Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication MONJUVI is a CD19-directed cytolytic antibody indicated: in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). FDA label
Also known as Monjuvi, MOR 00208, MOR 208, Tafasitamab-cxix, XmAb-5574, INCMOR00208
Tafasitamab · 15 trials · 24 indications
Percentage of participants having best response of Complete Response (CR) or Partial Response (PR) as per Independent Review Committee and investigator's assessment.
Progression-Free Survival as assessed by the investigator using the Lugano Response Criteria for Malignant Lymphoma
PD, positron emission tomography (PET): score 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) for lymph node/extra lymphatic sites with increase in intensity of Baseline uptake and/or new fluorodeoxyglucose (FDG)-avid foci consistent with lymphoma at interim/end-of-treatment assessment; new/recurrent FDG-avid foci in bone marrow; new FDG-avid foci consistent with lymphoma versus other etiology in new lesions. PD, computed tomography (CT): abnormal individual node/lesion with longest diameter (LDi ) \>1.5 centimeters (cm) and increase by ≥50% from the product of the perpendicular diameters (PPD) nadir and increase in LDi or shortest diameter (SDi) from nadir; new/clear progression of preexisting nontarget lesions; new/recurrent splenomegaly and bone marrow involvement; regrowth of previously resolved lesions. New node \>1.5 cm in any axis. New extranodal site \>1.0 cm in any axis; if \<1.0 cm, presence is unequivocal and attributable to lymphoma.
PD, PET: score 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) for lymph node/extra lymphatic sites with increase in intensity of Baseline uptake and/or new FDG-avid foci consistent with lymphoma at interim/end-of-treatment assessment; new/recurrent FDG-avid foci in bone marrow; new FDG-avid foci consistent with lymphoma versus other etiology in new lesions. PD, CT: abnormal individual node/lesion with LDi \>1.5 cm and increase by ≥50% from the PPD nadir and increase in LDi or SDi from nadir; new/clear progression of preexisting nontarget lesions; new/recurrent splenomegaly and bone marrow involvement; regrowth of previously resolved lesions. New node \>1.5 cm in any axis. New extranodal site \>1.0 cm in any axis; if \<1.0 cm, presence is unequivocal and attributable to lymphoma. Kaplan-Meier estimates indicate the percent probability of a participant being alive at the indicated time after treatment start.
Assessed by positron emission tomography (PET)/computed tomography (CT) and diagnostic CT scans based on Lugano criteria. Will report the number of complete response (CR) at the best response within one year of starting study treatment and the estimated CR rate with 95% exact binomial confidence interval (CI).
The CRR will be determined by IRC and according to IPCG criteria. This endpoint reflects the proportion of patients who can potentially proceed to different consolidation or maintenance strategies to achieve durable responses.
Efficacy of the addition of tafasitamab (tafa) to dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin with our without rituximab (DA-EPOCH±R) will be assessed using the rate of minimal residual disease (MRD) as measured by multiparameter flow cytometry (MFC) in the University of Washington hematopathology lab. Will consider an absolute increase in the rate of MRD- after one cycle to 50% to be a signal of interest (i.e., increase from 28%).
Defined as any Adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug up to 90 days after the last dose of study drug.
Progression-free survival was defined as the time from randomization to tumor progression or death from any cause.
Progression-free survival was defined as the time from randomization to tumor progression or death from any cause.
Non hematologic AEs will be measured during cycle 1 (first 28 days) and hematologic AEs will be measured during the first 42 days for all dose levels. DLTs are graded for severity by the Common Terminology Criteria for Adverse Events v5.0 (CTCAEv5.0) criteria.
Determination of the RP2D of Zanubrutinib, when used in combination with Tafasitamab, based on evaluation of dose limiting toxicity (DLT) in participants during the Phase 1 part of the study. DLT will be defined as the occurrence of specified adverse events (AEs) at least possibly related to the study therapy during the DLT review period.
The complete response (CR) rate among study participants in Phase 2 to Zanubrutinib at the RP2D in combination with Tafasitamab will be assessed. Response will be assessed using positron emission tomography (PET)/computerized tomography (CT) according to the Lugano 2014 criteria. CR will be defined by a Deauville score of less than or equal to (≤) 3.
