Diffuse Large B-cell Lymphoma
Conditions
Keywords
DLBCL, Efficacy, MOR00208, Tafasitamab, lenalidomide
Brief summary
This is a Phase II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy of Lenalidomide Combined with MOR00208 in Participants with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R-R DLBCL).
Detailed description
The aim of this single-arm, multicentre, open-label Phase II study is to evaluate the Lenalidomide (LEN) combined with Tafasitamab (MOR00208) in adult participants with DLBCL who had relapsed after or were refractory to at least one, but no more than three previous systemic regimens administered for the treatment of their DLBCL and who were not candidates for high-dose chemotherapy and subsequent Autologous stem cell transplants and were thus considered to have exhausted their therapeutic options. One prior therapy line had to include an anti-CD20 targeted therapy (e.g., rituximab \[RTX\]). MOR00208 and LEN were administered for up to 12 cycles (28 days each), followed by MOR00208 monotherapy until progression, in participants with at least stable disease or a better response.
Interventions
DRUGTafasitamab
12 mg/kg
DRUGLenalidomide
25 mg
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
Major Inclusion Criteria: 1. Age \>18 years 2. Histologically confirmed diagnosis of DLBCL 3. Tumour tissue for central pathology review and correlative studies had to be provided. 4. Participants must had: * relapsed and/or refractory disease * at least one bidimensionally measurable, PET positive disease site (transverse diameter of ≥1.5 cm and perpendicular diameter of ≥1.0 cm at baseline) * received at least one, but no more than three previous systemic regimens for the treatment of DLBCL and one therapy line must had included a CD20-targeted therapy * Eastern Cooperative Oncology Group 0 to 2 5. Participants were not considered in the opinion of the investigator eligible, or participants unwilling to undergo intensive salvage therapy including ASCT 6. Participants had to meet the following laboratory criteria at screening: * absolute neutrophil count ≥1.5 × 10˄9/L * platelet count ≥90 × 10˄9/L * total serum bilirubin ≤2.5 × ULN or ≤5 × ULN in cases of Glibert's Syndrome or liver involvement by lymphoma * alanine transaminase, aspartate aminotransferase and alkaline phosphatase ≤3 × ULN or \<5 × ULN in cases of liver involvement * serum creatinine clearance ≥60 mL/minute 7. Females of childbearing potential (FCBP) must: * not be pregnant * refrain from breastfeeding and donating blood or oocytes * agreed to ongoing pregnancy testing * committed to continued abstinence from heterosexual intercourse, or agree to use and be able to comply with the use of double-barrier contraception 8. Males (if sexually active with a FCBP) had to * use an effective barrier method of contraception * refrain from donating blood or sperm 9. In the opinion of the investigator the participants had to: * be able and willing to receive adequate prophylaxis and/or therapy for thromboembolic events * be able to understand, give written informed consent and comply with all study-related procedures, medication use, and evaluations * had no history of noncompliance in relation to medical regimens or not be considered potentially unreliable and/or uncooperative * be able to understand the reason for complying with the special conditions of the pregnancy prevention risk management plan and gave written acknowledgement of this. Major
Exclusion criteria
1. Participants who had: * other histological type of lymphoma * primary refractory DLBCL * a history of double/triple hit genetics 2. Participants who had, within 14 days prior to Day 1 dosing: * not discontinued CD20-targeted therapy, chemotherapy, radiotherapy, investigational anticancer therapy or other lymphoma specific therapy * underwent major surgery or suffered from significant traumatic injury * received live vaccines. * required parenteral antimicrobial therapy for active, intercurrent infections 3. Participants who: * had, in the opinion of the investigator, not recovered sufficiently from the adverse toxic effects of prior therapies * were previously treated with CD19-targeted therapy or immunomodulatory drugs (IMiDs)® (e.g., thalidomide, LEN) * had a history of hypersensitivity to compounds of similar biological or chemical composition to MOR00208, IMiDs® and/or the excipients contained in the study drug formulations * had undergone ASCT within the period ≤ 3 months prior to the signing of the Informed Consent Form. Patients who had a more distant history of ASCT had to exhibit full haematological recovery before enrolment into the study * had undergone previous allogenic stem cell transplantation * had a history of deep venous thrombosis/embolism, threatening thromboembolism or known thrombophilia or were at a high risk for a thromboembolic event in the opinion of the investigator and who were not willing/able to take venous thromboembolic event prophylaxis during the entire treatment period * concurrently used other anti-cancer or experimental treatments 4. Prior history of malignancies other than DLBCL, unless the participant had been free of the disease for ≥5 years prior to screening. 