Kite Pharma (KITE) Releases Data On Lead Drug For Leukemia

Kite Pharma, Inc. (NASDAQ:KITE) announced results from phase I trial, ZUMA-3, on lead candidateKTE-C19 (axicabtagene ciloleucel) in adults with high burden relapsed/refractory acute lymphoblastic leukemia (r/r ALL). The results showed that 73% of patients achieved complete remission, including those with incomplete or partial recovery of bone marrow, in adults with high burden relapsed/refractory acute lymphoblastic leukemia (r/r ALL). The results were presented at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting.

Notably, KTE-C19 is the company’s anti-CD19 chimeric antigen receptor (CAR) T cell therapy.

Kite Pharma’s shares rose 64.2% year to date comparing favorably with an increase of 2.8% for the Zacks classified Medical - Biomedical and Genetics industry.

11 patients were treated with KTE-C19 at two target dose levels. No dose-limiting toxicities (DLT) occurred in the trial. Both doses were tolerable and responses were achieved at each level. Out of 11 patients, three of them (27%) had severe cytokine release syndrome (CRS) and 55 % suffered serious neurological problems.

However, the company had reported a year ago that one patient experienced fatal CRS. In order to further improve the safety profile of KTE-C19, ZUMA-3 is also evaluating additional patients who will receive Roche Holding (SIX:ROG) AG’s (RHHBY) Actemra within 36 hours post-KTE-C19 infusion, and a lower dose of 0.5×106 CAR T cells/kg.

We note that in Mar 2017, the company completed the rolling submission with the FDA for KTE-C19.

The BLA seeks FDA approval treatment of patients with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma (NHL) who are ineligible for autologous stem cell transplant (ASCT).

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 FDA and Priority Medicines (PRIME) regulatory support for DLBCL in the EU.

The rolling submission was based on the 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 NHL. Moving ahead, Kite Pharma plans to initiate phase II of the ZUMA-3 trial in 2017.

Kite Pharma, Inc. Price

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Zacks Rank and Stocks to Consider

Kite Pharma carries a Zacks Rank #3 (Hold). Better-ranked stocks in the health care sector include VIVUS, Inc. (NASDAQ:VVUS) , MEI Pharma, Inc. (NASDAQ:MEIP) and Aeglea BioTherapeutics (NASDAQ:AGLE) . While VIVUS and MEI Pharma sport a Zacks Rank #1 (Strong Buy), Aeglea carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

VIVUS’ loss per share estimates narrowed from 50 cents to 39 cents for 2017 over the last 30 days. The company posted positive earnings surprises in all of the four trailing quarters, with an average beat of 233.69%.

MEI Pharma’s estimates narrowed from loss per share of 1 cent to gain per share of 1 cent for 2017 over the last 30 days. The company posted positive earnings surprises in three of the four trailing quarters, with an average beat of 66.56%.

Aeglea’s loss per share estimates narrowed from $3.64 to $2.48 for 2017 over the last 60 days. The company posted positive earnings surprises in three of the four trailing quarters, with an average beat of 20.75%.

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