A Phase 3 interventional study of ABP 798 and Rituximab in Lymphoma, Non-Hodgkin, sponsored by Amgen. Completed at 98 sites in 20 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-10.
Sponsored by Amgen · Phase 3, Interventional, and Treatment
This was a randomized, double-blind, active-controlled, multiple-dose, clinical similarity study to evaluate the efficacy, pharmacokinetics, pharmacodynamics, safety, tolerability and immunogenicity of ABP 798 compared with rituximab in subjects with grade 1, 2, or 3a follicular B-cell NHL and low tumor burden.
Subjects were randomized in a 1:1 ratio to receive a 375 mg/m\^2 intravenous infusion of either ABP 798 or rituximab once weekly for 4 weeks followed by dosing at weeks 12 and 20.
2,043 studies on the registry are indexed under Lymphoma, Non-Hodgkin; 309 are open to participants now.
This study's enrollment of 256 is above the median of 40 across 1,744 interventional studies indexed under Lymphoma, Non-Hodgkin.
Browse Lymphoma, Non-Hodgkin studies →Amgen is the lead sponsor of 1,044 studies on the registry; 51 are open to participants now.
Of its 246 completed or terminated interventional studies of FDA-regulated products, 164 (67%) have results posted.
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Stage 2, 3, or 4 (per Cotswold's Modification of Ann Arbor Staging System) with measurable disease (per International Working Group)
Low tumor burden based on the Groupe d'Etudes des Lymphomes Folliculaires (GELF) criteria
Exclusion Criteria:
ABP 798 was administered at a dose of 375 mg/m\^2 as an intravenous (IV) infusion once weekly for 4 weeks followed by dosing at weeks 12 and 20.
Biological: ABP 798
Rituximab was administered at a dose of 375 mg/m\^2 as an IV infusion once weekly for 4 weeks followed by dosing at weeks 12 and 20.
Biological: Rituximab
ABP 798 was supplied as a sterile, preservative-free liquid concentrate for IV infusion at a concentration of 10 mg/mL in either 100 mg/10 mL or 500 mg/50 mL single-dose vials. Subjects were to receive premedications before each infusion. Premedications were to be given according to local practice for administration of rituximab therapy.
Also known as: biosimilar to rituximab
Rituximab was procured from commercial supplies in the US and was supplied as a sterile, clear, colorless, preservative-free liquid concentrate for IV infusion at a concentration of 10 mg/mL in either 100-mg/10 mL or 500-mg/50 mL single-dose vials. Subjects were to receive premedications before each infusion. Premedications were to be given according to local practice for administration of rituximab therapy.
Also known as: Rituxan
Percentage of Participants Who Responded (Overall Response Rate - ORR) by Week 28 Based on Independent Central Assessment of Disease
Overall response within the first treatment cycle was assessed according to International Working Group - Non-Hodgkin Lymphoma criteria (IWG-NHL criteria \[Cheson et al, 1999\]) by a central reader. Response was evaluated using computerized tomography (CT) scans and positron emission tomography (PET) (to assess nodal disease/organ enlargement), and bone marrow biopsy (to assess bone marrow infiltration). ORR was the percentage of participants with a best overall response of complete response (CR), unconfirmed complete response (CRu) or partial response (PR). Participants that do not meet the criteria for response were considered non-responders. CR was defined as no evidence of disease. CRu showed nodes in the original sum of the products (SPD) regressed by \>75% and/or indeterminate bone marrow results. PR was a ≥ 50% decrease in SPD of the six largest dominant nodes; \>=50% decrease in liver and spleen nodes, and no increase in size of other nodes nor any new sites of disease.
Time frame: Post treatment up to Week 28
Percentage of Participants Who Responded (Overall Response Rate - ORR) at Week 12 Based on Independent Central Assessment of Disease
Overall response within the first treatment cycle was assessed according to International Working Group - Non-Hodgkin Lymphoma criteria (IWG-NHL criteria \[Cheson et al, 1999\]) by a central reader. Response was evaluated using computerized tomography (CT) scans and positron emission tomography (PET) (to assess nodal disease/organ enlargement), and bone marrow biopsy (to assess bone marrow infiltration). ORR was the percentage of participants with a best overall response of complete response (CR), unconfirmed complete response (CRu) or partial response (PR). Participants that do not meet the criteria for response were considered non-responders. CR was defined as no evidence of disease. CRu showed nodes in the original sum of the products (SPD) regressed by \>75% and/or indeterminate bone marrow results. PR was a ≥ 50% decrease in SPD of the six largest dominant nodes; \>=50% decrease in liver and spleen nodes, and no increase in size of other nodes nor any new sites of disease.
