Efficacy and Safety of ABP 798: Results from the JASMINE Trial in Patients with Follicular Lymphoma in Comparison with Rituximab Reference Product
Jazyk angličtina Země Francie Médium print
Typ dokumentu časopisecké články, randomizované kontrolované studie, práce podpořená grantem
PubMed
33044684
PubMed Central
PMC7568694
DOI
10.1007/s11523-020-00748-4
PII: 10.1007/s11523-020-00748-4
Knihovny.cz E-zdroje
- MeSH
- dvojitá slepá metoda MeSH
- folikulární lymfom farmakoterapie MeSH
- lidé středního věku MeSH
- lidé MeSH
- protinádorové látky imunologicky aktivní farmakologie terapeutické užití MeSH
- rituximab farmakologie terapeutické užití MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- Názvy látek
- protinádorové látky imunologicky aktivní MeSH
- rituximab MeSH
INTRODUCTION: ABP 798 is being developed as a biosimilar to rituximab reference product (RP), a CD20-directed cytolytic antibody that is approved in the US and EU for the treatment of non-Hodgkin lymphoma (NHL). METHODS: This randomized, double-blind, comparative clinical study (JASMINE) evaluated the efficacy and safety of ABP 798 compared with rituximab RP. Adult, anti-CD20 treatment naïve patients diagnosed with grade 1, 2, or 3a follicular B-cell NHL expressing CD20 were randomized 1:1 to receive a 375 mg/m2 infusion of either ABP 798 or rituximab RP once weekly for 4 weeks and at weeks 12 and 20. Tumor assessments were performed at baseline and weeks 12 and 28. Primary endpoint was the risk difference (RD) of overall response rate (ORR) of complete response, unconfirmed complete response, or partial response by week 28 based on data from central, independent, and blinded assessments of disease. RESULTS: Of the 256 randomized patients, 254 were treated with ABP 798 (n = 128; 100%) or rituximab RP (n = 126; 98.4%); 96 (78.0%) patients in the ABP 798 group and 87 (70.2%) in the rituximab RP group had a best ORR by week 28. The point estimate of RD in ORR between ABP 798 and rituximab RP from the adjusted generalized linear model for stratification factors was 7.7%. Clinical equivalence was based on sequential testing of the one-sided 95% lower confidence limits and one-sided 95% upper confidence limits of RD in ORR (- 1.4% and 16.8%, respectively) which was within the prespecified non-inferiority margin (- 15%) and non-superiority margin (35.5%), respectively. Results of sensitivity analyses were consistent with the primary efficacy analysis. ABP 798 was also comparable to rituximab RP across additional secondary endpoints, further supporting the conclusion of similarity, and including: RD of ORR at week 12; trough serum concentrations; percent of patients with complete depletion of CD19+ cell count at day 8; safety; and immunogenicity. CONCLUSIONS: These results support a conclusion of similar clinical efficacy between ABP 798 and rituximab RP in patients with follicular lymphoma. NCT NUMBER: NCT02747043; first posted April 21, 2016. EUDRACT NUMBER: 2013-005,542-11; submitted 14 October, 2014.
Amgen Inc Thousand Oaks CA USA
Division of Hematology and Oncology University of Leipzig Liebigstr 19 04106 Leipzig Germany
Gosford Hospital Gosford NSW Australia
Hematology Department ASST Spedali Civili Brescia Brescia Italy
Lithuanian University of Health Sciences Kaunas Lithuania
Oncology Hematology and Cell Therapy Centre Hospitalier Universitaire de Poitiers Poitiers France
School of Medicine Aichi Medical University Nagakute Aichi Nagoya Japan
Schulich School of Medicine Western University Windsor ON Canada
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NCT02747043