5. Participants with: * positive hepatitis B and/or C serology. * known seropositivity for or history of active viral infection with human immunodeficiency virus (HIV) * CNS lymphoma involvement * history or evidence of clinically significant cardiovascular, CNS and/or other systemic disease that would in the investigator's opinion preclude participation in the study or compromised the participant's ability to give informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Best Objective Response Rate (ORR) | Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled | ORR = complete response \[CR\] + partial response \[PR\]; Independent Radiology/Clinical Review Committee (IRC) Evaluation. ORR after MOR00208 and Lenalidomide combination therapy assessed by the IRC evaluation. ORR was defined as the number of participants of the total number of participants treated with MOR00208 + LEN with CR or PR as best response achieved at any time during the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DoR by Investigator (INV) Evaluation | Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled | DoR \[months\] = (date of assessment of tumour progression or death - date of assessment of first documented response of (CR or PR) + 1)/30.4375. |
| Progression-free Survival (PFS) by IRC Evaluation | Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled | PFS time was defined as the time (in months) from the date of the first administration of any study drug to the date of tumor progression or death from any cause. |
| PFS by INV Evaluation | Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled | PFS time was defined as the time (in months) from the date of the first administration of any study drug to the date of tumor progression or death from any cause. |
| Overall Survival (OS) | Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled | OS was defined as the time from the date of the first administration of any study drug until death from any cause (documented by the date of death). |
| Disease Control Rate (DCR) by IRC Evaluation | Approximately 2.5 years after first participant enrolled | DCR = CR + PR + SD (Stable disease); IRC Evaluation DCR was defined as the number of participants having CR, PR or SD based on the best objective response achieved at any time during the study. |
| DCR by INV Evaluation | Approximately 2.5 years after first participant enrolled | DCR = CR + PR + SD (Stable disease); IRC Evaluation DCR was defined as the number of participants having CR, PR or SD based on the best objective response achieved at any time during the study. |
| Time to Progression (TTP) by IRC Evaluation | Approximately 2.5 years after first participant enrolled | TTP is defined as the time from the first administration of any study drug until documented DLBCL progression or death as a result of lymphoma. |
| Duration of Response (DoR) by IRC Evaluation | Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled | DoR \[months\] = (date of assessment of tumor progression or death - date of assessment of first documented response of (CR or PR) + 1)/30.4375. |
| Time to Next Treatment (TTNT) | Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled | Kaplan-Meier analysis of TTNT in FAS population. TTNT is defined as the time from the first administration of any study drug to the institution of next anti-neoplastic therapy (for any reason including disease progression, treatment toxicity and participant preference) or death of any cause, whatever comes first. |
| Event-free Survival (EFS) by IRC Evaluation | Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled | EFS is defined as the time (in months) from the date of the first administration of any study drug to the date of tumour progression, first initiation of a new non-study anti-neoplastic therapy or death from any cause whichever comes first. |
| Serum Drug Levels of MOR00208 | Cycle 1 Days 1, 4, 15 predose and 1 hr post-dose; Cycle 2 Days 1, 15 predose and 1 hr post-dose; Cycle 3 Days 1, 15 predose and 1 hr post-dose; Cycles 4, 5, 6, 7, 9, 11,13, 15, 17, 19, 21, 23 Day 1 predose; End of Treatment | The pharmacokinetics (PK) profile of MOR00208 was investigated by quantifying serum drug levels at baseline and after repeated IV administrations for up to 24 treatment cycles using sparse sampling. MOR00208 PK sample was taken pre-dose and 1 hour ± 10 min after the end of MOR00208 infusion for Cycle 1 to Cycle 23. MOR00208 PK sample (pre-dose only) were taken in odd numbered additional treatment cycles only (e.g., treatment Cycles 13, 15,17, 19, 21, 23). |
