Kite Pharma, Inc. KITE announced it has initiated a rolling submission of the Biologic License Application (BLA) for its lead pipeline candidate, KTE-C19, to the FDA.
We note that KTE-C19 is the company’s anti-CD19 chimeric antigen receptor (CAR) T cell therapy.
Kite Pharma’s shares rose 11.1% in the past one month comparing favorably with an increase of 3% for the Zacks classified Biomet/Genetic industry.
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A rolling submission will allow Kite Pharma to submit portions of the regulatory application to the FDA as and when they are completed.
The BLA is for the treatment for patients with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma (NHL) who are ineligible for autologous stem cell transplant (ASCT).
The rolling submission is expected to be completed by the end of the first quarter of 2017. KTE-C19, which has been given the brand name axicabtagene ciloleucel, is expected to be launched in 2017 if approved. The regulatory filings for axicabtagene ciloleucel in Europe will be done in 2017.
The rolling submission was based on the phase I-II study – ZUMA-1 – of axicabtagene ciloleucel 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 NHL. Kite Pharma is looking for a broader label for aggressive NHL including DLBCL, TFL and PMBCL indications.
In Sep 2016, the company announced encouraging top-line results from the phase II part of the ZUMA-1 study. Moreover, the primary analysis of 92 patients with chemorefractory aggressive NHL (DLBCL, TFL and PMBCL), which will include about six months of follow-up data, is anticipated in the first quarter of 2017.
Kite Pharma is also evaluating KTE-C19 in a phase II study (ZUMA-2) in patients with relapsed/refractory mantle cell lymphoma (MCL) and in two additional pivotal studies (phase I/II) for acute lymphoblastic leukemia (ALL). These studies are ZUMA-3 for adult ALL and ZUMA-4 for pediatric ALL.
In a separate press release, Kite Pharma announced that it has presented preliminary results from the phase I portion of the ZUMA-3 and ZUMA-4 studies at the annual meeting of the American Society of Hematology (ASH). Data from the studies showed that 82% (9 out of 11) of patients enrolled in the studies achieved complete remission. Phase II portions of these studies are expected to be initiated next year.
Kite Pharma plans to move KTE-C19 into a second series of studies for additional indications and earlier lines of therapy in DLBCL patients in 2017. A phase Ib/II combination study (ZUMA-6) evaluating KTE-C19 plus Genentech’s Tecentriq (atezolizumab) in patients with chemorefractory DLBCL commenced in October.
Note that Kite Pharma inked a collaboration with Genentech, a member of the Roche Holding AG RHHBY this March, with an aim to evaluate the safety and efficacy of the combination therapy.
We note that the development of CAR T cell therapies has been attracting a lot of attention lately with several companies eyeing this field. Juno Therapeutics Inc. JUNO is also working on developing therapies utilizing the CAR T cell technology. In fact, interest in immunotherapy is building up fast.
The basic concept of cancer immunotherapy or immuno-oncology is to utilize certain parts of the immune system to fight the disease. This can be done by stimulating the immune system to attack cancer cells or by introducing immune system components into the body.
Merck & Co., Inc.’s MRK anti-PD-1 therapy, Keytruda, is being studied for more than 30 types of cancers. Amgen’s Blincyto, a BiTE antibody, gained earlier-than-expected FDA approval in Dec 2014. Blincyto has the potential to be developed for other hematologic malignancies as well.
Kite carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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