FDA Approves CAR T-Cell Therapy for Mantle Cell Lymphoma

Mantle Cell Lymphoma Treatment Now Includes CAR T-Cell Therapy Option

The FDA has granted accelerated approval to a cell-based gene therapy for patients with mantle cell lymphoma (MCL) who have not responded to or who have relapsed following other kinds of treatment.

Tecartus (brexucabtagene autoleucel, formerly KTE-X19), a chimeric antigen receptor (CAR) T-cell therapy, is the first cell-based gene therapy approved by the FDA for the treatment of relapsed or refractory MCL.

“Despite promising advances, there are still major gaps in treatment for patients with MCL who progress following initial therapy,” said lead investigator Dr. Michael Wang in a press release from the drug maker Kite, a Gilead Company. Dr. Wang is a professor in the department of lymphoma and myeloma at the University of Texas MD Anderson Cancer Center in Houston, Texas.

He added: “Many patients have high-risk disease and are more likely to keep progressing, even after subsequent treatments.

What is Mantle Cell Lymphoma?

MCL is a rare form of B cell non-Hodgkin lymphoma (NHL). It’s a type of cancer that usually occurs in middle-aged to older adults. In patients with MCL, B cells, a type of white blood cell which helps the body fight infection, change into cancer cells that form tumors in the mantle zone, or outer edge, of the lymph node. The cancer cells grow out of control and quickly spread to other parts of the body.

MCL patients represent only about 6 percent (about 4,200 cases) of all new cases of NHL in the United States, according to the Leukemia & Lymphoma Society.

Clinical Trial Leads to New Treatment for Mantle Cell Lymphoma

Tecartus, which was approved on July 24, is a customized treatment that is created using a patient’s immune system. The patient’s T cells are collected and genetically modified to include “a new gene that facilitates the targeting and killing of the lymphoma cells,” according to the FDA’s press release announcing the approval. The modified T cells are then infused back into the patient.

The FDA based its decision on data from the ZUMA-2 trial, which showed that 87% of patients receiving CAR-T cells responded to a single infusion of the CAR T-cell therapy. Sixty-two percent of those patients achieved a complete response. The study included 74 adult patients with relapsed or refractory MCL who had previously received anthracycline – or bendamustine-containing chemotherapy, an anti-CD20 antibody therapy and a Bruton tyrosine kinase inhibitor (ibrutinib or acalabrutinib).

“Tremendous progress has been made in the discovery of new therapies for debilitating diseases that are difficult to treat,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation, in the agency’s press release. “This approval is yet another example of customized treatments that use a patient’s own immune system to help fight cancer, while using a scientific advance in this promising new area of medicine.”

Side Effects of Tecartus in MCL Patients

Tecartus carries a boxed warning for cytokine release syndrome (CRS), which is a systemic response to the activation and proliferation of CAR-T cells causing high fever and flu-like symptoms, and for neurologic toxicities. Both CRS and neurologic toxicities can be fatal or life-threatening. Among patients evaluated for safety, 18% experienced Grade 3 or higher CRS and 37% experienced Grade 3 or higher neurologic toxicities

The most common side effects include serious infections, low blood cell counts, and a weakened immune system. Side effects from treatment usually appear within the first one to two weeks after treatment, but some side effects may occur later.

Is a Cure for MCL on the Horizon?

“There is hope,” said Dr. Wang in an interview with Patient Power Co-Founder Esther Schorr at the 2019 ASH Annual Meeting and Exposition. He presented his research on CAR T-cell therapy at the Orlando conference. “There's I think a fraction of patients who could even be cured very soon, and we would like to work so hard to increase the speed of the curability that a fraction of people would get cured.”

Learn more about Tecartus.

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