Monjuvi Precision Cancer Medicine for Treatment of B Cell NHL
by Dr. C.H. Weaver M.D. 12/2020
Topline results from Re-MIND, an observational retrospective study, demonstrated that the combination of Monjuvi (tafasitamab-cxix) with Revlimid (lenalidomide) is an effective treatment option for 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) Evaluation as first line therapy is ongoing.
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, 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 Monjuvi 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) Patients received Monjuvi 12 mg/kg intravenously with Oral Revlimid on days 1 to 21 of each 28-day cycle for a maximum of 12 cycles, followed by Monjuvi as monotherapy.
Initial findings from the L-MIND trial demonstrated that the Monjuvi+ Revlimid combination 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. Patients survived and average of 16.2 months without lymphoma progression and the one year survival rate was 73%. (1)
When the study authors compared the Monjuvi + 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 Monjuvi + Revlimid compared to only 12% for treatment with Revlimid alone. Follow up presented at the 2020 American Society of Hematology Meeting confirms that treatment resulted in durable responses after ≥2 years of follow-up.(6)
Monjuvi represent a new precision medicine with promise for the treatment of B cell NHL and will undergo continued evaluation to determine its optimal use. To that end the "frontMIND" Phase 3 clinical trial evaluating Monjuvi plus Revlimd in combination with R-CHOP compared to R-CHOP alone as first-line treatment for patients with newly diagnosed DLBCL has begun enrolling patients. (5)
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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
- Belada D, M.D., Ph.D., et al. A Phase 1b, Open-label, Randomized Study to Assess Safety and Preliminary Efficacy of Tafasitamab (MOR208) or Tafasitamab + Lenalidomide in Addition to R-CHOP in Patients with Newly Diagnosed Diffuse Large B-Cell Lymphoma: Analysis of the Safety Run-In Phase. 62nd American Society of Hematology Annual Meeting & Exposition (ASH). Abstract #3028.
- Maddocks KJ, M.D., et al. Long-Term Subgroup Analyses from L-MIND, a Phase 2 Study of Tafasitamab (MOR208) Combined with Lenalidomide in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma. 62nd American Society of Hematology Annual Meeting & Exposition (ASH). Abstract #3021.