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Long-term Clinical Outcomes With Tisagenlecleucel in High-risk Relapsed/refractory Follicular Lymphoma

Strategic Insights

— 2 min read

A new study published in the Haematologica journal provides four-year follow-up results on the efficacy, safety, and pharmacokinetics of tisagenlecleucel treatment for patients with relapsed/refractory follicular lymphoma. The study, led by researchers from the University Teaching Hospital, demonstrates robust and durable responses with tisagenlecleucel and a favorable safety profile, even in high-risk subgroups. The research suggests that baseline high-risk disease characteristics are not associated with reduced efficacy following tisagenlecleucel infusion.

Key Takeaways:

  • The study included 97 patients with relapsed/refractory follicular lymphoma who received a single infusion of tisagenlecleucel (0.6-6 x 10 CAR-positive viable T cells).
  • The median follow-up was 53 months (range: 46-62 months), and at baseline, high-risk subgroups were identified: 66.0% had bulky disease, and 64.9% experienced disease progression within two years of initial therapy (POD24).
  • The median progression-free survival (PFS) across all patients was 53.3 months (95% CI: 18.2-not estimable), and at 48 months, the PFS was 50.2% in the overall population and 66.1% in patients who achieved the best overall response.
  • In high-risk subgroups, 48-month PFS rates were 45.5% in the POD24 group, 45.5% for high FLIPI, 45.2% in participants with bulky disease, and 52.8% for double refractory.
  • The overall survival (OS) rate among efficacy-evaluable patients at 48 months was 79.3%, and the 48-month OS rates were 80.8% for POD24, 73.2% for those with high FLIPI, 73.0% for patients with bulky disease, 83.7% for double refractory, and 65.5% for those with high tumor burden.
  • No new safety signals have been reported since the last data cut, and six patients (6.2%) developed second primary malignancies.

Statistics:

  • 97 patients with relapsed/refractory follicular lymphoma received tisagenlecleucel treatment.
  • 66.0% of patients had bulky disease, and 64.9% experienced disease progression within two years of initial therapy (POD24).
  • 60.6% of patients had a high Follicular Lymphoma International Prognostic Index (FLIPI 3), and 21.3% had a high tumor burden.
  • The median PFS was 53.3 months (95% CI: 18.2-not estimable).
  • The median OS was not reached.
  • 6.2% of patients developed second primary malignancies.

Sources:

  • C. Thieblemont, et al. Blood 2024; 144 (Suppl.1): 3034.
  • Haematologica - http://www.haematologica.org
  • B07 | Long-term Clinical Outcomes With Tisagenlecleucel in High-risk Relapsed/refractory Follicular Lymphoma: 4-YEAR Follow-up From The Phase 2 Elara Study. Haematologica, 2025, 110(s1)
  • NewsRx. University Teaching Hospital Researchers Have Provided New Study Findings on Follicular Lymphoma (B07 | Long-term Clinical Outcomes With Tisagenlecleucel in High-risk Relapsed/refractory Follicular Lymphoma: 4-YEAR Follow-up From The Phase 2 ...). Hematology Week. November 3, 2025; p 79.

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