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>>> What's in the Cards for Kite Pharma (KITE) in Q2 Earnings



Zacks Equity Research

August 04, 2017



https://finance.yahoo.com/news/apos-cards-kite-pharma-kite-134101924.html



..Kite Pharma’s lead drug axicabtagene ciloleucel is currently under priority review in the U.S. for treating aggressive non-Hodgkin lymphoma (NHL) with a FDA decision expected on Nov 29. The Biologics License Application (BLA) filing was based on data from a phase I-II study (ZUMA-1) in patients with refractory diffuse large B cell lymphoma (DLBCL) including primary mediastinal B cell lymphoma (PMBCL) and transformed follicular lymphoma (TFL). All these are types of aggressive non-Hodgkin’s lymphoma (NHL). Kite Pharma is looking to get axicabtagene ciloleucel approved for a broader label for aggressive NHL including DLBCL, TFL and PMBCL indications.

Axicabtagene ciloleucel is expected to be approved and launched in 2017. In Europe, a regulatory application was filed last week.

Meanwhile, other studies with axicabtagene ciloleucel are also advancing. These include a phase II study (ZUMA-2) in patients with relapsed/refractory mantle cell lymphoma (MCL) and two additional pivotal studies (phase I/II) for acute lymphoblastic leukemia (ALL) – ZUMA-3 for adult ALL and ZUMA-4 for pediatric ALL.

ZUMA-5 study is evaluating axicabtagene ciloleucel in patients with indolent NHL. Earlier this week, the company announced that the first patient was dosed in this phase II study.

ZUMA-9 study is being conducted to provide patients access to axicabtagene ciloleucel during the regulatory review period. A phase Ib/II combination study (ZUMA-6) evaluating axicabtagene ciloleucel plus Roche Holding AG’s RHHBY Tecentriq (atezolizumab) in patients with chemorefractory DLBCL is also ongoing.

Preliminary data from ZUMA-3, ZUMA-4 and ZUMA-6 are expected later this year. The company also plans to move ZUMA-3 and ZUMA-4 into phase II studies later this year.

Apart from updates on axicabtagene ciloleucel, investor focus at the call will remain on the company’s progress with its other CAR-based candidates, including KITE-585 and KITE-718.

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