Gilead Sciences (NASDAQ:GILD), Inc.’s GILD Kite announced results from the interim analysis of ZUMA-12, a multicenter, open-label, single-arm phase II study evaluating Yescarta (axicabtagene ciloleucel), a chimeric antigen receptor (CAR) T cell t herapy in an oral session during the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition.
The study is evaluating Yescarta (axicabtagene ciloleucel) as a first-line therapy for patients with high-risk large B-cell lymphoma (LBCL).
Results showed that following a single infusion of Yescarta, 85% of patients achieved a response while 74% came up with a complete response. These results support the potential of CAR T in this earlier setting in patients with high risk.
Yescarta is already approved by the FDA for treating adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma (PMBCL), and high grade B-cell lymphoma and DLBCL arising from FL(follicular lymphoma).
We note that Kite is looking to expand Yescarta’s label in additional hematologic malignancies.
Earlier, Kite also released data at the ASH from the primary analysis of ZUMA-5, which is a global, multicenter, single-arm, open-label phase II study evaluating Yescarta in adult patients with relapsed or refractory indolent non-Hodgkin lymphoma (iNHL) after a minimum of two prior lines of therapy.
Results showed that post a single infusion of Yescarta, 92% iNHL patients (n=104 evaluable for efficacy) responded while 76% of the same cohort achieved a complete response at a median follow-up of 17.5 months.
The primary analysis supports the supplemental biologics license application (sBLA) for Yescarta, which is currently under a priority review by the FDA with a target action date set for Mar 5, 2021.
Kite also announced follow-up results from the pivotal ZUMA-2 study of Tecartus in adult patients with relapsed or refractory mantle cell lymphoma (MCL). Tecartus, a CAR T-cell therapy, was granted an accelerated approval by the FDA in July for the treatment of relapsed or refractory mantle cell lymphoma, based on the overall response rate and the durability of response. At a median follow-up of 17.5 months, 92% of patients achieved a response including 67% with a complete response.
Concurrently, Gilead posted updated results from the phase Ib study of magrolimab. The candidate is an investigational, potential first-in-class, anti-CD47 monoclonal antibody, currently being studied in previously untreated acute myeloid leukemia (AML) patients who are ineligible for intensive chemotherapy including those with TP53-mutant AML. The study continues to demonstrate high response rates for magrolimab and Vidaza combined with an overall response rate of 63% among the total patient population and 69% in TP53-mutant patients.
Gilead’s stock has lost 6.2% in the year so far against the industry's growth of 5.8%.
The massive decline in Gilead’s HCV franchise sales propelled the company to focus on its HIV franchise, Yescarta and other newer avenues. The rapid adoption of Biktarvy maintains momentum in the HIV space amid stiff competition from the likes of GlaxoSmithKline (NYSE:GSK) GSK. However, the uptake of Yescarta was slow and it faces fierce competition from Novartis’ NVS Kymriah.
Zacks Rank & Stock to Consider
Gilead currently carries a Zacks Rank #4 (Sell). A better-ranked player in the biotech space is Halozyme (NASDAQ:HALO) Therapeutics, Inc. HALO, which carries a Zacks Rank #2 (Buy), presently. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Halozyme’s current-year earnings estimates have been revised 21 cents upward in the past 60 days.
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