Kite Pharma's Yescarta Receives FDA Approval for Second-Line Treatment of Large B-Cell Lymphoma

Today, the U.S. FDA announced the approval of Kite Pharma, a subsidiary of Gilead Sciences, to expand the indication of its CD19-targeted CAR-T therapy Yescarta (axicabtagene ciloleucel) for second-line treatment of adult patients with large B-cell lymphoma (LBCL). These patients have developed resistance after receiving first-line chemoimmunotherapy or relapsed within 12 months after receiving first-line therapy. This therapy is not applicable for the treatment of primary central nervous system lymphoma. According to the press release issued by Kite Pharma, this is "the first approved therapy in nearly 30 years that has demonstrated improved patient outcomes compared to standard treatments."

Yescarta is the second CAR-T cell therapy approved by the FDA. It targets the CD19 antigen on the surface of B cells, guiding and activating T cells to kill cancerous B cells.

This approval is based on the positive results of the randomized, open-label clinical trial ZUMA-7. A total of 359 patients were randomly assigned to receive a single dose of Yescarta or standard second-line treatment. The primary efficacy endpoint was event-free survival (EFS). The trial results showed that the EFS was significantly prolonged in the Yescarta group (HR=0.40, 95% CI: 0.31, 0.51; p<0.0001). The estimated EFS in the Yescarta group was 8.3 months, compared to 2.0 months in the standard treatment group. The objective response rate assessed by the independent review committee in the Yescarta group was 83%, significantly better than the 50% in the control group.

In terms of safety, 90% of non-Hodgkin lymphoma patients receiving treatment experienced cytokine release syndrome (CRS), with 9% having grade 3 or higher CRS. The incidence of neurotoxicity was 78% (25% for grade 3 or higher).

Kite CEO Christi Shaw stated: "Kite started with a very bold goal: to create hope for survival through cell therapy. Today's FDA approval in the United States allows the power of CAR-T cell therapy to be utilized earlier in the treatment journey, bringing hope to more patients!"

References:

[1] FDA approves axicabtagene ciloleucel for second-line treatment of large B-cell lymphoma. Retrieved April 1, 2022, from https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-axicabtagene-ciloleucel-second-line-treatment-large-b-cell-lymphoma

[2] Yescarta® Receives U.S. FDA Approval as First CAR T-cell Therapy for Initial Treatment of Relapsed or Refractory Large B-cell Lymphoma (LBCL).

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