Time frame: Week 12
Pharmacokinetic Serum Concentrations by Visit
Pharmacokinetic serum samples were analyzed by a central lab. Lower limit of quantification (LLOQ) was 0.25 ug/mL. PK concentrations below the lower limit of quantification were assigned a value of 0. Geometric mean and geometric CV were only calculated using concentrations \>0.
Time frame: Weeks 2, 3, 4, 12 and 20
Percentage of Participants With Complete Depletion of Clusters of Differentiation 19-Positive (CD19+) Cell Count From Baseline to Day 8
Complete depletion of CD19+ cell count at any postdose time was defined as CD19+ cell counts \< 20 cell/μL (0.02 \* 10\^9 cell/L). Participants with missing CD19+ cell count at baseline or participants with CD19+ cell count \< 20 cell/μL at baseline were to be excluded from the derivation of complete depletion of CD19+ cell count.
Time frame: Baseline (Day 1), Study Day 8
Total Immunoglobulin G (IgG) Results by Visit
Samples were analyzed by a central lab.
Time frame: Baseline (Day 1), Day 8 (Week 2), Weeks 3, 4, 28
Total Immunoglobulin M (IgM) Results by Visit
Samples were analyzed by a central lab.
Time frame: Baseline (Day 1), Day 8 (Week 2), Weeks 3, 4, 28
Participants With Treatment-Emergent Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. The event does not necessarily have a causal relationship with study treatment. Each AE was graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, where Grade 1 = Mild AE Grade 2 = Moderate AE Grade 3 = Severe AE Grade 4 = Life-threatening or disabling AE Grade 5 = Death related to AE. Serious adverse events include any event that is fatal, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or other significant medical hazard. IP = investigational product
Time frame: Day 1 (post treatment) to Week 28
Percentage of Participants With Treatment-emergent Adverse Events of Interest (AEOIs)
The AEOIs prespecified for this study were infusion reactions including hypersensitivity, cardiac disorders, serious infections, progressive multifocal leukoencephalopathy, hematological reactions, hepatitis B reactivation, opportunistic infections, severe mucocutaneous reactions, tumor lysis syndrome, gastrointestinal perforation, and reversible posterior leukoencephalopathy syndrome. Infusion reactions including hypersensitivity adverse events of interest must have start date the same as, or one day after, an investigational product administration start date.
Time frame: Day 1 (post treatment) to Week 28
Number of Participants Who Developed Anti-drug Antibodies
Samples were first tested in an electrochemiluminescence (ECL)-based bridging immunoassay to detect antibodies capable of binding to ABP 798/rituximab (Binding Antibody Assay). Samples confirmed to be positive for binding antibodies were subsequently tested in a cell-based assay to determine neutralizing activity against ABP 798/rituximab (Neutralizing Antibody Assay). Developing antibody incidence was defined as participants with a negative or no binding antibody result at baseline and a positive antibody result at any post-baseline time point.
Time frame: Baseline (Day 1), Weeks 12, 20 and 28
Participants' Progression-Free Survival (PFS) Status Based on the Independent Central Assessment of Disease
PFS was based on disease assessments determined by the central, independent, blinded radiologists' and oncologist's review.
Time frame: Day 1 up to Week 28
Percentage of Participants Who Survived -- Overall Survival (OS)
Percentage of participants who were alive at the end of the study.
