The results of our prospective study have revealed great diversity in the treatment regimens used to manage MM in real-life practice. This diversity was linked to factors such as novel agent accessibility and evolving treatment recommendations. Our results provide insight into associated clinical benefits.
& on behalf of the RTXM83 study (2019) Rituximab biosimilar RTXM83 versus reference rituximab in combination with CHOP as first-line treatment for diffuse large B-cell lymphoma: a randomized, double-blind study,
BCD-020 (Acellbia, rituximab biosimilar candidate) was shown to be highly similar to innovator rituximab (MabThera®/Rituxan®) in terms of its quality characteristics, in vitro biological activity, as well as toxicology and PK/PD characteristics in non-human primates. International multicenter comparative randomized open-label clinical study was carried out in a period from 2011 to 2013 and involved over 30 centers in Russia, Ukraine and India. Its methodology and design complies with current EMA guidelines on similar biological products containing monoclonal antibodies (EMA/CHMP/BMWP/403543/2010). 92 patients with follicular non-Hodgkin’s lymphoma, stage I-IV by Ann Arbor, or marginal zone lymphoma, stage I-IV by Ann Arbor, ECOG 0-2, who had at least 1 measurable lesion were enrolled. According to study protocol patients with secondary transformed B-cell lymphomas or with highly aggressive types of tumor, bulky disease, severe concomitant somatic disorders and some other conditions were excluded. If a patient had previous story of chemotherapy or radiation he could be included after at least 3 weeks post-treatment. Participation of patients who were previously treated with any kind of monoclonal antibodies was prohibited. After signing standard informed consent form and completion of 28-days screening period eligible patients underwent stratification in accordance to their prognostic risk (FLIPI or IPI) and previous treatment (naïve or pretreated). Subsequently patients were randomized (1:1) into 2 groups: 46 patients were included in the main group where Acellbia (rituximab biosimilar) was administered at a dose of 375 mg/m2 as a slow IV infusion on day 1, 8, 15 and 22; 46 patients were included in the reference group where MabThera was used at the same regimen. Use of any other medicines for the treatment of lymphoma was strictly prohibited. Efficacy was assessed on the basis of computed tomography and bone marrow evaluation which were performed 1 month after the completion of treatment. Median age of patients in each group was 57.5 years (main group [50.0-64.0], reference group [47.0-65.0]). Manageable comorbidities were reported in 50% of patients in the main group and 34.78% of patients in the reference group, p=0.2053. Comparative analysis of the prognostic risk factors confirmed the equivalence of study groups. The number of pretreated patients in both groups was equal – 8 individuals per group. Statistical analysis didn’t find any difference in overall response rate in general population of patients (39.52% patients in the main group vs. 36.57% patients in the reference group, p=0.8250), as well as in population of pretreated patients (28.6% vs 37.5% respectively, p=1.00) and in population of naïve patients (42.8% vs 39.4% respectively, p=1.00). The lower limit of the two-tailed 95% CI for difference in proportions of ORR was equal to -0.17 and exceeded the predefined non-inferiority margin -0.2, which confirmed non-inferiority of Acellbia to MabThera in terms of efficacy. Treatment-associated AE of any grade were reported in 21.74% patients in both arms, in the absence of statistically or clinically significant difference (p = 0.8005). There were 2 cases of CTCAE 4.03 grade 3-4 AEs in each group. PK and PD parameters were shown to be equivalent in both study groups. Thus, study results suggest that Acellbia has same efficacy and safety in patients with B-cell non-Hodgkin’s lymphoma. Disclosures Chernyaeva: JCS BIOCAD: Employment. Ivanov:JCS BIOCAD: Employment. Isaev:JCS BIOCAD: Employment.
Global phase I/III pharmacokinetic and efficacy study comparing CT-P10, a biosimilar candidate to the rituximab reference product in patients with advanced stage follicular lymphoma (AFL) CT-P10 is a biosimilar candidate to the reference rituximab product, EU-approved MabThera® and US-licensed Rituxan®. CT-P10 has an identical amino acid sequence and highly similar physicochemical and in vitro functional properties to its reference drug. In patients with rheumatoid arthritis (RA), CT-P10 has demonstrated compelling similarity in pharmacokinetics, pharmacodynamics, efficacy, safety and immunogenicity (http://acrannualmeeting.org/abstracts/abstract-archives/,#1736 in 2013 and #1508 in 2014). This study is a randomized, parallel-group, active-controlled, double-blind, phase I/III study designed to demonstrate similarity in pharmacokinetics and non-inferiority in efficacy of CT-P10 to rituximab when co-administered with cyclophosphamide, vincristine, and prednisone (CVP) (NCT02162771). In this international multicenter trial, 134 patients with untreated advanced stage follicular lymphoma (AFL) will be administered CT-P10 or rituximab for 24 weeks at 3 weeks intervals, defined as Core Study Period. Patients who at least achieve a partial response after the Core Study Period will continue treatment with CT-P10 or rituximab as maintenance therapy over 24 months in 2 monthly intervals (Figure 1). The patients ≥18 years, with a histologically confirmed FL of grade 1 to 3a, Ann Arbor Stage III or IV disease, at least 1 measurable tumour mass that has not previously been irradiated, confirmed CD20+ lymphoma, ECOG performance status of 0-2, and adequate bone marrow, hepatic, and renal function reserves are included. The study has been initiated at >110 clinical sites across Europe, Latin America, Asia and Africa. Currently 83 patients were enrolled in this study, and a blinded initial review of initial safety data was carried out by the Data Safety Monitoring Board. As expected from the highly similar profile of CT-P10 accomplished through analytical studies and the CT-P10 RA trial (NCT01534884, NCT01873443), preliminary safety findings in terms of adverse events (AEs), serious AEs, AEs of special interest and survival characteristics with CT-P10 in AFL patients mirror those with the historical data of rituximab reference product. As currently 4 SAEs related to a study drug (CT-P10/Rituximab) were reported and these were resolved without sequelae. Qualitative feedback from study investigators throughout all regions indicates overall positive experience. Taken together, the study provides AFL patients with early access to a biosimilar investigational product assuring improved standards of care and long-term survival outcomes. In conclusion, it is expected that this ongoing study will demonstrate that CT-P10 is well tolerated in AFL patients with a similar safety profile to the rituximab reference product. Figure 1. Study Design Figure 1. Study Design Disclosures Kim: CELLTRION, Inc.: Consultancy, Honoraria. Ogura:CELLTRION, Inc.: Consultancy, Honoraria. Buske:CELLTRION, Inc.: Consultancy, Honoraria. Coiffier:CELLTRION, Inc.: Consultancy, Honoraria. Sancho:CELLTRION, Inc.: Research Funding. Jurczak:CELLTRION, Inc,: Research Funding. Kim:CELLTRION, Inc,: Research Funding. Nagarkar:CELLTRION, Inc,: Research Funding. Zhavrid:CELLTRION, Inc,: Research Funding. Hernandez Rivas:CELLTRION, Inc.: Research Funding. Vinnyk:CELLTRION, Inc.: Research Funding. Tsirigotis:CELLTRION, Inc.: Research Funding. Viero:CELLTRION, Inc.: Research Funding. Volodicheva:CELLTRION, Inc.: Research Funding. Fourie:CELLTRION, Inc.: Research Funding. Soler:CELLTRION, Inc.: Research Funding.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.