Tecartus MCL(Mantle cell lymphoma)
Tecartus MCL(Mantle cell lymphoma)
Mantle cell lymphoma (MCL) is a rare and aggressive form of non-Hodgkin lymphoma that arises from the “mantle zone” of the lymph nodes. It commonly affects older adults, typically over the age of 60, and has a higher prevalence in males. Despite recent advancements in treatment options, many patients experience disease progression or relapse after initial therapy, and their prognosis remains poor. However, a groundbreaking new treatment called Tecartus (brexucabtagene autoleucel) offers hope for these patients.
What is Tecartus
Tecartus is a chimeric antigen receptor (CAR) T-cell therapy, a cutting-edge form of immunotherapy that harnesses the power of the patient’s own immune system to fight cancer. On July 24, 2020, the FDA approved Tecatus for the treatment of relapsed/refractory mantle cell lymphoma (MCL) in adult patients, It is the first and only CAR-T therapy approved by the U.S. Food and Drug Administration (FDA) for the treatment of relapsed or refractory mantle cell lymphoma (R/R MCL) in adult patients.
The Revolutionary CAR-T Technology
CAR-T therapy involves extracting a patient’s T-cells (a type of immune cell) and genetically modifying them in the laboratory to express a synthetic receptor called a chimeric antigen receptor (CAR). This CAR is designed to recognize and bind to a specific protein (antigen) found on the surface of cancer cells. In the case of Tecartus, the CAR targets the CD19 antigen, which is present on the surface of B-cell malignancies, including MCL.
After the T-cells are engineered with the CAR, they are multiplied in the lab and then infused back into the patient’s body. Once in the patient’s system, these CAR-T cells can seek out and destroy cancer cells that express the target antigen, while sparing healthy cells.
Clinical Trial Evidence
The approval of Tecartus for R/R MCL was based on the results of the pivotal ZUMA-2 clinical trial, a single-arm, open-label, multicenter study that included 74 adult patients with R/R MCL who had previously received at least five prior therapies.
The primary endpoint of the trial was objective response rate (ORR), defined as the combined rate of complete responses (CR) and partial responses (PR) as assessed by an independent radiological review committee (IRRC). The results were impressive: Tecartus achieved an ORR of 87% and a CR rate of 62% in the evaluable patient population.
Furthermore, the median duration of response had not been reached at the time of the analysis, suggesting that the responses achieved with Tecartus were durable. While some patients experienced adverse events, such as cytokine release syndrome (CRS) and neurological toxicities, these were generally manageable with appropriate supportive care.