| Number of Participants Who Developed Anti-MOR00208 Antibodies | Baseline, Up to a maximum of 23 cycles. | The Anti-MOR00208 Antibodies were investigated by quantifying serum drug levels at baseline and after repeated intravenous (IV) administrations planned for up to 24 treatment cycles using sparse sampling. Anti-MOR00208 antibody sample (pre-dose only) were taken in odd numbered additional treatment cycles only (e.g., treatment Cycles 13, 15,17, 19, 21,23). |
| Number of Participants That Experienced Treatment-emergent Adverse Events (TEAEs) | Approximately 6.5 years after first participant enrolled | TEAEs are defined as any adverse event reported in the following time interval (including the lower and upper limits): date of first administration of study treatment; date of last administration of study treatment + 30 days, or if they are considered to be related to the study drug. |
| Severity of Treatment-emergent Adverse Events (TEAEs) | Approximately 6.5 years after first participant enrolled | Number of participants with Severity of TEAEs during MOR00208 and LEN combination therapy. |
| TTP by INV Evaluation | Approximately 2.5 years after first participant enrolled | TTP is defined as the time from the first administration of any study drug until documented DLBCL progression or death as a result of lymphoma. |
Countries
Belgium, Czechia, France, Germany, Hungary, Italy, Poland, Spain, United Kingdom, United States
Participant flow
Recruitment details
The participants were enrolled into this study at sites in Hungary, Belgium, Czechia, France, Poland, Italy, Germany, Spain, United Kingdom, and the United States.
Participants by arm
| Arm | Count |
|---|---|
| Treatment (MOR00208, Lenalidomide) MOR00208:
MOR00208 was administered via IV infusion at a dose of 12 mg/kg. For the first three cycles (Cycles 1 to 3) of the study each cycle consisted of a MOR00208 infusion on Day 1, Day 8, Day 15 and Day 22 of the cycle. Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter MOR00208 was administered on a bi-weekly (every 14 days) basis with infusions on Day 1 and Day 15 of each 28-day cycle.
LEN:
Participants self-administered a starting dose of 25 mg oral LEN daily on Days 1-21 of each cycle, for up to 12 cycles in total. LEN dose could be modified in a de-escalating fashion or discontinued based upon clinical and laboratory findings. On days when both study drugs were given together, LEN was administered prior to MOR00208. | 81 |
| Total | 81 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 16 |
| Overall Study | Death | 2 |
| Overall Study | Physician Decision | 5 |
| Overall Study | Progressive disease/ Disease relapse | 42 |
| Overall Study | Withdrawal by Subject | 8 |
Baseline characteristics
| Characteristic | Treatment (MOR00208, Lenalidomide) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 58 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants |
| Age, Continuous | 69.3 years STANDARD_DEVIATION 9.53 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants |
| Race (NIH/OMB) White | 72 Participants |
| Region of Enrollment Belgium | 5 Participants |
| Region of Enrollment Czechia | 3 Participants |
| Region of Enrollment France | 9 Participants |
| Region of Enrollment Germany | 11 Participants |
| Region of Enrollment Hungary | 7 Participants |
| Region of Enrollment Italy | 13 Participants |
| Region of Enrollment Poland | 7 Participants |
| Region of Enrollment Spain | 15 Participants |
| Region of Enrollment United Kingdom | 5 Participants |
| Region of Enrollment United States | 6 Participants |
| Sex: Female, Male Female | 37 Participants |
| Sex: Female, Male Male | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 45 / 81 |
| other Total, other adverse events | 75 / 81 |
| serious Total, serious adverse events | 47 / 81 |
Outcome results
Primary
Number of Participants With Best Objective Response Rate (ORR)
ORR = complete response \[CR\] + partial response \[PR\]; Independent Radiology/Clinical Review Committee (IRC) Evaluation. ORR after MOR00208 and Lenalidomide combination therapy assessed by the IRC evaluation. ORR was defined as the number of participants of the total number of participants treated with MOR00208 + LEN with CR or PR as best response achieved at any time during the study.
Time frame: Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled
Population: Full analysis set (FAS): The FAS included all participant who received at least one dose of MOR00208 and at least one dose of LEN. This meant that both study drugs had to be administered at least once.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment (MOR00208, Lenalidomide) | Number of Participants With Best Objective Response Rate (ORR) | Approximately 4.5 years after first participant enrolled | 46 Participants |
| Treatment (MOR00208, Lenalidomide) | Number of Participants With Best Objective Response Rate (ORR) | Approximately 6.5 years after first participant enrolled | 46 Participants |
Secondary
DCR by INV Evaluation
DCR = CR + PR + SD (Stable disease); IRC Evaluation DCR was defined as the number of participants having CR, PR or SD based on the best objective response achieved at any time during the study.
