Non-Hodgkin Lymphoma
Conditions
Keywords
NHL, CD19, MOR208, MOR00208, Xmab5574, B-Cell Non-Hodgkin´s Lymphoma, Fc-optimized Anti-CD19 Antibody, Tafasitamab
Brief summary
This is an open-label, multicenter study to characterize the safety and efficacy of the human anti-CD19 antibody MOR00208 in adult patients with relapsed/refractory non-Hodgkin's lymphoma (NHL) who have received at least 1 prior therapy containing rituximab (at least once).
Detailed description
The study enrols patients from four different NHL subtypes: follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL) and other indolent NHL (iNHL). The study will employ a two-stage design where the decision to further enrol any NHL subtype in stage 2 will depend on best responses after two or three cycles in stage 1.
Interventions
DRUGMOR00208 (formerly Xmab 5574)
Sponsors
MorphoSys AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female patients ≥ 18 years of age. 2. Histologically-confirmed diagnosis according to Revised European American Lymphoma/World Health Organization classification, of the following B-cell lymphomas: 1. FL 2. Other indolent NHL (eg, MZL/MALT) 3. DLBCL 4. MCL 3. Patients' NHL must have progressed after at least 1 prior rituximab containing regimen. 4. One site of measurable disease by magnetic resonance imaging (MRI) or computed tomography (CT) scan defined as at least one lesion that measures at least 1.5 × 1.5 cm. Exception: For patients with MCL only, patients with nonmeasurable disease but evaluable sites (bone marrow, spleen, peripheral blood, gastrointestinal tract) can be enrolled. 5. Patients who have previously received an autologous stem cell transplantation must be at least 4 weeks post-transplant before study drug administration and must have exhibited a full haematological recovery. 6. Discontinued previous monoclonal antibody therapy (except rituximab) or radioimmunotherapy administration for at least 60 days before study drug administration. 7. Off rituximab for at least 14 days before the screening visit and be confirmed to have either no response or have disease progression after rituximab treatment. 8. Patients with DLBCL had a positive \[18F\]fluorodeoxyglucose-positron emission tomography (FDG-PET) scan at baseline (Cheson 2007 response criteria). 9. Life expectancy of \> 3 months. 10. Eastern Cooperative Oncology Group (ECOG) performance status of \< 3. 11. Laboratory criteria at screening: 1. Absolute neutrophil count (ANC) ≥ 1.0 × 10\^9/L 2. Platelet count ≥ 75 × 10\^9/L without previous transfusion within 10 days of first study drug administration 3. Haemoglobin ≥ 8.0 g/dL (may have been transfused) 4. Serum creatinine \< 2.0 x upper limit of normal (ULN) 5. Total bilirubin ≤ 2.0 × ULN 6. Alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN 12. If a female of childbearing potential, a negative pregnancy test must be confirmed before enrolment and use of double-barrier contraception or oral contraceptive plus barrier contraceptive must be used during the study and for 3 months after the last dose, or confirmation of having undergone clinically documented total hysterectomy and/or oophorectomy, tubal ligation. 13. If a male, an effective barrier method of contraception must be used during the study and for 3 months after the last dose if the patient is sexually active with a female of childbearing potential. 14. Able to comply with all study-related procedures, medication use, and evaluations. 15. Able to understand and give written informed consent and comply with the study protocol.
Exclusion criteria
1. Previous treatment with cytotoxic chemotherapy, immunotherapy, radiotherapy or other lymphoma specific therapy within 14 days before the screening visit or patient has not recovered from side effects of previous lymphoma-specific therapy. 2. Treatment with a systemic investigational agent within 28 days before the screening visit. 3. Previous treatment with an anti-CD19 antibody or fragments. 4. Previous allogenic stem cell transplantation. 5. Known or suspected hypersensitivity to the excipients contained in the study drug formulation. 6. Clinically significant cardiovascular disease or cardiac insufficiency, cardiomyopathy, preexisting clinically significant arrhythmia, acute myocardial infarction within 3 months of enrolment, angina pectoris within 3 months of enrolment. 7. Patients with positive hepatitis serology: Hepatitis B (HBV): Patients with positive serology for HBV defined as positivity for hepatitis B surface antigen (HBsAg) or total anti-hepatitis B core antibody (anti-HBc). Patients positive for anti-HBc may be included if HBV DNA is not detectable. Hepatitis C (HCV): Patients positive HCV serology (defined as positive for anti-HCV antibody \[anti-HCV\]) unless HCV-ribonucleic acid (RNA) is confirmed negative. 8. History of HIV infection. 9. Any active systemic infection (viral, fungal, or bacterial) requiring active parenteral antibiotic therapy within 4 weeks of study drug administration. 10. Current treatment with immunosuppressive agents other than prescribed corticosteroids (not more than 10-mg prednisone equivalent). 11. Major surgery or radiation therapy within 4 weeks before first study drug administration. 12. Systemic diseases (cardiovascular, renal, hepatic, etc) that would prevent study treatment in the investigator's opinion. 13. History or clinical evidence of central nervous system (CNS), meningeal, or epidural disease, including brain metastasis. 14. Active treatment/chemotherapy for another primary malignancy within the past 5 years (except for ductal breast cancer in situ, non-melanoma skin cancer, prostate cancer not requiring treatment, and cervical carcinoma in situ). 15. Pregnancy or breastfeeding in women and women of childbearing potential not using an acceptable method of birth control. 16. History of noncompliance to medical regimens or patients who are considered potentially unreliable not cooperative.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) | From first dose until Follow-up Visit 12, up to 4.5 years | Proportion of patients with Complete Remission (CR; disappearance of all evidence of disease) or Partial Remission (PR; regression of measurable disease and no new sites), assessed as per the 2007 International Working Group (IWG) response criteria by radiographic evaluations (CT, PET, MRI, or other). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number and Proportion of Patients Who Potentially Developed Anti-MOR00208 Antibodies and Semiquantitative Anti-MOR00208 Antibody Assessments | From first dose until Follow-up Visit 3, up to 7 months | Number of patients with at least one positive (+ve) post-Baseline sample containing positive anti-MOR00208 antibodies; Baseline (pre-dose) sample has to be tested negative (-ve) |
| Stable Disease (SD) Rate | From first dose until Follow-up Visit 12, up to 4.5 years | Proportion of patients with Stable Disease (failure to attain CR/PR with no progressive disease) |
| Duration of Response (DoR) | From first dose until Follow-up Visit 12, up to 4.5 years | Time from first CR or PR to first documentation of relapse/progression (any new lesion or increase by ≥ 50% of previously identified site) |
| Time to Progression (TTP) | From first dose until Follow-up Visit 12, up to 4.5 years | Time from first dosing until documentation of progression or death due to lymphoma |
| Progression-free Survival (PFS) | From first dose until Follow-up Visit 12, up to 4.5 years | Time from first dosing until progression or death due to any case |
| Pharmacokinetic (PK) Parameter: Maximum Serum Concentration Observed (Cmax) of MOR00208 | Estimated from first dose (samples taken on first day of dosing at pre-dose, end of infusion, after 1 hour, 4 hours, 24 hours, and pre-dose on Day 8) | The highest concentration of MOR00208 measured in serum |
| PK Parameter: Time to Maximum Serum Concentration Observed (Tmax) of MOR00208 | Estimated from first dose (samples taken on first day of dosing at pre-dose, end of infusion, after 1 hour, 4 hours, 24 hours, and pre-dose on Day 8) | The time to highest concentration of MOR00208 measured in serum |
| PK Parameter: Apparent Trough Serum Concentration Before Dosing (Clast) of MOR00208 | Estimated from first dose (samples taken on first day of dosing at pre-dose, end of infusion, after 1 hour, 4 hours, 24 hours, and pre-dose on Day 8) | The last quantifiable concentration from the first dose of MOR00208 |
| PK Parameter: Area Under the Concentration Curve From Dose Time Zero to the Time the Last Quantifiable Concentration is Observed (AUC[0-t]) of MOR00208 | Estimated from first dose (samples taken on first day of dosing at pre-dose, end of infusion, after 1 hour, 4 hours, 24 hours, and pre-dose on Day 8) | Area under the concentration curve. The time curve from time zero (0) to the time that the last concentration above the lower limit of quantification (LLQ) is observed. |
| PK Parameter: Area Under the Concentration Curve From Dose Time Zero to Infinity (AUC[0-inf]) of MOR00208 | Estimated from final dose (samples collected on the last day of Cycle 3 [C3D28; each cycle is 28 days long], and Follow-up Visits 1 [C3D28 + 4 weeks], 2 [C3D28 + 10 weeks], and 3 [C3D28 + 16 weeks]) | Area under the concentration curve. The time curve from time zero (0) to infinity (inf), where infinity is computed from AUC0-t + \[Ct/λZ)\]. Ct is calculated from the concentration at the last sampling time at which the sample is above LLQ. |
| PK Parameter: Apparent Terminal Rate Constant (λz) of MOR00208 | Estimated from final dose (samples collected on the last day of Cycle 3 [C3D28; each cycle is 28 days long], and Follow-up Visits 1 [C3D28 + 4 weeks], 2 [C3D28 + 10 weeks], and 3 [C3D28 + 16 weeks]) | Apparent terminal rate constant calculated from the regression analysis (slope) from the log-transformed measured concentrations on the terminal phase of the time-point concentration curve |
| PK Parameter: Apparent Terminal Half-life (t[1/2]) of MOR00208 | Estimated from final dose (samples collected on the last day of Cycle 3 [C3D28; each cycle is 28 days long], and Follow-up Visits 1 [C3D28 + 4 weeks], 2 [C3D28 + 10 weeks], and 3 [C3D28 + 16 weeks]) | Apparent terminal half-life calculated from ln(2)/λz |
| PK Parameter: Total Body Clearance (CL) of MOR00208 | Estimated from final dose (samples collected on the last day of Cycle 3 [C3D28; each cycle is 28 days long], and Follow-up Visits 1 [C3D28 + 4 weeks], 2 [C3D28 + 10 weeks], and 3 [C3D28 + 16 weeks]) | Total body clearance calculated for single or multiple doses: dose(s)/AUC(0-inf) |
| Incidence and Severity of Adverse Events (AEs) | From first dose until 30 days after last dose of MOR00208, up to 8.5 years | Number of patients with treatment-emergent AEs rated Mild, Moderate, and Severe |
| Absolute Change From Baseline in Measurements of B-cell Populations | Cycle 1 Day 1 (Baseline) to Cycle 1: Days 8, 15, and 22; Cycles 2 and 3: Days 1, 15, and 28 (each cycle is 28 days); End of Study (up to 7.5 years) | Actual change from baseline will be summarized descriptively by visit for the pharmacodynamic parameter: B-cell populations |
| Percent Change From Baseline in Measurements of B-cell Populations | Cycle 1 Day 1 (Baseline) to Cycle 1: Days 8, 15, and 22; Cycles 2 and 3: Days 1, 15, and 28 (each cycle is 28 days); End of Study (up to 7.5 years) | Relative change from baseline will be summarized descriptively by visit for the pharmacodynamic parameter: B-cell populations |
| Absolute Change From Baseline in Measurements of T-cell Populations | Cycle 1 Day 1 (Baseline) to Cycle 1: Days 8, 15, and 22; Cycles 2 and 3: Days 1, 15, and 28 (each cycle is 28 days); End of Study (up to 7.5 years) | Actual change from baseline will be summarized descriptively by visit for the pharmacodynamic parameter: T-cell populations |
| Percent Change From Baseline in Measurements of T-cell Populations | Cycle 1 Day 1 (Baseline) to Cycle 1: Days 8, 15, and 22; Cycles 2 and 3: Days 1, 15, and 28 (each cycle is 28 days); End of Study (up to 7.5 years) | Relative change from baseline will be summarized descriptively by visit for the pharmacodynamic parameter: T-cell populations |
| Absolute Change From Baseline in Measurements of NK Cell Populations | Cycle 1 Day 1 (Baseline) to Cycle 1: Days 8, 15, and 22; Cycles 2 and 3: Days 1, 15, and 28 (each cycle is 28 days); End of Study (up to 7.5 years) | Actual change from baseline will be summarized descriptively by visit for the pharmacodynamic parameter: NK cell populations |
| Percent Change From Baseline in Measurements of NK Cell Populations | Cycle 1 Day 1 (Baseline) to Cycle 1: Days 8, 15, and 22; Cycles 2 and 3: Days 1, 15, and 28 (each cycle is 28 days); End of Study (up to 7.5 years) | Relative change from baseline will be summarized descriptively by visit for the pharmacodynamic parameter: NK cell populations |
| Evaluation of AEs Stratified by Baseline CD19 Expression on Malignant Lymphoma Cells | From first dose until 30 days after last dose of MOR00208, up to 8.5 years | Incidence of AEs as stratified by presence of CD19 on malignant lymphoma cells detected by tumor biopsy/aspirate during Screening |
| Evaluation of ORR Stratified by Baseline CD19 Expression on Malignant Lymphoma Cells | From first dose until Follow-up Visit 12, up to 4.5 years | The analysis of the primary endpoint (ORR) will additionally be stratified by presence of CD19 on malignant lymphoma cells detected by tumor biopsy/aspirate during Screening |
| Evaluation of AEs Stratified by FcγRIIa Polymorphism | From first dose until 30 days after last dose of MOR00208, up to 8.5 years | Incidence of AEs as stratified by FcγRIIa polymorphism subgroups (genotypes HH, HR, or RR) |
| Evaluation of AEs Stratified by FcγRIIIa Polymorphism | From first dose until 30 days after last dose of MOR00208, up to 8.5 years | Incidence of AEs as stratified by FcγRIIIa polymorphism subgroups (genotypes FF, FV, or VV) |
| Evaluation of ORR Stratified by FcγRIIa Polymorphism | From first dose until Follow-up Visit 12, up to 4.5 years | The analysis of the primary endpoint (ORR) will additionally be stratified by FcγRIIa polymorphism subgroups (genotypes HH, HR, or RR) |
| Evaluation of ORR Stratified by FcγRIIIa Polymorphism | From first dose until Follow-up Visit 12, up to 4.5 years | The analysis of the primary endpoint (ORR) will additionally be stratified by FcγRIIIa polymorphism subgroups (genotypes FF, FV, or VV) |
| PK Parameter: Apparent Volume of Distribution (Vz) of MOR00208 | Estimated from final dose (samples collected on the last day of Cycle 3 [C3D28; each cycle is 28 days long], and Follow-up Visits 1 [C3D28 + 4 weeks], 2 [C3D28 + 10 weeks], and 3 [C3D28 + 16 weeks]) | Apparent volume of distribution during the terminal phase, calculated from dose/(AUC(0-inf)\*λz) |
Countries
Belgium, Germany, Hungary, Italy, Poland, Spain, United States
Participant flow
Pre-assignment details
All patients who fulfilled all the inclusion criteria and none of the exclusion criteria were enrolled and received MOR00208 infusion. Per planned analyses, patient disposition and treatment discontinuation is summarized by NHL subtype.