Incidences of DLTs, serious AEs, and AEs of special interest experienced during cycle 2-6 evaluated. The severity of the AE assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 5. The international working chronic lymphocytic leukemia (iwCLL) grading system for hematological toxicities also utilized. Incidence and type of DLT reported.
MRD negativity in patients reported using the efficacy set. Point estimate, along with exact two-sided 95% confidence interval (CI) reported.
An adverse event (AE) was defined as any untoward medical occurrence in a participant temporally associated with the use of study treatment, whether or not considered related to the study treatment. Therefore, an AE could be any unfavorable or unintended sign (including an abnormal laboratory finding) or symptom temporally associated with the use of study treatment. A TEAE was defined as any AE that started or worsened after the first dose of study treatment until 90 days after the last dose of the study treatment. An AE that was present prior to study drug administration but increased in severity after treatment start was also included as a TEAE.
The toxicity grade of TEAEs was graded using the National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0) using the following definitions: Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: moderate; minimal; local or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living (refers to preparing meals, shopping for groceries or clothes, using the telephone, managing money, etc.). Grade 3: severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent intervention indicated. Grade 5: death related to AE.
Toxicities will be classified using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The DLT will be based on the tolerability observed during the first cycle. In order for a patient to be assessed for DLT, they must receive at least 75% of lenalidomide dose (16 of the planned 21 days of lenalidomide administration). The maximum tolerated dose of lenalidomide/Tafasitamab will be the highest dose at which fewer than one-third of patients experience dose limiting toxicity. If multiple toxicities are seen, the presence of dose limiting toxicity should be based on the most severe toxicity experienced.
The MTD is the highest dose at which no more than one instance of a DLT is observed among 6 participants treated.
The RP2D is the dose at which the Phase 2 portion of the study will begin enrolling. RP2D will be determined based on all data including available pharmacokinetics (PK), pharmacodynamic (PD), target engagement, efficacy, safety and tolerability data collected during Phase 1
Response to the combination lenalidomide/Tafasitamab treatment is defined as achieving clinical benefit better at three months restaging. That is overall tumor shrinkage within three months of treatment initiation or stable disease at three months restaging. Response criteria will be graded using the Cytologic Response Criteria, Neurologic Response Criteria, and Radiographic Response Criteria developed by the International Workshop to Standardize Baseline Evaluation and Response Criteria in Primary CNS Lymphoma The response rate is defined as the proportion of study participants meeting the definition of response in Efficacy Analysis Set (EAS). Response rate will be summarized by percentage, along with the corresponding exact 95% confidence intervals (CIs).
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as any new AE/worsening of an event from the first dose to 90 days (30 days until Amendment 3) after the last dose.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. A TEAE was defined as any new AE/worsening of an event from the first dose to 90 days (30 days until Amendment 3) after the last dose. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grades 1 through 5. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.
A DLT was defined as the occurrence of any protocol-defined toxicity occurring up to and including Day 28 (Day 21 in Group 5 only), except those with a clear alternative explanation.
OR=percentage of participants with a complete response/complete metabolic response (CR/CMR) or partial response/partial metabolic response (PR/PMR). CR: (1) target nodes/nodal masses of lymph nodes/extralymphatic sites regressed to ≤1.5 centimeters (cm) in the longest dimension transverse diameter of lesion (LDi); (2) absence of non-measured lesions; (3) organ enlargement regressed to normal; (4) no new lesions; (5) normal bone marrow morphology; if indeterminate, immunohistochemistry negative. PR: (1) lymph nodes/extralymphatic sites: ≥50% decrease in the sum of the product of perpendicular diameters for multiple lesions of up to 6 target measurable nodes/extranodal sites; (2) absent/regressed non-measured lesions, no increase; (3) organ enlargement; spleen regressed by \>50% in length beyond normal; (4) no new lesions.