Time frame: Approximately 2.5 years after first participant enrolled
Population: FAS: The FAS included all participants who received at least one dose of MOR00208 and at least one dose of LEN. This meant that both study drugs had to be administered at least once.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment (MOR00208, Lenalidomide) | DCR by INV Evaluation | 60 Participants |
Secondary
Disease Control Rate (DCR) by IRC Evaluation
DCR = CR + PR + SD (Stable disease); IRC Evaluation DCR was defined as the number of participants having CR, PR or SD based on the best objective response achieved at any time during the study.
Time frame: Approximately 2.5 years after first participant enrolled
Population: FAS: The FAS included all participants who received at least one dose of MOR00208 and at least one dose of LEN. This meant that both study drugs had to be administered at least once.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment (MOR00208, Lenalidomide) | Disease Control Rate (DCR) by IRC Evaluation | 59 Participants |
Secondary
DoR by Investigator (INV) Evaluation
DoR \[months\] = (date of assessment of tumour progression or death - date of assessment of first documented response of (CR or PR) + 1)/30.4375.
Time frame: Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled
Population: FAS: The FAS included all participants who received at least one dose of MOR00208 and at least one dose of LEN. This meant that both study drugs had to be administered at least once. Inclusive of participants with available data.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Treatment (MOR00208, Lenalidomide) | DoR by Investigator (INV) Evaluation | Approximately 4.5 years after first participant enrolled | 43.9 Months |
| Treatment (MOR00208, Lenalidomide) | DoR by Investigator (INV) Evaluation | Approximately 6.5 years after first participant enrolled | 43.4 Months |
Secondary
Duration of Response (DoR) by IRC Evaluation
DoR \[months\] = (date of assessment of tumor progression or death - date of assessment of first documented response of (CR or PR) + 1)/30.4375.
Time frame: Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled
Population: FAS: The FAS included all participants who received at least one dose of MOR00208 and at least one dose of LEN. This meant that both study drugs had to be administered at least once. Inclusive of participants with available data.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Treatment (MOR00208, Lenalidomide) | Duration of Response (DoR) by IRC Evaluation | Approximately 4.5 years after first participant enrolled | 43.9 Months |
| Treatment (MOR00208, Lenalidomide) | Duration of Response (DoR) by IRC Evaluation | Approximately 6.5 years after first participant enrolled | NA Months |
Secondary
Event-free Survival (EFS) by IRC Evaluation
EFS is defined as the time (in months) from the date of the first administration of any study drug to the date of tumour progression, first initiation of a new non-study anti-neoplastic therapy or death from any cause whichever comes first.
Time frame: Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled
Population: FAS: The FAS includes all participants who received at least one dose of MOR00208 and one dose of LEN. This means that both study drugs must have been applied at least once. Inclusive of participants with available data.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Treatment (MOR00208, Lenalidomide) | Event-free Survival (EFS) by IRC Evaluation | Approximately 4.5 years after first participant enrolled | 8.7 Months |
| Treatment (MOR00208, Lenalidomide) | Event-free Survival (EFS) by IRC Evaluation | Approximately 6.5 years after first participant enrolled | 9.1 Months |
Secondary
Number of Participants That Experienced Treatment-emergent Adverse Events (TEAEs)
TEAEs are defined as any adverse event reported in the following time interval (including the lower and upper limits): date of first administration of study treatment; date of last administration of study treatment + 30 days, or if they are considered to be related to the study drug.
Time frame: Approximately 6.5 years after first participant enrolled
Population: Safety analysis set (SAF):~The SAF includes all participants who received at least one dose of MOR00208 or LEN and had at least one post-baseline safety assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment (MOR00208, Lenalidomide) | Number of Participants That Experienced Treatment-emergent Adverse Events (TEAEs) | 81 Participants |
Secondary
Number of Participants Who Developed Anti-MOR00208 Antibodies
The Anti-MOR00208 Antibodies were investigated by quantifying serum drug levels at baseline and after repeated intravenous (IV) administrations planned for up to 24 treatment cycles using sparse sampling. Anti-MOR00208 antibody sample (pre-dose only) were taken in odd numbered additional treatment cycles only (e.g., treatment Cycles 13, 15,17, 19, 21,23).
