Trial Outcomes & Findings for Study to Assess if ABP798 is Safe & Effective in Treating Non Hodgkin Lymphoma Compared to Rituximab (NCT NCT02747043)
NCT ID: NCT02747043
Last Updated: 2022-09-10
Results Overview
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.
COMPLETED
PHASE3
256 participants
Post treatment up to Week 28
2022-09-10
Participant Flow
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.
Participants were randomized centrally to receive either ABP 798 or rituximab in a 1:1 manner. The randomization was stratified based on geographic region (Europe, Americas, Japan, Asia Pacific - Other) and age group (\> 60 years of age, ≤ 60 years of age).
Participant milestones
| Measure |
ABP 798
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.
|
Rituximab
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.
|
|---|---|---|
|
Overall Study
STARTED
|
128
|
128
|
|
Overall Study
Treated
|
128
|
126
|
|
Overall Study
COMPLETED
|
118
|
123
|
|
Overall Study
NOT COMPLETED
|
10
|
5
|
Reasons for withdrawal
| Measure |
ABP 798
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.
|
Rituximab
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.
|
|---|---|---|
|
Overall Study
Other
|
1
|
1
|
|
Overall Study
Adverse Event
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Disease progression
|
4
|
0
|
Baseline Characteristics
Study to Assess if ABP798 is Safe & Effective in Treating Non Hodgkin Lymphoma Compared to Rituximab
Baseline characteristics by cohort
| Measure |
ABP 798
n=128 Participants
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.
|
Rituximab
n=128 Participants
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.
|
Total
n=256 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.6 years
STANDARD_DEVIATION 12.72 • n=93 Participants
|
58.2 years
STANDARD_DEVIATION 12.20 • n=4 Participants
|
57.9 years
STANDARD_DEVIATION 12.45 • n=27 Participants
|
|
Age, Customized
<= 60 years
|
71 Participants
n=93 Participants
|
70 Participants
n=4 Participants
|
141 Participants
n=27 Participants
|
|
Age, Customized
> 60 years
|
57 Participants
n=93 Participants
|
58 Participants
n=4 Participants
|
115 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=93 Participants
|
62 Participants
n=4 Participants
|
130 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=93 Participants
|
66 Participants
n=4 Participants
|
126 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
102 Participants
n=93 Participants
|
101 Participants
n=4 Participants
|
203 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian, Non-Japanese
|
17 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
31 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian, Japanese
|
7 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Missing
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White, Asian-Non-Japanese
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
119 Participants
n=93 Participants
|
119 Participants
n=4 Participants
|
238 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
8 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Not allowed to collect
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Weight
|
75.29 kg
STANDARD_DEVIATION 19.135 • n=93 Participants
|
75.19 kg
STANDARD_DEVIATION 16.981 • n=4 Participants
|
75.24 kg
STANDARD_DEVIATION 18.063 • n=27 Participants
|
|
Height
|
166.81 cm
STANDARD_DEVIATION 10.737 • n=93 Participants
|
167.64 cm
STANDARD_DEVIATION 10.292 • n=4 Participants
|
167.22 cm
STANDARD_DEVIATION 10.506 • n=27 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 0
|
107 Participants
n=93 Participants
|
110 Participants
n=4 Participants
|
217 Participants
n=27 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 1
|
21 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
39 Participants
n=27 Participants
|
|
Region of Enrollment
Europe
|
88 Participants
n=93 Participants
|
86 Participants
n=4 Participants
|
174 Participants
n=27 Participants
|
|
Region of Enrollment
Asia Pacific - Other
|
23 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
46 Participants
n=27 Participants
|
|
Region of Enrollment
Americas
|
10 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
|
Region of Enrollment
Japan
|
7 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Time Since Original Diagnosis
|
6.31 months
STANDARD_DEVIATION 16.325 • n=93 Participants
|
5.17 months
STANDARD_DEVIATION 10.181 • n=4 Participants
|
5.74 months
STANDARD_DEVIATION 13.590 • n=27 Participants
|
|
Previous Radiation Treatment
Yes
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Previous Radiation Treatment
No
|
125 Participants
n=93 Participants
|
125 Participants
n=4 Participants
|
250 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Post treatment up to Week 28Population: The modified full analysis set included all randomized participants with evidence of disease at baseline per the tumor assessment from the central, independent, blinded assessments. Analyses for the modified full analysis set was based on randomized treatment assignment.
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.
