During the European Hematology Association (EHA)’s 26th Annual Meeting, taking place virtually, biopharmaceutical company Kite (part of Gilead) shared longer-term follow-up data on Yescarta (axicabtagene ciloleucel) for patients with relapsed or refractory (R/R) follicular lymphoma. The presentation compared data from the Phase 2 ZUMA-5 clinical trial with data from the retrospective SCHOLAR-5 study. Altogether, Yescarta showed improved overall and progression-free survival rates over other available therapies. Interested in learning more? Check out the late-breaking abstract here.

Yescarta

According to the National Cancer Institute (NCI), Yescarta is:

[a type of CAR T-cell therapy] used to treat adults with follicular lymphoma or certain types of large B-cell lymphoma that relapsed or did not get better after treatment with at least two other types of systemic therapy. Yescarta binds to a protein called CD19, which is found on most B-cell lymphoma cells, [to help] the body’s immune system kill cancer cells.

This intravenously administered immunotherapy is designed to improve patient outcomes. Earlier this year, in March, Yescarta received accelerated approval from the FDA. However, the treatment is currently only available through the Yescarta and Tecartus REMS Program. Ultimately, this is because Yescarta could potentially cause a number of neurological toxicity issues, as well as cytokine release syndrome (CRS), which can be fatal.

Clinical Trial Data

Altogether, the data presented at EHA2021 compared follow-up data from the ZUMA-5 study to weight samples from the SCHOLAR-5 external cohort of current therapies. 146 patients enrolled in the ZUMA-5 study; data from 86 was used. Alternately, data from 85 SCHOLAR-5 cohort controls were used. Researchers determined that:

• Patients receiving Yescarta had significantly higher response rates than patients receiving current therapies. For example, 94% of patients in ZUMA-5 responded, compared to 50% in the other cohort.
• Additionally, Yescarta treatment reduced mortality risk by 58%, and follicular lymphoma relapse or progression by 70%.
• In the ZUMA-5 trial, neither median overall survival rate nor progression-free survival could be determined at this point.
• Approximately 21% of patients receiving Yescarta experienced neurological toxicities, which typically appeared within 4-7 days of treatment. These included headache, aphasia (loss of ability to understand or effectively express language), encephalopathy, insomnia, delirium, dizziness, tremors, seizures, and cerebral edema.
• Additionally, 8% of patients treated with Yescarta experienced Grade 3+ CRS. Typically, CRS symptoms manifest as fever and chills, headache, abnormally low blood pressure, abnormal/high heart rate, nausea and vomiting, hypoxia, and cardiac arrhythmias, arrest, or failure.

While Yescarta does show promise for treating patients with follicular lymphoma and other forms of cancer, the treatment does come with an additional host of potential side effects in addition to those shown above. These include:

• Allergic reactions
• Serious and sometimes fatal infections
• Anemia (low red blood cell count)
• Neutropenia (low white blood cell count)
• Thrombocytopenia (low platelet count)
• Fatigue
• Appetite loss
• Diarrhea or constipation
• Cough

Follicular Lymphoma

Follicular lymphoma exists under the umbrella of non-Hodgkin’s lymphoma (NHL), which affects the lymphatic system. In a majority of follicular lymphoma diagnoses, the cancer is indolent (slow-growing). This cancer typically affects those around age 60 or older. Overall, follicular lymphoma forms from B-cells, which normally fight infection, create antibodies, and play a role in immune function. But when mutations occur in B-cell DNA, the cells grow abnormally, accumulating throughout the lymphatic system and crowding out healthy cells. Ultimately, this prevents the immune system from properly functioning.

In early stages of cancer, patients may remain asymptomatic. However, if and when symptoms appear, these include:

• Unintended weight loss
• Fatigue
• Shortness of breath
• Fever
• Night sweats
• Painless but swollen lymph nodes (particularly in the groin, neck, abdomen, or underarms)

Learn more about follicular lymphoma.