A study presented at the 2020 ASH Annual Meeting found that R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) in combination with tafasitamab with or without lenalidomide is a safe treatment option for patients with treatment-naïve diffuse large B-cell lymphoma (DLBCL).
Tafasitamab is a humanized, Fc-enhanced, anti-CD19 monoclonal antibody with improved antibody-dependent cellular cytotoxicity and phagocytosis. Tafasitamab monotherapy has shown clinical activity in patients with relapsed/refractory non-Hodgkin lymphoma. In the phase II, single-arm L-MIND study, tafasitamab plus lenalidomide induced a complete response in a high proportion of patients with relapsed/refractory DLBCL.
The randomized, phase Ib First-MIND study is assessing R-CHOP plus tafasitamab or R-CHOP plus tafasitamab and lenalidomide in patients with newly diagnosed DLBCL.
Adult treatment-naïve patients with histologically confirmed DLBCL not otherwise specified with intermediate- to high-risk disease and an Eastern Cooperative Oncology Group performance status score of 0-2 were included in the study. Patients with known double- or triple-hit lymphoma and transformed lymphoma were excluded.
Patients (n=36) were treated with six 21-day cycles of tafasitamab 12 mg/kg intravenously (IV) plus R-CHOP (arm A; n=18; median age at baseline, 67 years; range, 47-76 years) or tafasitamab 12 mg/kg IV plus lenalidomide 25 mg orally in addition to R-CHOP (arm B; n=18; median age at baseline, 65 years; range, 40-74 years). All patients received granulocyte-colony stimulating factor prophylaxis. Most patients had advanced disease (stages III/IV; 92%), and approximately 50% had bulky disease.
The data presented at the ASH Annual Meeting were from the safety run-in phase consisting of 24 patients: 13 in arm A and 11 in arm B. All patients completed the first treatment cycle—88% of patients entered into cycle 2, and 50% entered into cycle 3.
Cell of origin was determined to be germinal center B-cell (GCB) DLBCL in 13%, non-GCB DLBCL in 42%, and not yet classified in 46% of cases. A total of 248 treatment-related adverse events (AEs) occurred: 111 in arm A and 137 in arm B. Grade ≥3 neutropenia occurred in 54% of patients in arm A and 46% in arm B. Grade ≥3 thrombocytopenia occurred in 8% and 18%, respectively. Diarrhea, fatigue, and vomiting were comparable between the two arms, and febrile neutropenia occurred in one patient in each cohort.
A total of 23 serious AEs were reported: 11 in arm A and 12 in arm B. One suspected unexpected serious AE was reported in arm B: pneumocystis jirovecii pneumonia. No treatment-related deaths occurred.
“R-CHOP can be safely combined with tafasitamab or tafasitamab plus lenalidomide in patients with treatment-naïve DLBCL. Toxicities appear to be similar to what is expected with R-CHOP alone or in combination with lenalidomide,” the researchers concluded. The study is ongoing.
Belada D, Nowakowski GS, Bergua Burgues JM, et al. A Phase Ib, 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. Abstract 3028. Presented at the 62nd American Society of Hematology Annual Meeting & Exposition, December 2-11, 2020.