Please use this identifier to cite or link to this item:
http://hdl.handle.net/2445/209548
Title: | Tafasitamab for patients with relapsed or refractory diffuse large B-cell lymphoma: final 5-year efficacy and safety findings in the phase II L-MIND study |
Author: | Duell, Johannes Abrisqueta, Pau Andre, Marc Gaidano, Gianluca González Barca, Eva Jurczak, Wojciech Kalakonda, Nagesh Liberati, Anna Marina Maddocks, Kami J. Menne, Tobias Nagy, Zsolt Tournilhac, Olivier Kuffer, Christian Bakuli, Abhishek Amin, Aasim Gurbanov, Konstantin Salles, Gilles |
Keywords: | Limfomes Anticossos monoclonals Lymphomas Monoclonal antibodies |
Issue Date: | 31-Aug-2023 |
Publisher: | Ferrata Storti Foundation (Haematologica) |
Abstract: | Tafasitamab, an anti-CD19 immunotherapy, is used with lenalidomide for patients with autologous stem cell transplant -ineligible relapsed/refractory diffuse large B -cell lymphoma based on the results of the phase II L -MIND study (NCT02399085). We report the final 5 -year analysis of this study. Eighty patients >= 18 years who had received one to three prior systemic therapies, and had Eastern Cooperative Oncology Group performance status 0-2 received up to 12 cycles of co -administered tafasitamab and lenalidomide, followed by tafasitamab monotherapy until disease progression or unacceptable toxicity. The primary endpoint was the best objective response rate. Secondary endpoints included duration of response, progression -free survival, overall survival, and safety. Exploratory analyses evaluated efficacy endpoints by prior lines of therapy. At data cutoff on November 14, 2022, the objective response rate was 57.5%, with a complete response rate of 41.3% (n=33), which was consistent with prior analyses. With a median follow-up of 44.0 months, the median duration of response was not reached. The median progression -free survival was 11.6 months (95% confidence interval [95% CI]: 5.7-45.7) with a median follow-up of 45.6 months. The median overall survival was 33.5 months (95% CI: 18.3 -not reached) with a median follow-up of 65.6 months. Patients who had received one prior line of therapy (n=40) showed a higher objective response rate (67.5%; 52.5% complete responses) compared to patients who had received two or more prior lines of therapy (n=40; 47.5%; 30% complete responses), but the median duration of response was not reached in either subgroup. Other exploratory analyses revealed consistent long-term efficacy results across subgroups. Adverse events were consistent with those described in previous reports, were manageable, and their frequency decreased during tafasitamab monotherapy, with no new safety concerns. This final 5 -year analysis of L -MIND demonstrates that the immunotherapy combination of tafasitamab and lenalidomide is well tolerated and has long-term clinical benefit with durable responses. |
Note: | Reproducció del document publicat a: https://doi.org/10.3324/haematol.2023.283480 |
It is part of: | Haematologica, 2023, vol. 109, num. 2, p. 553-566 |
URI: | http://hdl.handle.net/2445/209548 |
Related resource: | https://doi.org/10.3324/haematol.2023.283480 |
ISSN: | 1592-8721 |
Appears in Collections: | Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) |
Files in This Item:
File | Description | Size | Format | |
---|---|---|---|---|
11244-Article Text-82035-5-10-20240129.pdf | 7.13 MB | Adobe PDF | View/Open |
This item is licensed under a
Creative Commons License