Kite, a Gilead Sciences GILD company, announced updated results from a phase I/II study, ZUMA-3, on experimental candidate KTE-X19 at the Annual Meeting of the American Society of Hematology (ASH).
KTE-C19 is a CD19 chimeric antigen receptor T (CAR T) cell therapy being evaluated in adult patients with relapsed or refractory acute lymphoblastic leukemia (ALL). ZUMA-3 is an ongoing multicenter, registrational phase I/II study in adult patients (≥18) with ALL.
In the study, 69% of evaluable patients (n=25/36) achieved complete tumor remission, defined as complete remission (CR) or CR with incomplete hematological recovery (CRi), with a median follow-up of 15.1 months (range 3.7 – 28.6 months) following a single infusion of KTE-X19. The rate of undetectable minimal residual disease (MRD) in patients who achieved complete tumor remission was 100%.
Adverse events were consistent with the known toxicities of CD19 CAR T treatment, including Grade 3 or higher cytokine release syndrome (CRS) and neurologic events in 23% (n=10/44) and 39% (n=17/44) of patients, respectively. However, two patients died due to adverse events.
Based on these data, Gilead initiated a phase II study, evaluating KTE-X19 in a larger set of adult patients with ALL.
We note that the candidate was added to Gilead’s portfolio following the acquisition of Kite Pharma in 2017. Kite is a pioneer in cell therapy, having developed engineered cell therapies that express either a CAR or an engineered T cell receptor (TCR) depending on the type of cancer.
The approval of lead candidate Yescarta for the treatment of refractory aggressive non-Hodgkin lymphoma, which includes diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL) and primary mediastinal B-cell lymphoma (PMBCL), was a significant boost for Gilead.
Gilead’s stock has gained 2.7% in the past six months, worse than the industry's decline of 6.5%.
Given the persistent decline in HCV sales, Gilead is banking on HIV and newer avenues to help the top line. The initial uptake of Yescarta is also encouraging but it will take some time for sales to contribute significantly to the top line, given the high cost of treatment. Moreover, Novartis’ NVS Kymriah is also in the market, posing competition.
Going forward, Gilead will have to generate substantial revenues from its HIV franchise to offset the HCV sales decline. This will be a challenging task for the company with stiff competition from the likes of GlaxoSmithKline GSK in the HIV market. Gilead has promising late-stage candidates — selonsertib and filgotinib — in the NASH and inflammation markets. The company also has a collaboration agreement with Sangamo Therapeutics, Inc. SGMO to use Sangamo’s zinc finger nuclease technology platform for the development of next-generation ex vivo cell therapies in oncology.
Gilead currently carries a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
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