prikaz prve stranice dokumenta A Randomized, Double-Blind, Efficacy and Safety Study of PF-05280586 (a Rituximab Biosimilar) Compared with Rituximab Reference Product (MabThera®) in Subjects with Previously Untreated CD20-Positive, Low-Tumor-Burden Follicular Lymphoma (LTB-FL)
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A Randomized, Double-Blind, Efficacy and Safety Study of PF-05280586 (a Rituximab Biosimilar) Compared with Rituximab Reference Product (MabThera®) in Subjects with Previously Untreated CD20-Positive, Low-Tumor-Burden Follicular Lymphoma (LTB-FL)
BioDrugs, 34 (2020), 2; 171-181. https://doi.org/10.1007/s40259-019-00398-7
Sharman, Jeff P.; Liberati, Anna Marina; Ishizawa, Kenichi; Khan, Tahira; Robbins, Jeffery; Alcasid, Ann; Rosenberg, Julie Ann; Aurer, Igor

Citirajte ovaj rad

Sharman, J. P., Liberati, A. M., Ishizawa, K., Khan, T., Robbins, J., Alcasid, A. ... Aurer, I. (2020). A Randomized, Double-Blind, Efficacy and Safety Study of PF-05280586 (a Rituximab Biosimilar) Compared with Rituximab Reference Product (MabThera®) in Subjects with Previously Untreated CD20-Positive, Low-Tumor-Burden Follicular Lymphoma (LTB-FL). BioDrugs, 34. (2), 171-181. doi: 10.1007/s40259-019-00398-7

Sharman, Jeff P., et al. "A Randomized, Double-Blind, Efficacy and Safety Study of PF-05280586 (a Rituximab Biosimilar) Compared with Rituximab Reference Product (MabThera®) in Subjects with Previously Untreated CD20-Positive, Low-Tumor-Burden Follicular Lymphoma (LTB-FL)." BioDrugs, vol. 34, br. 2, 2020, str. 171-181. https://doi.org/10.1007/s40259-019-00398-7

Sharman, Jeff P., Anna Marina Liberati, Kenichi Ishizawa, Tahira Khan, Jeffery Robbins, Ann Alcasid, Julie Ann Rosenberg i Igor Aurer. "A Randomized, Double-Blind, Efficacy and Safety Study of PF-05280586 (a Rituximab Biosimilar) Compared with Rituximab Reference Product (MabThera®) in Subjects with Previously Untreated CD20-Positive, Low-Tumor-Burden Follicular Lymphoma (LTB-FL)." BioDrugs 34, br. 2 (2020): 171-181. https://doi.org/10.1007/s40259-019-00398-7

Sharman, J. P., et al. (2020) 'A Randomized, Double-Blind, Efficacy and Safety Study of PF-05280586 (a Rituximab Biosimilar) Compared with Rituximab Reference Product (MabThera®) in Subjects with Previously Untreated CD20-Positive, Low-Tumor-Burden Follicular Lymphoma (LTB-FL)', BioDrugs, 34(2), str. 171-181. doi: 10.1007/s40259-019-00398-7

Sharman JP, Liberati AM, Ishizawa K, Khan T, Robbins J, Alcasid A, i sur.. A Randomized, Double-Blind, Efficacy and Safety Study of PF-05280586 (a Rituximab Biosimilar) Compared with Rituximab Reference Product (MabThera®) in Subjects with Previously Untreated CD20-Positive, Low-Tumor-Burden Follicular Lymphoma (LTB-FL). BioDrugs [Internet]. 04.2020. [pristupljeno 22.12.2024.];34(2):171-181. doi: 10.1007/s40259-019-00398-7

J. P. Sharman, et al., "A Randomized, Double-Blind, Efficacy and Safety Study of PF-05280586 (a Rituximab Biosimilar) Compared with Rituximab Reference Product (MabThera®) in Subjects with Previously Untreated CD20-Positive, Low-Tumor-Burden Follicular Lymphoma (LTB-FL)", BioDrugs, vol. 34, br. 2, str. 171-181, Travanj 2020. [Online]. Dostupno na: https://urn.nsk.hr/urn:nbn:hr:105:921728. [Citirano: 22.12.2024.]