Participants by arm
| Arm | Count |
|---|---|
| FL Subtype Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion. | 34 |
| DLBCL Subtype Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion. | 35 |
| MCL Subtype Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion. | 12 |
| Other iNHL Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion. | 11 |
| Total | 92 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Main Study Treatment (Cycles 1 - 2) | Adverse Event | 2 | 0 | 0 | 1 |
| Main Study Treatment (Cycles 1 - 2) | Death | 0 | 3 | 1 | 0 |
| Main Study Treatment (Cycles 1 - 2) | Physician Decision | 0 | 2 | 0 | 0 |
| Main Study Treatment (Cycles 1 - 2) | Progressive Disease | 2 | 4 | 1 | 0 |
| Main Study Treatment (Cycles 1 - 2) | Protocol Violation | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Other iNHL | Total | FL Subtype | DLBCL Subtype | MCL Subtype |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 9 Participants | 49 Participants | 15 Participants | 19 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 43 Participants | 19 Participants | 16 Participants | 6 Participants |
| Age, Continuous | 70.91 years | 65.57 years | 62.88 years | 66.71 years | 64.92 years |
| BMI | 25.36 kg/m^2 | 26.86 kg/m^2 | 27.26 kg/m^2 | 26.52 kg/m^2 | 28.03 kg/m^2 |
| Height | 167.64 cm | 169.30 cm | 170.26 cm | 168.24 cm | 171.00 cm |
| NHL Subtype Diffuse large B-cell lymphoma | 0 Participants | 35 Participants | 0 Participants | 35 Participants | 0 Participants |
| NHL Subtype Follicular lymphoma | 0 Participants | 34 Participants | 34 Participants | 0 Participants | 0 Participants |
| NHL Subtype Mantle cell lymphoma | 0 Participants | 12 Participants | 0 Participants | 0 Participants | 12 Participants |
| NHL Subtype Other indolent NHL | 11 Participants | 11 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 3 Participants | 2 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 11 Participants | 87 Participants | 32 Participants | 33 Participants | 11 Participants |
| Sex: Female, Male Female | 6 Participants | 36 Participants | 18 Participants | 11 Participants | 1 Participants |
| Sex: Female, Male Male | 5 Participants | 56 Participants | 16 Participants | 24 Participants | 11 Participants |
| Weight | 71.53 kg | 77.10 kg | 78.62 kg | 75.52 kg | 82.52 kg |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 9 / 92 | 1 / 34 | 6 / 35 | 2 / 12 | 0 / 11 | 1 / 45 |
| other Total, other adverse events | 77 / 92 | 27 / 34 | 31 / 35 | 9 / 12 | 10 / 11 | 37 / 45 |
| serious Total, serious adverse events | 30 / 92 | 7 / 34 | 18 / 35 | 2 / 12 | 3 / 11 | 10 / 45 |
Outcome results
Primary
Overall Response Rate (ORR)
Proportion of patients with Complete Remission (CR; disappearance of all evidence of disease) or Partial Remission (PR; regression of measurable disease and no new sites), assessed as per the 2007 International Working Group (IWG) response criteria by radiographic evaluations (CT, PET, MRI, or other).
Time frame: From first dose until Follow-up Visit 12, up to 4.5 years
Population: The Intent-to-treat (ITT) Population consisted of all patients who received at least one dose of study drug. Patients without any post-Baseline assessment of NHL response were included as non-responders. Per pre-specified analysis plan, efficacy analyses are summarized overall, by NHL subtype, and for the combined group comprising FL patients + other iNHL patients.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Total | Overall Response Rate (ORR) | Complete remission | 6 Participants |
| Total | Overall Response Rate (ORR) | Partial remission | 16 Participants |
| FL Subtype | Overall Response Rate (ORR) | Complete remission | 2 Participants |
| FL Subtype | Overall Response Rate (ORR) | Partial remission | 8 Participants |
| DLBCL Subtype | Overall Response Rate (ORR) | Complete remission | 2 Participants |
| DLBCL Subtype | Overall Response Rate (ORR) | Partial remission | 7 Participants |
| MCL Subtype | Overall Response Rate (ORR) | Complete remission | 0 Participants |
| MCL Subtype | Overall Response Rate (ORR) | Partial remission | 0 Participants |
| Other iNHL | Overall Response Rate (ORR) | Complete remission | 2 Participants |
| Other iNHL | Overall Response Rate (ORR) | Partial remission | 1 Participants |
| FL + Other iNHL | Overall Response Rate (ORR) | Complete remission | 4 Participants |
| FL + Other iNHL | Overall Response Rate (ORR) | Partial remission | 9 Participants |
Secondary
Absolute Change From Baseline in Measurements of B-cell Populations
Actual change from baseline will be summarized descriptively by visit for the pharmacodynamic parameter: B-cell populations
Time frame: Cycle 1 Day 1 (Baseline) to Cycle 1: Days 8, 15, and 22; Cycles 2 and 3: Days 1, 15, and 28 (each cycle is 28 days); End of Study (up to 7.5 years)
Population: Pharmacodynamic samples were collected at timepoints through the study where possible. Per pre-specified analysis plan, statistical summaries are provided overall, by NHL subtype, and for the combined group comprising FL patients + other iNHL patients.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Total | Absolute Change From Baseline in Measurements of B-cell Populations | Cycle 2 Day 15 | -24.00 10^6 cells/L |
| Total | Absolute Change From Baseline in Measurements of B-cell Populations | Study Completion/Early Termination | -15.00 10^6 cells/L |
| Total | Absolute Change From Baseline in Measurements of B-cell Populations | Cycle 2 Day 1 | -14.00 10^6 cells/L |
| Total | Absolute Change From Baseline in Measurements of B-cell Populations | Cycle 1 Day 22 | -14.00 10^6 cells/L |
| Total | Absolute Change From Baseline in Measurements of B-cell Populations | Cycle 1 Day 15 | -15.00 10^6 cells/L |
| Total | Absolute Change From Baseline in Measurements of B-cell Populations | Cycle 2 Day 28 | -27.68 10^6 cells/L |
| Total | Absolute Change From Baseline in Measurements of B-cell Populations | Cycle 1 Day 8 | -13.60 10^6 cells/L |
| Total | Absolute Change From Baseline in Measurements of B-cell Populations | Cycle 3 Day 15 | -36.50 10^6 cells/L |
| Total | Absolute Change From Baseline in Measurements of B-cell Populations | Cycle 3 Day 28 | -46.00 10^6 cells/L |
| Total | Absolute Change From Baseline in Measurements of B-cell Populations | Cycle 3 Day 1 | -36.00 10^6 cells/L |
| FL Subtype | Absolute Change From Baseline in Measurements of B-cell Populations | Cycle 1 Day 15 | -60.50 10^6 cells/L |
| FL Subtype | Absolute Change From Baseline in Measurements of B-cell Populations | Cycle 3 Day 15 | -33.50 10^6 cells/L |
| FL Subtype | Absolute Change From Baseline in Measurements of B-cell Populations | Cycle 3 Day 28 | -60.50 10^6 cells/L |
| FL Subtype | Absolute Change From Baseline in Measurements of B-cell Populations | Cycle 2 Day 28 | -28.00 10^6 cells/L |
| FL Subtype | Absolute Change From Baseline in Measurements of B-cell Populations | Cycle 1 Day 22 | -34.00 10^6 cells/L |
| FL Subtype | Absolute Change From Baseline in Measurements of B-cell Populations | Study Completion/Early Termination | -72.00 10^6 cells/L |
| FL Subtype | Absolute Change From Baseline in Measurements of B-cell Populations | Cycle 2 Day 1 | -45.00 10^6 cells/L |
| FL Subtype | Absolute Change From Baseline in Measurements of B-cell Populations | Cycle 1 Day 8 | -68.00 10^6 cells/L |
| FL Subtype | Absolute Change From Baseline in Measurements of B-cell Populations | Cycle 2 Day 15 | -47.50 10^6 cells/L |
| FL Subtype | Absolute Change From Baseline in Measurements of B-cell Populations | Cycle 3 Day 1 | -43.00 10^6 cells/L |
| DLBCL Subtype | Absolute Change From Baseline in Measurements of B-cell Populations | Study Completion/Early Termination | -1.67 10^6 cells/L |
| DLBCL Subtype | Absolute Change From Baseline in Measurements of B-cell Populations | Cycle 2 Day 1 | -4.00 10^6 cells/L |
| DLBCL Subtype | Absolute Change From Baseline in Measurements of B-cell Populations | Cycle 1 Day 8 | 0.00 10^6 cells/L |
| DLBCL Subtype | Absolute Change From Baseline in Measurements of B-cell Populations | Cycle 3 Day 1 | -16.00 10^6 cells/L |
| DLBCL Subtype | Absolute Change From Baseline in Measurements of B-cell Populations | Cycle 2 Day 15 | -14.25 10^6 cells/L |
| DLBCL Subtype | Absolute Change From Baseline in Measurements of B-cell Populations | Cycle 1 Day 15 | -3.00 10^6 cells/L |
| DLBCL Subtype | Absolute Change From Baseline in Measurements of B-cell Populations | Cycle 2 Day 28 | -14.50 10^6 cells/L |
| DLBCL Subtype | Absolute Change From Baseline in Measurements of B-cell Populations | Cycle 3 Day 15 | -22.00 10^6 cells/L |
| DLBCL Subtype | Absolute Change From Baseline in Measurements of B-cell Populations | Cycle 1 Day 22 | -4.25 10^6 cells/L |
| DLBCL Subtype | Absolute Change From Baseline in Measurements of B-cell Populations | Cycle 3 Day 28 | -16.50 10^6 cells/L |
| MCL Subtype | Absolute Change From Baseline in Measurements of B-cell Populations | Cycle 3 Day 28 | -43.00 10^6 cells/L |
| MCL Subtype | Absolute Change From Baseline in Measurements of B-cell Populations | Cycle 3 Day 15 | -256.72 10^6 cells/L |
| MCL Subtype | Absolute Change From Baseline in Measurements of B-cell Populations | Cycle 2 Day 1 | -51.71 10^6 cells/L |
| MCL Subtype | Absolute Change From Baseline in Measurements of B-cell Populations | Cycle 3 Day 1 | -13.06 10^6 cells/L |
| MCL Subtype | Absolute Change From Baseline in Measurements of B-cell Populations | Cycle 1 Day 22 | -65.01 10^6 cells/L |
| MCL Subtype | Absolute Change From Baseline in Measurements of B-cell Populations | Cycle 1 Day 15 | -47.00 10^6 cells/L |
| MCL Subtype | Absolute Change From Baseline in Measurements of B-cell Populations | Cycle 2 Day 28 | -176.85 10^6 cells/L |
| MCL Subtype | Absolute Change From Baseline in Measurements of B-cell Populations | Cycle 1 Day 8 | -61.13 10^6 cells/L |
| MCL Subtype | Absolute Change From Baseline in Measurements of B-cell Populations | Cycle 2 Day 15 | -61.45 10^6 cells/L |
| MCL Subtype | Absolute Change From Baseline in Measurements of B-cell Populations | Study Completion/Early Termination | -49.00 10^6 cells/L |
| Other iNHL | Absolute Change From Baseline in Measurements of B-cell Populations | Cycle 3 Day 28 | -59.00 10^6 cells/L |
| Other iNHL | Absolute Change From Baseline in Measurements of B-cell Populations | Cycle 1 Day 8 | -65.00 10^6 cells/L |
| Other iNHL | Absolute Change From Baseline in Measurements of B-cell Populations | Cycle 1 Day 15 | -47.00 10^6 cells/L |
| Other iNHL | Absolute Change From Baseline in Measurements of B-cell Populations | Cycle 1 Day 22 | -60.00 10^6 cells/L |
| Other iNHL | Absolute Change From Baseline in Measurements of B-cell Populations | Cycle 2 Day 1 | -3.00 10^6 cells/L |
| Other iNHL | Absolute Change From Baseline in Measurements of B-cell Populations | Cycle 2 Day 15 | -56.00 10^6 cells/L |
| Other iNHL | Absolute Change From Baseline in Measurements of B-cell Populations | Cycle 2 Day 28 | -38.00 10^6 cells/L |
| Other iNHL | Absolute Change From Baseline in Measurements of B-cell Populations | Cycle 3 Day 1 | -68.00 10^6 cells/L |
| Other iNHL | Absolute Change From Baseline in Measurements of B-cell Populations | Cycle 3 Day 15 | -77.00 10^6 cells/L |
| Other iNHL | Absolute Change From Baseline in Measurements of B-cell Populations | Study Completion/Early Termination | -40.50 10^6 cells/L |
| FL + Other iNHL | Absolute Change From Baseline in Measurements of B-cell Populations | Cycle 3 Day 1 | -64.00 10^6 cells/L |
| FL + Other iNHL | Absolute Change From Baseline in Measurements of B-cell Populations | Cycle 2 Day 28 | -28.00 10^6 cells/L |
| FL + Other iNHL | Absolute Change From Baseline in Measurements of B-cell Populations | Cycle 2 Day 15 | -56.00 10^6 cells/L |
| FL + Other iNHL | Absolute Change From Baseline in Measurements of B-cell Populations | Cycle 3 Day 28 | -60.50 10^6 cells/L |
| FL + Other iNHL | Absolute Change From Baseline in Measurements of B-cell Populations | Cycle 2 Day 1 | -34.00 10^6 cells/L |
| FL + Other iNHL | Absolute Change From Baseline in Measurements of B-cell Populations | Cycle 1 Day 22 | -44.00 10^6 cells/L |
