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Tisagenlecleucel in Korean patients with relapsed or refractory diffuse large B-cell lymphomaNew Lymphoma Therapy Helps Patients Live Longer

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Key Takeaway
Consider that early complete response after tisagenlecleucel strongly predicts survival in Korean patients with relapsed or refractory diffuse large B-cell lymphoma.

This retrospective cohort study from Catholic Hematology Hospital, Korea, included 79 Korean patients with relapsed or refractory diffuse large B-cell lymphoma who received tisagenlecleucel. The median follow-up was 11.6 months. The overall response rate before infusion was 40.6%, and the complete response rate before infusion was 14.1%. At 3 months after treatment, the overall response rate was 72.9% and the complete response rate was 64.4%. The median progression-free survival was 4.9 months, and the median overall survival was 21.6 months. Achieving a complete response at 3 months was strongly associated with superior survival (p < 0.001).

Safety events included cytokine release syndrome in 70.9% of patients (grade ≥3 in 22.8%) and immune effector cell–associated neurotoxicity syndrome in 21.5% (grade ≥3 in 8.8%). The median onset of cytokine release syndrome was 2 days, and the median onset of immune effector cell–associated neurotoxicity syndrome was 5 days. Non-relapse mortality was 11.7%. Tocilizumab was used in 45.6% of patients and dexamethasone in 13.9%.

Key limitations include the retrospective design, single-center setting, and lack of a comparator group. The study population was limited to Korean patients, which may affect generalizability. The practice relevance notes that tisagenlecleucel demonstrated favorable efficacy and manageable safety in this cohort, with early complete response strongly predicting long-term outcomes.

Diffuse large B-cell lymphoma is a common type of blood cancer. It grows fast and needs quick action to stop it. When it comes back, doctors call it relapsed or refractory disease. Finding a new way to fight it is urgent.

Patients face a difficult choice when their first treatment fails. Many have already tried several different drugs by this point. The goal is to find something that works when others do not.

The Shift in Treatment

This approach is called CAR T-cell therapy. It is a major change from standard chemotherapy methods. It changes how the body recognizes and attacks the cancer cells.

Think of your immune cells as soldiers on a mission. This therapy trains them to recognize cancer cells specifically. It changes the soldiers so they can find and destroy the enemy.

How The Body Fights Back

It is like giving them a new map to the target. The cells are taken from the patient and modified in a lab. They are sent back into the body to hunt down the disease.

Researchers looked at 79 patients in Korea for this report. They treated them between 2022 and 2025 at one hospital. The drug used was called Tisagenlecleucel. It is the only second-generation version available in that region.

Real-World Results Explained

Most patients saw their tumors shrink significantly after the treatment. About 64 percent had no signs of cancer three months later. The average survival time was nearly two years. This is a strong result for this stage of the disease.

About 73 percent of patients saw some tumor reduction. This means the therapy worked for the majority of people. However, not everyone achieved a complete response to the treatment.

This doesn’t mean this treatment is available yet.

Safety and Side Effects

There are risks involved with the therapy that must be managed. Some patients had high fevers or confusion during the process. Doctors call these side effects cytokine release (severe immune reaction) and neurotoxicity (brain confusion).

They need careful management to stay safe during treatment. About 12 percent of patients died from causes other than cancer. Infections and severe reactions were the main reasons for this.

Is It Ready For You?

Experts note that reaching a complete response early is key. Patients who had no cancer signs at three months lived longer. This helps doctors predict who might benefit most from the care.

This therapy is not a magic fix for everyone. It is approved in some places but not all. Patients should talk to their oncologist about eligibility. It is a powerful tool for specific cases.

The process takes time to prepare the cells for use. Some patients wait over a month for the final dose. Logistics can be a challenge for those needing quick action.

Study Limitations

The study looked at one hospital only. The follow-up time was about one year. We need more data to know long-term effects. More research is needed to confirm these results.

Scientists will keep testing this therapy in larger groups. They want to see if it works better with fewer side effects. Approval processes take time to ensure safety. Hope is growing for those facing difficult diagnoses.

Study Details

Study typeCohort
EvidenceLevel 3
PublishedApr 2026
View Original Abstract ↓
IntroductionTisagenlecleucel (Tisa-cel), approved by the Korean Ministry of Food and Drug Safety (MFDS) in 2021 and reimbursed since April 2022, is currently the only second-generation chimeric antigen receptor (CAR) T-cell therapy available in Korea. This study aimed to evaluate the real-world efficacy, safety, logistics, and outcomes of Tisa-cel in Korean patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) and identify prognostic factors associated with survival.MethodsWe retrospectively analyzed 79 patients with R/R DLBCL who received Tisa-cel at the Catholic Hematology Hospital between April 2022 and January 2025.ResultsThe median decision-to-infusion and vein-to-vein times were 49 and 40 days, respectively. Bridging chemotherapy was administered to 64 patients, with an overall response rate (ORR) of 40.6% and a complete response (CR) rate of 14.1% before infusion. Three months after Tisa-cel treatment, the ORR and CR rates were 72.9% and 64.4%, respectively. Tisa-cel was administered as third-line therapy in 50.6% of the patients, and 48.1% had refractory disease. Of the patients who experienced relapse (43%), approximately half transitioned to palliative care, 8.8% were enrolled in clinical trials, and 5.9% proceeded to allogeneic transplantation. Non-relapse mortality was 11.7%, primarily due to infections (n = 7) and immune effector cell–associated neurotoxicity syndrome (ICANS)-related events (n = 2). Cytokine release syndrome occurred in 70.9% of patients (grade ≥ 3 in 22.8%) and ICANS in 21.5% (grade ≥ 3 in 8.8%), with a median onset at 2 and 5 days, respectively. Tocilizumab and dexamethasone were used in 45.6% and 13.9% of the patients, respectively. With a median follow-up of 11.6 months, the median progression-free survival was 4.9 months, and the median overall survival was 21.6 months. Achieving CR at 3 months was strongly associated with superior survival (p < 0.001).DiscussionTisa-cel demonstrated favorable efficacy and manageable safety in Korean patients with R/R DLBCL. Early CR strongly predicted long-term outcomes, whereas ICANS occurrence and steroid use were associated with poorer prognosis, underscoring the need to optimize toxicity management.
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