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Naslov (engleski)A Randomized, Double-Blind, Efficacy and Safety Study of PF-05280586 (a Rituximab Biosimilar) Compared with Rituximab Reference Product (MabThera®) in Subjects with Previously Untreated CD20-Positive, Low-Tumor-Burden Follicular Lymphoma (LTB-FL)
AutorJeff P. Sharman
AutorAnna Marina Liberati
AutorKenichi Ishizawa
AutorTahira Khan
AutorJeffery Robbins
AutorAnn Alcasid
AutorJulie Ann Rosenberg
AutorIgor Aurer
Autorova ustanovaSveučilište u Zagrebu
Medicinski fakultet
(KATEDRA ZA INTERNU MEDICINU)
Znanstveno / umjetničko
područje, polje i grana		BIOMEDICINA I ZDRAVSTVO
Kliničke medicinske znanosti
Interna medicina
Sažetak (engleski)
Background: Biosimilars are highly similar to the licensed biologic ("reference product"), with no clinically meaningful differences in safety, purity, or potency between the two products. ----- Objective: This comparative 52-week clinical study evaluated the efficacy, safety, immunogenicity, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-05280586 (Ruxience™ [a rituximab biosimilar]) versus rituximab reference product sourced from the EU (MabThera®; rituximab-EU). ----- Patients and methods: Subjects with CD20-positive, low-tumor-burden follicular lymphoma (LTB-FL) and an Eastern Cooperative Oncology Group performance status 0-1 were randomized (1:1) to PF-05280586 or rituximab-EU (375 mg/m2 intravenously [once weekly for 4 weeks at days 1, 8, 15, and 22]), stratified using the Follicular Lymphoma International Prognostic Index 2 classification. The primary endpoint was overall response rate (ORR) at week 26 (percentage of subjects achieving complete response [CR] or partial response [PR]). Therapeutic equivalence was concluded if the two-sided 95% confidence interval (CI) for the difference in ORR between groups was within the prespecified margin (± 16%). Secondary endpoints included progression-free survival (PFS), CR rate, safety, immunogenicity, PK, and PD. ----- Results: A total of 394 subjects were randomized: PF-05280586 (n = 196) or rituximab-EU (n = 198). ORR at week 26 was 75.5% (PF-05280586) versus 70.7% (rituximab-EU), for a difference of 4.66%; 95% CI (- 4.16 to 13.47), which was entirely within the prespecified equivalence margin. Rates of CR were 29.3% (PF-05280586) versus 31.0% (rituximab-EU). Estimated 1-year PFS rates were 78.2% (95% CI 70.2-84.2) and 83.0% (95% CI 75.0-88.6) for PF-05280586 and rituximab-EU, respectively. Safety, immunogenicity, and mean serum concentrations were similar between groups. ----- Conclusions: The efficacy, safety, immunogenicity, PK, and PD of PF-05280586 and rituximab-EU were similar up to week 52 in subjects with previously untreated CD20-positive LTB-FL.
Jezikengleski
Vrsta publikacijeZnanstveni rad - Izvorni znanstveni rad
Status objaveObjavljen
Vrsta recenzijeRecenziran
Verzija publikacijeObjavljena verzija rada (izdavačev PDF)
Naslov časopisaBioDrugs
Brojčani podacivol. 34, br. 2, str. 171-181
p-ISSN1173-8804
e-ISSN1179-190X
DOIhttps://doi.org/10.1007/s40259-019-00398-7
URN:NBNurn:nbn:hr:105:921728
Datum objave publikacije2020-04
URL dokumentahttp://link.springer.com/10.1007/s40259-019-00398-7
Vrsta resursaTekst
Prava pristupaOtvoreni pristup
Uvjeti korištenjaIkona licence Imenovanje-Nekomercijalno-Bez prerada 4.0 međunarodna (CC BY-NC-ND 4.0)
Datum i vrijeme pohrane2020-11-05 16:54:21