Table 3.
Rituximab Biosimilars at the Late Stages of Clinical Development for DLBCL and FL
| Agent/Company | Indication | Development Stage/Comparison | Comparison | Outcomes |
|---|---|---|---|---|
| CMAB304 (Retuxira)/Shanghai CP Guojian Pharmaceutical, Shanghai, China | DLBCL | Randomized, open-label phase III (NCT01459887) | CHOP + CMAB304 vs CHOP followed by CMAB304 | Status: Completed PCD: December 2010 Primary end point: ORR Secondary end point: EFS No results have been reported. |
| RTXM83/mAbxience SA, Madrid, Spain | First-line DLBCL | Randomized, double-blind phase III (NCT02268045) | RTXM83 + CHOP vs rituximab + CHOP | Status: recruiting patients Estimated PCD: May 2016 Primary end point: RR Secondary end points: EFS, safety, PK, PD, immunogenicity |
| MabionCD20/MABION SA, Kutno, Poland | DLBCL | Randomized, double-blind phase III (EudraCT2013-005506-56) | MabionCD20 vs rituximab | Status: ongoing Estimated trial duration: 1 year 6 mo Primary end point: PK Secondary end point: PK Objective: demonstrate high level of biosimilarity |
| PF-05280586/Pfizer Inc, New York, NY | First-line FL | Randomized, double-blind phase III (NCT02213263; EudraCT2014-000132-41) | PF-05280586 vs rituximab | Status: recruiting patients Estimated PCD: November 2016 Primary end point: ORR Secondary end points: TTF, PFS, complete remission rate, OS, duration of response, Cmax, Cmin, safety, ADA |
| CT-10/CeNtrion Inc, Incheon, South Korea | First-line FL | Randomized, double-blind phase I/III (NCT02162771; EudraCT2013-004493-96) | CT-10 + CVP vs rituximab + CVP | Status: recruiting patients Estimated PCD: February 2017 Primary end point: PK (AUCtau, Cmaxss) Secondary end point: ORR |
| GP2013/HEXAL AG, Holzkirchen, Germany | First-line FL | Randomized, double-blind phase III (NCT01419665; EudraCT2010-019522-13) | GP2013 vs rituximab | Status: active, not recruiting Estimated PCD: December 2017 Primary end point: ORR Secondary end point: % of patients with AEs |
| MK-8808/Merck Sharp & Dohme, Kenilworth, NJ | CD20+ FL | Open-label, single arm phase I (NCT01370694) | MK-8808 + CVP, followed by MK-8808 maintenance | Status: completed PCD: December 2014 Primary end point: AE Secondary end points: PK, clinical response |
| BI695500/Boehringer Ingelheim, Ingelheim, Germany | First-line FL | Randomized, double-blind phase I (NCT01950273) | BI695500 vs rituximab | Status: recruiting patients Estimated PCD: December 2015 Primary end point: AUC Secondary end points: AE, PK, PD (CD19+ B-cells), tumor response |
| ABP 798/Amgen Inc, Thousand Oaks, CA | CD20+ B-cell NHL | Randomized, double-blind phase I/III (EudraCT2013-005542-11) | ABP 798 vs rituximab | Status: ongoing Estimated trial duration: 2 year, 4 mo Primary end point: ORR risk difference Secondary end points: safety, PK, PD, ADA, PFS, OS |
Abbreviations: ADA = anti-drug antibodies; AE = adverse event; AUC = area under the concentrationetime curve; AUCtau = area under the concentrationetime curve at steady-state; CHOP = cyclophosphamide, doxorubicin, vincristine, and prednisone; Cmax = maximum observed concentration; Cmaxss = maximum concentration at steady-state; Cmin = minimum observed concentration; CVP = cyclophosphamide, vincristine, and prednisone; DLBCL = diffuse large B-cell lymphoma; EFS = event-free survival; FL = follicular lymphoma; NHL = NoneHodgkin lymphoma; ORR = overall or objective response rate; OS = overall survival; PCD = primary completion date; PD = pharmacodynamics; PFS = progression-free survival; PK = pharmacokinetics; RR = response rate; TTF = time to treatment failure.