Gilead Sciences, Inc. GILD announced encouraging results from the completed phase I of the single-arm ZUMA-3 study evaluating pipeline candidate KTE-X19, an investigational CD19 chimeric antigen receptor T (CAR T) cell therapy, at an oral session at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. The data was presented by Kite, a wholly-owned company of Gilead.
The study is being conducted in adult patients with relapsed or refractory acute lymphoblastic leukemia (ALL).
The study results provide guidance on dosing and safety management of KTE-X19 for the ongoing phase II study.
All together, 45 patients received KTE-X19 at one of three different dose levels [[2 x 106 cells/kg (n=6), 1 x 106 cells/kg (n=23), or 0.5 x 106 cells/kg (n=16)] by the end of phase I.
Patients enrolled in this study were primary refractory or relapsed/refractory after at least two prior lines of therapy. Of them, 68% achieved complete response (CR) with incomplete hematological recovery (CRi) and 100% had undetectable minimal residual disease (MRD) among the 41 patients, who were evaluable for efficacy after a minimum two months of follow-up (median follow-up of 16 months). Of the 23 patients treated with the dose level that will be used in the ongoing phase II study (1 x 106cells/kg), 19 were evaluable for efficacy. At the time of data cut-off, 16 patients achieved CR or CRi, and 12 were in ongoing response.
However, grade ≥3 cytokine release syndrome (CRS) events and neurologic events occurred in 29% and 38% of patients, respectively. The company had previously reported that two patients experienced KTE-X19-related grade 5 adverse events (AEs) during the study — one developed stroke in the context of CRS and neurologic events, and another experienced multi-organ failure secondary to CRS.
Consequently, a revised AE management protocol was implemented in nine patients treated with 1 x106 cells/kg of KTE-X19 during the study.
Management was encouraged by the high response rates in this study along with the reduced incidence and severity of CRS and neurologic events observed, following implementation of the revised safety management protocol. Consequently, the company is evaluating the use of KTE-X19 at the selected dose with this safety management protocol in the ongoing ZUMA-3 phase II study.
KTE-X19 is currently in phase I/II trials in ALL, mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL).
Kite also inked a collaboration with Humanigen, Inc. HGEN to conduct a phase I/II study on lenzilumab, an investigational anti-GM-CSF monoclonal antibody, with Yescarta (axicabtageneciloleucel) in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The goal of this study is to evaluate the effect of the drug on the safety of Yescarta. Kite will act as the sponsor of this study and be responsible for its conduct. The study will begin enrolling in the fourth quarter of 2019.
We note that Yescarta was the first FDA approved CAR T cell therapy to for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including DLBCL not otherwise specified, primary mediastinal large B-cell lymphoma, and high-grade B-cell lymphoma and DLBCL arising from follicular lymphoma.
Gilead’s stock has lost 0.5% in the year so far compared to the 2.2% decline for the industry.
Concurrent with the first quarter results, Gilead announced that Kite will become a separate business unit, going forward. The initial uptake of Yescarta (from the Kite Pharma acquisition) is also encouraging but it will take some time for its sales suite to contribute significantly to the acquired company’s top line, given the treatment’s exorbitant cost. Moreover, Novartis’ NVS Kymriah also exists in the market, posing a fierce rivalry for the stock.
Zacks Rank & Another Stock to Consider
Gilead currently carries a Zacks Rank #2 (Buy).
Another attractive stock in the healthcare space is Bristol-Myers Squibb Co. BMY, which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Bristol-Myers’ earnings per share estimates have increased from $4.78 to $5.03 for 2020 in the past 60 days.
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