| FL + Other iNHL | Absolute Change From Baseline in Measurements of B-cell Populations | Cycle 1 Day 15 | -57.00 10^6 cells/L |
| FL + Other iNHL | Absolute Change From Baseline in Measurements of B-cell Populations | Cycle 1 Day 8 | -65.00 10^6 cells/L |
| FL + Other iNHL | Absolute Change From Baseline in Measurements of B-cell Populations | Study Completion/Early Termination | -72.00 10^6 cells/L |
| FL + Other iNHL | Absolute Change From Baseline in Measurements of B-cell Populations | Cycle 3 Day 15 | -35.00 10^6 cells/L |
Secondary
Absolute Change From Baseline in Measurements of NK Cell Populations
Actual change from baseline will be summarized descriptively by visit for the pharmacodynamic parameter: NK cell populations
Time frame: Cycle 1 Day 1 (Baseline) to Cycle 1: Days 8, 15, and 22; Cycles 2 and 3: Days 1, 15, and 28 (each cycle is 28 days); End of Study (up to 7.5 years)
Population: Pharmacodynamic samples were collected at timepoints through the study where possible. Per pre-specified analysis plan, statistical summaries are provided overall, by NHL subtype, and for the combined group comprising FL patients + other iNHL patients.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Total | Absolute Change From Baseline in Measurements of NK Cell Populations | Cycle 2 Day 1 | -16.32 10^6 cells/L |
| Total | Absolute Change From Baseline in Measurements of NK Cell Populations | Cycle 1 Day 22 | -18.00 10^6 cells/L |
| Total | Absolute Change From Baseline in Measurements of NK Cell Populations | Study Completion/Early Termination | -11.00 10^6 cells/L |
| Total | Absolute Change From Baseline in Measurements of NK Cell Populations | Cycle 3 Day 28 | -15.00 10^6 cells/L |
| Total | Absolute Change From Baseline in Measurements of NK Cell Populations | Cycle 3 Day 15 | -33.00 10^6 cells/L |
| Total | Absolute Change From Baseline in Measurements of NK Cell Populations | Cycle 3 Day 1 | -23.00 10^6 cells/L |
| Total | Absolute Change From Baseline in Measurements of NK Cell Populations | Cycle 1 Day 15 | -23.00 10^6 cells/L |
| Total | Absolute Change From Baseline in Measurements of NK Cell Populations | Cycle 1 Day 8 | -2.20 10^6 cells/L |
| Total | Absolute Change From Baseline in Measurements of NK Cell Populations | Cycle 2 Day 28 | -1.00 10^6 cells/L |
| Total | Absolute Change From Baseline in Measurements of NK Cell Populations | Cycle 2 Day 15 | -19.00 10^6 cells/L |
| FL Subtype | Absolute Change From Baseline in Measurements of NK Cell Populations | Cycle 1 Day 15 | -36.99 10^6 cells/L |
| FL Subtype | Absolute Change From Baseline in Measurements of NK Cell Populations | Cycle 1 Day 8 | -20.00 10^6 cells/L |
| FL Subtype | Absolute Change From Baseline in Measurements of NK Cell Populations | Cycle 1 Day 22 | -28.00 10^6 cells/L |
| FL Subtype | Absolute Change From Baseline in Measurements of NK Cell Populations | Cycle 2 Day 1 | -11.01 10^6 cells/L |
| FL Subtype | Absolute Change From Baseline in Measurements of NK Cell Populations | Cycle 2 Day 15 | 6.00 10^6 cells/L |
| FL Subtype | Absolute Change From Baseline in Measurements of NK Cell Populations | Cycle 2 Day 28 | -3.00 10^6 cells/L |
| FL Subtype | Absolute Change From Baseline in Measurements of NK Cell Populations | Cycle 3 Day 1 | -10.00 10^6 cells/L |
| FL Subtype | Absolute Change From Baseline in Measurements of NK Cell Populations | Cycle 3 Day 15 | -27.50 10^6 cells/L |
| FL Subtype | Absolute Change From Baseline in Measurements of NK Cell Populations | Cycle 3 Day 28 | -5.66 10^6 cells/L |
| FL Subtype | Absolute Change From Baseline in Measurements of NK Cell Populations | Study Completion/Early Termination | -11.50 10^6 cells/L |
| DLBCL Subtype | Absolute Change From Baseline in Measurements of NK Cell Populations | Cycle 2 Day 1 | -21.31 10^6 cells/L |
| DLBCL Subtype | Absolute Change From Baseline in Measurements of NK Cell Populations | Cycle 3 Day 15 | -46.00 10^6 cells/L |
| DLBCL Subtype | Absolute Change From Baseline in Measurements of NK Cell Populations | Cycle 1 Day 8 | 20.00 10^6 cells/L |
| DLBCL Subtype | Absolute Change From Baseline in Measurements of NK Cell Populations | Cycle 2 Day 15 | -14.00 10^6 cells/L |
| DLBCL Subtype | Absolute Change From Baseline in Measurements of NK Cell Populations | Cycle 1 Day 22 | 27.06 10^6 cells/L |
| DLBCL Subtype | Absolute Change From Baseline in Measurements of NK Cell Populations | Cycle 1 Day 15 | -4.00 10^6 cells/L |
| DLBCL Subtype | Absolute Change From Baseline in Measurements of NK Cell Populations | Cycle 2 Day 28 | 52.00 10^6 cells/L |
| DLBCL Subtype | Absolute Change From Baseline in Measurements of NK Cell Populations | Cycle 3 Day 28 | 0.62 10^6 cells/L |
| DLBCL Subtype | Absolute Change From Baseline in Measurements of NK Cell Populations | Study Completion/Early Termination | -20.74 10^6 cells/L |
| DLBCL Subtype | Absolute Change From Baseline in Measurements of NK Cell Populations | Cycle 3 Day 1 | -11.76 10^6 cells/L |
| MCL Subtype | Absolute Change From Baseline in Measurements of NK Cell Populations | Cycle 3 Day 1 | -104.00 10^6 cells/L |
| MCL Subtype | Absolute Change From Baseline in Measurements of NK Cell Populations | Cycle 3 Day 15 | -99.00 10^6 cells/L |
| MCL Subtype | Absolute Change From Baseline in Measurements of NK Cell Populations | Cycle 1 Day 15 | -33.00 10^6 cells/L |
| MCL Subtype | Absolute Change From Baseline in Measurements of NK Cell Populations | Study Completion/Early Termination | 1.15 10^6 cells/L |
| MCL Subtype | Absolute Change From Baseline in Measurements of NK Cell Populations | Cycle 3 Day 28 | -70.00 10^6 cells/L |
| MCL Subtype | Absolute Change From Baseline in Measurements of NK Cell Populations | Cycle 1 Day 8 | -59.50 10^6 cells/L |
| MCL Subtype | Absolute Change From Baseline in Measurements of NK Cell Populations | Cycle 2 Day 28 | -93.00 10^6 cells/L |
| MCL Subtype | Absolute Change From Baseline in Measurements of NK Cell Populations | Cycle 2 Day 15 | -116.65 10^6 cells/L |
| MCL Subtype | Absolute Change From Baseline in Measurements of NK Cell Populations | Cycle 2 Day 1 | -64.00 10^6 cells/L |
| MCL Subtype | Absolute Change From Baseline in Measurements of NK Cell Populations | Cycle 1 Day 22 | -133.68 10^6 cells/L |
| Other iNHL | Absolute Change From Baseline in Measurements of NK Cell Populations | Cycle 3 Day 1 | -80.00 10^6 cells/L |
| Other iNHL | Absolute Change From Baseline in Measurements of NK Cell Populations | Cycle 2 Day 1 | -1.00 10^6 cells/L |
| Other iNHL | Absolute Change From Baseline in Measurements of NK Cell Populations | Cycle 2 Day 15 | -51.50 10^6 cells/L |
| Other iNHL | Absolute Change From Baseline in Measurements of NK Cell Populations | Cycle 2 Day 28 | 9.50 10^6 cells/L |
| Other iNHL | Absolute Change From Baseline in Measurements of NK Cell Populations | Cycle 1 Day 8 | 8.00 10^6 cells/L |
| Other iNHL | Absolute Change From Baseline in Measurements of NK Cell Populations | Cycle 3 Day 15 | -84.00 10^6 cells/L |
| Other iNHL | Absolute Change From Baseline in Measurements of NK Cell Populations | Study Completion/Early Termination | 22.00 10^6 cells/L |
| Other iNHL | Absolute Change From Baseline in Measurements of NK Cell Populations | Cycle 3 Day 28 | -13.50 10^6 cells/L |
| Other iNHL | Absolute Change From Baseline in Measurements of NK Cell Populations | Cycle 1 Day 22 | -60.00 10^6 cells/L |
| Other iNHL | Absolute Change From Baseline in Measurements of NK Cell Populations | Cycle 1 Day 15 | -79.00 10^6 cells/L |
| FL + Other iNHL | Absolute Change From Baseline in Measurements of NK Cell Populations | Cycle 2 Day 28 | -3.00 10^6 cells/L |
| FL + Other iNHL | Absolute Change From Baseline in Measurements of NK Cell Populations | Study Completion/Early Termination | -9.00 10^6 cells/L |
| FL + Other iNHL | Absolute Change From Baseline in Measurements of NK Cell Populations | Cycle 1 Day 15 | -38.97 10^6 cells/L |
| FL + Other iNHL | Absolute Change From Baseline in Measurements of NK Cell Populations | Cycle 1 Day 22 | -30.00 10^6 cells/L |
| FL + Other iNHL | Absolute Change From Baseline in Measurements of NK Cell Populations | Cycle 2 Day 15 | -7.00 10^6 cells/L |
| FL + Other iNHL | Absolute Change From Baseline in Measurements of NK Cell Populations | Cycle 3 Day 1 | -23.00 10^6 cells/L |
| FL + Other iNHL | Absolute Change From Baseline in Measurements of NK Cell Populations | Cycle 2 Day 1 | -7.00 10^6 cells/L |
| FL + Other iNHL | Absolute Change From Baseline in Measurements of NK Cell Populations | Cycle 3 Day 15 | -29.00 10^6 cells/L |
| FL + Other iNHL | Absolute Change From Baseline in Measurements of NK Cell Populations | Cycle 1 Day 8 | -20.00 10^6 cells/L |
| FL + Other iNHL | Absolute Change From Baseline in Measurements of NK Cell Populations | Cycle 3 Day 28 | -13.50 10^6 cells/L |
Secondary
Absolute Change From Baseline in Measurements of T-cell Populations
Actual change from baseline will be summarized descriptively by visit for the pharmacodynamic parameter: T-cell populations
Time frame: Cycle 1 Day 1 (Baseline) to Cycle 1: Days 8, 15, and 22; Cycles 2 and 3: Days 1, 15, and 28 (each cycle is 28 days); End of Study (up to 7.5 years)
Population: Pharmacodynamic samples were collected at timepoints through the study where possible. Per pre-specified analysis plan, statistical summaries are provided overall, by NHL subtype, and for the combined group comprising FL patients + other iNHL patients.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Total | Absolute Change From Baseline in Measurements of T-cell Populations | Cycle 2 Day 28 | 99.00 10^6 cells/L |
| Total | Absolute Change From Baseline in Measurements of T-cell Populations | Cycle 2 Day 1 | 17.50 10^6 cells/L |
| Total | Absolute Change From Baseline in Measurements of T-cell Populations | Cycle 1 Day 22 | -10.00 10^6 cells/L |
| Total | Absolute Change From Baseline in Measurements of T-cell Populations | Study Completion/Early Termination | -57.50 10^6 cells/L |
| Total | Absolute Change From Baseline in Measurements of T-cell Populations | Cycle 3 Day 28 | 102.45 10^6 cells/L |
| Total | Absolute Change From Baseline in Measurements of T-cell Populations | Cycle 3 Day 15 | 110.00 10^6 cells/L |
| Total | Absolute Change From Baseline in Measurements of T-cell Populations | Cycle 2 Day 15 | 88.00 10^6 cells/L |
| Total | Absolute Change From Baseline in Measurements of T-cell Populations | Cycle 1 Day 15 | 12.00 10^6 cells/L |
| Total | Absolute Change From Baseline in Measurements of T-cell Populations | Cycle 1 Day 8 | 41.00 10^6 cells/L |
| Total | Absolute Change From Baseline in Measurements of T-cell Populations | Cycle 3 Day 1 | 58.00 10^6 cells/L |
| FL Subtype | Absolute Change From Baseline in Measurements of T-cell Populations | Cycle 3 Day 1 | 45.00 10^6 cells/L |
| FL Subtype | Absolute Change From Baseline in Measurements of T-cell Populations | Cycle 1 Day 8 | 12.38 10^6 cells/L |
| FL Subtype | Absolute Change From Baseline in Measurements of T-cell Populations | Cycle 1 Day 15 | 3.00 10^6 cells/L |
| FL Subtype | Absolute Change From Baseline in Measurements of T-cell Populations | Cycle 1 Day 22 | -31.00 10^6 cells/L |
| FL Subtype | Absolute Change From Baseline in Measurements of T-cell Populations | Cycle 2 Day 1 | -26.00 10^6 cells/L |
| FL Subtype | Absolute Change From Baseline in Measurements of T-cell Populations | Cycle 2 Day 15 | 59.98 10^6 cells/L |
| FL Subtype | Absolute Change From Baseline in Measurements of T-cell Populations | Cycle 2 Day 28 | 32.87 10^6 cells/L |
| FL Subtype | Absolute Change From Baseline in Measurements of T-cell Populations | Cycle 3 Day 15 | 94.00 10^6 cells/L |
| FL Subtype | Absolute Change From Baseline in Measurements of T-cell Populations | Cycle 3 Day 28 | 72.23 10^6 cells/L |
| FL Subtype | Absolute Change From Baseline in Measurements of T-cell Populations | Study Completion/Early Termination | -104.00 10^6 cells/L |
| DLBCL Subtype | Absolute Change From Baseline in Measurements of T-cell Populations | Cycle 3 Day 15 | 203.50 10^6 cells/L |
