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Kite Pharma soars after positive CAR-T data in lymphoma

Looks to become first marketed CAR-T drug as phase II results pave way for US filing

Kite PharmaKite Pharma has said it should be able to file for approval of its lead CAR-T candidate KTE-C19 in the US after it met its targets in a phase II trial.

Interim results from the ZUMA-1 study showed that the therapy achieved a 44% response rate, with 39% of patients with aggressive forms of non-Hodgkin's lymphoma (NHL) showing a complete response to the treatment after three months, despite having previously-failed chemotherapy.

The company says it intends to file for approval of KTE-C19 in three types of aggressive NHL - diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL) and primary mediastinal B-cell lymphoma (PMBCL) - on the strength of the trial results.

The combined complete response rate represents nearly a five-fold increase from an 8% response rate seen in the SCHOLAR-1 study, which looked at historical data on treatments in a similar patient population, commented Jeff Wiezorek, Kite's senior vice president of clinical development.

News of the data caused Kite Pharma's shares to leap in after-hours trading and also pulled up other CAR-T players such as Juno Therapeutics, which have been a little volatile of late.

The positive data has gone a long way to calm investor nerves about CAR-T, an emerging technology that relies on the use of modified immune cells that are engineered to attack and destroy malignant cells.

Patient deaths in an earlier Juno trial - now attributed to a cytotoxic drug used to prime the patient for the therapy - gave shareholders some anxiety earlier this year. That has since been exacerbated by Novartis' decision to close a cell therapy unit working on CAR-T - despite assertions its development CAR-T programmes remain on track - as well as questions about the complexity of the manufacturing and treatment process.

"ZUMA-1 is the largest CAR-T study reported in NHL," said Wiezorek. "We were able to manufacture KTE-C19 for 99% of patients enrolled in the study, and successfully handle the study logistics and adverse event management at over 20 sites, most of which had no prior experience in CAR-T therapy."

The main analysis of 101 patients in ZUMA-1 will be carried out after approximately six months of follow-up and is expected in the first quarter of 2017. If the company can secure approval for KTE-C19 in its hoped-for timeframe it could leapfrog both Novartis and Juno and be the first to bring a CAR-T drug to market. 

Article by
Phil Taylor

27th September 2016

From: Research



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