Longitudinal safety of lisocabtagene maraleucel (liso-cel) in patients (pt) with second-line or later (2L+) large B-cell lymphoma (LBCL).

Abstract

7031 Background: Liso-cel has shown favorable efficacy and a manageable, consistent safety profile across B-cell malignancies, including R/R LBCL. Here, we present pooled longitudinal safety results in pts who received liso-cel as 2L+ treatment for LBCL in 3 pivotal clinical trials. Methods: Data from liso-cel–treated pts in the TRANSFORM (2L transplant-eligible LBCL, NCT03575351), PILOT (2L transplant-noneligible LBCL, NCT03483103), and TRANSCEND NHL 001 (third-line or later LBCL, NCT02631044) trials were pooled. Incidences of infections, laboratory parameters, and concomitant medication/procedure use were assessed from Day (D) 0–15, D16–30, Month (M) 2–3, M4–6, M7–9, M10–12, M13–18, M19–24, and M25 to end of study (EOS). Incidences were calculated as pts with ≥ 1 event divided by ongoing pts during that period. Results: A total of 420 pts were included. Incidence of grade (gr) ≥ 3 neutropenia was highest from D0–15 (Table), decreased sharply after M6, then remained low. Overall, 62% of pts received growth factors for neutropenia, with highest use from D0–15 and minimal use after M3. Rate of gr ≥ 3 anemia was highest from D0–15, declined by M9, then remained low. A total of 49% of pts received red blood cell (RBC) transfusions at any point with highest use from D0–15 and minimal use after M3. Incidence of gr ≥ 3 thrombocytopenia was highest from D0–M3, declined by M9, then remained low. Platelet transfusions were received by 31% of pts at any point with highest use from D0–M3 and minimal use after M3. Use of erythropoiesis- and thrombopoiesis-stimulating agents was rare (1% and 2% at any point, respectively). Incidence of gr ≥ 3 infections was 15% overall and remained low in all periods (Table). Hypogammaglobulinemia (serum immunoglobulin < 500 mg/dL) ranged from 43% to 63% across periods with IVIG use in 20% of pts at any point on study. B-cell aplasia declined over time from 99% from D0–15 to 73% by M12 and < 50% beyond M18. The overall incidence of second primary malignancies was 6%. Conclusions: In these longitudinal analyses in liso-cel–treated pts with 2L+ LBCL, gr ≥ 3 cytopenias and concomitant medication use decreased over time with minimal needs for growth factors or transfusions after M3. Gr ≥ 3 infections remained low in the short- and long-term periods despite persistent hypogammaglobulinemia and B-cell aplasia in most pts at M12. These data underscore the favorable long-term safety of liso-cel in pts with 2L+ LBCL, reinforcing the feasibility of outpatient management and the potential for low health care resource utilization in clinical practice. Clinical trial information: NCT03575351 , NCT03483103 , and NCT02631044 . Period Gr ≥ 3 neutropenia, % Growth factor for neutropenia, % Gr ≥ 3 anemia, % RBC transfusion,% Gr ≥ 3 thrombo-cytopenia, % Platelet transfusion, % Gr ≥ 3 infection, % D0–15D16–30M2–3M4–6M7–9M10–12M13–18M19–24M25–EOS 8736332612151046 421816512< 111 2912171242132 351920521< 1< 11 2335321691331 12221832< 1001 6252< 11< 121