| DLBCL Subtype | Absolute Change From Baseline in Measurements of T-cell Populations | Study Completion/Early Termination | -84.00 10^6 cells/L |
| DLBCL Subtype | Absolute Change From Baseline in Measurements of T-cell Populations | Cycle 2 Day 28 | 176.64 10^6 cells/L |
| DLBCL Subtype | Absolute Change From Baseline in Measurements of T-cell Populations | Cycle 2 Day 15 | 72.00 10^6 cells/L |
| DLBCL Subtype | Absolute Change From Baseline in Measurements of T-cell Populations | Cycle 2 Day 1 | 42.50 10^6 cells/L |
| DLBCL Subtype | Absolute Change From Baseline in Measurements of T-cell Populations | Cycle 1 Day 22 | 26.00 10^6 cells/L |
| DLBCL Subtype | Absolute Change From Baseline in Measurements of T-cell Populations | Cycle 1 Day 15 | 28.00 10^6 cells/L |
| DLBCL Subtype | Absolute Change From Baseline in Measurements of T-cell Populations | Cycle 3 Day 28 | 198.31 10^6 cells/L |
| DLBCL Subtype | Absolute Change From Baseline in Measurements of T-cell Populations | Cycle 3 Day 1 | 115.00 10^6 cells/L |
| DLBCL Subtype | Absolute Change From Baseline in Measurements of T-cell Populations | Cycle 1 Day 8 | 89.00 10^6 cells/L |
| MCL Subtype | Absolute Change From Baseline in Measurements of T-cell Populations | Cycle 3 Day 1 | 174.00 10^6 cells/L |
| MCL Subtype | Absolute Change From Baseline in Measurements of T-cell Populations | Cycle 1 Day 8 | -55.92 10^6 cells/L |
| MCL Subtype | Absolute Change From Baseline in Measurements of T-cell Populations | Cycle 1 Day 22 | -3.00 10^6 cells/L |
| MCL Subtype | Absolute Change From Baseline in Measurements of T-cell Populations | Study Completion/Early Termination | 165.00 10^6 cells/L |
| MCL Subtype | Absolute Change From Baseline in Measurements of T-cell Populations | Cycle 3 Day 15 | 599.00 10^6 cells/L |
| MCL Subtype | Absolute Change From Baseline in Measurements of T-cell Populations | Cycle 2 Day 15 | 164.00 10^6 cells/L |
| MCL Subtype | Absolute Change From Baseline in Measurements of T-cell Populations | Cycle 2 Day 1 | -96.00 10^6 cells/L |
| MCL Subtype | Absolute Change From Baseline in Measurements of T-cell Populations | Cycle 1 Day 15 | -22.00 10^6 cells/L |
| MCL Subtype | Absolute Change From Baseline in Measurements of T-cell Populations | Cycle 2 Day 28 | 133.00 10^6 cells/L |
| MCL Subtype | Absolute Change From Baseline in Measurements of T-cell Populations | Cycle 3 Day 28 | 131.00 10^6 cells/L |
| Other iNHL | Absolute Change From Baseline in Measurements of T-cell Populations | Cycle 1 Day 15 | -94.00 10^6 cells/L |
| Other iNHL | Absolute Change From Baseline in Measurements of T-cell Populations | Cycle 2 Day 1 | -40.00 10^6 cells/L |
| Other iNHL | Absolute Change From Baseline in Measurements of T-cell Populations | Cycle 2 Day 15 | 54.50 10^6 cells/L |
| Other iNHL | Absolute Change From Baseline in Measurements of T-cell Populations | Cycle 2 Day 28 | 108.00 10^6 cells/L |
| Other iNHL | Absolute Change From Baseline in Measurements of T-cell Populations | Cycle 3 Day 1 | -32.00 10^6 cells/L |
| Other iNHL | Absolute Change From Baseline in Measurements of T-cell Populations | Cycle 1 Day 8 | 16.00 10^6 cells/L |
| Other iNHL | Absolute Change From Baseline in Measurements of T-cell Populations | Cycle 3 Day 15 | -27.00 10^6 cells/L |
| Other iNHL | Absolute Change From Baseline in Measurements of T-cell Populations | Study Completion/Early Termination | 361.50 10^6 cells/L |
| Other iNHL | Absolute Change From Baseline in Measurements of T-cell Populations | Cycle 3 Day 28 | 72.50 10^6 cells/L |
| Other iNHL | Absolute Change From Baseline in Measurements of T-cell Populations | Cycle 1 Day 22 | -41.00 10^6 cells/L |
| FL + Other iNHL | Absolute Change From Baseline in Measurements of T-cell Populations | Cycle 1 Day 8 | 16.00 10^6 cells/L |
| FL + Other iNHL | Absolute Change From Baseline in Measurements of T-cell Populations | Cycle 2 Day 28 | 38.00 10^6 cells/L |
| FL + Other iNHL | Absolute Change From Baseline in Measurements of T-cell Populations | Cycle 1 Day 22 | -36.00 10^6 cells/L |
| FL + Other iNHL | Absolute Change From Baseline in Measurements of T-cell Populations | Cycle 1 Day 15 | -19.00 10^6 cells/L |
| FL + Other iNHL | Absolute Change From Baseline in Measurements of T-cell Populations | Cycle 3 Day 28 | 72.50 10^6 cells/L |
| FL + Other iNHL | Absolute Change From Baseline in Measurements of T-cell Populations | Cycle 2 Day 15 | 59.98 10^6 cells/L |
| FL + Other iNHL | Absolute Change From Baseline in Measurements of T-cell Populations | Study Completion/Early Termination | -55.00 10^6 cells/L |
| FL + Other iNHL | Absolute Change From Baseline in Measurements of T-cell Populations | Cycle 3 Day 15 | 80.00 10^6 cells/L |
| FL + Other iNHL | Absolute Change From Baseline in Measurements of T-cell Populations | Cycle 3 Day 1 | -4.00 10^6 cells/L |
| FL + Other iNHL | Absolute Change From Baseline in Measurements of T-cell Populations | Cycle 2 Day 1 | -40.00 10^6 cells/L |
Secondary
Duration of Response (DoR)
Time from first CR or PR to first documentation of relapse/progression (any new lesion or increase by ≥ 50% of previously identified site)
Time frame: From first dose until Follow-up Visit 12, up to 4.5 years
Population: Patients in the ITT Population who had any response (CR or PR) during the study. Per pre-specified analysis plan, efficacy analyses are summarized overall, by NHL subtype, and for the combined group comprising FL patients + other iNHL patients.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Total | Duration of Response (DoR) | 24.0 months |
| FL Subtype | Duration of Response (DoR) | 24.0 months |
| DLBCL Subtype | Duration of Response (DoR) | 20.1 months |
| Other iNHL | Duration of Response (DoR) | NA months |
| FL + Other iNHL | Duration of Response (DoR) | NA months |
Secondary
Evaluation of AEs Stratified by Baseline CD19 Expression on Malignant Lymphoma Cells
Incidence of AEs as stratified by presence of CD19 on malignant lymphoma cells detected by tumor biopsy/aspirate during Screening
Time frame: From first dose until 30 days after last dose of MOR00208, up to 8.5 years
Population: Per pre-specified analysis plan, if CD19 expression on tumor cells was able to be measured in less than 15% of the ITT population at screening, the stratification analyses by baseline CD19 expression (as planned in the protocol) would not be performed. It was not possible to measure CD19 expression in sufficient cases for such an analysis to be meaningful.
Secondary
Evaluation of AEs Stratified by FcγRIIa Polymorphism
Incidence of AEs as stratified by FcγRIIa polymorphism subgroups (genotypes HH, HR, or RR)
Time frame: From first dose until 30 days after last dose of MOR00208, up to 8.5 years
Population: Genotyping for FcγRIIa and FcγRIIIa polymorphisms was performed for patients who consented to an optional mucosal cheek swab. Per pre-specified analysis plan, statistical summaries are provided overall, by NHL subtype, and for the combined group comprising FL patients + other iNHL patients.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Total | Evaluation of AEs Stratified by FcγRIIa Polymorphism | Genotype HR | 188 adverse events |
| Total | Evaluation of AEs Stratified by FcγRIIa Polymorphism | Genotype HH | 210 adverse events |
| Total | Evaluation of AEs Stratified by FcγRIIa Polymorphism | Genotype RR | 61 adverse events |
| FL Subtype | Evaluation of AEs Stratified by FcγRIIa Polymorphism | Genotype HR | 83 adverse events |
| FL Subtype | Evaluation of AEs Stratified by FcγRIIa Polymorphism | Genotype HH | 64 adverse events |
| FL Subtype | Evaluation of AEs Stratified by FcγRIIa Polymorphism | Genotype RR | 5 adverse events |
| DLBCL Subtype | Evaluation of AEs Stratified by FcγRIIa Polymorphism | Genotype HR | 51 adverse events |
| DLBCL Subtype | Evaluation of AEs Stratified by FcγRIIa Polymorphism | Genotype HH | 109 adverse events |
| DLBCL Subtype | Evaluation of AEs Stratified by FcγRIIa Polymorphism | Genotype RR | 44 adverse events |
| MCL Subtype | Evaluation of AEs Stratified by FcγRIIa Polymorphism | Genotype HR | 6 adverse events |
| MCL Subtype | Evaluation of AEs Stratified by FcγRIIa Polymorphism | Genotype HH | 29 adverse events |
| MCL Subtype | Evaluation of AEs Stratified by FcγRIIa Polymorphism | Genotype RR | 4 adverse events |
| Other iNHL | Evaluation of AEs Stratified by FcγRIIa Polymorphism | Genotype HR | 48 adverse events |
| Other iNHL | Evaluation of AEs Stratified by FcγRIIa Polymorphism | Genotype HH | 8 adverse events |
| Other iNHL | Evaluation of AEs Stratified by FcγRIIa Polymorphism | Genotype RR | 8 adverse events |
| FL + Other iNHL | Evaluation of AEs Stratified by FcγRIIa Polymorphism | Genotype HH | 72 adverse events |
| FL + Other iNHL | Evaluation of AEs Stratified by FcγRIIa Polymorphism | Genotype RR | 13 adverse events |
| FL + Other iNHL | Evaluation of AEs Stratified by FcγRIIa Polymorphism | Genotype HR | 131 adverse events |
Secondary
Evaluation of AEs Stratified by FcγRIIIa Polymorphism
Incidence of AEs as stratified by FcγRIIIa polymorphism subgroups (genotypes FF, FV, or VV)
Time frame: From first dose until 30 days after last dose of MOR00208, up to 8.5 years
Population: Genotyping for FcγRIIa and FcγRIIIa polymorphisms was performed for patients who consented to an optional mucosal cheek swab. Per pre-specified analysis plan, statistical summaries are provided overall, by NHL subtype, and for the combined group comprising FL patients + other iNHL patients.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Total | Evaluation of AEs Stratified by FcγRIIIa Polymorphism | Genotype FV | 149 adverse events |
| Total | Evaluation of AEs Stratified by FcγRIIIa Polymorphism | Genotype VV | 200 adverse events |
| Total | Evaluation of AEs Stratified by FcγRIIIa Polymorphism | Genotype FF | 110 adverse events |
| FL Subtype | Evaluation of AEs Stratified by FcγRIIIa Polymorphism | Genotype FV | 75 adverse events |
| FL Subtype | Evaluation of AEs Stratified by FcγRIIIa Polymorphism | Genotype FF | 51 adverse events |
| FL Subtype | Evaluation of AEs Stratified by FcγRIIIa Polymorphism | Genotype VV | 26 adverse events |
| DLBCL Subtype | Evaluation of AEs Stratified by FcγRIIIa Polymorphism | Genotype VV | 112 adverse events |
| DLBCL Subtype | Evaluation of AEs Stratified by FcγRIIIa Polymorphism | Genotype FF | 59 adverse events |
| DLBCL Subtype | Evaluation of AEs Stratified by FcγRIIIa Polymorphism | Genotype FV | 33 adverse events |
| MCL Subtype | Evaluation of AEs Stratified by FcγRIIIa Polymorphism | Genotype FV | 33 adverse events |
| MCL Subtype | Evaluation of AEs Stratified by FcγRIIIa Polymorphism | Genotype FF | 0 adverse events |
| MCL Subtype | Evaluation of AEs Stratified by FcγRIIIa Polymorphism | Genotype VV | 6 adverse events |
| Other iNHL | Evaluation of AEs Stratified by FcγRIIIa Polymorphism | Genotype FV | 8 adverse events |
| Other iNHL | Evaluation of AEs Stratified by FcγRIIIa Polymorphism | Genotype FF | 0 adverse events |
| Other iNHL | Evaluation of AEs Stratified by FcγRIIIa Polymorphism | Genotype VV | 56 adverse events |
| FL + Other iNHL | Evaluation of AEs Stratified by FcγRIIIa Polymorphism | Genotype VV | 82 adverse events |
| FL + Other iNHL | Evaluation of AEs Stratified by FcγRIIIa Polymorphism | Genotype FV | 83 adverse events |
| FL + Other iNHL | Evaluation of AEs Stratified by FcγRIIIa Polymorphism | Genotype FF | 51 adverse events |
Secondary
Evaluation of ORR Stratified by Baseline CD19 Expression on Malignant Lymphoma Cells
The analysis of the primary endpoint (ORR) will additionally be stratified by presence of CD19 on malignant lymphoma cells detected by tumor biopsy/aspirate during Screening
Time frame: From first dose until Follow-up Visit 12, up to 4.5 years
Population: Per pre-specified analysis plan, if CD19 expression on tumor cells was able to be measured in less than 15% of the ITT population at screening, the stratification analyses by baseline CD19 expression (as planned in the protocol) would not be performed. It was not possible to measure CD19 expression in sufficient cases for such an analysis to be meaningful.
