Monjuvi Precision Cancer Medicine for Treatment of B Cell NHL
by Dr. C.H. Weaver M.D. 8/2020
Topline results from Re-MIND, an observational retrospective study, demonstrated that the combination of Monjuvi (tafasitamab-cxix) with Revlimid (lenalidomide) appears promising for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who were not eligible for high-dose chemotherapy and stem cell transplant. (1)
On July 31, 2020, the Food and Drug Administration granted accelerated approval to Monjuvi (tafasitamab-cxix), a precision cancer medicine that targets the CD19 antigen on lymphoma cells. (4)
Monjuvi, previously known as MOR208 is a humanized monoclonal antibody precision medicine directed against the CD19 antigen which is expressed on early B lymphocytes and B cell lymphomas which makes it a potential target for the treatment of non-Hodgkin’s lymphoma (NHL), including diffuse large B cell lymphoma (DLBCL), as well as chronic lymphocytic leukemia (CLL).
In the L-MIND clinical trial, 81 patients who had failed 1 to 3 prior lines of systemic treatment were treated with a combination of MOR208 combined with Revlimid.(2) The treatment results of the 81 patients were then compared to matched patients selected from 490 transplant-ineligible patients with relapsed/refractory DLBCL who had been previously treated with single-agent Revlimid in the Re-MIND clinical study. (1)
The efficacy of tafasitamab-cxix with lenalidomide was evaluated in L-MIND (NCT02399085), an open label, multicenter single-arm trial in 81 patients. Patients received tafasitamab-cxix 12 mg/kg intravenously with lenalidomide (25 mg orally on days 1 to 21 of each 28-day cycle) for maximum of 12 cycles, followed by tafasitamab-cxix as monotherapy.
Preliminary findings from the L-MIND trial, presented at the 2018 ASH Annual Meeting demonstrated that MOR208 + Revlimid combination therapy was fairly well tolerated however 42% of patients did require a Revlimid dose reduction. An overall response rate of 58% and 33% complete remissions were reported following treatment with the MOR208 + Revlimid combination. Patients survived and average of 16.2 without lymphoma progression and the one year survival rate was 73%. (1)
When the study authors compared the MOR208 + Revlimid treated patients to those treated with Revlimid alone 67% of patients treated with the combination regimen responded to treatment compared to 34% of matched patients treated with Revlimid. The complete remission rate was 40% for MOR208+Revlimid compared to only 12% for treatment with Revlimid alone.
MOR208 appears to represent a new precision medicine with promise for the treatment of B cell NHL and will undergo continued evaluation and ultimately submission to the United States Food and Drug Administration for approval.
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- MorphoSys AG: Primary Endpoint met in Real-World Data Study Demonstrating Clinical Superiority of the Combination of Tafasitamab and Lenalidomide compared to Lenalidomide alone. Planegg/Munich: MorphoSys AG; October 29, 2019. Accessed October 30, 2019.
- MorphoSys Provides Updates on L-MIND and B-MIND Clinical Trials of MOR208 in Relapsed/Refractory DLBCL [press release]. Planegg/Munich: MorphoSys AG; March 7, 2019. https://bit.ly/2IYLR5T. Accessed October 30, 2019.
- Salles GA, Guell J, González-Barca E, et al. Single-arm phase II study of MOR208 combined with lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma: L-mind. *Blood.*2018;132(suppl 1; abstr 227). doi: 10.1182/blood-2018-99-113399.
- FDA grants accelerated approval to tafasitamab-cxix for diffuse large B-cell lymphoma
MorphoSys Provides Updates on L-MIND and B-MIND Clinical Trials of MOR208 in Relapsed/Refractory DLBCL
MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; Nasdaq: MOR) today provided updates on L-MIND and B-MIND, its two ongoing clinical trials of the investigational Fc-enhanced anti-CD19 antibody MOR208 in patients with relapsed or refractory diffuse large B cell lymphoma (r/r DLBCL), who are not eligible for high-dose chemotherapy and autologous stem cell transplantation.