805MO - Real-world efficacy and safety of tisagenlecleucel (CTL019) for relapse or refractory follicular lymphoma patients included in the early access program through the French DESCAR-T registry

Background

Tisagenlecleucel (Tisa-cel) is approved in adults with relapsed or refractory (R/R) follicular lymphoma (FL) after ≥ 2 lines of systemic therapy. The phase 2 ELARA clinical trial, with a median follow-up of 29 months, demonstrated a high overall response rate (ORR) of 86% with a complete response rate (CRR) of 68% and durable responses. However, data on efficacy and safety in real-life settings (RWE) are limited.

Methods

We report the characteristics of R/R FL patients as well as the efficacy and safety of Tisa-cel. All patients were included in a French early access program through the DESCAR-T registry.

Results

Between October 2021 and September 2023, 129 patients (on 144 included in 24 French centers) received Tisa-cel with a median follow-up since infusion of 9.8 months. Most included patients were male (66.7%), had a median age of 63.7 (34-87) years old at inclusion and a median of 3 (2-9) prior lines of therapy. A total of 78.0% of patients were refractory to previous treatment and 75.0% were relapsed during or within 6 months after completion of maintenance therapy. The median time between leukapheresis and delivery was 29 (Q1-Q3: 27-35) days. Among the 113 patients for whom a response was evaluated, the ORR was 98.2% with a best CRR of 85.8%. Progression as best response was only 1.8%. The 12-month progression-free survival (PFS) and overall survival (OS) rates were 62.6% and 84.9%, respectively (both medians were not reached). Among the 106 patients with safety data in the DESCAR-T registry, <1% had a grade 3-4 cytokine release syndrome (CRS) and/or grade 3-4 Immune effector Cell-associated Neurotoxicity Syndrome (ICANS). No adverse drug reactions led to death.

Conclusions

These RWE data show excellent response rates and safety profile of Tisa-cel and confirm previous efficacy data from the pivotal ELARA trial, with ORR of 98.2% and best CRR of 85.8%. No new safety concerns were identified, especially on the frequencies of grade 3-4 CRS and grade 3-4 neurotoxicity which were both very low. With a limited median follow-up of 9.8 months, the 12-month PFS and OS rates were also comparable to those reported in the ELARA trial.

Clinical trial identification

Editorial acknowledgement

Medical writing assistance was provided by ICTA PM (Joëlle Castellani, PhD).

Legal entity responsible for the study

Novartis Pharma S.A.S.

Funding

Novartis Pharma S.A.S.