Outcome measures
| Measure |
ABP 798
n=123 Participants
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.
|
Rituximab
n=124 Participants
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.
|
|---|---|---|
|
Percentage of Participants Who Responded (Overall Response Rate - ORR) by Week 28 Based on Independent Central Assessment of Disease
|
78.0 percentage of participants
Interval 70.7 to 85.4
|
70.2 percentage of participants
Interval 62.1 to 78.2
|
SECONDARY outcome
Timeframe: Week 12Population: The modified full analysis set included all randomized participants with evidence of disease at baseline per the tumor assessment from the central, independent, blinded assessments. Analyses for the modified full analysis set was based on randomized treatment assignment.
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.
Outcome measures
| Measure |
ABP 798
n=123 Participants
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.
|
Rituximab
n=124 Participants
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.
|
|---|---|---|
|
Percentage of Participants Who Responded (Overall Response Rate - ORR) at Week 12 Based on Independent Central Assessment of Disease
|
59.3 percentage of participants
Interval 50.7 to 68.0
|
58.1 percentage of participants
Interval 49.4 to 66.7
|
SECONDARY outcome
Timeframe: Weeks 2, 3, 4, 12 and 20Population: Safety Analysis Set of participants with available data. Participants with PK concentrations below the lower limit of quantification (LLOQ) were excluded from these analyses.
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.
Outcome measures
| Measure |
ABP 798
n=128 Participants
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.
|
Rituximab
n=126 Participants
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.
|
|---|---|---|
|
Pharmacokinetic Serum Concentrations by Visit
Week 2 (predose)
|
58.66 microgram/mL
Geometric Coefficient of Variation 50.4
|
58.63 microgram/mL
Geometric Coefficient of Variation 76.9
|
|
Pharmacokinetic Serum Concentrations by Visit
Week 3 (predose)
|
105.39 microgram/mL
Geometric Coefficient of Variation 37.8
|
108.77 microgram/mL
Geometric Coefficient of Variation 59.1
|
|
Pharmacokinetic Serum Concentrations by Visit
Week 4 (predose)
|
132.70 microgram/mL
Geometric Coefficient of Variation 42.6
|
140.23 microgram/mL
Geometric Coefficient of Variation 57.9
|
|
Pharmacokinetic Serum Concentrations by Visit
Week 12 (predose)
|
21.86 microgram/mL
Geometric Coefficient of Variation 156.1
|
20.55 microgram/mL
Geometric Coefficient of Variation 194.1
|
|
Pharmacokinetic Serum Concentrations by Visit
Week 12 (postdose)
|
207.05 microgram/mL
Geometric Coefficient of Variation 58.1
|
209.14 microgram/mL
Geometric Coefficient of Variation 66.8
|
|
Pharmacokinetic Serum Concentrations by Visit
Week 20 (predose)
|
13.37 microgram/mL
Geometric Coefficient of Variation 138.7
|
16.45 microgram/mL
Geometric Coefficient of Variation 115.8
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Study Day 8Population: Full analysis set of participants with available data. 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.
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.
Outcome measures
| Measure |
ABP 798
n=115 Participants
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.
|
Rituximab
n=116 Participants
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.
|
|---|---|---|
|
Percentage of Participants With Complete Depletion of Clusters of Differentiation 19-Positive (CD19+) Cell Count From Baseline to Day 8
|
98.3 percentage of participants
|
98.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 8 (Week 2), Weeks 3, 4, 28Population: Full analysis set of participants with available data
Samples were analyzed by a central lab.
Outcome measures
| Measure |
ABP 798
n=128 Participants
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.
|
Rituximab
n=128 Participants
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.
|
|---|---|---|
|
Total Immunoglobulin G (IgG) Results by Visit
Week 3
|
9.545 g/L
Standard Deviation 2.5933
|
10.374 g/L
Standard Deviation 2.3214
|
|
Total Immunoglobulin G (IgG) Results by Visit
Week 4
|
9.744 g/L
Standard Deviation 2.5805
|
10.196 g/L
Standard Deviation 2.2842
|
|
Total Immunoglobulin G (IgG) Results by Visit
Baseline
|
9.740 g/L
Standard Deviation 2.5988
|
10.570 g/L
Standard Deviation 2.5970
|
|
Total Immunoglobulin G (IgG) Results by Visit
Day 8 (Week 2)
|
9.790 g/L
Standard Deviation 2.5719
|
10.486 g/L
Standard Deviation 2.4916
|
|
Total Immunoglobulin G (IgG) Results by Visit
Week 28
|
9.846 g/L
Standard Deviation 2.6316
|
10.281 g/L
Standard Deviation 2.3617
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 8 (Week 2), Weeks 3, 4, 28Population: Full analysis set of participants with available data.