Secondary
Evaluation of ORR Stratified by FcγRIIa Polymorphism
The analysis of the primary endpoint (ORR) will additionally be stratified by FcγRIIa polymorphism subgroups (genotypes HH, HR, or RR)
Time frame: From first dose until Follow-up Visit 12, up to 4.5 years
Population: Genotyping for FcγRIIa and FcγRIIIa polymorphisms was performed for patients who consented to an optional mucosal cheek swab. Per pre-specified analysis plan, statistical summaries are provided overall, by NHL subtype, and for the combined group comprising FL patients + other iNHL patients.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Total | Evaluation of ORR Stratified by FcγRIIa Polymorphism | Genotype HR | 8 Participants |
| Total | Evaluation of ORR Stratified by FcγRIIa Polymorphism | Genotype HH | 6 Participants |
| Total | Evaluation of ORR Stratified by FcγRIIa Polymorphism | Genotype RR | 3 Participants |
| FL Subtype | Evaluation of ORR Stratified by FcγRIIa Polymorphism | Genotype HR | 3 Participants |
| FL Subtype | Evaluation of ORR Stratified by FcγRIIa Polymorphism | Genotype HH | 2 Participants |
| FL Subtype | Evaluation of ORR Stratified by FcγRIIa Polymorphism | Genotype RR | 0 Participants |
| DLBCL Subtype | Evaluation of ORR Stratified by FcγRIIa Polymorphism | Genotype HR | 3 Participants |
| DLBCL Subtype | Evaluation of ORR Stratified by FcγRIIa Polymorphism | Genotype HH | 4 Participants |
| DLBCL Subtype | Evaluation of ORR Stratified by FcγRIIa Polymorphism | Genotype RR | 2 Participants |
| MCL Subtype | Evaluation of ORR Stratified by FcγRIIa Polymorphism | Genotype HR | 0 Participants |
| MCL Subtype | Evaluation of ORR Stratified by FcγRIIa Polymorphism | Genotype HH | 0 Participants |
| MCL Subtype | Evaluation of ORR Stratified by FcγRIIa Polymorphism | Genotype RR | 0 Participants |
| Other iNHL | Evaluation of ORR Stratified by FcγRIIa Polymorphism | Genotype HR | 2 Participants |
| Other iNHL | Evaluation of ORR Stratified by FcγRIIa Polymorphism | Genotype HH | 0 Participants |
| Other iNHL | Evaluation of ORR Stratified by FcγRIIa Polymorphism | Genotype RR | 1 Participants |
| FL + Other iNHL | Evaluation of ORR Stratified by FcγRIIa Polymorphism | Genotype HH | 2 Participants |
| FL + Other iNHL | Evaluation of ORR Stratified by FcγRIIa Polymorphism | Genotype RR | 1 Participants |
| FL + Other iNHL | Evaluation of ORR Stratified by FcγRIIa Polymorphism | Genotype HR | 5 Participants |
Secondary
Evaluation of ORR Stratified by FcγRIIIa Polymorphism
The analysis of the primary endpoint (ORR) will additionally be stratified by FcγRIIIa polymorphism subgroups (genotypes FF, FV, or VV)
Time frame: From first dose until Follow-up Visit 12, up to 4.5 years
Population: Genotyping for FcγRIIa and FcγRIIIa polymorphisms was performed for patients who consented to an optional mucosal cheek swab. Per pre-specified analysis plan, statistical summaries are provided overall, by NHL subtype, and for the combined group comprising FL patients + other iNHL patients.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Total | Evaluation of ORR Stratified by FcγRIIIa Polymorphism | Genotype FV | 5 Participants |
| Total | Evaluation of ORR Stratified by FcγRIIIa Polymorphism | Genotype VV | 2 Participants |
| Total | Evaluation of ORR Stratified by FcγRIIIa Polymorphism | Genotype FF | 10 Participants |
| FL Subtype | Evaluation of ORR Stratified by FcγRIIIa Polymorphism | Genotype FV | 2 Participants |
| FL Subtype | Evaluation of ORR Stratified by FcγRIIIa Polymorphism | Genotype FF | 1 Participants |
| FL Subtype | Evaluation of ORR Stratified by FcγRIIIa Polymorphism | Genotype VV | 2 Participants |
| DLBCL Subtype | Evaluation of ORR Stratified by FcγRIIIa Polymorphism | Genotype VV | 0 Participants |
| DLBCL Subtype | Evaluation of ORR Stratified by FcγRIIIa Polymorphism | Genotype FF | 6 Participants |
| DLBCL Subtype | Evaluation of ORR Stratified by FcγRIIIa Polymorphism | Genotype FV | 3 Participants |
| MCL Subtype | Evaluation of ORR Stratified by FcγRIIIa Polymorphism | Genotype FF | 0 Participants |
| MCL Subtype | Evaluation of ORR Stratified by FcγRIIIa Polymorphism | Genotype FV | 0 Participants |
| MCL Subtype | Evaluation of ORR Stratified by FcγRIIIa Polymorphism | Genotype VV | 0 Participants |
| Other iNHL | Evaluation of ORR Stratified by FcγRIIIa Polymorphism | Genotype FV | 0 Participants |
| Other iNHL | Evaluation of ORR Stratified by FcγRIIIa Polymorphism | Genotype FF | 3 Participants |
| Other iNHL | Evaluation of ORR Stratified by FcγRIIIa Polymorphism | Genotype VV | 0 Participants |
| FL + Other iNHL | Evaluation of ORR Stratified by FcγRIIIa Polymorphism | Genotype FF | 4 Participants |
| FL + Other iNHL | Evaluation of ORR Stratified by FcγRIIIa Polymorphism | Genotype VV | 2 Participants |
| FL + Other iNHL | Evaluation of ORR Stratified by FcγRIIIa Polymorphism | Genotype FV | 2 Participants |
Secondary
Incidence and Severity of Adverse Events (AEs)
Number of patients with treatment-emergent AEs rated Mild, Moderate, and Severe
Time frame: From first dose until 30 days after last dose of MOR00208, up to 8.5 years
Population: The Safety Population consisted of all patients who received at least one dose of study drug. Per pre-specified analysis plan, adverse event analyses are summarized overall, by NHL subtype, and for the combined group comprising FL patients + other iNHL patients.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Total | Incidence and Severity of Adverse Events (AEs) | Mild | 29 Participants |
| Total | Incidence and Severity of Adverse Events (AEs) | Severe | 6 Participants |
| Total | Incidence and Severity of Adverse Events (AEs) | Moderate | 20 Participants |
| FL Subtype | Incidence and Severity of Adverse Events (AEs) | Moderate | 8 Participants |
| FL Subtype | Incidence and Severity of Adverse Events (AEs) | Mild | 10 Participants |
| FL Subtype | Incidence and Severity of Adverse Events (AEs) | Severe | 2 Participants |
| DLBCL Subtype | Incidence and Severity of Adverse Events (AEs) | Moderate | 8 Participants |
| DLBCL Subtype | Incidence and Severity of Adverse Events (AEs) | Mild | 12 Participants |
| DLBCL Subtype | Incidence and Severity of Adverse Events (AEs) | Severe | 4 Participants |
| MCL Subtype | Incidence and Severity of Adverse Events (AEs) | Mild | 1 Participants |
| MCL Subtype | Incidence and Severity of Adverse Events (AEs) | Moderate | 2 Participants |
| MCL Subtype | Incidence and Severity of Adverse Events (AEs) | Severe | 0 Participants |
| Other iNHL | Incidence and Severity of Adverse Events (AEs) | Moderate | 2 Participants |
| Other iNHL | Incidence and Severity of Adverse Events (AEs) | Mild | 6 Participants |
| Other iNHL | Incidence and Severity of Adverse Events (AEs) | Severe | 0 Participants |
| FL + Other iNHL | Incidence and Severity of Adverse Events (AEs) | Severe | 2 Participants |
| FL + Other iNHL | Incidence and Severity of Adverse Events (AEs) | Mild | 16 Participants |
| FL + Other iNHL | Incidence and Severity of Adverse Events (AEs) | Moderate | 10 Participants |
Secondary
Number and Proportion of Patients Who Potentially Developed Anti-MOR00208 Antibodies and Semiquantitative Anti-MOR00208 Antibody Assessments
Number of patients with at least one positive (+ve) post-Baseline sample containing positive anti-MOR00208 antibodies; Baseline (pre-dose) sample has to be tested negative (-ve)
Time frame: From first dose until Follow-up Visit 3, up to 7 months
Population: The Safety Population (all patients who received at least one dose of study drug). Per pre-specified analysis plan, statistical summaries are provided overall, by NHL subtype, and for the combined group comprising FL patients + other iNHL patients.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Total | Number and Proportion of Patients Who Potentially Developed Anti-MOR00208 Antibodies and Semiquantitative Anti-MOR00208 Antibody Assessments | Not evaluable (pre-dose Baseline sample tested +ve) | 5 Participants |
| Total | Number and Proportion of Patients Who Potentially Developed Anti-MOR00208 Antibodies and Semiquantitative Anti-MOR00208 Antibody Assessments | No (Baseline and all post-Baseline samples are -ve) | 82 Participants |
| Total | Number and Proportion of Patients Who Potentially Developed Anti-MOR00208 Antibodies and Semiquantitative Anti-MOR00208 Antibody Assessments | Yes (at least 1 +ve post-Baseline sample, including +ve last sample; Baseline must be -ve) | 0 Participants |
| Total | Number and Proportion of Patients Who Potentially Developed Anti-MOR00208 Antibodies and Semiquantitative Anti-MOR00208 Antibody Assessments | Missing (no post-Baseline measurement available) | 5 Participants |
| Total | Number and Proportion of Patients Who Potentially Developed Anti-MOR00208 Antibodies and Semiquantitative Anti-MOR00208 Antibody Assessments | Transient (at least 1 +ve post-Baseline sample but -ve last sample; Baseline must be -ve) | 0 Participants |
| FL Subtype | Number and Proportion of Patients Who Potentially Developed Anti-MOR00208 Antibodies and Semiquantitative Anti-MOR00208 Antibody Assessments | No (Baseline and all post-Baseline samples are -ve) | 31 Participants |
| FL Subtype | Number and Proportion of Patients Who Potentially Developed Anti-MOR00208 Antibodies and Semiquantitative Anti-MOR00208 Antibody Assessments | Not evaluable (pre-dose Baseline sample tested +ve) | 3 Participants |
| FL Subtype | Number and Proportion of Patients Who Potentially Developed Anti-MOR00208 Antibodies and Semiquantitative Anti-MOR00208 Antibody Assessments | Yes (at least 1 +ve post-Baseline sample, including +ve last sample; Baseline must be -ve) | 0 Participants |
| FL Subtype | Number and Proportion of Patients Who Potentially Developed Anti-MOR00208 Antibodies and Semiquantitative Anti-MOR00208 Antibody Assessments | Missing (no post-Baseline measurement available) | 0 Participants |
| FL Subtype | Number and Proportion of Patients Who Potentially Developed Anti-MOR00208 Antibodies and Semiquantitative Anti-MOR00208 Antibody Assessments | Transient (at least 1 +ve post-Baseline sample but -ve last sample; Baseline must be -ve) | 0 Participants |
| DLBCL Subtype | Number and Proportion of Patients Who Potentially Developed Anti-MOR00208 Antibodies and Semiquantitative Anti-MOR00208 Antibody Assessments | No (Baseline and all post-Baseline samples are -ve) | 31 Participants |
| DLBCL Subtype | Number and Proportion of Patients Who Potentially Developed Anti-MOR00208 Antibodies and Semiquantitative Anti-MOR00208 Antibody Assessments | Not evaluable (pre-dose Baseline sample tested +ve) | 1 Participants |
| DLBCL Subtype | Number and Proportion of Patients Who Potentially Developed Anti-MOR00208 Antibodies and Semiquantitative Anti-MOR00208 Antibody Assessments | Missing (no post-Baseline measurement available) | 3 Participants |
| DLBCL Subtype | Number and Proportion of Patients Who Potentially Developed Anti-MOR00208 Antibodies and Semiquantitative Anti-MOR00208 Antibody Assessments | Transient (at least 1 +ve post-Baseline sample but -ve last sample; Baseline must be -ve) | 0 Participants |
| DLBCL Subtype | Number and Proportion of Patients Who Potentially Developed Anti-MOR00208 Antibodies and Semiquantitative Anti-MOR00208 Antibody Assessments | Yes (at least 1 +ve post-Baseline sample, including +ve last sample; Baseline must be -ve) | 0 Participants |
| MCL Subtype | Number and Proportion of Patients Who Potentially Developed Anti-MOR00208 Antibodies and Semiquantitative Anti-MOR00208 Antibody Assessments | Transient (at least 1 +ve post-Baseline sample but -ve last sample; Baseline must be -ve) | 0 Participants |
| MCL Subtype | Number and Proportion of Patients Who Potentially Developed Anti-MOR00208 Antibodies and Semiquantitative Anti-MOR00208 Antibody Assessments | Yes (at least 1 +ve post-Baseline sample, including +ve last sample; Baseline must be -ve) | 0 Participants |
| MCL Subtype | Number and Proportion of Patients Who Potentially Developed Anti-MOR00208 Antibodies and Semiquantitative Anti-MOR00208 Antibody Assessments | No (Baseline and all post-Baseline samples are -ve) | 10 Participants |
| MCL Subtype | Number and Proportion of Patients Who Potentially Developed Anti-MOR00208 Antibodies and Semiquantitative Anti-MOR00208 Antibody Assessments | Not evaluable (pre-dose Baseline sample tested +ve) | 1 Participants |
| MCL Subtype | Number and Proportion of Patients Who Potentially Developed Anti-MOR00208 Antibodies and Semiquantitative Anti-MOR00208 Antibody Assessments | Missing (no post-Baseline measurement available) | 1 Participants |
| Other iNHL | Number and Proportion of Patients Who Potentially Developed Anti-MOR00208 Antibodies and Semiquantitative Anti-MOR00208 Antibody Assessments | Not evaluable (pre-dose Baseline sample tested +ve) | 0 Participants |
| Other iNHL | Number and Proportion of Patients Who Potentially Developed Anti-MOR00208 Antibodies and Semiquantitative Anti-MOR00208 Antibody Assessments | Yes (at least 1 +ve post-Baseline sample, including +ve last sample; Baseline must be -ve) | 0 Participants |
| Other iNHL | Number and Proportion of Patients Who Potentially Developed Anti-MOR00208 Antibodies and Semiquantitative Anti-MOR00208 Antibody Assessments | Missing (no post-Baseline measurement available) | 1 Participants |
| Other iNHL | Number and Proportion of Patients Who Potentially Developed Anti-MOR00208 Antibodies and Semiquantitative Anti-MOR00208 Antibody Assessments | No (Baseline and all post-Baseline samples are -ve) | 10 Participants |
| Other iNHL | Number and Proportion of Patients Who Potentially Developed Anti-MOR00208 Antibodies and Semiquantitative Anti-MOR00208 Antibody Assessments | Transient (at least 1 +ve post-Baseline sample but -ve last sample; Baseline must be -ve) | 0 Participants |
| FL + Other iNHL | Number and Proportion of Patients Who Potentially Developed Anti-MOR00208 Antibodies and Semiquantitative Anti-MOR00208 Antibody Assessments | Yes (at least 1 +ve post-Baseline sample, including +ve last sample; Baseline must be -ve) | 0 Participants |
| FL + Other iNHL | Number and Proportion of Patients Who Potentially Developed Anti-MOR00208 Antibodies and Semiquantitative Anti-MOR00208 Antibody Assessments | Not evaluable (pre-dose Baseline sample tested +ve) | 3 Participants |
| FL + Other iNHL | Number and Proportion of Patients Who Potentially Developed Anti-MOR00208 Antibodies and Semiquantitative Anti-MOR00208 Antibody Assessments | No (Baseline and all post-Baseline samples are -ve) | 41 Participants |
| FL + Other iNHL | Number and Proportion of Patients Who Potentially Developed Anti-MOR00208 Antibodies and Semiquantitative Anti-MOR00208 Antibody Assessments | Missing (no post-Baseline measurement available) | 1 Participants |
