What type of drug is Yescarta (axicabtagene ciloleucel)?

Yescarta (axicabtagene ciloleucel) is a CD19-directed chimeric antigen receptor T cell (CAR T) therapy. Yescarta is approved to treat adults with certain forms of large B-cell lymphoma or follicular lymphoma. CAR T-cell therapy is a form of immunotherapy, a type of gene therapy. Yescarta, from Kite Pharma, was first FDA-approved in October 2017.

• In CAR T, a patient's T cells (type of white blood cell) are separated out and engineered to express a chimeric antigen receptor (CAR) to target the tumor antigen CD19. CD19 is a protein found on the cell surface of certain lymphomas and leukemias.
• The re-engineered CAR T-cell is then infused back into the patient and redirects the T cells to kill the cancerous cells. CAR T activation allows the release of cytokines and chemokines (inflammatory proteins) that leads to the elimination of CD19-expressing cells.
• CAR T therapy is manufactured specifically for each individual patient and is considered a breakthrough in hematologic (blood) cancer treatment. It is only given in a certified healthcare facility.
• Yescarta carries a Boxed Warning for the risks of cytokine release syndrome (CRS) and neurologic toxicities.

Yescarta Studies

In October 2017, Yescarta was first approved for adult patients with large B-cell lymphoma after at least two other kinds of treatment failed.

• Lymphoma types approved for treatment include diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma.
• The ZUMA-1 Phase 2 study was an open-label and included 101 adult patients with large B-cell lymphoma whose first treatment did not work or their cancer returned within one year of first treatment. Researchers primarily looked at complete remission (CR) rate and duration of response (DOR).
• The overall objective response rate was 72%.
• Results showed that 51% achieved complete remission (meaning no signs of cancer could be seen). This does not always mean the cancer has been cured. Plus, 21% achieved partial response (meaning the cancer decreased but was not fully gone). The median time to a response after treatment was 0.9 months (range: 0.8 to 6.2 months) and the median duration of response was 9.2 months.
• In the ZUMA-1 trial 5-year survival results, 42.6% of study patients treated with Yescarta were alive at 5 years and 92% of those patients needed no additional cancer treatment.
• Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma.

In March 2021, Yescarta was approved to treat relapsed or refractory follicular lymphoma (FL) in adults after two or more lines of systemic therapy.

• Follicular lymphoma is a form of non-Hodgkin lymphoma in which malignant tumors slowly grow but can become more aggressive over time. FL is the second most common type of lymphoma globally. It accounts for about 22% of all lymphomas diagnosed worldwide.
• In the ZUMA-5 Phase 2 open-label study, 81 patients were evaluated for efficacy that experienced 2 previous treatment failures for follicular lymphoma.
• The objective response rate, the primary endpoint, was 91%. Overall, 60% of patients treated with Yescarta achieved complete remission (meaning no signs of cancer could be seen). However, this does not always mean the cancer has been cured. In addition, 31% of patients achieved partial remission, meaning the cancer had decreased but was not fully gone.
• About 50% of patients achieved remission within one month, ranging between 0.8 months and 3.1 months to achieve remission.
• Most of the patients who achieved remission are still in remission a year and a half after treatment.
• This use is approved by the FDA under accelerated approval based on a response rate. Continued approval for this use may depend upon verification of Yescarta's benefit in further clinical trials.

In April 2022, the FDA cleared Yescarta to treat adults with large B-cell lymphoma that is refractory (has not responded) to first-line chemoimmunotherapy or that relapses (has returned) within 12 months of first-line chemoimmunotherapy.

• In the ZUMA-7 Phase 3 study, Yescarta showed significant improvement in event-free survival (EFS; hazard ratio 0.398; P< 0.0001), defined as the time from randomization to the earliest date of disease progression, commencement of new lymphoma therapy, or death from any cause.
• The median EFS was 8.3 months with Yescarta vs. 2 months with standard-of-care (SOC). SOC therapy for this patient population has historically been a multi-step process expected to end with a stem cell transplant.
• In addition, 2.5 times more patients receiving Yescarta (40.5%) were alive at two years without progression of disease or need for additional cancer therapy compared to standard-of-care (16.3%).

Other U.S. approved CAR-T cell therapies include: Abecma, Breyanzi, Kymriah, and Tecartus.

This is not all the information you need to know about Yescarta (axicabtagene ciloleucel) for safe and effective use and does not take the place of talking to your doctor about your treatment. Review the full Yescarta information here, and discuss this information and any questions you have with your doctor or other health care provider.

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