FDA Grants Priority Review to CAR-T Cell Therapy for Mantle Cell Lymphoma


The Food and Drug Administration granted a priority review to KTE-X19 for the treatment of adult patients with relapsed or refractory mantle cell lymphoma.

The Food and Drug Administration (FDA) granted a priority review to KTE-X19, a chimeric antigen receptor (CAR)-T cell therapy, for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL), according to Kite — the agent’s manufacturer.

“Despite recent advances, patients with relapsed/refractory mantle cell lymphoma currently face a significant lack of effective treatment options once their disease no longer responds to currently available therapy,” Dr. Ken Takeshita, Kite’s global head of clinical development, said in a press release. “Based on the encouraging results for KTE-X19, we are eager to continue discussions with the FDA on how to bring this innovative treatment to these patients who may benefit from CAR T therapy.”

The agency accepted Kite’s biologics license application, which was supported by data from the single arm, open-label, Phase 2 ZUMA-2 trial — designed to evaluate the efficacy (in 60 patients) and safety (in 68 patients) of a single infusion of KTE-X19 given to 74 adults with MCL whose disease is refractory to or has relapsed following up to five prior lines of therapy.

The researchers of the study aimed to evaluate overall response rates (ORR; including complete and partial responses to treatment), as well as duration of response to treatment, progression-free survival (the time from treatment to disease progression or worsening), overall survival, incidence of side effects, incidence of anti-CD19 CAR antibodies, levels of anti-CD19 CAR T cells in the blood, levels of cytokines in serum and changes over time in the EQ-5D scale score and visual analogue scale score.

After a median follow-up of 12.3 months, patients demonstrated an ORR of 93%, including 67% who achieved a complete response to one infusion of KTE-X19.

In the safety analysis, grade 3 or higher cytokine release syndrome and neurologic events were seen in 15% and 31% of patients, respectively.

Findings from the study, which is ongoing, were presented at the American Society of Hematology (ASH) Annual Meeting and Exposition, held in Orlando, Florida, last December.

The FDA is set to make its decision by Aug. 10, 2020.

KTE-X19 is a type of CAR-T cell therapy that works by modifying a patient’s own T cells to treat their cancer. A patient’s blood is collected, where T cells are harvested from, activated and genetically modified to produce CAR. The cells are then infused back into the patient’s body to recognize CD19, which is found on certain types of lymphoma cells. The treatment brings the activated T cells to the cancerous cells, targeting them to kill the cancer cells.

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