Gilead Sciences Inc.'s cancer medicine KTE-X19 benefitted mantle cell lymphoma patients whose disease returned or was resistant to prior therapies, according to the results of a phase 2 trial.
Gilead inherited the medicine after acquiring Kite Pharma Inc. in 2017. According to results presented from the Zuma-2 clinical trial at the 2019 American Society of Hematology annual meeting, 93% of the 60 patients eligible for evaluation saw a decrease in their disease, including 67% who had no detectable cancer remaining after a single infusion of KTE-X19, a chimeric antigen receptor T cell therapy.
A total of 74 patients with mantle cell lymphoma, a cancer of the white blood cells, are enrolled in the Zuma-2 clinical trial.
At a median follow-up of 12.3 months, 57% of patients continued to respond to the treatment. Of the 28 patients that were dosed first with Gilead's therapy, 43% were alive and remained in continued remission without additional therapy after two years, the company said.
In the 68 patients on whom the treatment's safety could be evaluated, 91% experienced an inflammatory response in the body known as cytokine release syndrome and 63% experienced neurologic events.
The companies plan to submit KTE-X19 for approval to the U.S. Food and Drug Administration by the end of this year and to the European Medicines Agency in the first quarter of 2020.
The therapy previously received a label of breakthrough therapy by the FDA and of priority medicine by the EMA. The labels speed up the development and review processes for drugs receiving the designations.