Time frame: Day 1 up to Week 28
A total of 380 subjects were screened and 256 participants (128 in the ABP 798 treatment group and 128 in the rituximab treatment group) were randomized at 91 centers across 20 countries.
| Milestone | ABP 798 | Rituximab |
|---|---|---|
| Started | 128 | 128 |
| Treated | 128 | 126 |
| Completed | 118 | 123 |
| Not completed | 10 | 5 |
| Withdrew: Other | 1 | 1 |
| Withdrew: Adverse event | 3 | 1 |
| Withdrew: Withdrawal by subject | 1 | 1 |
| Withdrew: Physician decision | 1 | 1 |
| Withdrew: Protocol violation | 0 | 1 |
| Withdrew: Disease progression | 4 | 0 |
Overall response within the first treatment cycle was assessed according to International Working Group - Non-Hodgkin Lymphoma criteria (IWG-NHL criteria \[Cheson et al, 1999\]) by a central reader. Response was evaluated using computerized tomography (CT) scans and positron emission tomography (PET) (to assess nodal disease/organ enlargement), and bone marrow biopsy (to assess bone marrow infiltration). ORR was the percentage of participants with a best overall response of complete response (CR), unconfirmed complete response (CRu) or partial response (PR). Participants that do not meet the criteria for response were considered non-responders. CR was defined as no evidence of disease. CRu showed nodes in the original sum of the products (SPD) regressed by \>75% and/or indeterminate bone marrow results. PR was a ≥ 50% decrease in SPD of the six largest dominant nodes; \>=50% decrease in liver and spleen nodes, and no increase in size of other nodes nor any new sites of disease.
| percentage of participants | ABP 798 | Rituximab |
|---|---|---|
| Percentage of Participants Who Responded (Overall Response Rate - ORR) by Week 28 Based on Independent Central Assessment of Disease | 78.0 (70.7 to 85.4) | 70.2 (62.1 to 78.2) |
Overall response within the first treatment cycle was assessed according to International Working Group - Non-Hodgkin Lymphoma criteria (IWG-NHL criteria \[Cheson et al, 1999\]) by a central reader. Response was evaluated using computerized tomography (CT) scans and positron emission tomography (PET) (to assess nodal disease/organ enlargement), and bone marrow biopsy (to assess bone marrow infiltration). ORR was the percentage of participants with a best overall response of complete response (CR), unconfirmed complete response (CRu) or partial response (PR). Participants that do not meet the criteria for response were considered non-responders. CR was defined as no evidence of disease. CRu showed nodes in the original sum of the products (SPD) regressed by \>75% and/or indeterminate bone marrow results. PR was a ≥ 50% decrease in SPD of the six largest dominant nodes; \>=50% decrease in liver and spleen nodes, and no increase in size of other nodes nor any new sites of disease.
| percentage of participants | ABP 798 | Rituximab |
|---|---|---|
| Percentage of Participants Who Responded (Overall Response Rate - ORR) at Week 12 Based on Independent Central Assessment of Disease | 59.3 (50.7 to 68.0) | 58.1 (49.4 to 66.7) |
Pharmacokinetic serum samples were analyzed by a central lab. Lower limit of quantification (LLOQ) was 0.25 ug/mL. PK concentrations below the lower limit of quantification were assigned a value of 0. Geometric mean and geometric CV were only calculated using concentrations \>0.
| microgram/mL | ABP 798 | Rituximab |
|---|---|---|
| Week 2 (predose) | 58.66 ± 50.4 | 58.63 ± 76.9 |
| Week 3 (predose) | 105.39 ± 37.8 | 108.77 ± 59.1 |
| Week 4 (predose) | 132.70 ± 42.6 | 140.23 ± 57.9 |
| Week 12 (predose) | 21.86 ± 156.1 | 20.55 ± 194.1 |
| Week 12 (postdose) | 207.05 ± 58.1 | 209.14 ± 66.8 |
| Week 20 (predose) | 13.37 ± 138.7 | 16.45 ± 115.8 |
Complete depletion of CD19+ cell count at any postdose time was defined as CD19+ cell counts \< 20 cell/μL (0.02 \* 10\^9 cell/L). Participants with missing CD19+ cell count at baseline or participants with CD19+ cell count \< 20 cell/μL at baseline were to be excluded from the derivation of complete depletion of CD19+ cell count.
| percentage of participants | ABP 798 | Rituximab |
|---|---|---|
| Percentage of Participants With Complete Depletion of Clusters of Differentiation 19-Positive (CD19+) Cell Count From Baseline to Day 8 | 98.3 | 98.3 |
Samples were analyzed by a central lab.