| FL + Other iNHL | Number and Proportion of Patients Who Potentially Developed Anti-MOR00208 Antibodies and Semiquantitative Anti-MOR00208 Antibody Assessments | Transient (at least 1 +ve post-Baseline sample but -ve last sample; Baseline must be -ve) | 0 Participants |
Secondary
Percent Change From Baseline in Measurements of B-cell Populations
Relative change from baseline will be summarized descriptively by visit for the pharmacodynamic parameter: B-cell populations
Time frame: Cycle 1 Day 1 (Baseline) to Cycle 1: Days 8, 15, and 22; Cycles 2 and 3: Days 1, 15, and 28 (each cycle is 28 days); End of Study (up to 7.5 years)
Population: Pharmacodynamic samples were collected at timepoints through the study where possible. Per pre-specified analysis plan, statistical summaries are provided overall, by NHL subtype, and for the combined group comprising FL patients + other iNHL patients.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Total | Percent Change From Baseline in Measurements of B-cell Populations | Cycle 2 Day 1 | -55.63 percentage change from baseline |
| Total | Percent Change From Baseline in Measurements of B-cell Populations | Cycle 1 Day 22 | -55.88 percentage change from baseline |
| Total | Percent Change From Baseline in Measurements of B-cell Populations | Study Completion/Early Termination | -49.31 percentage change from baseline |
| Total | Percent Change From Baseline in Measurements of B-cell Populations | Cycle 3 Day 28 | -80.00 percentage change from baseline |
| Total | Percent Change From Baseline in Measurements of B-cell Populations | Cycle 3 Day 15 | -72.07 percentage change from baseline |
| Total | Percent Change From Baseline in Measurements of B-cell Populations | Cycle 3 Day 1 | -79.63 percentage change from baseline |
| Total | Percent Change From Baseline in Measurements of B-cell Populations | Cycle 1 Day 15 | -50.00 percentage change from baseline |
| Total | Percent Change From Baseline in Measurements of B-cell Populations | Cycle 1 Day 8 | -42.07 percentage change from baseline |
| Total | Percent Change From Baseline in Measurements of B-cell Populations | Cycle 2 Day 28 | -76.47 percentage change from baseline |
| Total | Percent Change From Baseline in Measurements of B-cell Populations | Cycle 2 Day 15 | -73.80 percentage change from baseline |
| FL Subtype | Percent Change From Baseline in Measurements of B-cell Populations | Cycle 1 Day 15 | -87.11 percentage change from baseline |
| FL Subtype | Percent Change From Baseline in Measurements of B-cell Populations | Cycle 1 Day 8 | -80.64 percentage change from baseline |
| FL Subtype | Percent Change From Baseline in Measurements of B-cell Populations | Cycle 1 Day 22 | -83.23 percentage change from baseline |
| FL Subtype | Percent Change From Baseline in Measurements of B-cell Populations | Cycle 2 Day 1 | -82.65 percentage change from baseline |
| FL Subtype | Percent Change From Baseline in Measurements of B-cell Populations | Cycle 2 Day 15 | -81.98 percentage change from baseline |
| FL Subtype | Percent Change From Baseline in Measurements of B-cell Populations | Cycle 2 Day 28 | -87.25 percentage change from baseline |
| FL Subtype | Percent Change From Baseline in Measurements of B-cell Populations | Cycle 3 Day 1 | -93.06 percentage change from baseline |
| FL Subtype | Percent Change From Baseline in Measurements of B-cell Populations | Cycle 3 Day 15 | -76.61 percentage change from baseline |
| FL Subtype | Percent Change From Baseline in Measurements of B-cell Populations | Cycle 3 Day 28 | -96.06 percentage change from baseline |
| FL Subtype | Percent Change From Baseline in Measurements of B-cell Populations | Study Completion/Early Termination | -87.00 percentage change from baseline |
| DLBCL Subtype | Percent Change From Baseline in Measurements of B-cell Populations | Cycle 2 Day 1 | -40.18 percentage change from baseline |
| DLBCL Subtype | Percent Change From Baseline in Measurements of B-cell Populations | Cycle 3 Day 15 | -45.24 percentage change from baseline |
| DLBCL Subtype | Percent Change From Baseline in Measurements of B-cell Populations | Cycle 1 Day 8 | -0.64 percentage change from baseline |
| DLBCL Subtype | Percent Change From Baseline in Measurements of B-cell Populations | Cycle 2 Day 15 | -67.32 percentage change from baseline |
| DLBCL Subtype | Percent Change From Baseline in Measurements of B-cell Populations | Cycle 1 Day 22 | -35.77 percentage change from baseline |
| DLBCL Subtype | Percent Change From Baseline in Measurements of B-cell Populations | Cycle 1 Day 15 | -32.35 percentage change from baseline |
| DLBCL Subtype | Percent Change From Baseline in Measurements of B-cell Populations | Cycle 2 Day 28 | -59.07 percentage change from baseline |
| DLBCL Subtype | Percent Change From Baseline in Measurements of B-cell Populations | Cycle 3 Day 28 | -66.27 percentage change from baseline |
| DLBCL Subtype | Percent Change From Baseline in Measurements of B-cell Populations | Study Completion/Early Termination | -45.44 percentage change from baseline |
| DLBCL Subtype | Percent Change From Baseline in Measurements of B-cell Populations | Cycle 3 Day 1 | -82.64 percentage change from baseline |
| MCL Subtype | Percent Change From Baseline in Measurements of B-cell Populations | Cycle 3 Day 1 | -3.67 percentage change from baseline |
| MCL Subtype | Percent Change From Baseline in Measurements of B-cell Populations | Cycle 3 Day 15 | -72.07 percentage change from baseline |
| MCL Subtype | Percent Change From Baseline in Measurements of B-cell Populations | Cycle 1 Day 15 | -40.17 percentage change from baseline |
| MCL Subtype | Percent Change From Baseline in Measurements of B-cell Populations | Study Completion/Early Termination | -75.09 percentage change from baseline |
| MCL Subtype | Percent Change From Baseline in Measurements of B-cell Populations | Cycle 3 Day 28 | -79.63 percentage change from baseline |
| MCL Subtype | Percent Change From Baseline in Measurements of B-cell Populations | Cycle 1 Day 8 | -40.32 percentage change from baseline |
| MCL Subtype | Percent Change From Baseline in Measurements of B-cell Populations | Cycle 2 Day 28 | -71.67 percentage change from baseline |
| MCL Subtype | Percent Change From Baseline in Measurements of B-cell Populations | Cycle 2 Day 15 | -74.07 percentage change from baseline |
| MCL Subtype | Percent Change From Baseline in Measurements of B-cell Populations | Cycle 2 Day 1 | -72.03 percentage change from baseline |
| MCL Subtype | Percent Change From Baseline in Measurements of B-cell Populations | Cycle 1 Day 22 | -82.62 percentage change from baseline |
| Other iNHL | Percent Change From Baseline in Measurements of B-cell Populations | Cycle 3 Day 1 | -76.06 percentage change from baseline |
| Other iNHL | Percent Change From Baseline in Measurements of B-cell Populations | Cycle 2 Day 1 | -27.27 percentage change from baseline |
| Other iNHL | Percent Change From Baseline in Measurements of B-cell Populations | Cycle 2 Day 15 | -71.76 percentage change from baseline |
| Other iNHL | Percent Change From Baseline in Measurements of B-cell Populations | Cycle 2 Day 28 | -52.89 percentage change from baseline |
| Other iNHL | Percent Change From Baseline in Measurements of B-cell Populations | Cycle 1 Day 8 | -74.47 percentage change from baseline |
| Other iNHL | Percent Change From Baseline in Measurements of B-cell Populations | Cycle 3 Day 15 | -90.59 percentage change from baseline |
| Other iNHL | Percent Change From Baseline in Measurements of B-cell Populations | Study Completion/Early Termination | -40.86 percentage change from baseline |
| Other iNHL | Percent Change From Baseline in Measurements of B-cell Populations | Cycle 3 Day 28 | -66.60 percentage change from baseline |
| Other iNHL | Percent Change From Baseline in Measurements of B-cell Populations | Cycle 1 Day 22 | -63.83 percentage change from baseline |
| Other iNHL | Percent Change From Baseline in Measurements of B-cell Populations | Cycle 1 Day 15 | -50.00 percentage change from baseline |
| FL + Other iNHL | Percent Change From Baseline in Measurements of B-cell Populations | Cycle 2 Day 28 | -82.87 percentage change from baseline |
| FL + Other iNHL | Percent Change From Baseline in Measurements of B-cell Populations | Study Completion/Early Termination | -87.00 percentage change from baseline |
| FL + Other iNHL | Percent Change From Baseline in Measurements of B-cell Populations | Cycle 1 Day 15 | -82.71 percentage change from baseline |
| FL + Other iNHL | Percent Change From Baseline in Measurements of B-cell Populations | Cycle 1 Day 22 | -68.39 percentage change from baseline |
| FL + Other iNHL | Percent Change From Baseline in Measurements of B-cell Populations | Cycle 2 Day 15 | -78.05 percentage change from baseline |
| FL + Other iNHL | Percent Change From Baseline in Measurements of B-cell Populations | Cycle 3 Day 1 | -79.63 percentage change from baseline |
| FL + Other iNHL | Percent Change From Baseline in Measurements of B-cell Populations | Cycle 2 Day 1 | -80.18 percentage change from baseline |
| FL + Other iNHL | Percent Change From Baseline in Measurements of B-cell Populations | Cycle 3 Day 15 | -90.59 percentage change from baseline |
| FL + Other iNHL | Percent Change From Baseline in Measurements of B-cell Populations | Cycle 1 Day 8 | -76.47 percentage change from baseline |
| FL + Other iNHL | Percent Change From Baseline in Measurements of B-cell Populations | Cycle 3 Day 28 | -90.45 percentage change from baseline |
Secondary
Percent Change From Baseline in Measurements of NK Cell Populations
Relative change from baseline will be summarized descriptively by visit for the pharmacodynamic parameter: NK cell populations
Time frame: Cycle 1 Day 1 (Baseline) to Cycle 1: Days 8, 15, and 22; Cycles 2 and 3: Days 1, 15, and 28 (each cycle is 28 days); End of Study (up to 7.5 years)
Population: Pharmacodynamic samples were collected at timepoints through the study where possible. Per pre-specified analysis plan, statistical summaries are provided overall, by NHL subtype, and for the combined group comprising FL patients + other iNHL patients.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Total | Percent Change From Baseline in Measurements of NK Cell Populations | Cycle 2 Day 1 | -11.17 percentage change from baseline |
| Total | Percent Change From Baseline in Measurements of NK Cell Populations | Cycle 1 Day 22 | -13.38 percentage change from baseline |
| Total | Percent Change From Baseline in Measurements of NK Cell Populations | Study Completion/Early Termination | -11.01 percentage change from baseline |
| Total | Percent Change From Baseline in Measurements of NK Cell Populations | Cycle 3 Day 28 | -6.10 percentage change from baseline |
| Total | Percent Change From Baseline in Measurements of NK Cell Populations | Cycle 3 Day 15 | -20.13 percentage change from baseline |
| Total | Percent Change From Baseline in Measurements of NK Cell Populations | Cycle 3 Day 1 | -14.08 percentage change from baseline |
| Total | Percent Change From Baseline in Measurements of NK Cell Populations | Cycle 1 Day 15 | -18.85 percentage change from baseline |
| Total | Percent Change From Baseline in Measurements of NK Cell Populations | Cycle 1 Day 8 | -1.62 percentage change from baseline |
| Total | Percent Change From Baseline in Measurements of NK Cell Populations | Cycle 2 Day 28 | -1.92 percentage change from baseline |
| Total | Percent Change From Baseline in Measurements of NK Cell Populations | Cycle 2 Day 15 | -8.11 percentage change from baseline |
| FL Subtype | Percent Change From Baseline in Measurements of NK Cell Populations | Cycle 1 Day 15 | -22.39 percentage change from baseline |
| FL Subtype | Percent Change From Baseline in Measurements of NK Cell Populations | Cycle 1 Day 8 | -11.58 percentage change from baseline |
| FL Subtype | Percent Change From Baseline in Measurements of NK Cell Populations | Cycle 1 Day 22 | -13.38 percentage change from baseline |
| FL Subtype | Percent Change From Baseline in Measurements of NK Cell Populations | Cycle 2 Day 1 | -8.03 percentage change from baseline |
| FL Subtype | Percent Change From Baseline in Measurements of NK Cell Populations | Cycle 2 Day 15 | 9.03 percentage change from baseline |
| FL Subtype | Percent Change From Baseline in Measurements of NK Cell Populations | Cycle 2 Day 28 | -4.23 percentage change from baseline |
| FL Subtype | Percent Change From Baseline in Measurements of NK Cell Populations | Cycle 3 Day 1 | -12.83 percentage change from baseline |
| FL Subtype | Percent Change From Baseline in Measurements of NK Cell Populations | Cycle 3 Day 15 | -17.76 percentage change from baseline |
| FL Subtype | Percent Change From Baseline in Measurements of NK Cell Populations | Cycle 3 Day 28 | -2.72 percentage change from baseline |
| FL Subtype | Percent Change From Baseline in Measurements of NK Cell Populations | Study Completion/Early Termination | -11.06 percentage change from baseline |
| DLBCL Subtype | Percent Change From Baseline in Measurements of NK Cell Populations | Cycle 2 Day 1 | -14.97 percentage change from baseline |
| DLBCL Subtype | Percent Change From Baseline in Measurements of NK Cell Populations | Cycle 3 Day 15 | -16.17 percentage change from baseline |
| DLBCL Subtype | Percent Change From Baseline in Measurements of NK Cell Populations | Cycle 1 Day 8 | 13.16 percentage change from baseline |
| DLBCL Subtype | Percent Change From Baseline in Measurements of NK Cell Populations | Cycle 2 Day 15 | -7.13 percentage change from baseline |
| DLBCL Subtype | Percent Change From Baseline in Measurements of NK Cell Populations | Cycle 1 Day 22 | 18.16 percentage change from baseline |
| DLBCL Subtype | Percent Change From Baseline in Measurements of NK Cell Populations | Cycle 1 Day 15 | -1.14 percentage change from baseline |
| DLBCL Subtype | Percent Change From Baseline in Measurements of NK Cell Populations | Cycle 2 Day 28 | 32.57 percentage change from baseline |
| DLBCL Subtype | Percent Change From Baseline in Measurements of NK Cell Populations | Cycle 3 Day 28 | 1.78 percentage change from baseline |
| DLBCL Subtype | Percent Change From Baseline in Measurements of NK Cell Populations | Study Completion/Early Termination | -23.94 percentage change from baseline |
| DLBCL Subtype | Percent Change From Baseline in Measurements of NK Cell Populations | Cycle 3 Day 1 | -8.33 percentage change from baseline |
| MCL Subtype | Percent Change From Baseline in Measurements of NK Cell Populations | Cycle 3 Day 1 | -42.34 percentage change from baseline |
| MCL Subtype | Percent Change From Baseline in Measurements of NK Cell Populations | Cycle 3 Day 15 | -33.00 percentage change from baseline |
