Understanding How CAR T Works in the Real World for Follicular Lymphoma

For patients with relapsed or refractory follicular lymphoma (FL), the development of CAR T-cell therapy has been a beacon of hope.

While clinical trial results of tisagenlecleucel (KYMRIAH, Novartis), a CAR T-cell therapy, demonstrated remarkable efficacy, researchers led by Daniel J. Landsburg, MD, of the University of Pennsylvania, sought to understand how the therapy performed in real-world settings. These presentings were shared at the 2024 ASH conference this past December. 

Their goal was to explore whether the outcomes mirrored clinical trial results when the therapy became commercially available to patients with two or more lines of prior follicular lymphoma treatment.

What the Study Examined

The study focused on real-world data (RWD) from follicular lymphoma patients treated with tisagenlecleucel after it became available outside of clinical trials. 

Researchers analyzed the outcomes of 190 follicular lymphoma patients from 22 medical centers across North America who received the therapy between 2018 and 2023. The study aimed to understand how effective and safe the therapy was when applied in diverse healthcare settings outside the controlled environment of clinical trials.

Key Findings

1. Effectiveness of tisagenlecleucel

• After receiving tisagenlecleucel, an impressive 91% of patients achieved a response to the therapy.

• Among these, 74% achieved a complete response (CR), indicating no detectable lymphoma cells.

2. Durability of responses

• The study revealed a two-year progression-free survival (PFS) rate of 64%. This means that over half of the patients who responded to the therapy had not experienced a return of their disease within two years.

• The two-year overall survival (OS) rate was 91%, highlighting the therapy’s life-prolonging potential.

3. Safety Profile

• The most common side effects were cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), both known complications of CAR T-cell therapy.

• CRS occurred in 61% of patients, but most cases were mild (Grade 1 or 2). Severe CRS (Grade 3 or higher) occurred in 3% of patients.

• ICANS affected 7% of patients, with 2% experiencing severe symptoms.

4. Patient Population

• Because it highlighted patients receiving the treatment commercially, the study showed the diversity of real-world patients, including those with more complex medical histories or who were older—populations often underrepresented in clinical trials.

• This shows the treatment to be safe across various patient types- an encouarging statistic that should exist amongst all clinical trials. 

What These Results Mean for Patients with Follicular Lymphoma

These findings demonstrate that tisagenlecleucel offers hope for patients with relapsed/refractory follicular lymphoma, with high response rates and long-lasting remissions in real-world settings. The low incidence of severe side effects also suggests the therapy is safe for broader patient populations.

This is encouraging news for patients and caregivers. It shows that CAR T-cell therapy is effective not only in carefully controlled trials but can also deliver meaningful results in everyday clinical practice.

Questions for Your Doctor: Could This Be Right for You?

If you or your loved one has follicular lymphoma and is considering tisagenlecleucel, here are a few questions to ask your healthcare provider:

• Am I eligible for CAR T-cell therapy?
• What are the potential risks and benefits for someone in my situation?
• How should we prepare for the treatment and manage potential side effects like CRS or ICANS?
• Where is the nearest treatment center that offers tisagenlecleucel?

Looking Ahead

The success of CAR T-cell therapy in real-world settings underscores the importance of continued research and collaboration between healthcare providers, researchers, and patients. As more data emerges, we hope to see further advancements in improving outcomes for follicular lymphoma patients.

If you’re considering this treatment, reach out to your care team to see if CAR T-cell therapy might be right for you.

To continue your understanding of how follicular lymphoma treatments are advancing, click here: Follicular Lymphoma News

Source:

• Efficacy and Safety of Tisagenlecleucel in Patients with Relapsed/Refractory Follicular Lymphoma: A Real-World Analysis from the Center for Blood and Marrow Transplant Research (CIBMTR) Registry