Disclosure

E. Bachy: Financial Interests, Personal, Other, Clinical research: Amgen, BMS, Daiichi Sankyo; Financial Interests, Personal, Advisory Board: Incyte, Roche, Takeda, ADC Therapeutics, Novartis, Kite/Gilead, Miltenyi; Financial Interests, Personal, Training: Incyte, Roche, Takeda, BMS, Novartis, Kite/Gilead, Sandoz, Janssen, Sanofi; Financial Interests, Personal, Other, Expenses for international conferences: Roche, Gilead, AbbVie. C. Thieblemont: Financial Interests, Personal, Advisory Board: Roche, Novartis, Kyte/Gilead, Incyte, Amgen, AbbVie; Financial Interests, Personal, Other, Transportation expenses: Roche, Novartis, Kyte/Gilead, Incyte, Amgen, AbbVie. R. Houot: Financial Interests, Personal, Financially compensated role: AbbVie, Celgene Corporation, Bristol Myers Squibb, Novartis Pharma, Gilead Sciences, Miltenyi Biomedicine, IQVIA, Incyte Biosciences, ADC Therapeutics, Olimpe, Takeda, Kephren; Financial Interests, Personal, Speaker, Consultant, Advisor: AbbVie, Celgene Corporation, Bristol Myers Squibb, Novartis Pharma, Gilead Sciences, Roche, Miltenyi Biomedicine, Agence Européenne Informatique, IQVIA, Amgen, Xencor, Incyte Biosciences, ADC Therapeutics, Olimpe, Takeda, Kephren; Financial Interests, Personal, Other, Travel and Accommodation Expenses: Novartis Pharma, Gilead Sciences, Agence Européenne Informatique, Amgen; Financial Interests, Personal, Other, Travel Expenses: Roche; Financial Interests, Personal, Other, Accommodation Expenses: Kephren. S. Choquet: Financial Interests, Institutional, Speaker, Consultant, Advisor: Novartis, Gilead-Kite, AbbVie. G. Cartron: Financial Interests, Personal, Speaker, Consultant, Advisor: Roche, Celgene-BMS, AbbVie, Milteny; Financial Interests, Personal, Advisory Board: Onwards Therapeutics, MedxCell, EmerCell, MabQi; Financial Interests, Personal, Financially compensated role: Sanofi, AbbVie, Takeda, Janssen, Roche, Celgene, Novartis, AstraZeneca. G. Brisou: Financial Interests, Personal, Speaker, Consultant, Advisor: Novartis, Gilead-Kite, Incyte, BMS; Financial Interests, Personal, Other, Travel and accommodation expenses: Novartis, Gilead-Kite, Incyte, BMS. O. Casasnovas: Financial Interests, Personal, Financially compensated role: MSD France, B3TSI, Roche, A+A, Lilly, Exafield, BeiGene, Bristol Myers Squibb, AstraZeneca, Takeda, Incyte Biosciences, ADC Therapeutics, Gilead Sciences; Financial Interests, Personal, Speaker, Consultant, Advisor: MSD France, Roche, Lilly, BeiGene, Bristol Myers Squibb, AbbVie, AstraZeneca, Takeda, Incyte Biosciences, ADC Therapeutics, Janssen-Cilag, Gilead Sciences, Novartis Pharma; Financial Interests, Personal, Other, Travel and accommodation expenses: Roche, Lilly, Bristol Myers Squibb, AbbVie, Takeda, Janssen-Cilag, Gilead Sciences; Financial Interests, Personal, Training: AstraZeneca. F. Gros: Financial Interests, Personal, Other, Travel expenses: Novartis, Gilead, Miltenyi, AbbVie; Financial Interests, Personal, Advisory Board: Novartis, Gilead, Miltenyi, AbbVie; Financial Interests, Personal, Speaker, Consultant, Advisor: Novartis, Gilead, Miltenyi, AbbVie. F. Morschhauser: Financial Interests, Personal, Financially compensated role: BeiGene, Takeda, Roche, Gilead Sciences, Miltenyi Biomedicine, Seagen, AbbVie, AstraZeneca, Incyte Biosciences, Edimark; Financial Interests, Personal, Speaker, Consultant, Advisor: BeiGene, Takeda, Roche, Gilead Sciences, Miltenyi Biomedicine, Celgene, AbbVie, AstraZeneca, Chugai Pharma, Kephren Publishing, Parexel, Janssen-Cilag, Incyte Biosciences, Edimark; Financial Interests, Personal, Other, Accommodation Expenses: Takeda, Gilead Sciences, AbbVie, AstraZeneca; Financial Interests, Personal, Other, Travel And Accommodation Expenses: Roche, Chugai Pharma, Kephren Publishing, Janssen-Cilag. F. Jardin: Financial Interests, Personal, Speaker, Consultant, Advisor: 3M Health Care, Gilead Sciences, Edimark, Sanofi Winthrop Industrie, Takeda, AbbVie, Janssen-Cilag, Incyte Biosciences, Bristol Myers Squibb, BeiGene, Novartis Pharma, AstraZeneca, Jazz Pharmaceuticals, Kyowa Kirin, Kephren Publishing, Sanofi Aventis, Parexel, Celgene; Financial Interests, Personal, Financially Compensated Role: Gilead Sciences, Takeda, AbbVie, Bristol Myers Squibb, BeiGene, Novartis Pharma, AstraZeneca, Kyowa Kirin, Kephren Publishing; Financial Interests, Personal, Other, Accommodation Expenses: Gilead Sciences, Sanofi Winthrop Industrie, Takeda, Janssen-Cilag, Roche, Jazz Pharmaceuticals, Kyowa Kirin, Kephren Publishing, Sanofi Aventis; Financial Interests, Personal, Other, Travel Expenses: Edimark; Financial Interests, Personal, Other, Travel and accommodation expenses: AbbVie; Financial Interests, Personal, Advisory Role: Roche. L. Ysebaert: Financial Interests, Personal, Advisory Board: AbbVie, AstraZeneca, BeiGene, BMS/Celgene, Gilead-Kite, Janssen, Roche. D. Beziz, C. Droumaguet-Gregoire, A. Filipovics, P. Miquel, C. Oprea: Financial Interests, Personal, Full or part-time Employment: Novartis.