Duell, Johannes, Maddocks, Kami J, Gonzalez-Barca, Eva, Jurczak, Wojciech, Liberati, Anna Marina, de Vos, Sven, Nagy, Zsolt, Obr, Ales, Gaidano, Gianluca, Abrisqueta, Pau et al (show 11 more authors)
(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.
, Italy.
Abstract
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.
| Item Type: | Conference or Workshop Item (Unspecified) |
|---|---|
| Uncontrolled Keywords: | Humans, Antineoplastic Combined Chemotherapy Protocols, Treatment Outcome, Hematopoietic Stem Cell Transplantation, Transplantation, Autologous, Lymphoma, Large B-Cell, Diffuse, Antibodies, Monoclonal, Humanized, Lenalidomide |
| Divisions: | Faculty of Health and Life Sciences Faculty of Health and Life Sciences > Institute of Systems, Molecular and Integrative Biology |
| Depositing User: | Symplectic Admin |
| Date Deposited: | 12 Jul 2021 09:44 |
| Last Modified: | 18 Jan 2023 21:36 |
| DOI: | 10.3324/haematol.2020.275958 |
| Open Access URL: | https://doi.org/10.3324/haematol.2020.275958 |
| Related URLs: | |
| URI: | https://livrepository.liverpool.ac.uk/id/eprint/3129744 |
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