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2020-07-30| Trials & Approvals

First and Only CAR T Therapy for Mantle Cell Lymphoma Gets FDA Nod

by Sangeeta Chakraborty
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By Sangeeta Chakraborty, Ph.D.

On July 24th, the FDA announced an accelerated approval for Kite Pharma’s (a Gilead subsidiary) CAR-T cell therapy, Tecartus, for the treatment of adults with relapsed or refractory mantle cell lymphoma (MCL). The approval comes shortly after the FDA’s initial acceptance to expeditiously review Kite’s biologics license application for Tecartus, which also bagged a breakthrough therapy designation from the agency for the same indication.

“This approval marks the first CAR T cell therapy approved for mantle cell lymphoma patients and represents a new frontier in the treatment of this disease,” said Meghan Gutierrez, CEO, Lymphoma Research Foundation.

 

Mantle Cell Lymphoma

MCL is a particularly aggressive and rare subtype of non-Hodgkin lymphoma (NHL) with a distinctive histological signature; the lymphoma in MCL originates from the mantle zones of secondary follicles and bear B cell markers. Except for a handful of patients who survive disease-free for many years owing to stem cell transplants, most suffer from an aggressive relapse. Unfortunately, the current therapies for relapsed or refractory (cancer cells are unresponsive to treatment) MCL are not curative. Stem cell transplant or intense chemotherapy can potentially keep the lymphoma in check for longer, but the disease under most circumstances relapses with aggressive outcomes.

 

Tecartus- The One Dose “Living Drug”

Tecartus (brexucabtagene autoleucel) is an autologous T cell immunotherapy that targets the CD19 antigen on the lymphoma cells. Patients are required to take only one dose of this therapy to see clinical benefits. Each dose of Tecartus is customized by first isolating a patient’s T cells, followed by an enrichment using the XLP platform. The enriched T cells are genetically modified to express a receptor (chimeric antigen receptor) that selectively targets the CD19 protein on the cancer cells and are then infused back into the patient’s body. In addition to MCL, Tecartus is also currently in Phase 1/2 trials for acute lymphoblastic leukemia (ALL) and chronic lymphocytic leukemia (CLL).

 

ZUMA-2 Trial

The approval is an outcome of encouraging results from the ongoing, multicenter, open-label, ZUMA-2 trial that enrolled 105 individuals with relapsed or refractory MCL who had previously received up to five prior therapies, including anthracycline- or bendamustine-containing chemotherapy, an anti-CD20 antibody and a Bruton’s tyrosine kinase inhibitor (ibrutinib or acalabrutinib). The patients were followed for at least six months after their first objective disease response. The trial showed that with a single infusion of Tecartus, 87% of patients with relapsed or refractory MCL responded positively with reduced tumor burden, including 62% of patients achieving a complete tumor eradication (complete response-CR).

 

Adverse Effects

The therapy, however, comes with a warning for cytokine release syndrome (CRS). Most commonly, patients experience a hyperinflammatory systemic response, characterized by fever and flu-like symptoms, owing to the activation and expansion of the modified T cells in their body. Additionally, neurological toxicities have also been reported in patients undergoing Tecartus (typical of CAR T cell therapies) therapy. Both CRS and neurotoxicity can be fatal or life-threatening.

In the trial, 18% of patients experienced Grade 3 or higher CRS, and 37% experienced neurologic events. The FDA approved Tecartus therapy can only be received through a Risk Evaluation and Mitigation Strategy (REMS), which ensures the benefits outweigh the risk of these adverse effects. The Tecartus REMS has been combined with the Yescarta REMS and is now called the “Yescarta and Tecartus REMS Program.”

“The availability of Tecartus as the first-ever cell therapy for patients with relapsed/refractory MCL provides an important option with a response rate of nearly 90% and early clinical evidence suggesting durable remissions in later lines of therapy,” said Michael Wang, MD, ZUMA-2’s lead investigator and a professor at the University of Texas MD Anderson Cancer Center.

Related Article: Bavencio Bags FDA Approval as First-line Maintenance Treatment for Urothelial Carcinoma

References
  1. https://www.fda.gov/media/140415/download
  2. https://www.kitepharma.com/news/press-releases/2020/7/us-fda-approves-kites-tecartus-the-first-and-only-car-t-treatment-for-relapsed-or-refractory-mantle-cell-lymphoma
  3. https://www.fda.gov/news-events/press-announcements/fda-approves-first-cell-based-gene-therapy-adult-patients-relapsed-or-refractory-mcl

 

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