Gilead-owned Kite has filed a second CAR-T therapy with the US Food and Drug Administration, raising hopes for the first such treatment for mantel cell lymphoma.
The submission for KTE-X19 is based on data from the Phase II ZUMA-2 trial, which showed an overall response rate of 93%, including 67% with complete response, following a single infusion of the cell therapy.
In the safety analysis, Grade 3 or higher cytokine release syndrome (CRS) and neurologic events were seen in 15% and 31% of patients, respectively, but there were no Grade 5 CRS or neurologic events observed.
“There remains a significant need for new treatments for patients with relapsed/refractory MCL despite recent advances, so this regulatory filing is an especially important milestone for the MCL community,” said Ken Takeshita, Kite’s global head of Clinical Development.
The firm said a filing in Europe for KTE-X19 as a treatment for MCL is expected early next year.