Kite completes FDA CAR-T filing, posts improved data

FDA
Kite CEO Arie Belldegrun

Kite Pharma completed an FDA submission for its CAR-T therapy hours before its self-imposed target passed. Finishing the application on Friday meant Kite met its goal of filing in the first quarter, and put it days behind Novartis in the race to bring a CAR-T therapy to market.

By wrapping up the submission before the end of March, Kite has kept on a track it sees leading to the commercial introduction of CAR-T ciloleucel—previously known as KTE-C19—later this year. Achievement of that goal is dependent on the FDA granting a priority review to ciloleucel, a status the agency has already awarded to Novartis’ CTL019. If both candidates board the fast track, they may advance through advisory committee meetings and to approvals in lockstep.

Kite thinks it has a strong hand going into the regulatory process. Two days after completing the BLA, the CAR-T specialist further burnished its dataset with an update on the ZUMA-1 trial that forms the bedrock of its pitch for approval of ciloleucel.

Notably, the latest data are better than the top-line six-month results Kite released earlier this year. The new data presented at AACR featured results for four patients who were excluded from the top-line readout. Confirmed responses among these four patients drove up the overall and complete response rates to 44% and 39%, as compared to 41% and 36% in the top-line results.

The uptick was driven by results from the 24 patients with primary mediastinal B-cell lymphoma or transformed follicular lymphoma. In this cohort, the overall and complete response rates now stand at 67% and 63%. Kite put the numbers at 54% and 50% when it originally reported the six-month data.

Kite and many analysts think the data are strong enough to secure approval of ciloleucel in patients with relapsed or refractory aggressive non-Hodgkin lymphoma who are ineligible for autologous stem cell transplant. If that happens, attention will turn to the label given to the drug by FDA and the ability of Kite to successfully commercialize an autologous cell therapy.

Presentations at AACR suggest third parties will contribute to Kite’s commercialization push. The University of Chicago’s Michael Bishop, M.D. has contacted all major insurance carriers in Illinois, analysts at Jefferies report, and his employer has expanded its cell processing operation. Bishop and his colleagues have taken the actions in anticipation of eventually treating up to 200 patients a year with ciloleucel.