| Arm | Type | Description |
|---|---|---|
| Tafasitamab and Lenalidomide | EXPERIMENTAL | Tafasitamab and lenalidomide will be coadministered for up to 12 cycles (28 days per cycle).followed by tafasitamab monotherapy (in participants with stable disease or better) until treatment withdrawal criteria are met. |
| Tafasitamab plus lenalidomide in addition to R-CHOP | EXPERIMENTAL | Patients will receive tafasitamab plus lenalidomide in addition to R-CHOP for six 21-day cycles: Tafasitamab dose: 12 mg/kg body weight. Each 21-day cycle (cycles 1-6) will comprise of a tafasitamab IV infusion on Day 1, Day 8 and Day 15. Lenalidomide dose: 25 mg as a starting dose per os (orally) once per day on Days 1-10 of each 21-day cycle R-CHOP dose: Rituximab (or locally approved biosimilar) 375 mg/m2, IV Day 1 of every 21-day cycle; Cyclophosphamide 750 mg/m2, IV Day 1 of 21-day cycle; Doxorubicin 50 mg/m2, IV Day 1 of 21-day cycle; Vincristine 1.4 mg/m2 (max 2 mg) IV Day 1 of 21-day cycle; Prednisone/prednisolone 100 mg/day, per os, Day 1-5 of every 21-day cycle |
| Tafasitamab placebo plus lenalidomide placebo in addition to R-CHOP | PLACEBO_COMPARATOR | Patients will receive tafasitamab placebo plus lenalidomide placebo in addition to R-CHOP for six 21-day cycles: Tafasitamab placebo: 0.9% saline solution Days 1, 8 and 15 of each 21-day cycle Lenalidomide placebo: Days 1-10 of each 21-day cycle R-CHOP dose: Rituximab (or locally approved biosimilar) 375 mg/m2, IV Day 1 of every 21-day cycle; Cyclophosphamide 750 mg/m2, IV Day 1 of 21-day cycle; Doxorubicin 50 mg/m2, IV Day 1 of 21-day cycle; Vincristine 1.4 mg/m2 (max 2 mg) IV Day 1 of 21-day cycle; Prednisone/prednisolone 100 mg/day, per os, Day 1-5 of every 21-day cycle |
| Arm A : tafasitamab + rituximab + lenalidomide | EXPERIMENTAL | Adult patients with Relapsed/Refractory (R/R) Follicular Lymphoma (FL) Grade 1 to 3a or R/R Marginal Zone Lymphoma (MZL) |
| Arm B : placebo+rituximab+lenalidomide | PLACEBO_COMPARATOR | Adult patients with Relapsed/Refractory (R/R) Follicular Lymphoma (FL) Grade 1 to 3a or R/R Marginal Zone Lymphoma (MZL) |
| Treatment (Tafasitamab and rituximab) | EXPERIMENTAL | CYCLES 1-3: Patients receive rituximab IV on day 1 and tafasitamab IV on days 1, 8, 15 and 22 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. CYCLES 4-6; Patients receive rituximab IV on day 1 and tafasitamab IV on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients then undergo disease assessment. Patients with complete response undergo active surveillance. Patients with less than complete response go on to receive cycles 7-12. CYCLES 7-12: Patients receive tafasitamab IV on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo PET scan, CT scan, bone marrow biopsy and aspiration and blood sample collection throughout the study. |
| combination of Tafasitamab (Minjuvi®), Lenalidomide, Rituximab and Methotrexate | EXPERIMENTAL | All patients will receive tafasitamab (Minjuvi®) 12 mg/KG body weight and rituximab 375 mg/m² on days 0 and 5, followed by methotrexate 3,5 g/m² on day 1 as an intravenous infusion. Lenalidomide will be administered orally at 20 mg/day during the first cycle and at 25 mg/day during subsequent cycles on days 4-17 of each 21-day cycle for a total number of 4 cycles. The treatment duration per patient will be 84 days. |
| Treatment (DA-EPOCH+/-R, tafasitamab) | EXPERIMENTAL | Patients receive etoposide, doxorubicin, and vincristine IV continuously over 96 hours on days 1-4 of each cycle, cyclophosphamide IV over 1 hour on day 5 of each cycle, prednisone PO BID on days 1-5 of each cycle, and tafasitamab IV weekly on days 1, 8, and 15 of each cycle. CD20 positive patients also receive rituximab IV per guidelines on days 1 or 5 of each cycle. Treatment repeats every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow aspiration or biopsy, CT scan, lumbar puncture and undergo blood sample and cerebrospinal fluid collection throughout the trial. |
