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Pharmacokinetics and safety of subcutaneous rituximab in follicular lymphoma (SABRINA): stage 1 analysis of a randomised phase 3 study
Abstract
Background Intravenous rituximab is a mainstay of treatment for follicular lymphoma. A subcutaneous formulation that achieves equivalent rituximab serum concentrations might improve convenience and save health-care resources without sacrificing clinical activity. We aimed to assess pharmacokinetic non-inferiority of 3 week cycles of fixed-dose subcutaneous rituximab versus standard intravenous rituximab.Methods In our two-stage, randomised, open-label, phase 3 trial, we enrolled patients with previously untreated grade 1-3a, CD20-positive follicular lymphoma at 67 centres in 23 countries. In stage 1, we randomly allocated patients 1:1 with the Pocock and Simon algorithm to intravenous rituximab (375 mg/m(2)) or fixed-dose subcutaneous rituximab (1400 mg), stratified by induction chemotherapy regimen (cyclophosphamide, doxorubicin, vincristine, prednisone or cyclophosphamide, vincristine, prednisone), Follicular Lymphoma International Prognostic Index score, and region. After randomisation, patients received one induction dose of intravenous rituximab in cycle 1 and then allocated treatment for cycles 2-8. Patients with a complete or partial response following induction therapy continued intravenous or subcutaneous rituximab as maintenance every 8 weeks. The primary endpoint was the ratio of observed rituximab serum trough concentrations (Ctrough) between groups at cycle 7 (before cycle 8 dosing) of induction treatment in a per-protocol population. Patients were analysed as treated for safety endpoints. Stage 2 follow-up is ongoing and is fully accrued. This study is registered with ClinicalTrials.gov, number NCT01200758.Findings Between Feb 4, 2010, and Oct 21, 2011, we enrolled 127 patients. Pharmacokinetic data were available for 48 (75%) of 64 patients randomly allocated intravenous rituximab and 54 (86%) of 63 patients randomly allocated subcutaneous rituximab. Geometric mean Ctrough was 83·13 μg/mL in the intravenous group and 134·58 μg/mL in the subcutaneous group (ratio 1·62, 90% CI 1·36-1·94), showing non-inferiority of subcutaneous rituximab. 57 (88%) of 65 patients in the intravenous rituximab safety population had adverse events (30 [46%] grade ≥3), as did 57 (92%) of 62 patients in the subcutaneous rituximab safety population (29 [47%] grade ≥3). The most common grade 3 or worse adverse event in both groups was neutropenia (14 [22%] patients in the intravenous group and 16 [26%] patients in the subcutaneous group). Adverse events related to administration were mostly grade 1-2 and occurred in 21 (32%) patients in the intravenous group and 31 (50%) patients in the subcutaneous group.Interpretation Stage 1 data show that the pharmacokinetic profile of subcutaneous rituximab was non-inferior to intravenous rituximab and was not associated with new safety concerns. Stage 2 will provide data for efficacy and safety of the subcutaneous administration.Funding F Hoffmann-La Roche.
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“Furthermore, population pharmacokinetic (PopPK) modeling using data from clinical trials of various biotherapeutics has confirmed that fixed dosing of mAbs could be feasible for the majority of molecules assessed, without impairing the safety and efficacy of the treatment [20–23].”
From Subcutaneous Administration of Biotherapeutics: An Overview of Current Challenges and Opportunities (2018) · cites this paper as [21]
In the citing paper
“When developing the subcutaneous formulation for trastuzumab and rituximab, the change from intravenous to subcutaneous administration included a switch from weight- and body surface area-adjusted dosing to a fixed dose [21, 39, 74].”
From Subcutaneous Administration of Biotherapeutics: An Overview of Current Challenges and Opportunities (2018) · cites this paper as [21]
In the citing paper
“The fixed-dose regimens for trastuzumab and rituximab were further supported by exposure–response analyses of response and grade ≥ 3 adverse events, which did not identify a statistically meaningful impact of bodyweight or body surface area, respectively, nor of exposure or route of administration of the respective mAbs [21, 74].”