Samples were analyzed by a central lab.
Outcome measures
| Measure |
ABP 798
n=128 Participants
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.
|
Rituximab
n=128 Participants
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.
|
|---|---|---|
|
Total Immunoglobulin M (IgM) Results by Visit
Baseline
|
1.021 g/L
Standard Deviation 1.0072
|
1.247 g/L
Standard Deviation 3.4018
|
|
Total Immunoglobulin M (IgM) Results by Visit
Day 8 (Week 2)
|
1.004 g/L
Standard Deviation 1.0300
|
1.280 g/L
Standard Deviation 3.7292
|
|
Total Immunoglobulin M (IgM) Results by Visit
Week 3
|
1.001 g/L
Standard Deviation 1.0564
|
1.370 g/L
Standard Deviation 5.0250
|
|
Total Immunoglobulin M (IgM) Results by Visit
Week 4
|
0.985 g/L
Standard Deviation 1.0459
|
1.385 g/L
Standard Deviation 5.3266
|
|
Total Immunoglobulin M (IgM) Results by Visit
Week 28
|
0.816 g/L
Standard Deviation 0.8505
|
1.127 g/L
Standard Deviation 3.6752
|
SECONDARY outcome
Timeframe: Day 1 (post treatment) to Week 28Population: Safety Analysis Set
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
Outcome measures
| Measure |
ABP 798
n=128 Participants
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.
|
Rituximab
n=126 Participants
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.
|
|---|---|---|
|
Participants With Treatment-Emergent Adverse Events
Any grade >=3 AE
|
14 Participants
|
13 Participants
|
|
Participants With Treatment-Emergent Adverse Events
Any AE
|
107 Participants
|
95 Participants
|
|
Participants With Treatment-Emergent Adverse Events
Any fatal AE
|
0 Participants
|
0 Participants
|
|
Participants With Treatment-Emergent Adverse Events
Any serious AE
|
5 Participants
|
5 Participants
|
|
Participants With Treatment-Emergent Adverse Events
Any AE leading to discontinuation of IP
|
4 Participants
|
1 Participants
|
|
Participants With Treatment-Emergent Adverse Events
Any AE leading to dose delay/withheld IP
|
9 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Day 1 (post treatment) to Week 28Population: Safety analysis set
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.
Outcome measures
| Measure |
ABP 798
n=128 Participants
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.
|
Rituximab
n=126 Participants
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.
|
|---|---|---|
|
Percentage of Participants With Treatment-emergent Adverse Events of Interest (AEOIs)
Any AEOI
|
49.2 percentage of participants
|
45.2 percentage of participants
|
|
Percentage of Participants With Treatment-emergent Adverse Events of Interest (AEOIs)
Infusion reactions including hypersensitivity
|
43.0 percentage of participants
|
42.9 percentage of participants
|
|
Percentage of Participants With Treatment-emergent Adverse Events of Interest (AEOIs)
Hematological reactions
|
5.5 percentage of participants
|
4.8 percentage of participants
|
|
Percentage of Participants With Treatment-emergent Adverse Events of Interest (AEOIs)
Cardiac disorders
|
2.3 percentage of participants
|
1.6 percentage of participants
|
|
Percentage of Participants With Treatment-emergent Adverse Events of Interest (AEOIs)
Serious infections
|
1.6 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Treatment-emergent Adverse Events of Interest (AEOIs)
Severe mucocutaneous reactions
|
0.8 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Treatment-emergent Adverse Events of Interest (AEOIs)
Gastrointestinal perforation
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Treatment-emergent Adverse Events of Interest (AEOIs)
Hepatitis B reactivation
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Treatment-emergent Adverse Events of Interest (AEOIs)
Opportunistic infection
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Treatment-emergent Adverse Events of Interest (AEOIs)
Progressive multifocal leukoencephalopathy
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Treatment-emergent Adverse Events of Interest (AEOIs)
Reversible posterior leukoencephalopathy
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Treatment-emergent Adverse Events of Interest (AEOIs)
Tumor lysis syndrome
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Weeks 12, 20 and 28Population: Safety Analysis Set
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.