| Tafasitamab Dose | EXPERIMENTAL | Treatment with tafasitamab is as per the treatment dose and schedule they received in the parent protocols. |
| Tafasitamab and bendamustine | EXPERIMENTAL | Tafasitamab and bendamustine |
| Rituximab and bendamustine | ACTIVE_COMPARATOR | Rituximab and bendamustine |
| Rtx + Tafasitamab in combination with allogeneic NK Cells | EXPERIMENTAL | This arm includes dose escalation for allogeneic NK cells. All other therapies are given according to standard of care. The length of the treatment period is 28 days per cycle. Participants will be expected to complete one cycle and may have the option to complete a second cycle unless there is evidence of disease progression at the end of the first cycle. |
| Zanu-Tafa Phase 1 Group | EXPERIMENTAL | Participants in this group will receive combination therapy of Zanubrutinib (Zanu) and Tafasitamab (Tafa) for up to 24 cycles, followed by maintenance therapy with Zanubrutinib until progression. Each cycle is 28 days in length. Combination therapy will be administered via induction phases as follows: 1. Early induction - cycles 1 to 3 (12 weeks) 2. Late induction - cycles 4 to 12 (36 weeks) 3. Extended induction - cycles 13-24 (48 weeks) Subsequent maintenance Zanu therapy may last up to 2 years. Total study participation is up to four (4) years. |
| Zanu-Tafa Phase 2 Group | EXPERIMENTAL | Participants in this group will receive the combination therapy of Zanubrutinib (Zanu) at the recommended phase 2 dose (RP2D) determined during Phase 1, and Tafasitamab at standard doses, followed by maintenance therapy with Zanubrutinib until progression.. Combination therapy will be administered via induction phases as follows: 1. Early induction - cycles 1 to 3 (12 weeks) 2. Late induction - cycles 4 to 12 (36 weeks) 3. Extended induction - cycles 13-24 (48 weeks) Subsequent maintenance Zanu therapy may last up to 2 years. Total study participation is up to four (4) years. |
| Treatment (tafasitamab, obinutuzumab, acalabrutinib) | EXPERIMENTAL | See Detailed DescriptionPatients receive obinutuzumab IV over a rate titrated up to 400 mg/hour on days 1, 2, 8, and 15 for cycle 1 then on day 1 for cycles 2-6 and tafasitamab IV over 1.5-2 hours on days 1, 4, 8, 15, and 22 for cycle 2, on days 1, 8, 15, and 22 for cycles 3-4, and on days 1 and 15 for cycles 5-7. Patients also receive acalabrutinib PO BID in each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection and CT throughout the trial. Patients may undergo an ECHO at baseline as clinically indicated and may also undergo bone marrow biopsy and/or aspiration at baseline and/or follow-up. |
| Treatment (Tafasitamab + Lenalidomide) | EXPERIMENTAL | Treatment: Tafasitamab will be combined with lenalidomide in R/R DLBCL patients. Dose: Cohort 1: The dose of tafasitamab will be level 1 high dose in combination with the approved dose Cohort 2: The dose of tafasitamab will be level 2 high dose in combination with the approved dose Expansion Cohort: The dose of tafasitamab will be the dose that is deemed safe and tolerable as determined from cohort 1 \& cohort 2 Treatment consisting of tafasitamab and lenalidomide combination will be administered until disease progression, unacceptable toxicity, or discontinuation for any other reason, whichever comes first. Lenalidomide can be given for up to 12 cycles in total, after which patients can continue with tafasitamab as monotherapy until progression or unacceptable toxicity. |
| Phase 1 (Tafasitamab, Lenalidomide) | EXPERIMENTAL | Participants will be given 12mg of Tafasitamab on days 1, 4, 8, 15, and 22 of cycle 1, days 1, 8, 15, and 22 of cycles 2 \& 3, and days 1 and 15 for any cycle thereafter. Participants will also be given daily Lenalidomide on days 1-21 of each cycle. |
