Tafasitamab + Lenalidomide + R-CHOP Versus R-CHOP in Newly Diagnosed High-intermediate and High Risk DLBCL Patients
Summary
This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed to compare the efficacy and safety of the humanized monoclonal anti CD19 antibody tafasitamab plus lenalidomide in addition to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) versus R-CHOP in previously untreated, high-intermediate and high-risk patients with newly-diagnosed DLBCL
Timeline
- Start
- 2021-05-11
- Primary completion
- 2026-09-01
- Completion
- 2027-11-01
Outcome
Met primary endpoint
paper progression-free survival was improved in the tafa-len-R-CHOP group versus the R-CHOP group (hazard ratio [HR] 0·75 [95% CI 0·59-0·96]; p=0·0194) PMID 42217458 ↗
paper Progression-free survival was significantly improved with tafa-len-R-CHOP versus R-CHOP; PMID 42217458 ↗
release “frontMIND trial evaluating the efficacy and safety of tafasitamab (Monjuvi®/Minjuvi®) and lenalidomide in addition to R-CHOP met its primary endpoint of progression-free survival (PFS)” incyte.com ↗
Publications
- Lenz G, Trneny M, Burke JM, Nowakowski GS, Fox CP, Chiappella A, Duell J, Jeon YW, Cheah CY, Westin J, Ye JZ, Caguioa PB, Belada D, Shin HJ, Oh SY, Amorim S, Ku M, Mocikova H, Jimenez JL, Gaidano G, Rosenwald A, Chiarle R, Colucci P, Ioannidis S, Cheng L, Vitolo U; frontMIND Study Investigators. Tafasitamab plus lenalidomide and R-CHOP versus R-CHOP for first-line treatment of patients with high-risk diffuse large B-cell lymphoma (frontMIND): a global, phase 3, randomised, double-blind, placebo-controlled trial. Lancet. 2026 Jun 20;407(10547):2528-2541. doi: 10.1016/S0140-6736(26)00866-4. Epub 2026 May 30.
- Jelicic J, Juul-Jensen K, Bukumiric Z, Runason Simonsen M, Roost Clausen M, Ludvigsen Al-Mashhadi A, Schou Pedersen R, Poulsen CB, Gang AO, Brown P, El-Galaly TC, Stauffer Larsen T. International Prognostic Models as Tools for Selection of Higher-risk Trial-eligible Patients With Diffuse Large B-Cell lymphoma. Clin Lymphoma Myeloma Leuk. 2026 Jan;26(1):e62-e76. doi: 10.1016/j.clml.2025.08.020. Epub 2025 Sep 3.
- Belada D, Kopeckova K, Bergua Burgues JM, Stevens D, Andre M, Persona EP, Pichler P, Staber PB, Trneny M, Duell J, Waldron-Lynch M, Wagner S, Mukhopadhyay A, Dirnberger-Hertweck M, Burke JM, Nowakowski GS. Safety and efficacy of tafasitamab with or without lenalidomide added to first-line R-CHOP for DLBCL: the phase 1b First-MIND study. Blood. 2023 Oct 19;142(16):1348-1358. doi: 10.1182/blood.2023020637.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lenalidomide | Other / unclassified | 25 mg | Oral |
| Subject | Tafasitamab | Monoclonal antibody | 12 mg/kg | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 750 mg/m2 | Intravenous |
| Background | Doxorubicin | Other / unclassified | 50 mg/m2 | Intravenous |
| Background | Prednisone | Other / unclassified | 100 mg | Oral |
| Background | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |
| Background | Vincristine | Small molecule | 1.4 mg/m2 | Intravenous |