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Kite Pharma's cancer therapy study shows good results in first CAR-T trial

PBR Staff Writer Published 01 March 2017

Kite Pharma’s axicabtagene ciloleucel demonstrated an objective response rate (ORR) of 82% and a complete response (CR) rate of 54% for patients with aggressive non-Hodgkin lymphoma in the ZUMA-1 trial.

The positive top-line results from the trial showed the treatment effect of axicabtagene ciloleucel in a patient population of 101 having multiple types of aggressive NHL, said Kite Pharma.

Patients enrolled in the trial included those with diffuse large B-cell lymphoma (DLBCL) enrolled in Cohort 1, patients with primary mediastinal B-cell lymphoma (PMBCL) and transformed follicular lymphoma (TFL) put into Cohort 2.

As per the ZUMA-1 trial findings, 41% of patients showed ORR with 36% showing complete response at the sixth month of treatment.

Kite Pharma clinical development senior VP Jeff Wiezorek said: "These results with axicabtagene ciloleucel are exceptional and suggest that more than a third of patients with refractory aggressive NHL could potentially be cured after a single infusion of axicabtagene ciloleucel.

"The ZUMA-1 study was built on a foundation of support and commitment from Dr. Steven Rosenberg and the National Cancer Institute and our ZUMA-1 clinical trial investigators who believed in the potential for CAR-T therapy to change the paradigm of cancer treatment."

Based on the combined data recorded from all the patients in the ZUMA-1 trial, Kite will seek regulatory approval of axicabtagene ciloleucel in aggressive NHL.

The company is planning to submit the biologics license application for the drug by the end of the first quarter this year.

The US Food and Drug Administration granted axicabtagene ciloleucel breakthrough therapy designation status for diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL). 

It also has Priority Medicines (PRIME) regulatory support for DLBCL in the European Union.