| Phase 2 (Tafasitamab, Lenalidomide) | EXPERIMENTAL | Participants will be given 12mg of Tafasitamab on days 1, 4, 8, 15, and 22 of cycle 1, days 1, 8, 15, and 22 of cycles 2 \& 3, and days 1 and 15 for any cycle thereafter. Participants will also be given daily Lenalidomide on days 1-21 of each cycle at the recommended phase 2 dose. |
| Part 1 : tafasitimab monotherapy | EXPERIMENTAL | Dose-finding to evaluate the safety and tolerability and to determine the RP2Ds of single-agent tafasitamab in Japanese participants with NHL. Part 1 consists of 1 group (Group 1) to evaluate weight-based doses of tafasitamab. |
| Part 2 : tafasitamab combination therapy | EXPERIMENTAL | tafasitamab will be combined with lenalidomide (Group 3) or parsaclisib (Group 4a) in R/R DLBCL participants or lenalidomide plus R-CHOP (Group 5) in previously untreated DLBCL participants. Modified tafasitamab dosing when combined with lenalidomide (Group 2) in participants with R/R DLBCL will be evaluated to determine the recommended clinical dose. The dose of tafasitamab will be based on the weight-based RP2D that is deemed safe and tolerable in Part 1. |
| Part 3 : Dose Expansion of tafasitamab +parsaclisib | EXPERIMENTAL | tafasitamab in combination with parsaclisib will be further evaluated in Group 4b at RP2D determined in Part 2 |
| Part 4: tafasitamab combination therapy | EXPERIMENTAL | tafasitamiab in combination with lenalidomide will be further evaluated in Group 6 at RP2D determined in Part 2. |
| Venetoclax + R-GDP | EXPERIMENTAL | - |
| Glofitamab + R-GDP | EXPERIMENTAL | - |
| Tafasitamab + R-GDP | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Tafasitamab | DRUG | Tafasitamab will be administered intravenously in 28-day cycles. During Cycles 1 through 3, tafasitamab will be administered weekly on Days 1, 8, 15, and 22; an additional loading dose will be administered on Cycle 1 Day 4. Starting with Cycle 4, tafasitamab will be administered on Days 1 and 15 of each cycle. |
| Lenalidomide | DRUG | Participants will self-administer lenalidomide capsules orally on Days 1-21 of each 28-day cycle, up to 12 cycles. |
| Rituximab | DRUG | Rituximab IV infusion will be administered as per the schedule specified in the respective arm. |
| Cyclophosphamide | DRUG | Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm. |
| Doxorubicin | DRUG | Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm. |
| Vincristine | DRUG | Vincristine IV infusion will be administered as per the schedule specified in the respective arm. |
| Prednisone | DRUG | Prednisone PO will be administered as per the schedule specified in the respective arm. |
| Tafasitamab placebo | DRUG | 0.9% saline solution IV infusion will be administered as per the schedule specified in the respective arm. |
| Lenalidomide placebo | DRUG | Placebo matching to lenalidomide PO will be administered as per the schedule specified in the respective arm. |
| placebo | DRUG | placebo will be administered IV for 12 cycles |
| Biospecimen Collection | PROCEDURE | Undergo blood sample collection |
| Bone Marrow Aspiration | PROCEDURE | Undergo bone marrow aspiration |
| Bone Marrow Biopsy | PROCEDURE | Undergo bone marrow biopsy |
| Computed Tomography | PROCEDURE | Undergo CT scan |
| Positron Emission Tomography | PROCEDURE | Undergo PET scan |
| Survey Administration | OTHER | Ancillary studies |
| Methotrexate | DRUG | IV |
| Etoposide | DRUG | Given IV |
| Lumbar Puncture | PROCEDURE | Undergo lumbar puncture |
| Rituximab (RTX) | DRUG | Rituximab: Dose: 375 mg/m2 IV |
| Bendamustine (BEN) | DRUG | - |
| Allogeneic NK cells | DRUG | Allogeneic NK cells are given intravenously (IV) weekly for 3 weeks on Days 0, 7, 14. Dose escalation will be conducted using a Bayesian optimal interval (BOIN) design starting at dose level 1 (500 x 106 cells) and proceeding to dose level 2 (1,000 x 106 cells) if criteria are met. |
| Interleukin-2 | DRUG | Interleukin-2 is dosed at 5 million IU and given weekly for 3 weeks on Days 0,7,14. |
| Fludarabine/cyclophosphamide | DRUG | Fludarabine is dosed at 30 mg/m2/d with dose adjustment for renal function, and cyclophosphamide is dosed at 500 mg/m2/d. These are given on 3 days (Days -5 to -3). |
