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Observational Study
. 2024 May;38(5):1107-1114.
doi: 10.1038/s41375-024-02213-x. Epub 2024 Mar 8.

Axicabtagene ciloleucel treatment is more effective in primary mediastinal large B-cell lymphomas than in diffuse large B-cell lymphomas: the Italian CART-SIE study

Annalisa Chiappella  1 , Beatrice Casadei  2 , Patrizia Chiusolo  3 , Alice Di Rocco  4 , Silva Ljevar  5 , Martina Magni  6 , Piera Angelillo  7 , Anna Maria Barbui  8 , Ilaria Cutini  9 , Anna Dodero  6 , Francesca Bonifazi  2 , Maria Chiara Tisi  10 , Stefania Bramanti  11 , Maurizio Musso  12 , Mirko Farina  13 , Massimo Martino  14 , Mattia Novo  15 , Giovanni Grillo  16 , Francesca Patriarca  17 , Giulia Zacchi  18 , Mauro Krampera  19 , Martina Pennisi  6 , Eugenio Galli  3 , Maurizio Martelli  4 , Andrés J M Ferreri  7 , Silvia Ferrari  8 , Riccardo Saccardi  9 , Anisa Bermema  6 , Anna Guidetti  6   20 , Rosalba Miceli  5 , Pier Luigi Zinzani  2   21 , Paolo Corradini  6   20
Affiliations
Observational Study

Axicabtagene ciloleucel treatment is more effective in primary mediastinal large B-cell lymphomas than in diffuse large B-cell lymphomas: the Italian CART-SIE study

Annalisa Chiappella et al. Leukemia. 2024 May.

Abstract

Axicabtagene ciloleucel showed efficacy for relapsed/refractory large B-cell lymphomas (LBCL), including primary mediastinal B-cell lymphomas (PMBCL); however, only few PMBCLs were reported. Aim was to evaluate efficacy and safety of axicabtagene ciloleucel in patients with PMBCL compared to those with other LBCL, enrolled in the Italian prospective observational CART-SIE study. PMBCLs (n = 70) were younger, with higher percentage of bulky and refractory disease, compared to other LBCLs (n = 190). Median follow-up time for infused patients was 12.17 months (IQR 5.53,22.73). The overall (complete + partial) response rate (ORR,CR + PR) after bridging was 41% for PMBCL and 28% for other LBCL, p = 0.0102. Thirty days ORR was 78% (53/68) with 50% (34) CR in PMBCL, and 75% (141/187) with 53% (100) CR in other LBCL, p = 0.5457. Ninety days ORR was 69% (45/65) with 65% (42) CR in PMBCL, and 54% (87/162) with 47% (76) CR in other LBCL; progressive disease was 21% in PMBCL and 45% in other LBCL, p = 0.0336. Twelve months progression-free survival was 62% (95% CI: 51-75) in PMBCL versus 48% (95% CI: 41-57) in other LBCL, p = 0.0386. Twelve months overall survival was 86% (95% CI: 78-95) in PMBCL versus 71% (95% CI: 64-79) in other LBCL, p = 0.0034. All grade cytokine release syndrome was 88% (228/260); all grade neurotoxicity was 34% (88/260), with 6% of fatal events in PMBCL. Non-relapse mortality was 3%. In conclusion, PMBCLs achieved significantly better response and survival rates than other LBCLs.

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Conflict of interest statement

AC - Advisory boards: Gilead-Sciences, Ideogen, Roche, SecuraBIO, Takeda; honoraria for lectures/educational events: Abbvie, Eli Lilly, Gilead-Sciences, Incyte, Janssen-Cilag, Novartis, Takeda. BC - Advisory boards and honoraria for lectures/educational events: Kite Gilead, Novartis. FB - Advisory boards and honoraria for lectures/educational events: Kite Gilead, Novartis. SB - Speaker bureau: Bristol-Myers Squibb, Gilead, Novartis; advisory board: Novartis; Travel accommodation: Novartis, Roche. AJMF has received speaker fees from Adienne, AstraZeneca, Bristol-Myers Squibb, Gilead, Novartis, and Roche; was a member of advisory boards of Abbvie, AstraZeneca, Bristol-Myers Squibb, Genmab, Gilead, Incyte, Juno, Novartis, PletixaPharm, and Roche; and currently receives research grants from Abbvie, Amgen, ADC Therapeutics, Bayer HealthCare Pharmaceuticals, Beigene, Bristol Myers Squibb, Genmab, Gilead, Hutchison Medipharma, Incyte, Janssen Research & Development, MEI Pharma, Novartis, Pfizer, Pharmacyclics, PletixaPharm, Protherics, Roche, and Takeda; and holds patents on NGR-hTNF-alfa in brain tumours and NGR-hTNF/R-CHOP in relapsed or refractory PCNSL and SNGR-hTNF in brain tumors. PLZ – Consultant: MSD, Eusapharma, Novartis; Advisory boards: ADC Therapeutics, Astrazeneca, BeiGene, BMS, Celltrion, Eusapharma, Gilead, Incyte, Janssen-Cilag, KyowaKirin, MSD, Novartis, Roche, Sandoz, SecuraBio, Servier, Takeda; speakers bureau: Astrazeneca, Beigene, BMS, Celltrion, Eusapharma, Gilead, Incyte, Janssen-Cilag, Kyowa-Kirin, MSD, Novartis, Roche, Servier, Takeda. PCo - Advisory boards: AbbVie, ADC Therapeutics, Amgen, BeiGene, Celgene, Daiichi Sankyo, Gilead/Kite, GSK, Incyte, Janssen, KyowaKirin, Nerviano Medical Science, Novartis, Roche, Sanofi, Takeda; honoraria for lectures: AbbVie, Amgen, Celgene, Gilead/Kite, Janssen, Novartis, Roche, Sanofi, Takeda. The other authors declare that they have no conflict of interest.

Figures

Fig. 1
Fig. 1. Patient flow: March 2019–July 2023.
e-crf electronic Case Report Form, axi-cel axicabtagene ciloleucel, tisa-cel tisagenlecleucel, PMBCL primary mediastinal B-cell lymphoma, other LBCL large B-cell lymphoma other than primary mediastinal B-cell lymphoma.
Fig. 2
Fig. 2. Progression-free survival and Overall survival.
A Progression-free survival. PMBCL primary mediastinal B-cell lymphoma, other LBCL large B-cell lymphoma other than primary mediastinal B-cell lymphoma. Log-rank test p value 0.0386. B Overall survival. PMBCL primary mediastinal B-cell lymphoma, other LBCL large B-cell lymphoma other than primary mediastinal B-cell lymphoma. Log-rank test p value 0.0034.
See this image and copyright information in PMC

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