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Title: | Final analysis of the phase 3 non-inferiority COLUMBA study of subcutaneous versus intravenous daratumumab in patients with relapsed or refractory multiple myeloma |
Author: | Usmani, Saad Z. Nahi, Hareth Legiec, Wojciech Grosicki, Sebastian Vorobyev, Vladimir Spicka, Ivan Hungria, Vania Korenkova, Sibirina Bahlis, Nizar J. Flogegard, Max Bladé, J. (Joan) Moreau, Philippe Kaiser, Martin Iida, Shinsuke Laubach, Jacob Magen, Hila Cavo, Michele Hulin, Cyrille White, Darrell Stefano, Valerio de Lantz, Kristen O'Rourke, Lisa Heuck, Christoph Delioukina, Maria Qin, Xiang Nnane, Ivo Qi, Ming Mateos, María Victoria |
Keywords: | Administració de medicaments Mieloma múltiple Anticossos monoclonals Administration of drugs Multiple myeloma Monoclonal antibodies |
Issue Date: | Oct-2022 |
Publisher: | Ferrata Storti Foundation |
Abstract: | In the primary analysis of the phase III COLUMBA study, daratumumab by subcutaneous administration (DARA SC) demon-strated non-inferiority to intravenous administration (DARA IV) for relapsed or refractory multiple myeloma (RRMM). Here, we report the final analysis of efficacy and safety from COLUMBA after a median of 29.3 months follow-up (additional 21.8 months after the primary analysis). In total, 522 patients were randomized (DARA SC, n=263; DARA IV, n=259). With longer follow-up, DARA SC and DARA IV continued to show consistent efficacy and maximum trough daratumumab concentration as compared with the primary analysis. The overall response rate was 43.7% for DARA SC and 39.8% for DARA IV. The maxi-mum mean (standard deviation [SD]) trough concentration (cycle 3, day 1 pre-dose) of serum DARA was 581 (SD, 315) mu g/mL for DARA SC and 496 (SD, 231) mu g/mL for DARA IV. Median progression-free survival was 5.6 months for DARA SC and 6.1 months for DARA IV; median overall survival was 28.2 months and 25.6 months, respectively. Grade 3/4 treatment-emergent adverse events occurred in 50.8% of patients in the DARA SC group and 52.7% in the DARA IV group; the most common (>= 10%) were thrombocytopenia (DARA SC, 14.2%; DARA IV, 13.6%), anemia (13.8%; 15.1%), and neutropenia (13.1%; 7.8%). The safety profile remained consistent with the primary analysis after longer follow-up. In summary, DARA SC and DARA IV continue to demonstrate similar efficacy and safety, with a low rate of infusion-related reactions (12.7% vs. 34.5%, respectively) and shorter administration time (3-5 minutes vs. 3-7 hours) supporting DARA SC as a preferable therapeutic choice. (Clinicaltrials gov. Identifier: NCT03277105. |
Note: | Reproducció del document publicat a: https://doi.org/10.3324/haematol.2021.279459 |
It is part of: | Haematologica, 2022, vol. 107, num. 10, p. 2408-2417 |
URI: | http://hdl.handle.net/2445/202060 |
Related resource: | https://doi.org/10.3324/haematol.2021.279459 |
ISSN: | 1592-8721 |
Appears in Collections: | Articles publicats en revistes (IDIBAPS: Institut d'investigacions Biomèdiques August Pi i Sunyer) |
Files in This Item:
File | Description | Size | Format | |
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Final analysis of the phase III non-inferiority COLUMBA_Haematologica.pdf | 5.53 MB | Adobe PDF | View/Open |
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