for 8 cycles. In ASSIST-FL, patients were similarly assigned to receive 8 cycles of CVP plus rituximab or GP2013 (the combination phase) followed by 2 years of single-agent (GP2013 or rituximab, as originally assigned) maintenance therapy for 2 years.