NEW YORK – Gilead subsidiary Kite Pharma on Monday said it will discuss with regulators the latest data on axicabtagene ciloleucel (Yescarta) showing that its autologous CAR T-cell therapy improved certain lymphoma patients' outcomes in the second-line treatment setting versus standard-of-care chemotherapy plus stem cell transplant.
Based on top-line results from the Phase III Zuma-7 trial, Kite plans to begin talks with the US Food and Drug Administration and European Medicines Agency, among other regulators, in the hopes of submitting a supplemental Biologics License Application for axi-cel later this year.
In the Zuma-7 trial, researchers randomly assigned nearly 360 patients with relapsed or refractory diffuse large B-cell lymphoma, or LBCL, to either a one-time infusion of axi-cel or standard-of-care treatment. In the standard-of-care control arm, patients received chemotherapy followed by stem cell transplant contingent on chemo responses.
Kite said that axi-cel met both its primary endpoints in the study and improved event-free survival and objective response rate over standard care within Zuma-7. The firm noted that although it is presently too soon to report overall survival results, the results are trending toward an improvement with axi-cel. There were no new safety signals observed in Zuma-7, and adverse events were less frequent and severe than those seen in the third-line treatment setting with standard-of-care treatments.
Kite will present at an upcoming medical conference detailed results from Zuma-7, which it claims is the first randomized trial to evaluate CAR T-cell therapy in the earlier, second-line LBCL setting.
Axi-cel is currently approved for diffuse LBCL and follicular lymphoma patients following two or more lines of prior treatment. The indication explored in Zuma-7, if approved by regulators, would allow the company to expand the indication of the drug to a broader B-cell lymphoma population and in an earlier treatment setting.