FIRST RESULTS OF DLBCL PATIENTS TREATED WITH CAR‐T CELLS AND ENROLLED IN DESCAR‐T REGISTRY, A FRENCH REAL‐LIFE DATABASE FOR CAR‐T CELLS IN HEMATOLOGIC MALIGNANCIES

Abstract

Background: DESCAR-T is the French national registry for patients treated with commercial CAR-T cells (DLBCL and ALL). DESCAR-T has been designed by LYSA/LYSARC and aims to collect real-life data. DESCAR-T was approved by the French authorities in 2019 and is the reference registry for CAR-T cells reimbursement by French health authorities. Data (patients’ characteristics, safety, efficacy and long-term outcome…) from time of medical decision to treat with CAR-T cells to up to 15 years after CAR-T cells infusion are registered in DESCAR-T. Several complementary registries are also linked to DESCAR-T database (immune-monitoring, blood and tumor biobanking -CeVi-CART, imagery platform). We present the first analyses regarding DLBCL patients' characteristics and outcome registered in DESCAR-T. Methods: All patients with DLBCL registered in DESCAR-T were eligible for the present study. All patients gave informent consent befor DESCAR-T registration. Results: To date (Jan 2021), 14 out of 24 CAR-T cells accredited French centers have registered patients in DESCAR-T (other centers are being opened). The first patient was registered in December 2019. At the time of the analysis, 537 DLBCL patients have been registered. CAR-T cells product has been ordered for 517 patients of whom 463 have been infused. At the time of registration in DESCAR-T, median age was 63.0 years (range, 53-70), 40.6% of patients were > 65yrs and 3.5% > 75yrs. Lymphoma subtypes were DLBCL (91%), PMBL (3%), and high-grade B-cell lymphoma (2%). Among patients for whom CAR-T cells have been ordered (n = 517), 313 (60.5%) were male, 76 (14.7%) had a PS≥2, 377 (72.9%) had an advanced disease (stage III or IV), 330 (63.8%) had elevated LDH. Median number of prior lines of treatment was 3 (range, 2 – 3) and 21% of patients have been previously transplanted. Median time from CAR-T cells order to infusion was 50 days [range, 43-60]. Median time from leukapheresis to CAR-T infusion was 41.1 days (range, 36-48). Overall, 65% of patients received Axi-cel and 35% received Tisa-acel. Response was available in 419 infused patients. Best ORR was 70.2% (65.5% - 74.5%). At D30 after CAR-T cell infusion, 157 (38%) patients achieved CR and 112 (27%) achieved PR. Among the 157 patients who achieved a CR at D30, 96 (61%) remained in CR at D90. The median follow-up calculated from CAR-T cells order was 7.4 months (range, 5.8-7.9) and 6m [range, 5.5-6.2] from CAR-T infusion. The median OS calculated from time of CAR-T infusion is 12.7m [range, 10.6-NA]. Summary/Conclusion: This first analysis from DESCAR-T registry seems to confirm CAR-T cells efficacy in real life. Updated results will be presented at the meeting. Overall, 537 DLBCL patients have been registered in DESCAR-T in 13 months. This demontrates that CAR-T cells therapy has become a key treatment for R/R DLBCL. In 2021, DESCAR-T will be extended to MCL and multiple myeloma. EA - previously submitted to EHA 2021. Keywords: Aggressive B-cell non-Hodgkin lymphoma, Cellular therapies Conflicts of interests pertinent to the abstract S. Le Gouill Consultant or advisory role: Gilead; Novartis

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