According to a story from Targeted Oncology, the results of a recent clinical trial have left drug developers Kite and Gilead with the confidence to proceed with regulatory approval from both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). The trial was testing the investigational treatment KTE-X19, a CAR-T cell therapy that targets CD19, as a treatment for mantle cell lymphoma.
About Mantle Cell Lymphoma (MCL)
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 phase 2 trial, KTE-X19 was able to produce a complete remission rate of 67 percent and an objective response rate of 93 percent in patients with relapsed or refractory mantle cell lymphoma. Over time, 40 percent of the patients that had initially had a partial response to the therapy eventually transitioned to a complete response. The median time to this transition was three months. The median age of patients in the trial was 65 years and a total of 74 patients were enrolled overall. 85 percent had more advanced, stage IV disease and most had received at least three prior treatments (81 percent).
In the next few weeks, the developers plan to deliver a biologics license application for the drug to the FDA. A marketing authorization will also be submitted to the EMA in early 2020.
About CAR-T Cell Therapy
CAR-T cell therapies like KTE-X19 have been gaining notoriety for the treatment of blood cancers in recent years. These drugs function in a process that entails the removal of T-cells from the body of the patient. These cells are subsequently modified so that they can target and destroy that patient’s cancerous cells. The immune T-cells are then propagated in the lab setting before being reintroduced into the patient’s body.