| Zanubrutinib | DRUG | Participants will be administered Zanubrutinib orally (PO) via capsules daily during each 28-day cycle at the following dose levels: * Phase 1 Dose Level 1: 320 mg * Phase 1 Dose Level -1: 240 mg * Phase 2: Recommended dose determined in Phase 1. |
| Acalabrutinib | DRUG | Given PO |
| Echocardiography | PROCEDURE | Undergo ECHO |
| Obinutuzumab | BIOLOGICAL | Given IV |
| Questionnaire Administration | OTHER | Ancillary studies |
| parsaclisib | DRUG | parsaclisib will be administered at protocol defined timepoints based on the groups participants are assigned. |
| R-CHOP | DRUG | R-CHOP is a combination regimen consisting of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone. R-CHOP will be administered at protocol defined timepoints based on the groups participants are assigned. |
| Venetoclax | DRUG | Dose Level -1: Venetoclax 200 mg/day days 4-8 cycle 1, days 1-5 cycle 2 and 3, + R-GDP Dose Level 1: Venetoclax 200 mg/day days 4-10 cycle 1, days 1-10 cycle 2 and 3, + R-GDP Dose Level 2: Venetoclax 400 mg/day days 4-10 cycle 1, days 1-10 cycle 2 and 3, + R-GDP Dose Level 3: Venetoclax 800 mg/day days 4-10 cycle 1, days 1-10 cycle 2 and 3, + R-GDP |
| Rituximab Injection | DRUG | 375 mg/m2 - Day 1, cycle 1. |
| Rituximab SC | DRUG | 1400 mg fixed dose - Day 1, cycle 2 and 3 |
| Gemcitabine | DRUG | 1000 mg/m2 - Day 1 to day 8 |
| Dexamethasone | DRUG | 40 mg daily - Day 1 to day 4 |
| Cisplatin | DRUG | 75mg/m2 - Day 1 |
| Glofitamab | DRUG | Cycle 1: Glofitamab 2.5 mg (day 8) and 10 mg (day 15) + R-GDP Cycle 2: Glofitamab 30 mg (day 8) + R-GDP Cycle 3: Glofitamab 30 mg (day 8) + R-GDP |
Inclusion Criteria: * Histologically-confirmed diagnosis of any of the following: 1. Diffuse large B-cell lymphoma not otherwise specified 2. T cell/histiocyte-rich large B-cell lymphoma 3. Epstein-Barr virus positive DLBCL of the elderly 4. Grade 3b follicular lymphoma 5. Composite lymp...
Tafasitamab is an investigational monoclonal antibody being studied in B-cell blood cancers, including diffuse large B cell lymphoma, follicular lymphoma, chronic lymphocytic leukemia, B acute lymphoblastic leukemia, and CNS lymphoma. It is also being evaluated in mantle cell lymphoma and other B-cell non-Hodgkin lymphomas. It is not yet approved for these uses.
Tafasitamab targets CD19, a protein found on the surface of B cells. By binding CD19, the antibody is designed to engage the immune system against malignant B cells. CD19 is a validated target in many B-cell malignancies, which is why tafasitamab is being tested across several lymphoma and leukemia subtypes.
Tafasitamab is being developed by Incyte Corporation, which trades on the Nasdaq under the ticker INCY. Incyte is running or supporting the clinical trial program for tafasitamab in B-cell malignancies, including combination studies with rituximab, zanubrutinib, and allogeneic NK cells.
Tafasitamab is in Phase 2 clinical development. It is investigational and has not been approved by the FDA for any indication. The Phase 2 program includes studies in follicular lymphoma and an extension study for patients with hematologic malignancies who were previously enrolled in tafasitamab trials.
Tafasitamab is being studied in several recruiting trials: NCT07731789 combines tafasitamab with rituximab in newly diagnosed follicular lymphoma; NCT07225439 tests rituximab plus tafasitamab with allogeneic NK cells in relapsed or refractory B-cell non-Hodgkin lymphoma; NCT06465433 is an extension study; and NCT06029309 evaluates tafasitamab with zanubrutinib in mantle cell lymphoma.
Tafasitamab is also known by the brand name Monjuvi. Both names refer to the same CD19-targeting monoclonal antibody developed by Incyte Corporation. Monjuvi is the proprietary name used in some regulatory and clinical contexts, while tafasitamab is the international nonproprietary name.