Gilead Sciences’ GILD Kite announced positive top-line results from the primary analysis of the global phase III multicenter study, ZUMA-7.
ZUMA-7 evaluated a one-time infusion of the CAR T-cell therapy Yescarta compared to the standard of care (SOC) in adult patients with relapsed or refractory large B-cell lymphoma (LBCL).
Results showed the superiority of Yescarta over the SOC in the targeted patient population. Yescarta improved event-free survival by 60% over chemotherapy plus stem cell transplant in second-line relapsed or refractory LBCL.
With a median follow-up of two years, the study met the primary endpoint of event-free survival. The study also met the key secondary endpoint of objective response rate (ORR). The interim analysis of overall survival (OS) showed a trend favoring Yescarta but this data is immature at this time, and further analyses are planned for the future.
Yescarta is a CD19-directed, genetically modified autologous T cell immunotherapy, indicated for the treatment of adult patients with relapsed or refractory LBCL after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL). It is also approved for adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy,
Please note that ZUMA-7 was conducted under a Special Protocol Agreement (SPA) with the FDA, whereby the trial design, clinical endpoints and statistical analysis were agreed on, in advance, with the agency.
Based on the positive results of this study, Kite plans to initiate discussions with the FDA, the European Medicines Agency and other global health authorities regarding the submission of a supplemental biologics license application later this year for a potential label expansion of Yescarta.
Gilead acquired Kite Pharma to foray into the emerging field of cell therapy. Gilead’s CAR T cell therapy franchise comprises Yescarta and Tecartus. Tecartus is approved for the treatment of relapsed or refractory mantle cell lymphoma. Both drugs are gaining traction and have bolstered the cell therapy product franchise for the company.
Gilead’s stock has gained 16.6% in the year so far compared with the industry's growth of 1%.
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The massive decline in sales of its HCV franchise has prompted it to focus on the HIV franchise, Yescarta and other newer avenues. The approval of other indications for these therapies will boost the franchise’s performance. However, competition is stiff from the likes of Novartis’ NVS Kymriah. The FDA recently approved Bristol-Myers’ BMY Breyanzi, a CAR T cell therapy for certain types of non-Hodgkin lymphoma. Other players in this evolving innovative field of CAR T cell therapies include Allogene Therapeutics (NASDAQ:ALLO), Inc. ALLO.
Concurrently, Gilead completed the submission of a new drug application (NDA) to the FDA seeking approval of lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, for the treatment of HIV-1 infection in heavily treatment-experienced (HTE) people with multi-drug resistant (MDR) HIV-1 infection. The company plans to submit marketing authorization applications for lenacapavir to the European Medicines Agency and other global agencies in the coming months.
Gilead currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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