$KITE Demonstrate Positive Results in B-cell non-Hodgkin Lymphoma

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Blog Coverage Kite Pharma CAR-T Cancer Therapy Demonstrate Positive Results in B-cell non-Hodgkin Lymphoma

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One of Kite Pharma’s competitors within the Biotechnology space, Grifols, S.A. (NASDAQ: GRFS), is estimated to report earnings on March 06, 2017. AWS will be initiating a research report on Grifols following the release of its next earnings results.

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What is Axicabtagene ciloleucel?

Kite Pharma’s lead product candidate, axicabtagene ciloleucel, formerly known as KTE-C19 is an investigational therapy in which a patient’s T cells are engineered to express a chimeric antigen receptor (CAR) to target the antigen CD19, and redirect the T cells to kill cancer cells. Axicabtagene ciloleucel has been granted Breakthrough Therapy Designation status for diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL) by the US Food and Drug Administration (FDA) and Priority Medicines (PRIME) regulatory support for DLBCL in the EU.

Zuma-1 Trial

Kite announced that the Zuma-1 study met the primary endpoint of achieving an objective response rate (ORR), or rates of tumor response recorded after a single infusion of axicabtagene ciloleucel, with 82%. The Company stated that these results demonstrated the treatment effect of axicabtagene ciloleucel in a patient population with multiple types of aggressive NHL, including diffuse large B-cell lymphoma (DLBCL) enrolled in Cohort 1, as well as primary mediastinal B-cell lymphoma (PMBCL) and transformed follicular lymphoma (TFL) enrolled in Cohort 2.

One hundred one patients were treated in ZUMA-1. Four of the 101 patients in ongoing CR did not have a month 6 tumor assessment prior to the data cut-off and are therefore categorized as non-responders for month 6. At month 6, 41% of treated patients achieved a response; including 36% in CR. Five of the 101 patients (5%) continue to experience highly significant and durable partial responses (PR) with minimal abnormalities in PET scans. One of these PRs converted to a CR at month 9. With a median follow-up of 8.7 months for this primary analysis, the median overall survival (OS) has not yet been reached. In a similar patient population, the median OS was estimated to be 6.6 months (SCHOLAR-1 study, ASCO 2016).

“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,” said Jeff Wiezorek, M.D., Senior Vice President of Clinical Development, “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.”

Way Ahead

Kite intends to seek regulatory approval of axicabtagene ciloleucel in aggressive NHL based upon the combined data from all 101 patients and plans to complete its rolling submission of the Biologics License Application (BLA) by the end of Q1 2017. In addition, Kite plans to submit a marketing authorization application (MAA) for axicabtagene ciloleucel for the treatment of relapsed or refractory DLBCL, PMBCL and TFL with the European Medicines Agency (EMA) in 2017. Kite announced that the full data from the primary analysis will be presented at the American Association for Cancer Research in April 2017 in Washington, D.C.

Stock Performance

On Wednesday, March 01, 2017, the stock closed the trading session at $79.62, surging 12.51% from its previous closing price of $70.77. A total volume of 6.98 million shares have exchanged hands, which was higher than the 3-month average volume of 1.04 million shares. Kite Pharma’s stock price rallied 63.36% in the last month, 64.67% in the past three months, and 37.18% in the previous six months. The company’s shares soared 77.56% since the beginning of the year. At Wednesday’s closing price, the stock’s net capitalization stands at $4.00 billion.

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