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Final analysis of t...
Final analysis of the phase III non-inferiority COLUMBA study of subcutaneous versus intravenous daratumumab in patients with relapsed or refractory multiple myeloma
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Usmani, SZ (author)
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- Nahi, H (author)
- Karolinska Institutet
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Legiec, W (author)
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Grosicki, S (author)
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Vorobyev, V (author)
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Spicka, I (author)
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Hungria, V (author)
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Korenkova, S (author)
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Bahlis, NJ (author)
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Flogegard, M (author)
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Blade, J (author)
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Moreau, P (author)
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Kaiser, M (author)
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Iida, S (author)
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Laubach, J (author)
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Magen, H (author)
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Cavo, M (author)
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Hulin, C (author)
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White, D (author)
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De Stefano, V (author)
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Lantz, K (author)
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O'Rourke, L (author)
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Heuck, C (author)
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Delioukina, M (author)
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Qin, X (author)
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Nnane, I (author)
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Qi, M (author)
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Mateos, MV (author)
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(creator_code:org_t)
- 2022-03-31
- 2022
- English.
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In: Haematologica. - : Ferrata Storti Foundation (Haematologica). - 1592-8721 .- 0390-6078. ; 107:10, s. 2408-2417
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https://doi.org/10.3...
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Abstract
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- In the primary analysis of the phase III COLUMBA study, daratumumab by subcutaneous administration (DARA SC) demonstrated 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 maximum mean (standard deviation [SD]) trough concentration (cycle 3, day 1 pre-dose) of serum DARA was 581 (SD, 315) μg/mL for DARA SC and 496 (SD, 231) μg/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.
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- art (subject category)
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To the university's database
- By the author/editor
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Usmani, SZ
-
Nahi, H
-
Legiec, W
-
Grosicki, S
-
Vorobyev, V
-
Spicka, I
-
show more...
-
Hungria, V
-
Korenkova, S
-
Bahlis, NJ
-
Flogegard, M
-
Blade, J
-
Moreau, P
-
Kaiser, M
-
Iida, S
-
Laubach, J
-
Magen, H
-
Cavo, M
-
Hulin, C
-
White, D
-
De Stefano, V
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Lantz, K
-
O'Rourke, L
-
Heuck, C
-
Delioukina, M
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Qin, X
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Nnane, I
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Qi, M
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Mateos, MV
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show less...
- Articles in the publication
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Haematologica
- By the university
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Karolinska Institutet