Phase 3
Completed N=394
A Study Of PF-05280586 (Rituximab-Pfizer) Or MabThera® (Rituximab-EU) For The First-Line Treatment Of Patients With CD20-Positive, Low Tumor Burden, Follicular Lymphoma (REFLECTIONS B328-06)
Source: ClinicalTrials.gov NCT02213263 ↗Enrolled (actual)
394
Serious AEs
8.1%
Results posted
Oct 2018
Primary outcomePrimary: Overall Response Rate (ORR): Percentage of Participants With Overall Response (OR) at Week 26 — 70.7; 75.5 percentage of participants
◆ Published Evidence
Established
43citations · ~7 / year
A Randomized, Double-Blind, Efficacy and Safety Study of PF-05280586 (a Rituximab Biosimilar) Compared with Rituximab Reference Product (MabThera<sup>®</sup>) in Subjects with Previously Untreated CD20-Positive, Low-Tumor-Burden Follicular Lymphoma (LTB-FL).
Summary
This study will compare the safety and effectiveness of PF-05280586 versus rituximab-EU in patients with CD20-positive, low tumor burden follicular lymphoma. The primary hypothesis to be tested in this study is that the effectiveness of PF-05280586, as measured by the Overall Response Rate, is similar to that of rituximab-EU.
Linked Publications (2)
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A Randomized, Double-Blind, Efficacy and Safety Study of PF-05280586 (a Rituximab Biosimilar) Compared with Rituximab Reference Product (MabThera<sup>®</sup>) in Subjects with Previously Untreated CD20-Positive, Low-Tumor-Burden Follicular Lymphoma (LTB-FL).
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Factors Influencing Infusion-Related Reactions Following Dosing of Reference Rituximab and PF-05280586, a Rituximab Biosimilar.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate (ORR): Percentage of Participants With Overall Response (OR) at Week 26 |
70.7; 75.5 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
145; 156; 15; 17 | — |
| SECONDARY Number of Participants With Treatment Related Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
94; 86; 2; 2 | — |
| SECONDARY Number of Participants With Grade 3 or Higher Treatment-Emergent Adverse Events (AEs) as Graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 |
26; 28 | — |
| SECONDARY Number of Participants With Grade 3 or Higher Treatment-Related Treatment-Emergent Adverse Events (AEs) as Graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 |
8; 9 | — |
| SECONDARY Number of Participants With Clinically Significant Laboratory Abnormalities |
194; 192; 3; 3; 196; 195 | — |
| SECONDARY Time to Treatment Failure (TTF) |
18.9; NA | 0.450 |
| SECONDARY Progression-Free Survival (PFS) |
18.9; NA | 0.189 |
| SECONDARY Percentage of Participants With Complete Remission (CR) at Week 26 |
28.3; 26.0 | — |
| SECONDARY Duration of Response (DOR) |
15.4; NA | 0.185 |
| SECONDARY Overall Survival |
18.9; NA | 0.319 |
| SECONDARY Maximum Observed Serum Concentration (Cmax) of PF-05280586 and Rituximab-EU |
334848.88; 337708.05 | — |
| SECONDARY Minimum Observed (Trough) Serum Concentration (Ctrough) of PF-05280586 and Rituximab-EU |
0.01; 0.01; 62311.74; 66669.15; 109619.73; 119026.91 | — |
| SECONDARY Cluster of Differentiation (CD) 19-Positive B-Cell Counts |
114.2; 119.9; 1.0; 0.8; 0.6; 0.6 | — |
| SECONDARY Number of Participants With Positive Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) |
39; 43; 0; 0 | — |
| SECONDARY Number of Participants Reporting Immune-Based Adverse Effects |
59; 49; 17; 17; 48; 39 | — |
Eligibility Criteria
Inclusion Criteria
- Confirmed diagnosis of low tumor burden, CD20-positive follicular lymphoma
- Ann Arbor Stage II, III, or IV
Exclusion Criteria
- Not a candidate for treatment with rituximab as a single-agent
- Evidence of transformation to a high grade or diffuse large B-cell lymphoma
- Any previous systemic therapy for B-cell NHL, including chemotherapy, immunotherapy, or steroids
- Any prior treatment with rituximab
- Active, uncontrolled infection
Data sourced from ClinicalTrials.gov (NCT02213263) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.