Time frame: Baseline, Up to a maximum of 23 cycles.
Population: Immunogenicity analysis set (IAS): The IAS included participants who had at least one anti-MOR00208 antibody assessment.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment (MOR00208, Lenalidomide) | Number of Participants Who Developed Anti-MOR00208 Antibodies | Yes (Treatment-emergent ADAs) | 0 Participants |
| Treatment (MOR00208, Lenalidomide) | Number of Participants Who Developed Anti-MOR00208 Antibodies | No (Negative baseline and post baseline results) | 72 Participants |
| Treatment (MOR00208, Lenalidomide) | Number of Participants Who Developed Anti-MOR00208 Antibodies | Not evaluable (Positive baseline results) | 2 Participants |
| Treatment (MOR00208, Lenalidomide) | Number of Participants Who Developed Anti-MOR00208 Antibodies | Missing (No post baseline results available) | 7 Participants |
Secondary
Overall Survival (OS)
OS was defined as the time from the date of the first administration of any study drug until death from any cause (documented by the date of death).
Time frame: Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled
Population: FAS: The FAS includes all participants who received at least one dose of MOR00208 and one dose of LEN. This means that both study drugs must have been applied at least once. Inclusive of participants with available data.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Treatment (MOR00208, Lenalidomide) | Overall Survival (OS) | Approximately 4.5 years after first participant enrolled | 33.5 Months |
| Treatment (MOR00208, Lenalidomide) | Overall Survival (OS) | Approximately 6.5 years after first participant enrolled | 33.5 Months |
Secondary
PFS by INV Evaluation
PFS time was defined as the time (in months) from the date of the first administration of any study drug to the date of tumor progression or death from any cause.
Time frame: Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled
Population: FAS: The FAS includes all participants who received at least one dose of MOR00208 and one dose of LEN. This meant that both study drugs had to be administered at least once. Inclusive of participants with available data.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Treatment (MOR00208, Lenalidomide) | PFS by INV Evaluation | Approximately 4.5 years after first participant enrolled | 9.1 Months |
| Treatment (MOR00208, Lenalidomide) | PFS by INV Evaluation | Approximately 6.5 years after first participant enrolled | 9.1 Months |
Secondary
Progression-free Survival (PFS) by IRC Evaluation
PFS time was defined as the time (in months) from the date of the first administration of any study drug to the date of tumor progression or death from any cause.
Time frame: Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled
Population: FAS: The FAS included all participants who received at least one dose of MOR00208 and at least one dose of LEN. This meant that both study drugs had to be administered at least once. Inclusive of participants with available data.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Treatment (MOR00208, Lenalidomide) | Progression-free Survival (PFS) by IRC Evaluation | Approximately 6.5 years after first participant enrolled | 11.6 Months |
| Treatment (MOR00208, Lenalidomide) | Progression-free Survival (PFS) by IRC Evaluation | Approximately 4.5 years after first participant enrolled | 11.6 Months |
Secondary
Serum Drug Levels of MOR00208
The pharmacokinetics (PK) profile of MOR00208 was investigated by quantifying serum drug levels at baseline and after repeated IV administrations for up to 24 treatment cycles using sparse sampling. MOR00208 PK sample was taken pre-dose and 1 hour ± 10 min after the end of MOR00208 infusion for Cycle 1 to Cycle 23. MOR00208 PK sample (pre-dose only) were taken in odd numbered additional treatment cycles only (e.g., treatment Cycles 13, 15,17, 19, 21, 23).
