Kite Pharma, Inc. announced encouraging top-line data from a pre-planned interim analysis of a pivotal phase II portion of the ZUMA-1 study on its lead pipeline candidate, KTE-C19 (an anti-CD19 CAR-based therapy). The candidate is being evaluated for the treatment of patients with chemorefractory diffuse large B-cell lymphoma (DLBCL). We expect investors to react positively to the news.
The ZUMA-1 study enrolled patients with chemorefractory aggressive non-Hodgkin lymphoma (NHL) into two cohorts. While cohort 1 enrolled patients with DLBCL, cohort 2 included patients with transformed follicular lymphoma (TFL) and primary mediastinal B-cell lymphoma (PMBCL). Interim analysis of the first 51 patients showed that KTE-C19 achieved the primary endpoint of an objective response rate of 76%, including a complete remission rate of 47%. However, two patients died due to KTE-C19-related adverse events across the two cohorts of the study.
Kite Pharma plans to file for a regulatory approval for KTE-C19 in the DLBCL, TFL and PMBCL indications, based on combined data from both the cohorts. Meanwhile, the company intends to present additional data from the interim analysis at an upcoming scientific meeting. Moreover, the primary analysis of 101 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 three other pivotal studies. These include ZUMA-2 in patients with relapsed/refractory mantle cell lymphoma (MCL), ZUMA-3 in adults with acute lymphoblastic leukemia (ALL) and ZUMA-4 in pediatric ALL. The company expects to report data from ZUMA-2 and the phase II portions of ZUMA-3 and ZUMA-4 in 2017. Positive data from these studies would allow the company to file for an FDA approval for these indications.
KITE PHARMA INC Price
We note that KTE-C19 enjoys Breakthrough Therapy status for DLBCL, TFL, and PMBCL in the U.S. It also has Orphan Drug status in the U.S. and the EU for DLBCL, PMBCL, ALL, MCL, FL and chronic lymphocytic leukemia. The candidate also has Priority Medicines (PRIME) regulatory support for DLBCL in the EU.
Other companies working on CAR T-cell treatments include Juno Therapeutics Inc. (JUNO - Free Report) and Novartis AG (NVS - Free Report) .
Kite Pharma currently carries a Zacks Rank #3 (Hold).
A Stock to Consider
A better-ranked stock in the health care sector is Ligand Pharmaceuticals Incorporated (LGND - Free Report) , sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
For 2016, Ligand witnessed a 12.13% increase in its earnings estimates over the past 60 days. The company has also posted an average positive earnings surprise of 36.66% over the last four trailing quarters. The company’s share price has soared 10.4% year to date.
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