| g/L | ABP 798 | Rituximab |
|---|---|---|
| Baseline | 9.740 ± 2.5988 | 10.570 ± 2.5970 |
| Day 8 (Week 2) | 9.790 ± 2.5719 | 10.486 ± 2.4916 |
| Week 3 | 9.545 ± 2.5933 | 10.374 ± 2.3214 |
| Week 4 | 9.744 ± 2.5805 | 10.196 ± 2.2842 |
| Week 28 | 9.846 ± 2.6316 | 10.281 ± 2.3617 |
Samples were analyzed by a central lab.
| g/L | ABP 798 | Rituximab |
|---|---|---|
| Baseline | 1.021 ± 1.0072 | 1.247 ± 3.4018 |
| Day 8 (Week 2) | 1.004 ± 1.0300 | 1.280 ± 3.7292 |
| Week 3 | 1.001 ± 1.0564 | 1.370 ± 5.0250 |
| Week 4 | 0.985 ± 1.0459 | 1.385 ± 5.3266 |
| Week 28 | 0.816 ± 0.8505 | 1.127 ± 3.6752 |
An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. The event does not necessarily have a causal relationship with study treatment. Each AE was graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, where Grade 1 = Mild AE Grade 2 = Moderate AE Grade 3 = Severe AE Grade 4 = Life-threatening or disabling AE Grade 5 = Death related to AE. Serious adverse events include any event that is fatal, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or other significant medical hazard. IP = investigational product
| Participants | ABP 798 | Rituximab |
|---|---|---|
| Any AE | 107 | 95 |
| Any grade >=3 AE | 14 | 13 |
| Any fatal AE | 0 | 0 |
| Any serious AE | 5 | 5 |
| Any AE leading to discontinuation of IP | 4 | 1 |
| Any AE leading to dose delay/withheld IP | 9 | 9 |
The AEOIs prespecified for this study were infusion reactions including hypersensitivity, cardiac disorders, serious infections, progressive multifocal leukoencephalopathy, hematological reactions, hepatitis B reactivation, opportunistic infections, severe mucocutaneous reactions, tumor lysis syndrome, gastrointestinal perforation, and reversible posterior leukoencephalopathy syndrome. Infusion reactions including hypersensitivity adverse events of interest must have start date the same as, or one day after, an investigational product administration start date.
| percentage of participants | ABP 798 | Rituximab |
|---|---|---|
| Any AEOI | 49.2 | 45.2 |
| Infusion reactions including hypersensitivity | 43.0 | 42.9 |
| Hematological reactions | 5.5 | 4.8 |
| Cardiac disorders | 2.3 | 1.6 |
| Serious infections | 1.6 | 0 |
| Severe mucocutaneous reactions | 0.8 | 0 |
| Gastrointestinal perforation | 0 | 0 |
| Hepatitis B reactivation | 0 | 0 |
| Opportunistic infection | 0 | 0 |
| Progressive multifocal leukoencephalopathy | 0 | 0 |
| Reversible posterior leukoencephalopathy | 0 | 0 |
| Tumor lysis syndrome | 0 | 0 |
Samples were first tested in an electrochemiluminescence (ECL)-based bridging immunoassay to detect antibodies capable of binding to ABP 798/rituximab (Binding Antibody Assay). Samples confirmed to be positive for binding antibodies were subsequently tested in a cell-based assay to determine neutralizing activity against ABP 798/rituximab (Neutralizing Antibody Assay). Developing antibody incidence was defined as participants with a negative or no binding antibody result at baseline and a positive antibody result at any post-baseline time point.
| Participants | ABP 798 | Rituximab |
|---|---|---|
| Binding antibody positive | 3 | 1 |
| Neutralizing antibody positive | 1 | 1 |
PFS was based on disease assessments determined by the central, independent, blinded radiologists' and oncologist's review.
| percentage of participants | ABP 798 | Rituximab |
|---|---|---|
| Participants with disease progression or death | 3.1 | 2.4 |
| Participants alive and progression-free | 96.9 | 97.6 |
Percentage of participants who were alive at the end of the study.