Time frame: Cycle 1 Days 1, 4, 15 predose and 1 hr post-dose; Cycle 2 Days 1, 15 predose and 1 hr post-dose; Cycle 3 Days 1, 15 predose and 1 hr post-dose; Cycles 4, 5, 6, 7, 9, 11,13, 15, 17, 19, 21, 23 Day 1 predose; End of Treatment
Population: PK analysis set (PKAS): The PKAS included all participants who received at least one dose of MOR00208 and had at least one quantifiable MOR00208 serum concentration.~Number analyzed includes only participants with data at each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment (MOR00208, Lenalidomide) | Serum Drug Levels of MOR00208 | Cycle 1 Day 1 (Predose) | 6.7 ng/mL | Standard Deviation 53.09 |
| Treatment (MOR00208, Lenalidomide) | Serum Drug Levels of MOR00208 | Cycle 1 Day 1 (1 hour post dose) | 249075.9 ng/mL | Standard Deviation 53724.93 |
| Treatment (MOR00208, Lenalidomide) | Serum Drug Levels of MOR00208 | Cycle 1 Day 4 (pre-dose) | 126306.8 ng/mL | Standard Deviation 39105.37 |
| Treatment (MOR00208, Lenalidomide) | Serum Drug Levels of MOR00208 | Cycle 1 Day 4 (1 hour post-dose) | 363626.2 ng/mL | Standard Deviation 82971.54 |
| Treatment (MOR00208, Lenalidomide) | Serum Drug Levels of MOR00208 | Cycle 1 Day 15 (pre dose) | 157722.3 ng/mL | Standard Deviation 50655.86 |
| Treatment (MOR00208, Lenalidomide) | Serum Drug Levels of MOR00208 | Cycle 1 Day 15 (1 hour post-dose) | 396262.1 ng/mL | Standard Deviation 97215.09 |
| Treatment (MOR00208, Lenalidomide) | Serum Drug Levels of MOR00208 | Cycle 2 Day 1 (predose) | 181870.8 ng/mL | Standard Deviation 72582.62 |
| Treatment (MOR00208, Lenalidomide) | Serum Drug Levels of MOR00208 | Cycle 2 Day 1 (1 hour post-dose) | 439788.2 ng/mL | Standard Deviation 126930.55 |
| Treatment (MOR00208, Lenalidomide) | Serum Drug Levels of MOR00208 | Cycle 2 Day 15 (Pre Dose) | 217846.9 ng/mL | Standard Deviation 77799.93 |
| Treatment (MOR00208, Lenalidomide) | Serum Drug Levels of MOR00208 | Cycle 2 Day 15 (1 hour post-dose) ) | 442940.2 ng/mL | Standard Deviation 85475.9 |
| Treatment (MOR00208, Lenalidomide) | Serum Drug Levels of MOR00208 | Cycle 3 Day 1 (predose) | 208520.6 ng/mL | Standard Deviation 68866.46 |
| Treatment (MOR00208, Lenalidomide) | Serum Drug Levels of MOR00208 | Cycle 3 Day 1 (1 hour post-dose) | 466135.8 ng/mL | Standard Deviation 112647.31 |
| Treatment (MOR00208, Lenalidomide) | Serum Drug Levels of MOR00208 | Cycle 3 Day 15 (predose) | 223909.4 ng/mL | Standard Deviation 85170.91 |
| Treatment (MOR00208, Lenalidomide) | Serum Drug Levels of MOR00208 | Cycle 3 Day 15 (1 hour post-dose) | 455635.0 ng/mL | Standard Deviation 104198.64 |
| Treatment (MOR00208, Lenalidomide) | Serum Drug Levels of MOR00208 | Cycle 4 Day 1 (predose) ) | 216328.4 ng/mL | Standard Deviation 94553.25 |
| Treatment (MOR00208, Lenalidomide) | Serum Drug Levels of MOR00208 | Cycle 5 Day 1 (pre dose) | 142134.4 ng/mL | Standard Deviation 72691.16 |
| Treatment (MOR00208, Lenalidomide) | Serum Drug Levels of MOR00208 | Cycle 6 Day 1 (pre dose) | 115132.3 ng/mL | Standard Deviation 55774.77 |
| Treatment (MOR00208, Lenalidomide) | Serum Drug Levels of MOR00208 | Cycle 7 Day 1 (pre dose) | 114661.5 ng/mL | Standard Deviation 73328.15 |
| Treatment (MOR00208, Lenalidomide) | Serum Drug Levels of MOR00208 | Cycle 9 Day 1 (pre dose) | 108640.4 ng/mL | Standard Deviation 52282.72 |
| Treatment (MOR00208, Lenalidomide) | Serum Drug Levels of MOR00208 | Cycle 11 Day 1 (pre dose) | 126472.0 ng/mL | Standard Deviation 64872.47 |
| Treatment (MOR00208, Lenalidomide) | Serum Drug Levels of MOR00208 | Cycle 13 Day 1 (pre dose) | 100853.5 ng/mL | Standard Deviation 61229.42 |
| Treatment (MOR00208, Lenalidomide) | Serum Drug Levels of MOR00208 | Cycle 15 Day 1 (pre dose) | 159676.5 ng/mL | Standard Deviation 61199.32 |
