ABCL-023 frontMIND: A Phase III, Randomized, Double-Blind Study of Tafasitamab + Lenalidomide + R-CHOP Versus R-CHOP Alone for Newly Diagnosed High-Intermediate and High-Risk Diffuse Large B-Cell Lymphoma

Umberto Vitolo, Grzegorz S. Nowakowski, John M. Burke, Christopher P. Fox, Marek Trneny, Annalisa Chiappella, Maeve Waldron-Lynch, Nira Hadar, Alok Pachori, Georg Lenz

Research output: Contribution to journalArticlepeer-review

Abstract

Context: The chemo-free immunotherapy tafasitamab + lenalidomide (LEN), has received accelerated approval in the United States (2020) and conditional marketing authorization in Europe and Canada (2021) for treatment of relapsed/refractory diffuse large cell lymphoma (DLBCL), in patients ineligible for autologous stem cell transplant. The primary analysis of First-MIND (NCT04134936) demonstrated that adding tafasitamab + LEN does not impair dosing and scheduling of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP), and toxicities were similar to those expected with R-CHOP alone (ASH 2021; #3556). Objective: frontMIND (NCT04824092) will investigate the efficacy and safety of R-CHOP + tafasitamab + LEN versus R-CHOP alone in previously untreated patients with high-intermediate and high-risk DLBCL. Design: A Phase III, multicenter, randomized, double-blind, placebo-controlled study. Setting: Approximately 350 centers from the Americas, Europe, and the Asia-Pacific region. Patients: Eligible patients (n=880) will be aged 18–80 years with previously untreated local biopsy-proven, CD20-positive DLBCL, International Prognostic Index (IPI) score 3–5 (age-adjusted IPI 2–3 if ≤60 years), and ECOG performance score 0–2. Patients with transformed lymphoma are excluded. Interventions: Patients will be randomized 1:1 to receive six 21-day cycles of either R-CHOP + tafasitamab (12 mg/kg intravenously, Days 1, 8, and 15) + LEN (25 mg orally, Days 1–10) or R-CHOP + tafasitamab + LEN placebos. Main Outcome Measures: The primary endpoint is investigator-assessed progression-free survival; secondary endpoints include event-free survival, overall survival, and safety. Minimal residual disease parameters will also be investigated. Results: Results for this study are not yet available. Conclusions: There remains a high unmet need to improve treatment options for newly diagnosed patients with high-intermediate and high-risk DLBCL. The combination of tafasitamab + LEN + R-CHOP may have synergistic potential. Preliminary data from the First-MIND study suggest that tafasitamab ± LEN + R-CHOP may be tolerable in patients with treatment-naïve DLBCL. frontMIND will provide further evaluation of clinical benefits and safety in patients with newly diagnosed high-intermediate and high-risk DLBCL. The study is funded by MorphoSys AG and conducted with the scientific support of members of the Fondazione Italiana Linfomi and the German Lymphoma Alliance.

Original languageEnglish (US)
Pages (from-to)S352-S353
JournalClinical Lymphoma, Myeloma and Leukemia
Volume22
DOIs
StatePublished - Oct 2022

Keywords

  • ABCL
  • DLBCL
  • frontMIND
  • lenalidomide
  • Phase III
  • R-CHOP
  • tafasitamab

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Cancer Research

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