| percentage of participants | ABP 798 | Rituximab |
|---|---|---|
| Percentage of Participants Who Survived -- Overall Survival (OS) | 100 | 100 |
Collected over Day 1 to 28 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ABP 798 | 0/128 (0%) | 5/128 (3.9%) | 59/128 (46.1%) |
| Rituximab | 0/126 (0%) | 5/126 (4%) | 61/126 (48.4%) |
| Event | ABP 798 | Rituximab |
|---|---|---|
| Coronary artery stenosisCardiac disorders | 0/128 | 1/126 |
| Abdominal painGastrointestinal disorders | 0/128 | 1/126 |
| Colitis ulcerativeGastrointestinal disorders | 0/128 | 1/126 |
| DysphagiaGastrointestinal disorders | 0/128 | 1/126 |
| ChillsGeneral disorders | 0/128 | 1/126 |
| HeadacheNervous system disorders | 0/128 | 1/126 |
| Erectile dysfunctionReproductive system and breast disorders | 0/128 | 1/126 |
| RhinorrhoeaRespiratory, thoracic and mediastinal disorders | 0/128 | 1/126 |
| StomatitisGastrointestinal disorders | 1/128 | 0/126 |
| PyrexiaGeneral disorders | 1/128 | 0/126 |
| Event | ABP 798 | Rituximab |
|---|---|---|
| HeadacheNervous system disorders | 15/128 | 12/126 |
| NauseaGastrointestinal disorders | 6/128 | 14/126 |
| FatigueGeneral disorders | 13/128 | 12/126 |
| PruritusSkin and subcutaneous tissue disorders | 6/128 | 12/126 |
| AstheniaGeneral disorders | 12/128 | 6/126 |
| Abdominal painGastrointestinal disorders | 4/128 | 9/126 |
| DiarrhoeaGastrointestinal disorders | 3/128 | 9/126 |
| Throat irritationRespiratory, thoracic and mediastinal disorders | 9/128 | 8/126 |
| RashSkin and subcutaneous tissue disorders | 9/128 | 6/126 |
| PyrexiaGeneral disorders | 8/128 | 8/126 |
Enrolled
| Age, Continuous(years) | ABP 798 | Rituximab | Total |
|---|---|---|---|
| Mean | 57.6 ± 12.72 | 58.2 ± 12.20 | 57.9 ± 12.45 |
| Age, Customized(Participants) | ABP 798 | Rituximab | Total |
|---|---|---|---|
| <= 60 years | 71 | 70 | 141 |
| > 60 years | 57 | 58 | 115 |
| Sex: Female, Male(Participants) | ABP 798 | Rituximab | Total |
|---|---|---|---|
| Female | 68 | 62 | 130 |
| Male | 60 | 66 | 126 |
| Race/Ethnicity, Customized(Participants) | ABP 798 | Rituximab | Total |
|---|---|---|---|
| White | 102 | 101 | 203 |
| Asian, Non-Japanese | 17 | 14 | 31 |
| Asian, Japanese | 7 | 8 | 15 |
| Missing | 1 | 2 | 3 |
| Other | 0 | 2 | 2 |
| American Indian or Alaska Native | 1 | 0 | 1 |
| White, Asian-Non-Japanese | 0 | 1 | 1 |
| Race/Ethnicity, Customized(Participants) | ABP 798 | Rituximab | Total |
|---|---|---|---|
| Not Hispanic or Latino | 119 | 119 | 238 |
| Hispanic or Latino | 8 | 7 | 15 |
| Not allowed to collect | 1 | 2 | 3 |
| Weight(kg) | ABP 798 | Rituximab | Total |
|---|---|---|---|
| Mean | 75.29 ± 19.135 | 75.19 ± 16.981 | 75.24 ± 18.063 |
| Height(cm) | ABP 798 | Rituximab | Total |
|---|---|---|---|
| Mean | 166.81 ± 10.737 | 167.64 ± 10.292 | 167.22 ± 10.506 |
| Eastern Cooperative Oncology Group (ECOG) Performance Status(Participants) | ABP 798 | Rituximab | Total |
|---|---|---|---|
| Grade 0 | 107 | 110 | 217 |
| Grade 1 | 21 | 18 | 39 |
3 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
Data sharing details ↗ · www.amgen.com
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