| Treatment (MOR00208, Lenalidomide) | Serum Drug Levels of MOR00208 | Cycle 17 Day 1 (pre dose) | 175855.1 ng/mL | Standard Deviation 64592.17 |
| Treatment (MOR00208, Lenalidomide) | Serum Drug Levels of MOR00208 | Cycle 19 Day 1 (pre dose) | 197045.0 ng/mL | Standard Deviation 69962.05 |
| Treatment (MOR00208, Lenalidomide) | Serum Drug Levels of MOR00208 | Cycle 21 Day 1 (pre dose) | 197228.0 ng/mL | Standard Deviation 53222.03 |
| Treatment (MOR00208, Lenalidomide) | Serum Drug Levels of MOR00208 | Cycle 23 Day 1 (pre dose) | 224253.3 ng/mL | Standard Deviation 64686.85 |
| Treatment (MOR00208, Lenalidomide) | Serum Drug Levels of MOR00208 | End of Treatment | 141240.7 ng/mL | Standard Deviation 114804.4 |
Secondary
Severity of Treatment-emergent Adverse Events (TEAEs)
Number of participants with Severity of TEAEs during MOR00208 and LEN combination therapy.
Time frame: Approximately 6.5 years after first participant enrolled
Population: SAF:~The SAF includes all participants who received at least one dose of MOR00208 or LEN and had at least one post-baseline safety assessment.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment (MOR00208, Lenalidomide) | Severity of Treatment-emergent Adverse Events (TEAEs) | Moderate | 31 Participants |
| Treatment (MOR00208, Lenalidomide) | Severity of Treatment-emergent Adverse Events (TEAEs) | Severe | 43 Participants |
| Treatment (MOR00208, Lenalidomide) | Severity of Treatment-emergent Adverse Events (TEAEs) | Mild | 6 Participants |
| Treatment (MOR00208, Lenalidomide) | Severity of Treatment-emergent Adverse Events (TEAEs) | Missing | 1 Participants |
Secondary
Time to Next Treatment (TTNT)
Kaplan-Meier analysis of TTNT in FAS population. TTNT is defined as the time from the first administration of any study drug to the institution of next anti-neoplastic therapy (for any reason including disease progression, treatment toxicity and participant preference) or death of any cause, whatever comes first.
Time frame: Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled
Population: FAS: The FAS includes all participants who received at least one dose of MOR00208 and one dose of LEN. This means that both study drugs must have been applied at least once. Inclusive of participants with available data.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Treatment (MOR00208, Lenalidomide) | Time to Next Treatment (TTNT) | Approximately 4.5 years after first participant enrolled | 12.1 Months |
| Treatment (MOR00208, Lenalidomide) | Time to Next Treatment (TTNT) | Approximately 6.5 years after first participant enrolled | 12.5 Months |
Secondary
Time to Progression (TTP) by IRC Evaluation
TTP is defined as the time from the first administration of any study drug until documented DLBCL progression or death as a result of lymphoma.
Time frame: Approximately 2.5 years after first participant enrolled
Population: FAS: The FAS included all participants who received at least one dose of MOR00208 and at least one dose of LEN. This meant that both study drugs had to be administered at least once. Inclusive of participants with available data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment (MOR00208, Lenalidomide) | Time to Progression (TTP) by IRC Evaluation | 16.2 Months |
Secondary
TTP by INV Evaluation
TTP is defined as the time from the first administration of any study drug until documented DLBCL progression or death as a result of lymphoma.
Time frame: Approximately 2.5 years after first participant enrolled
Population: FAS: The FAS included all participants who received at least one dose of MOR00208 and at least one dose of LEN. This meant that both study drugs had to be administered at least once. Inclusive of participants with available data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment (MOR00208, Lenalidomide) | TTP by INV Evaluation | 14.1 Months |