Outcome measures
| Measure |
ABP 798
n=126 Participants
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.
|
Rituximab
n=123 Participants
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.
|
|---|---|---|
|
Number of Participants Who Developed Anti-drug Antibodies
Binding antibody positive
|
3 Participants
|
1 Participants
|
|
Number of Participants Who Developed Anti-drug Antibodies
Neutralizing antibody positive
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to Week 28Population: Safety Analysis Set
PFS was based on disease assessments determined by the central, independent, blinded radiologists' and oncologist's review.
Outcome measures
| Measure |
ABP 798
n=128 Participants
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.
|
Rituximab
n=126 Participants
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.
|
|---|---|---|
|
Participants' Progression-Free Survival (PFS) Status Based on the Independent Central Assessment of Disease
Participants with disease progression or death
|
3.1 percentage of participants
|
2.4 percentage of participants
|
|
Participants' Progression-Free Survival (PFS) Status Based on the Independent Central Assessment of Disease
Participants alive and progression-free
|
96.9 percentage of participants
|
97.6 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 up to Week 28Population: Safety Analysis Set
Percentage of participants who were alive at the end of the study.
Outcome measures
| Measure |
ABP 798
n=128 Participants
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.
|
Rituximab
n=126 Participants
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.
|
|---|---|---|
|
Percentage of Participants Who Survived -- Overall Survival (OS)
|
100 percentage of participants
|
100 percentage of participants
|
Adverse Events
ABP 798
Rituximab
Serious adverse events
| Measure |
ABP 798
n=128 participants at risk
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.
|
Rituximab
n=126 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/128 • Day 1 to 28 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.79%
1/126 • Day 1 to 28 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/128 • Day 1 to 28 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.79%
1/126 • Day 1 to 28 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/128 • Day 1 to 28 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.79%
1/126 • Day 1 to 28 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/128 • Day 1 to 28 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.79%
1/126 • Day 1 to 28 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Stomatitis
|
0.78%
1/128 • Day 1 to 28 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/126 • Day 1 to 28 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Chills
|
0.00%
0/128 • Day 1 to 28 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.79%
1/126 • Day 1 to 28 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Pyrexia
|
0.78%
1/128 • Day 1 to 28 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/126 • Day 1 to 28 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.78%
1/128 • Day 1 to 28 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/126 • Day 1 to 28 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Septic shock
|
0.78%
1/128 • Day 1 to 28 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/126 • Day 1 to 28 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Viral infection
|
0.78%
1/128 • Day 1 to 28 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/126 • Day 1 to 28 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.78%
1/128 • Day 1 to 28 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/126 • Day 1 to 28 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Limb traumatic amputation
|
0.78%
1/128 • Day 1 to 28 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/126 • Day 1 to 28 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Headache
|
0.00%
0/128 • Day 1 to 28 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.79%
1/126 • Day 1 to 28 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/128 • Day 1 to 28 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.79%
1/126 • Day 1 to 28 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/128 • Day 1 to 28 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.79%
1/126 • Day 1 to 28 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Other adverse events
| Measure |
ABP 798
n=128 participants at risk
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.
|
Rituximab
n=126 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
3.1%
4/128 • Day 1 to 28 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
9/126 • Day 1 to 28 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.3%
3/128 • Day 1 to 28 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
9/126 • Day 1 to 28 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Nausea
|
4.7%
6/128 • Day 1 to 28 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
11.1%
14/126 • Day 1 to 28 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Asthenia
|
9.4%
12/128 • Day 1 to 28 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.8%
6/126 • Day 1 to 28 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Fatigue
|
10.2%
13/128 • Day 1 to 28 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
9.5%
12/126 • Day 1 to 28 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Pyrexia
|
6.2%
8/128 • Day 1 to 28 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.3%
8/126 • Day 1 to 28 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.5%
7/128 • Day 1 to 28 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.79%
1/126 • Day 1 to 28 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Headache
|
11.7%
15/128 • Day 1 to 28 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
9.5%
12/126 • Day 1 to 28 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
7.0%
9/128 • Day 1 to 28 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.3%
8/126 • Day 1 to 28 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.7%
6/128 • Day 1 to 28 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
9.5%
12/126 • Day 1 to 28 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.0%
9/128 • Day 1 to 28 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.8%
6/126 • Day 1 to 28 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.5%
7/128 • Day 1 to 28 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.6%
2/126 • Day 1 to 28 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER