According to a story from The ASCO Post, the promising results from a phase II clinical trial conducted last year suggests that CAR T-cell therapy could be an effective treatment for mantle cell lymphoma, a rare form of cancer. The experimental therapy is known as KTE-X19. Despite the fact that this was only a phase II study, the findings were so decisive that the drug developers, Gilead Sciences and Kite Pharma, filed an application for the drug to the US Food and Drug Administration (FDA) in December 2019.
About Mantle Cell Lymphoma
Mantle cell lymphoma is a rare type of non-Hodgkin’s lymphoma. There are only about 15,000 patients in the US. This blood cancer affects B-cells, a type of white blood cell. The risk factors for mantle cell lymphoma are not particularly well known; however, acquired genetic mutations in the affected cells are what eventually causes them to become malignant. Most patients are diagnosed in their 60s. In many cases, the disease is not diagnosed until it has reached an advanced stage. Symptoms include fever, night sweats, enlarged spleen and lymph nodes, and weight loss. Treatment options include immunotherapy, chemotherapy, and targeted therapies. Mantle cell lymphoma often relapses after treatment with chemotherapy. Prognosis is difficult to predict; the five year survival rate is 50 percent, but this figure improves to 70 percent with limited-stage disease. To learn more about mantle cell lymphoma, click here.
In the trial of 74 patients with relapsed or refractory disease, KTE-X19 was able to produce an objective response rate of 93 percent and a complete response rate of 67 percent. These were unprecedented findings and are considered the highest rate of response recorded in patients who were refractory to BTK inhibitors. 85 percent of patients had stage four disease and had been treated with a median of three previous therapies. 78 percent of complete responders were still in disease remission at 12.3 months median follow up. In addition, 83 percent of patients that responded were still alive after a median follow up of one year.
About CAR T-Cell Therapy
CAR T-cell therapies work through a process in which T-cells are extracted from the body of a patient. These cells are then modified in the lab to target a certain receptor that appears on the surface of cancerous cells. These modified cells are then propagated in the lab before being introduced into the patient’s body.
KTE-X19 has earned Breakthrough Therapy designation from the FDA and PRIME designation from the European Medicines Agency (EMA).