Long-term outcomes from the Phase II L-MIND study of tafasitamab (MOR208) plus lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma - Université Clermont Auvergne Accéder directement au contenu
Article Dans Une Revue Haematologica Année : 2021

Long-term outcomes from the Phase II L-MIND study of tafasitamab (MOR208) plus lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma

Johannes Duell
  • Fonction : Auteur
Kami Maddocks
  • Fonction : Auteur
Eva González-Barca
  • Fonction : Auteur
Wojciech Jurczak
  • Fonction : Auteur
Anna Marina Liberati
  • Fonction : Auteur
Sven de Vos
  • Fonction : Auteur
Zsolt Nagy
  • Fonction : Auteur
Aleš Obr
Gianluca Gaidano
  • Fonction : Auteur
Pau Abrisqueta
  • Fonction : Auteur
Nagesh Kalakonda
  • Fonction : Auteur
Marc André
  • Fonction : Auteur
Martin Dreyling
  • Fonction : Auteur
Tobias Menne
  • Fonction : Auteur
Marinela Augustin
  • Fonction : Auteur
Andreas Rosenwald
  • Fonction : Auteur
Maren Dirnberger-Hertweck
  • Fonction : Auteur
Johannes Weirather
  • Fonction : Auteur
Sumeet Ambarkhane
  • Fonction : Auteur
Gilles Salles

Résumé

Tafasitamab (MOR208), an Fc-modified, humanized, anti-CD19 monoclonal antibody, combined with the immunomodulatory drug lenalidomide was clinically active with a good tolerability profile in the open-label, single-arm, phase II L-MIND study of patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) ineligible for autologous stem-cell transplantation. To assess long-term outcomes, we report an updated analysis with ≥35 months’ follow-up. Patients were aged >18 years, had received one to three prior systemic therapies (including ≥1 CD20-targeting regimen) and Eastern Cooperative Oncology Group performance status 0-2. Patients received 28-day cycles of tafasitamab (12 mg/kg intravenously), once weekly during cycles 1-3, then every 2 weeks during cycles 4-12. Lenalidomide (25 mg orally) was administered on days 1-21 of cycles 1-12. After cycle 12, progression-free patients received tafasitamab every 2 weeks until disease progression. The primary endpoint was best objective response rate. After ≥35 months’ follow-up (data cut-off: October 30, 2020), the objective response rate was 57.5% (n=46/80), including a complete response in 40.0% of patients (n=32/80) and a partial response in 17.5% of patients (n=14/80). The median duration of response was 43.9 months (95% confidence interval [95% CI]: 26.1-not reached), the median overall survival was 33.5 months (95% CI: 18.3-not reached) and the median progression-free survival was 11.6 months (95% CI: 6.3-45.7). There were no unexpected toxicities. Subgroup analyses revealed consistent long-term efficacy results across most subgroups of patients. This extended follow-up of L-MIND confirms the long duration of response, meaningful overall survival, and well-defined safety profile of tafasitamab plus lenalidomide followed by tafasitamab monotherapy in patients with relapsed/refractory diffuse large B-cell lymphoma ineligible for autologous stem cell transplantation. ClinicalTrials.gov identifier: NCT02399085.

Domaines

Hématologie

Dates et versions

hal-03440612 , version 1 (22-11-2021)

Identifiants

Citer

Johannes Duell, Kami Maddocks, Eva González-Barca, Wojciech Jurczak, Anna Marina Liberati, et al.. Long-term outcomes from the Phase II L-MIND study of tafasitamab (MOR208) plus lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma. Haematologica, 2021, 106 (9), pp.2417-2426. ⟨10.3324/haematol.2020.275958⟩. ⟨hal-03440612⟩
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