In a recent press release, Kite, a biopharmaceutical company that is part of Gilead Sciences, announced one-year follow-up results from the ZUMA-2 clinical trial. Within the trial, researchers evaluated Tecartus as a potential treatment for patients with relapsed or refractory mantle cell lymphoma (MCL). While the company recently presented data at the ASH Annual Meeting and Exposition under Abstract 1120, Patient Worthy will also unpack the data below.

Tecartus

Developed by Kite, Tecartus is an autologous anti-CD19 CAR T-cell therapy. Autologous means that the cells are sourced directly from the patient. The National Cancer Institute (NCI) describes CAR T-cell therapy as:

a type of treatment in which a patient’s T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. The gene for a special receptor [chimeric antigen receptor] that binds to a certain protein on the patient’s cancer cells is added to the T cells in the laboratory [before being] given to the patient by infusion.

In this case, Tecartus is manufactured using the proprietary XLP process which enriches T cells. Currently, Tecartus is indicated for the treatment of MCL. However, researchers are also exploring it as a potential treatment for patients with chronic lymphocytic leukemia (CLL) and acute lymphoblastic leukemia (ALL). Interestingly, Tecartus is the first CAR T-cell therapy for MCL to receive FDA accelerated approval.

ZUMA-2 Clinical Trial

Altogether, 74 adults with MCL enrolled in the ZUMA-2 clinical trial. To enroll, patients must have previously been treated with chemotherapy including anthracycline or bendamustine, ibrutinib or acalabrutinib, and an anti-CD20 antibody treatment. Approximately 92% of participants experienced some treatment response within 17.5 months, with 67% reaching a complete response. However, the trial has not yet reached its secondary endpoint of overall survival. By the time the data was collected, 48% experienced sustained treatment responses, with an overall survival rate of 76%.

During the trial, some adverse reactions did occur. In fact, 66% of participants experienced a severe reaction. These included:

• Fatigue
• Fever
• Low blood pressure
• Headache
• Constipation or diarrhea
• Nausea and vomiting
• Hypoxia
• Appetite loss
• Rash
• Fast and abnormal heart rate
• Muscle pain and weakness
• Changes in sleep
• Difficulty breathing
• Pleural effusion
• Encephalopathy
• Renal insufficiency
• Infections
• Respiratory distress
• Cytokine release syndrome
• Muscle pain

Tecartus Safety Warnings

Because of the potential health issues with Tecartus, particularly the neurological and CRS-related issues, as well as its investigational nature, Tecartus is only available through the Yescarta and Tecartus Risk Evaluation and Mitigation Strategy (REMS) program. Unfortunately, Tecartus has been fatal for some patients; in one such case, it spurred a fatal moment of cytokine release syndrome (CRS). Typically, if CRS occurred, it occurred within 1-13 days of receiving the therapy. 91% of patients in the ZUMA-2 clinical trial experienced a CRS event, though only 18% were serious. Additional neurological issues and infections occurred during the trial. If patients receiving Tecartus begin experiencing neurological issues, infections, or other severe symptoms, they should speak to their health provider immediately.

Mantle Cell Lymphoma (MCL)

While doctors are unsure of the exact cause of mantle cell lymphoma (MCL), which exists under the umbrella of non-Hodgkin’s lymphomas, many believe it is caused by a gene mutation in B-cell lymphocytes. When this gene mutates, it causes the overproduction of a protein called cyclin D1, which spurs B-cell growth. MCL develops from cancerous white blood cells called lymphocytes within the mantle zone. As lymph nodes begin to enlarge, the cancer may spread throughout the body. Typically, MCL does not present symptoms until later stages of the cancer. However, symptoms that appear as the cancer progresses include:

• Nausea and vomiting
• Appetite loss
• Fever
• Enlarged tonsils, liver, and spleen
• Unintended weight loss
• Diarrhea
• Headache
• Dizziness
• Personality changes
• Swollen lymph nodes in the upper part of the body
• Back and leg pain
• Bloating
• Indigestion
• Heartburn