| MCL Subtype | Percent Change From Baseline in Measurements of NK Cell Populations | Cycle 1 Day 15 | -25.78 percentage change from baseline |
| MCL Subtype | Percent Change From Baseline in Measurements of NK Cell Populations | Study Completion/Early Termination | 0.78 percentage change from baseline |
| MCL Subtype | Percent Change From Baseline in Measurements of NK Cell Populations | Cycle 3 Day 28 | -38.33 percentage change from baseline |
| MCL Subtype | Percent Change From Baseline in Measurements of NK Cell Populations | Cycle 1 Day 8 | -32.20 percentage change from baseline |
| MCL Subtype | Percent Change From Baseline in Measurements of NK Cell Populations | Cycle 2 Day 28 | -48.44 percentage change from baseline |
| MCL Subtype | Percent Change From Baseline in Measurements of NK Cell Populations | Cycle 2 Day 15 | -41.00 percentage change from baseline |
| MCL Subtype | Percent Change From Baseline in Measurements of NK Cell Populations | Cycle 2 Day 1 | -50.00 percentage change from baseline |
| MCL Subtype | Percent Change From Baseline in Measurements of NK Cell Populations | Cycle 1 Day 22 | -50.87 percentage change from baseline |
| Other iNHL | Percent Change From Baseline in Measurements of NK Cell Populations | Cycle 3 Day 1 | -31.97 percentage change from baseline |
| Other iNHL | Percent Change From Baseline in Measurements of NK Cell Populations | Cycle 2 Day 1 | -0.16 percentage change from baseline |
| Other iNHL | Percent Change From Baseline in Measurements of NK Cell Populations | Cycle 2 Day 15 | -20.08 percentage change from baseline |
| Other iNHL | Percent Change From Baseline in Measurements of NK Cell Populations | Cycle 2 Day 28 | 35.32 percentage change from baseline |
| Other iNHL | Percent Change From Baseline in Measurements of NK Cell Populations | Cycle 1 Day 8 | 13.79 percentage change from baseline |
| Other iNHL | Percent Change From Baseline in Measurements of NK Cell Populations | Cycle 3 Day 15 | -32.43 percentage change from baseline |
| Other iNHL | Percent Change From Baseline in Measurements of NK Cell Populations | Study Completion/Early Termination | 42.15 percentage change from baseline |
| Other iNHL | Percent Change From Baseline in Measurements of NK Cell Populations | Cycle 3 Day 28 | -5.37 percentage change from baseline |
| Other iNHL | Percent Change From Baseline in Measurements of NK Cell Populations | Cycle 1 Day 22 | -36.21 percentage change from baseline |
| Other iNHL | Percent Change From Baseline in Measurements of NK Cell Populations | Cycle 1 Day 15 | -32.11 percentage change from baseline |
| FL + Other iNHL | Percent Change From Baseline in Measurements of NK Cell Populations | Cycle 2 Day 28 | -4.23 percentage change from baseline |
| FL + Other iNHL | Percent Change From Baseline in Measurements of NK Cell Populations | Study Completion/Early Termination | -10.49 percentage change from baseline |
| FL + Other iNHL | Percent Change From Baseline in Measurements of NK Cell Populations | Cycle 1 Day 15 | -22.45 percentage change from baseline |
| FL + Other iNHL | Percent Change From Baseline in Measurements of NK Cell Populations | Cycle 1 Day 22 | -14.59 percentage change from baseline |
| FL + Other iNHL | Percent Change From Baseline in Measurements of NK Cell Populations | Cycle 2 Day 15 | -1.51 percentage change from baseline |
| FL + Other iNHL | Percent Change From Baseline in Measurements of NK Cell Populations | Cycle 3 Day 1 | -13.22 percentage change from baseline |
| FL + Other iNHL | Percent Change From Baseline in Measurements of NK Cell Populations | Cycle 2 Day 1 | -6.48 percentage change from baseline |
| FL + Other iNHL | Percent Change From Baseline in Measurements of NK Cell Populations | Cycle 3 Day 15 | -20.37 percentage change from baseline |
| FL + Other iNHL | Percent Change From Baseline in Measurements of NK Cell Populations | Cycle 1 Day 8 | -8.66 percentage change from baseline |
| FL + Other iNHL | Percent Change From Baseline in Measurements of NK Cell Populations | Cycle 3 Day 28 | -5.37 percentage change from baseline |
Secondary
Percent Change From Baseline in Measurements of T-cell Populations
Relative change from baseline will be summarized descriptively by visit for the pharmacodynamic parameter: T-cell populations
Time frame: Cycle 1 Day 1 (Baseline) to Cycle 1: Days 8, 15, and 22; Cycles 2 and 3: Days 1, 15, and 28 (each cycle is 28 days); End of Study (up to 7.5 years)
Population: Pharmacodynamic samples were collected at timepoints through the study where possible. Per pre-specified analysis plan, statistical summaries are provided overall, by NHL subtype, and for the combined group comprising FL patients + other iNHL patients.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Total | Percent Change From Baseline in Measurements of T-cell Populations | Cycle 2 Day 1 | 2.93 percentage change from baseline |
| Total | Percent Change From Baseline in Measurements of T-cell Populations | Cycle 1 Day 22 | -1.63 percentage change from baseline |
| Total | Percent Change From Baseline in Measurements of T-cell Populations | Study Completion/Early Termination | -8.07 percentage change from baseline |
| Total | Percent Change From Baseline in Measurements of T-cell Populations | Cycle 3 Day 28 | 17.34 percentage change from baseline |
| Total | Percent Change From Baseline in Measurements of T-cell Populations | Cycle 3 Day 15 | 20.09 percentage change from baseline |
| Total | Percent Change From Baseline in Measurements of T-cell Populations | Cycle 3 Day 1 | 12.99 percentage change from baseline |
| Total | Percent Change From Baseline in Measurements of T-cell Populations | Cycle 1 Day 15 | 1.75 percentage change from baseline |
| Total | Percent Change From Baseline in Measurements of T-cell Populations | Cycle 1 Day 8 | 7.28 percentage change from baseline |
| Total | Percent Change From Baseline in Measurements of T-cell Populations | Cycle 2 Day 28 | 9.91 percentage change from baseline |
| Total | Percent Change From Baseline in Measurements of T-cell Populations | Cycle 2 Day 15 | 10.39 percentage change from baseline |
| FL Subtype | Percent Change From Baseline in Measurements of T-cell Populations | Cycle 1 Day 15 | 1.25 percentage change from baseline |
| FL Subtype | Percent Change From Baseline in Measurements of T-cell Populations | Cycle 1 Day 8 | 1.59 percentage change from baseline |
| FL Subtype | Percent Change From Baseline in Measurements of T-cell Populations | Cycle 1 Day 22 | -1.83 percentage change from baseline |
| FL Subtype | Percent Change From Baseline in Measurements of T-cell Populations | Cycle 2 Day 1 | -1.63 percentage change from baseline |
| FL Subtype | Percent Change From Baseline in Measurements of T-cell Populations | Cycle 2 Day 15 | 7.34 percentage change from baseline |
| FL Subtype | Percent Change From Baseline in Measurements of T-cell Populations | Cycle 2 Day 28 | 5.96 percentage change from baseline |
| FL Subtype | Percent Change From Baseline in Measurements of T-cell Populations | Cycle 3 Day 1 | 9.60 percentage change from baseline |
| FL Subtype | Percent Change From Baseline in Measurements of T-cell Populations | Cycle 3 Day 15 | 9.57 percentage change from baseline |
| FL Subtype | Percent Change From Baseline in Measurements of T-cell Populations | Cycle 3 Day 28 | 11.37 percentage change from baseline |
| FL Subtype | Percent Change From Baseline in Measurements of T-cell Populations | Study Completion/Early Termination | -12.80 percentage change from baseline |
| DLBCL Subtype | Percent Change From Baseline in Measurements of T-cell Populations | Cycle 2 Day 1 | 10.38 percentage change from baseline |
| DLBCL Subtype | Percent Change From Baseline in Measurements of T-cell Populations | Cycle 3 Day 15 | 20.66 percentage change from baseline |
| DLBCL Subtype | Percent Change From Baseline in Measurements of T-cell Populations | Cycle 1 Day 8 | 17.07 percentage change from baseline |
| DLBCL Subtype | Percent Change From Baseline in Measurements of T-cell Populations | Cycle 2 Day 15 | 15.35 percentage change from baseline |
| DLBCL Subtype | Percent Change From Baseline in Measurements of T-cell Populations | Cycle 1 Day 22 | 5.62 percentage change from baseline |
| DLBCL Subtype | Percent Change From Baseline in Measurements of T-cell Populations | Cycle 1 Day 15 | 8.81 percentage change from baseline |
| DLBCL Subtype | Percent Change From Baseline in Measurements of T-cell Populations | Cycle 2 Day 28 | 36.51 percentage change from baseline |
| DLBCL Subtype | Percent Change From Baseline in Measurements of T-cell Populations | Cycle 3 Day 28 | 21.90 percentage change from baseline |
| DLBCL Subtype | Percent Change From Baseline in Measurements of T-cell Populations | Study Completion/Early Termination | -8.07 percentage change from baseline |
| DLBCL Subtype | Percent Change From Baseline in Measurements of T-cell Populations | Cycle 3 Day 1 | 18.67 percentage change from baseline |
| MCL Subtype | Percent Change From Baseline in Measurements of T-cell Populations | Cycle 3 Day 1 | 17.49 percentage change from baseline |
| MCL Subtype | Percent Change From Baseline in Measurements of T-cell Populations | Cycle 3 Day 15 | 44.73 percentage change from baseline |
| MCL Subtype | Percent Change From Baseline in Measurements of T-cell Populations | Cycle 1 Day 15 | -4.01 percentage change from baseline |
| MCL Subtype | Percent Change From Baseline in Measurements of T-cell Populations | Study Completion/Early Termination | 12.32 percentage change from baseline |
| MCL Subtype | Percent Change From Baseline in Measurements of T-cell Populations | Cycle 3 Day 28 | 23.86 percentage change from baseline |
| MCL Subtype | Percent Change From Baseline in Measurements of T-cell Populations | Cycle 1 Day 8 | -7.26 percentage change from baseline |
| MCL Subtype | Percent Change From Baseline in Measurements of T-cell Populations | Cycle 2 Day 28 | 20.58 percentage change from baseline |
| MCL Subtype | Percent Change From Baseline in Measurements of T-cell Populations | Cycle 2 Day 15 | 12.25 percentage change from baseline |
| MCL Subtype | Percent Change From Baseline in Measurements of T-cell Populations | Cycle 2 Day 1 | -12.48 percentage change from baseline |
| MCL Subtype | Percent Change From Baseline in Measurements of T-cell Populations | Cycle 1 Day 22 | -0.41 percentage change from baseline |
| Other iNHL | Percent Change From Baseline in Measurements of T-cell Populations | Cycle 3 Day 1 | -2.37 percentage change from baseline |
| Other iNHL | Percent Change From Baseline in Measurements of T-cell Populations | Cycle 2 Day 1 | -12.78 percentage change from baseline |
| Other iNHL | Percent Change From Baseline in Measurements of T-cell Populations | Cycle 2 Day 15 | 3.46 percentage change from baseline |
| Other iNHL | Percent Change From Baseline in Measurements of T-cell Populations | Cycle 2 Day 28 | 17.52 percentage change from baseline |
| Other iNHL | Percent Change From Baseline in Measurements of T-cell Populations | Cycle 1 Day 8 | 5.11 percentage change from baseline |
| Other iNHL | Percent Change From Baseline in Measurements of T-cell Populations | Cycle 3 Day 15 | -7.63 percentage change from baseline |
| Other iNHL | Percent Change From Baseline in Measurements of T-cell Populations | Study Completion/Early Termination | 28.31 percentage change from baseline |
| Other iNHL | Percent Change From Baseline in Measurements of T-cell Populations | Cycle 3 Day 28 | 17.10 percentage change from baseline |
| Other iNHL | Percent Change From Baseline in Measurements of T-cell Populations | Cycle 1 Day 22 | -10.76 percentage change from baseline |
| Other iNHL | Percent Change From Baseline in Measurements of T-cell Populations | Cycle 1 Day 15 | -17.49 percentage change from baseline |
| FL + Other iNHL | Percent Change From Baseline in Measurements of T-cell Populations | Cycle 2 Day 28 | 7.64 percentage change from baseline |
| FL + Other iNHL | Percent Change From Baseline in Measurements of T-cell Populations | Study Completion/Early Termination | -12.21 percentage change from baseline |
| FL + Other iNHL | Percent Change From Baseline in Measurements of T-cell Populations | Cycle 1 Day 15 | -1.99 percentage change from baseline |
| FL + Other iNHL | Percent Change From Baseline in Measurements of T-cell Populations | Cycle 1 Day 22 | -3.17 percentage change from baseline |
| FL + Other iNHL | Percent Change From Baseline in Measurements of T-cell Populations | Cycle 2 Day 15 | 6.82 percentage change from baseline |
| FL + Other iNHL | Percent Change From Baseline in Measurements of T-cell Populations | Cycle 3 Day 1 | -1.13 percentage change from baseline |
| FL + Other iNHL | Percent Change From Baseline in Measurements of T-cell Populations | Cycle 2 Day 1 | -2.36 percentage change from baseline |
| FL + Other iNHL | Percent Change From Baseline in Measurements of T-cell Populations | Cycle 3 Day 15 | 6.38 percentage change from baseline |
| FL + Other iNHL | Percent Change From Baseline in Measurements of T-cell Populations | Cycle 1 Day 8 | 1.60 percentage change from baseline |
| FL + Other iNHL | Percent Change From Baseline in Measurements of T-cell Populations | Cycle 3 Day 28 | 14.15 percentage change from baseline |
Secondary
Pharmacokinetic (PK) Parameter: Maximum Serum Concentration Observed (Cmax) of MOR00208
The highest concentration of MOR00208 measured in serum
Time frame: Estimated from first dose (samples taken on first day of dosing at pre-dose, end of infusion, after 1 hour, 4 hours, 24 hours, and pre-dose on Day 8)
Population: The PK Population included all patients who had at least one quantifiable serum MOR00208 concentration. PK parameters were calculated as data permitted. Per pre-specified analysis plan, statistical summaries are provided overall, by NHL subtype, and for the combined group comprising FL patients + other iNHL patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total | Pharmacokinetic (PK) Parameter: Maximum Serum Concentration Observed (Cmax) of MOR00208 | 263.1 μg/mL | Standard Deviation 111.35 |
| FL Subtype | Pharmacokinetic (PK) Parameter: Maximum Serum Concentration Observed (Cmax) of MOR00208 | 276.6 μg/mL | Standard Deviation 73.1 |
| DLBCL Subtype | Pharmacokinetic (PK) Parameter: Maximum Serum Concentration Observed (Cmax) of MOR00208 | 253.4 μg/mL | Standard Deviation 157.79 |
| MCL Subtype | Pharmacokinetic (PK) Parameter: Maximum Serum Concentration Observed (Cmax) of MOR00208 | 260.0 μg/mL | Standard Deviation 69.85 |
| Other iNHL | Pharmacokinetic (PK) Parameter: Maximum Serum Concentration Observed (Cmax) of MOR00208 | 251.5 μg/mL | Standard Deviation 70.31 |
| FL + Other iNHL | Pharmacokinetic (PK) Parameter: Maximum Serum Concentration Observed (Cmax) of MOR00208 | 271.2 μg/mL | Standard Deviation 72.42 |
