{
  "abstract": "Background and Importance Diffuse large B-cell lymphoma (DLBCL) is the most common lymphoproliferative neoplasm among non-Hodgkin lymphomas, characterised by clinical aggressiveness and biological heterogeneity. Autologous Chimeric Antigen Receptor (CAR) T-cell therapies targeting CD19, such as axicabtagene ciloleucel (axi-cel), have emerged as a promising treatment option. However, evidence on their effectiveness in real-world settings remains limited.Aim and Objectives To evaluate the effectiveness of axi-cel as a third-line or later therapy in patients (p) with relapsed/refractory DLBCL.Material and Methods Observational, retrospective, descriptive and multicentre study including patients treated after ≥2 therapy lines with axi-cel between April 2019-May 2025. Variables: demographic (age/sex), clinical (disease type, ECOG, transplant previous, treatment line, time to infusion from relapse, therapy follow-up) and effectiveness at different assessment points (median follow-up/1/3/6/12/18 months [mo]): response (Overall-Objective-Response [ORR], Complete Response [CR], Partial Response [PR], Non-Estudied-Response [NOE], Stable-Disease [SD], Progression), Time-Maintenance-Response (TMR), mortality, median Survival-Free-Progression (mSFP), median Overall Survival (mOS).Data were collected from medical records/prescriptions, and analysed using descriptive and survival (Kaplan–Meier) analysis.Results A total of 37p (mean age 54.1±15.8 years; 59.7% male) were analysed, 83,78% DLBCL, 6p with transformed follicular lymphoma. ECOG: 0 (35.1%; 13p), 1 (64.9%; 24p). Seven had prior transplants: five autologous. Axi-cel was: 78.4% third-line; 18.9% fourth-line, 2.7% sixth-line. Median of 2.7 mo since last relapse. Median therapy follow-up:15.7 mo (0.4-62.2).Effectiveness analysis: Time\\Out-comes ORR [n(%)] CR [n(%)] PR [n(%)] SD [n(%)] Progress-ion [n(%)] NER[ n(%)] Deaths [n(%)] Median:15.7 mo 23 (62.2) 18 (48.6) 5 (13.5) 1 (2.7)* 11 (29.7) 2 (5.4)** 13 (35.1)*** Assessment points 1mo 13(35.1) 8(21.6) 5(13.5) – 4(10.8) 20(54.1) 1(2.7) 3mo 26(70.3) 16(43.2) 10(27.1) 1(2.7) 8(21.6) 2(5.4) 7(18.9) 6mo 26(70.3) 16(43.2) 10(27.1) 1(2.7) 8(21.6) 2(5.4) 9(24.3) 12mo 24(64.9) 18(48.7) 6(16.2) 1(2.7) 10(27.0) 2(5.4) 10(27.0) 18mo 23(62.2) 17(46.0) 6(16.2) 1(2.7) 11(29.7) 2(5.4) 10(27.0) *Patient who died with DS.**Patients who died before response determination.***3p died after 18 mo of infusion.Mortality (35.1%;13p) causes were: progression (6p), early (4p) and late (3p) complications.Median TMR: 14.0mo (IQR:12.8 mo; [0-61.3]).Estimated mPFS: 27.7mo (7.6-NA). mOS estimation not possible with the follow-up (19.4-NA). However, OS were: 75.7-73.0-73.0% at 6-12-18 mo.Conclusion and Relevance Axi-cel has demonstrated significant real-world effectiveness, with ORR/CR rates and mPFS higher than those described in ZUMA-1 (pivotal trial). These results suggest a faster, deeper, and more sustained response, likely influenced by baseline profile, use of bridging therapy and different eligibility criteria. Overall, the data confirm the high effectiveness and reinforce its role as one of the most effective strategies available in this context.Conflict of Interest No conflict of interest",
  "authors": [
    {
      "affiliations": [
        "Hospital Regional Universitario De Málaga, Unidad De Gestión Clínica De Farmacia, Málaga, Spain"
      ],
      "name": "R Díaz Perales"
    },
    {
      "affiliations": [
        "Hospital Regional Universitario De Málaga, Unidad De Gestión Clínica De Farmacia, Málaga, Spain"
      ],
      "name": "C Ortega De La Cruz"
    },
    {
      "affiliations": [
        "Hospital Regional Universitario De Málaga, Unidad De Gestión Clínica De Farmacia, Málaga, Spain"
      ],
      "name": "M Rouco Blanco Rajoy"
    },
    {
      "affiliations": [
        "Hospital Regional Universitario De Málaga, Unidad De Gestión Clínica De Farmacia, Málaga, Spain"
      ],
      "name": "A Ballesteros Fernandez"
    },
    {
      "affiliations": [
        "Hospital Regional Universitario De Málaga, Unidad De Gestión Clínica De Farmacia, Málaga, Spain"
      ],
      "name": "JC Del Rio Valencia"
    },
    {
      "affiliations": [
        "Hospital Regional Universitario De Málaga, Unidad De Gestión Clínica De Farmacia, Málaga, Spain"
      ],
      "name": "C Gallego Fernández"
    },
    {
      "affiliations": [
        "Hospital Regional Universitario De Málaga, Unidad De Gestión Clínica De Farmacia, Málaga, Spain"
      ],
      "name": "MB Tortajada Goitia"
    }
  ],
  "title": "5PSQ-164 Effectiveness of axicabtagene ciloleucel in clinical practice for the treatment of diffuse large B-cell lymphoma after ≥ 2 lines of systemic therapy",
  "uid": "bd5fb408-f252-522a-ba02-f44023c9ff5d"
}