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. 2023 Nov;111(5):715-721.
doi: 10.1111/ejh.14065. Epub 2023 Jul 27.

Idelalisib (PI3Kδ inhibitor) therapy for patients with relapsed/refractory chronic lymphocytic leukemia: A Swedish nation-wide real-world report on consecutively identified patients

Agnes Mattsson  1   2 , Sandra Eketorp Sylvan  1 , Per Axelsson  3 , Fredrik Ellin  4 , Christian Kjellander  5   6 , Karin Larsson  7 , Birgitta Lauri  8 , Catharina Lewerin  9 , Christian Scharenberg  10 , Love Tätting  11 , Hemming Johansson  1 , Anders Österborg  1   12 , Lotta Hansson  1   12
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Free article

Idelalisib (PI3Kδ inhibitor) therapy for patients with relapsed/refractory chronic lymphocytic leukemia: A Swedish nation-wide real-world report on consecutively identified patients

Agnes Mattsson et al. Eur J Haematol. 2023 Nov.
Free article

Abstract

Objectives: We examined the efficacy and toxicity of the PI3Kδ inhibitor idelalisib in combination with rituximab salvage therapy in consecutively identified Swedish patients with chronic lymphocytic leukemia (CLL).

Methods and results: Thirty-seven patients with relapsed/refractory disease were included. The median number of prior lines of therapy was 3 (range 1-11); the median age was 69 years (range 50-89); 22% had Cumulative Illness Rating Scale (CIRS) >6 and 51% had del(17p)/TP53 mutation. The overall response rate was 65% (all but one was partial response [PR]). The median duration of therapy was 9.8 months (range 0.9-44.8). The median progression-free survival was 16.4 months (95% CI: 10.4-26.3) and median overall survival had not been reached (75% remained alive at 24 months of follow-up). The most common reason for cessation of therapy was colitis (n = 8, of which seven patients experienced grade ≥3 colitis). The most common serious adverse event was grade ≥3 infection, which occurred in 24 patients (65%).

Conclusions: Our real-world results suggest that idelalisib is an effective and relatively safe treatment for patients with advanced-stage CLL when no other therapies exist. Alternative dosing regimens and new PI3K inhibitors should be explored, particularly in patients who are double-refractory to inhibitors of BTK and Bcl-2.

Keywords: CLL; PI3Kδ inhibitor; idelalisib; real-world.

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