Secondary
PK Parameter: Apparent Terminal Half-life (t[1/2]) of MOR00208
Apparent terminal half-life calculated from ln(2)/λz
Time frame: Estimated from final dose (samples collected on the last day of Cycle 3 [C3D28; each cycle is 28 days long], and Follow-up Visits 1 [C3D28 + 4 weeks], 2 [C3D28 + 10 weeks], and 3 [C3D28 + 16 weeks])
Population: The PK Population included all patients who had at least one quantifiable serum MOR00208 concentration. PK parameters were calculated as data permitted. Per pre-specified analysis plan, statistical summaries are provided overall, by NHL subtype, and for the combined group comprising FL patients + other iNHL patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total | PK Parameter: Apparent Terminal Half-life (t[1/2]) of MOR00208 | 14.75111 days | Standard Deviation 4.680075 |
| FL Subtype | PK Parameter: Apparent Terminal Half-life (t[1/2]) of MOR00208 | 14.87185 days | Standard Deviation 4.863339 |
| MCL Subtype | PK Parameter: Apparent Terminal Half-life (t[1/2]) of MOR00208 | 15.42457 days | Standard Deviation 6.690102 |
| Other iNHL | PK Parameter: Apparent Terminal Half-life (t[1/2]) of MOR00208 | 12.31761 days | — |
| FL + Other iNHL | PK Parameter: Apparent Terminal Half-life (t[1/2]) of MOR00208 | 14.61642 days | Standard Deviation 4.655799 |
Secondary
PK Parameter: Apparent Terminal Rate Constant (λz) of MOR00208
Apparent terminal rate constant calculated from the regression analysis (slope) from the log-transformed measured concentrations on the terminal phase of the time-point concentration curve
Time frame: Estimated from final dose (samples collected on the last day of Cycle 3 [C3D28; each cycle is 28 days long], and Follow-up Visits 1 [C3D28 + 4 weeks], 2 [C3D28 + 10 weeks], and 3 [C3D28 + 16 weeks])
Population: The PK Population included all patients who had at least one quantifiable serum MOR00208 concentration. PK parameters were calculated as data permitted. Per pre-specified analysis plan, statistical summaries are provided overall, by NHL subtype, and for the combined group comprising FL patients + other iNHL patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total | PK Parameter: Apparent Terminal Rate Constant (λz) of MOR00208 | 0.00214 1/h | Standard Deviation 0.000665 |
| FL Subtype | PK Parameter: Apparent Terminal Rate Constant (λz) of MOR00208 | 0.00214 1/h | Standard Deviation 0.000707 |
| MCL Subtype | PK Parameter: Apparent Terminal Rate Constant (λz) of MOR00208 | 0.00207 1/h | Standard Deviation 0.000896 |
| Other iNHL | PK Parameter: Apparent Terminal Rate Constant (λz) of MOR00208 | 0.00234 1/h | — |
| FL + Other iNHL | PK Parameter: Apparent Terminal Rate Constant (λz) of MOR00208 | 0.00216 1/h | Standard Deviation 0.00067 |
Secondary
PK Parameter: Apparent Trough Serum Concentration Before Dosing (Clast) of MOR00208
The last quantifiable concentration from the first dose of MOR00208
Time frame: Estimated from first dose (samples taken on first day of dosing at pre-dose, end of infusion, after 1 hour, 4 hours, 24 hours, and pre-dose on Day 8)
Population: The PK Population included all patients who had at least one quantifiable serum MOR00208 concentration. PK parameters were calculated as data permitted. Per pre-specified analysis plan, statistical summaries are provided overall, by NHL subtype, and for the combined group comprising FL patients + other iNHL patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total | PK Parameter: Apparent Trough Serum Concentration Before Dosing (Clast) of MOR00208 | 81.0 μg/mL | Standard Deviation 36.66 |
| FL Subtype | PK Parameter: Apparent Trough Serum Concentration Before Dosing (Clast) of MOR00208 | 88.6 μg/mL | Standard Deviation 39.5 |
| DLBCL Subtype | PK Parameter: Apparent Trough Serum Concentration Before Dosing (Clast) of MOR00208 | 69.6 μg/mL | Standard Deviation 28.96 |
| MCL Subtype | PK Parameter: Apparent Trough Serum Concentration Before Dosing (Clast) of MOR00208 | 82.4 μg/mL | Standard Deviation 34.54 |
| Other iNHL | PK Parameter: Apparent Trough Serum Concentration Before Dosing (Clast) of MOR00208 | 92.2 μg/mL | Standard Deviation 47.23 |
| FL + Other iNHL | PK Parameter: Apparent Trough Serum Concentration Before Dosing (Clast) of MOR00208 | 89.3 μg/mL | Standard Deviation 40.69 |
Secondary
PK Parameter: Apparent Volume of Distribution (Vz) of MOR00208
Apparent volume of distribution during the terminal phase, calculated from dose/(AUC(0-inf)\*λz)
Time frame: Estimated from final dose (samples collected on the last day of Cycle 3 [C3D28; each cycle is 28 days long], and Follow-up Visits 1 [C3D28 + 4 weeks], 2 [C3D28 + 10 weeks], and 3 [C3D28 + 16 weeks])
Population: The PK Population included all patients who had at least one quantifiable serum MOR00208 concentration. PK parameters were calculated as data permitted. Per pre-specified analysis plan, statistical summaries are provided overall, by NHL subtype, and for the combined group comprising FL patients + other iNHL patients.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Total | PK Parameter: Apparent Volume of Distribution (Vz) of MOR00208 | NA L |
| FL Subtype | PK Parameter: Apparent Volume of Distribution (Vz) of MOR00208 | NA L |
| DLBCL Subtype | PK Parameter: Apparent Volume of Distribution (Vz) of MOR00208 | NA L |
| MCL Subtype | PK Parameter: Apparent Volume of Distribution (Vz) of MOR00208 | NA L |
| Other iNHL | PK Parameter: Apparent Volume of Distribution (Vz) of MOR00208 | NA L |
| FL + Other iNHL | PK Parameter: Apparent Volume of Distribution (Vz) of MOR00208 | NA L |
Secondary
PK Parameter: Area Under the Concentration Curve From Dose Time Zero to Infinity (AUC[0-inf]) of MOR00208
Area under the concentration curve. The time curve from time zero (0) to infinity (inf), where infinity is computed from AUC0-t + \[Ct/λZ)\]. Ct is calculated from the concentration at the last sampling time at which the sample is above LLQ.
Time frame: Estimated from final dose (samples collected on the last day of Cycle 3 [C3D28; each cycle is 28 days long], and Follow-up Visits 1 [C3D28 + 4 weeks], 2 [C3D28 + 10 weeks], and 3 [C3D28 + 16 weeks])
Population: The PK Population included all patients who had at least one quantifiable serum MOR00208 concentration. PK parameters were calculated as data permitted. Per pre-specified analysis plan, statistical summaries are provided overall, by NHL subtype, and for the combined group comprising FL patients + other iNHL patients.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Total | PK Parameter: Area Under the Concentration Curve From Dose Time Zero to Infinity (AUC[0-inf]) of MOR00208 | NA h*μg/mL |
| FL Subtype | PK Parameter: Area Under the Concentration Curve From Dose Time Zero to Infinity (AUC[0-inf]) of MOR00208 | NA h*μg/mL |
| DLBCL Subtype | PK Parameter: Area Under the Concentration Curve From Dose Time Zero to Infinity (AUC[0-inf]) of MOR00208 | NA h*μg/mL |
| MCL Subtype | PK Parameter: Area Under the Concentration Curve From Dose Time Zero to Infinity (AUC[0-inf]) of MOR00208 | NA h*μg/mL |
| Other iNHL | PK Parameter: Area Under the Concentration Curve From Dose Time Zero to Infinity (AUC[0-inf]) of MOR00208 | NA h*μg/mL |
| FL + Other iNHL | PK Parameter: Area Under the Concentration Curve From Dose Time Zero to Infinity (AUC[0-inf]) of MOR00208 | NA h*μg/mL |
Secondary
PK Parameter: Area Under the Concentration Curve From Dose Time Zero to the Time the Last Quantifiable Concentration is Observed (AUC[0-t]) of MOR00208
Area under the concentration curve. The time curve from time zero (0) to the time that the last concentration above the lower limit of quantification (LLQ) is observed.
Time frame: Estimated from first dose (samples taken on first day of dosing at pre-dose, end of infusion, after 1 hour, 4 hours, 24 hours, and pre-dose on Day 8)
Population: The PK Population included all patients who had at least one quantifiable serum MOR00208 concentration. PK parameters were calculated as data permitted. Per pre-specified analysis plan, statistical summaries are provided overall, by NHL subtype, and for the combined group comprising FL patients + other iNHL patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total | PK Parameter: Area Under the Concentration Curve From Dose Time Zero to the Time the Last Quantifiable Concentration is Observed (AUC[0-t]) of MOR00208 | 21942.5 h*μg/mL | Standard Deviation 11847.35 |
| FL Subtype | PK Parameter: Area Under the Concentration Curve From Dose Time Zero to the Time the Last Quantifiable Concentration is Observed (AUC[0-t]) of MOR00208 | 25088.6 h*μg/mL | Standard Deviation 16245.82 |
| DLBCL Subtype | PK Parameter: Area Under the Concentration Curve From Dose Time Zero to the Time the Last Quantifiable Concentration is Observed (AUC[0-t]) of MOR00208 | 19106.3 h*μg/mL | Standard Deviation 8170.03 |
| MCL Subtype | PK Parameter: Area Under the Concentration Curve From Dose Time Zero to the Time the Last Quantifiable Concentration is Observed (AUC[0-t]) of MOR00208 | 21617.1 h*μg/mL | Standard Deviation 4577.21 |
| Other iNHL | PK Parameter: Area Under the Concentration Curve From Dose Time Zero to the Time the Last Quantifiable Concentration is Observed (AUC[0-t]) of MOR00208 | 20888.5 h*μg/mL | Standard Deviation 7669.67 |
| FL + Other iNHL | PK Parameter: Area Under the Concentration Curve From Dose Time Zero to the Time the Last Quantifiable Concentration is Observed (AUC[0-t]) of MOR00208 | 24188.6 h*μg/mL | Standard Deviation 14849.65 |
Secondary
PK Parameter: Time to Maximum Serum Concentration Observed (Tmax) of MOR00208
The time to highest concentration of MOR00208 measured in serum
Time frame: Estimated from first dose (samples taken on first day of dosing at pre-dose, end of infusion, after 1 hour, 4 hours, 24 hours, and pre-dose on Day 8)
Population: The PK Population included all patients who had at least one quantifiable serum MOR00208 concentration. PK parameters were calculated as data permitted. Per pre-specified analysis plan, statistical summaries are provided overall, by NHL subtype, and for the combined group comprising FL patients + other iNHL patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total | PK Parameter: Time to Maximum Serum Concentration Observed (Tmax) of MOR00208 | 5.8 hours | Standard Deviation 17.46 |
| FL Subtype | PK Parameter: Time to Maximum Serum Concentration Observed (Tmax) of MOR00208 | 4.7 hours | Standard Deviation 5.27 |
| DLBCL Subtype | PK Parameter: Time to Maximum Serum Concentration Observed (Tmax) of MOR00208 | 8.5 hours | Standard Deviation 27.99 |
| MCL Subtype | PK Parameter: Time to Maximum Serum Concentration Observed (Tmax) of MOR00208 | 3.0 hours | Standard Deviation 1.03 |
| Other iNHL | PK Parameter: Time to Maximum Serum Concentration Observed (Tmax) of MOR00208 | 3.4 hours | Standard Deviation 1.38 |
| FL + Other iNHL | PK Parameter: Time to Maximum Serum Concentration Observed (Tmax) of MOR00208 | 4.4 hours | Standard Deviation 4.72 |
Secondary
PK Parameter: Total Body Clearance (CL) of MOR00208
Total body clearance calculated for single or multiple doses: dose(s)/AUC(0-inf)
Time frame: Estimated from final dose (samples collected on the last day of Cycle 3 [C3D28; each cycle is 28 days long], and Follow-up Visits 1 [C3D28 + 4 weeks], 2 [C3D28 + 10 weeks], and 3 [C3D28 + 16 weeks])
Population: The PK Population included all patients who had at least one quantifiable serum MOR00208 concentration. PK parameters were calculated as data permitted. Per pre-specified analysis plan, statistical summaries are provided overall, by NHL subtype, and for the combined group comprising FL patients + other iNHL patients.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Total | PK Parameter: Total Body Clearance (CL) of MOR00208 | NA L/h |
| FL Subtype | PK Parameter: Total Body Clearance (CL) of MOR00208 | NA L/h |
| DLBCL Subtype | PK Parameter: Total Body Clearance (CL) of MOR00208 | NA L/h |
| MCL Subtype | PK Parameter: Total Body Clearance (CL) of MOR00208 | NA L/h |
| Other iNHL | PK Parameter: Total Body Clearance (CL) of MOR00208 | NA L/h |
| FL + Other iNHL | PK Parameter: Total Body Clearance (CL) of MOR00208 | NA L/h |
Secondary
Progression-free Survival (PFS)
Time from first dosing until progression or death due to any case
Time frame: From first dose until Follow-up Visit 12, up to 4.5 years
Population: Patients in the ITT Population with documented progression of disease or death from any cause. Per pre-specified analysis plan, efficacy analyses are summarized overall, by NHL subtype, and for the combined group comprising FL patients + other iNHL patients.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Total | Progression-free Survival (PFS) | 5.4 months |
| FL Subtype | Progression-free Survival (PFS) | 8.8 months |
| DLBCL Subtype | Progression-free Survival (PFS) | 2.7 months |
| MCL Subtype | Progression-free Survival (PFS) | 2.1 months |
| Other iNHL | Progression-free Survival (PFS) | NA months |
| FL + Other iNHL | Progression-free Survival (PFS) | 6.6 months |
Secondary
Stable Disease (SD) Rate
Proportion of patients with Stable Disease (failure to attain CR/PR with no progressive disease)
Time frame: From first dose until Follow-up Visit 12, up to 4.5 years
Population: The ITT Population consisted of all patients who received at least one dose of study drug. Patients without any post-Baseline assessment of NHL response were included as non-responders. Per pre-specified analysis plan, efficacy analyses are summarized overall, by NHL subtype, and for the combined group comprising FL patients + other iNHL patients.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Total | Stable Disease (SD) Rate | 31 Participants |
| FL Subtype | Stable Disease (SD) Rate | 16 Participants |
| DLBCL Subtype | Stable Disease (SD) Rate | 5 Participants |
| MCL Subtype | Stable Disease (SD) Rate | 6 Participants |
| Other iNHL | Stable Disease (SD) Rate | 4 Participants |
| FL + Other iNHL | Stable Disease (SD) Rate | 20 Participants |
Secondary
Time to Progression (TTP)
Time from first dosing until documentation of progression or death due to lymphoma
Time frame: From first dose until Follow-up Visit 12, up to 4.5 years
Population: Patients in the ITT Population with documented progression of disease. Per pre-specified analysis plan, efficacy analyses are summarized overall, by NHL subtype, and for the combined group comprising FL patients + other iNHL patients.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Total | Time to Progression (TTP) | 5.4 months |
| FL Subtype | Time to Progression (TTP) | 8.8 months |
| DLBCL Subtype | Time to Progression (TTP) | 3.1 months |
| MCL Subtype | Time to Progression (TTP) | 3.0 months |
| Other iNHL | Time to Progression (TTP) | NA months |
| FL + Other iNHL | Time to Progression (TTP) | 6.6 months |