From Subcutaneous Administration of Biotherapeutics: An Overview of Current Challenges and Opportunities (2018) · cites this paper as [21]
In the citing paper
“In both the HannaH and the Sabrina studies, subcutaneous administration of trastuzumab and rituximab resulted in noninferior Ctrough and efficacy to intravenous dosing and a similar safety profile [21, 39, 74].”
From Subcutaneous Administration of Biotherapeutics: An Overview of Current Challenges and Opportunities (2018) · cites this paper as [21]
In the citing paper
“Overall response at the end of induction was 84.9% (95% CI 79.2–89.5) in the intravenous group and 84.4% (78.7–89.1) in the subcutaneous group.”
From Subcutaneous Administration of Biotherapeutics: An Overview of Current Challenges and Opportunities (2018) · cites this paper as [21]
In the citing paper
“In Sabrina, the geometric mean ratio of Ctrough subcutaneous to Ctrough intravenous was 1.5 (90% CI 1.3–1.7).”
From Subcutaneous Administration of Biotherapeutics: An Overview of Current Challenges and Opportunities (2018) · cites this paper as [21]
In the citing paper
“With the pivotal noninferiority trials for trastuzumab and rituximab, the HannaH and Sabrina studies, respectively, two larger head-to-head studies comparing the immunogenicity of intravenous versus subcutaneous administration with the same dosing regimen have become available [21, 74].”
From Subcutaneous Administration of Biotherapeutics: An Overview of Current Challenges and Opportunities (2018) · cites this paper as [21]
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Metadata
- Authors
- Davies, A., Merli, F., Mihaljevic, B., Siritanaratkul, N., Solal-Céligny, P., Barrett, M., Berge, C., Bittner, B., Boehnke, A., McIntyre, C., & MacDonald, D.
- Affiliations
- Cancer Research UK (GB)
- Santa Maria Nuova Hospital (IT)
- Siriraj Hospital (TH)
- Institut de Cancérologie de l'Ouest (FR)
- Roche (United Kingdom) (GB)
- F. Hoffmann-La Roche AG (CH)
- Queen Elizabeth II Health Sciences Centre (CA)
- Corresponding author
- Davies, Andrew
- ORCID
- Venue
- The Lancet Oncology
- Publisher
- Elsevier BV
- Published
- 2014-03
- Volume
- 15
- Issue
- 3
- Pages
- 343-352
- ISSN
- 1470-2045 (ISSN-L)
- OpenAlex
- W2120711586
- Cited by
- 114
- References
- 27
- Citations by year
- 2026: 3 · 2025: 5 · 2024: 6 · 2023: 7 · 2022: 11 · 2021: 8 · 2020: 7 · 2019: 7 · 2018: 13 · 2017: 13 · 2016: 16 · 2015: 12 · 2014: 6
- FWCI
- 11.65
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The Lancet Oncology (publishedVersion)
- PubMed (publishedVersion)
- ePrints Soton (University of Southampton) (submittedVersion)
- Funders
- F. Hoffmann-La Roche
- Topics
- Health Sciences › Medicine › Pathology and Forensic Medicine › Lymphoma Diagnosis and Treatment
- Health Sciences › Medicine › Hematology › Chronic Lymphocytic Leukemia Research
- Health Sciences › Medicine › Oncology › Neutropenia and Cancer Infections
- Keywords
- follicular lymphoma, pharmacokinetics, non-inferiority, CD20-positive lymphoma, maintenance therapy, induction chemotherapy, fixed-dose dosing, adverse events, drug safety, previously untreated lymphoma, R-CHOP
- MeSH terms
- Rituximab, Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Female, Humans, Injections, Subcutaneous, Lymphoma, Follicular, Male, Middle Aged, Neoplasm Staging, Antibodies, Monoclonal, Murine-Derived
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