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Gilead (GILD) Announces Positive Long-Term Data on Yescarta
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Gilead Sciences, Inc. (GILD - Free Report) announced long-term data from the ZUMA-1 study on CAR T cell therapy Yescarta (axicabtagene ciloleucel) in adult patients with refractory large B-cell lymphoma at the 61st American Society of Hematology (ASH) Annual Meeting & Exposition in Orlando.
The data included updated overall survival data from the phase II study after three years, following a single infusion of Yescarta as well as an analysis from a separate safety management cohort of patients receiving early steroid intervention for cytokine release syndrome (CRS) and neurologic events.
With a minimum follow-up of three years after a single infusion of Yescarta (median follow-up of 39.1 months), approximately 47% of patients with refractory large B-cell lymphoma in ZUMA-1 phase II cohorts were alive, while the median overall survival (OS) was 25.8 months.
Yescarta is approved in the United States for the treatment of 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), primary mediastinal large B-cell lymphoma, and high-grade B-cell lymphoma and DLBCL arising from follicular lymphoma.
Moreover, updated results from a separate ZUMA-1 safety management study (Cohort 4) were presented at the meeting. In this analysis, patients with relapsed or refractory large B-cell lymphoma treated with Yescarta received earlier steroid intervention, beginning when patients experienced Grade 1 neurologic events or Grade 1 CRS with no improvement after three days of supportive care. Patients could receive optional bridging chemotherapy prior to Yescarta infusion.
The results from ZUMA-1 Cohort 4 demonstrated that early steroid intervention has the potential to reduce the rate of severe CRS and neurologic events.
The news bodes well for Yescarta, the uptake of which has been quite slow due to its exorbitant cost. Moreover, Novartis’ (NVS - Free Report) Kymriah is posing stiff competition in this space.
Gilead’s stock has gained 7.2% in the year so far compared with the industry's growth of 6.6%.
The massive decline in sales of the HCV franchise has 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 (GSK - Free Report) . Gilead’s intent to foray into the inflammation market to diversify the revenue base is encouraging as well.
Earnings estimates for 2019 have increased 23 cents for Vertex in the past 60 days.
The Hottest Tech Mega-Trend of All
Last year, it generated $24 billion in global revenues. By 2020, it's predicted to blast through the roof to $77.6 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.
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Gilead (GILD) Announces Positive Long-Term Data on Yescarta
Gilead Sciences, Inc. (GILD - Free Report) announced long-term data from the ZUMA-1 study on CAR T cell therapy Yescarta (axicabtagene ciloleucel) in adult patients with refractory large B-cell lymphoma at the 61st American Society of Hematology (ASH) Annual Meeting & Exposition in Orlando.
The data included updated overall survival data from the phase II study after three years, following a single infusion of Yescarta as well as an analysis from a separate safety management cohort of patients receiving early steroid intervention for cytokine release syndrome (CRS) and neurologic events.
With a minimum follow-up of three years after a single infusion of Yescarta (median follow-up of 39.1 months), approximately 47% of patients with refractory large B-cell lymphoma in ZUMA-1 phase II cohorts were alive, while the median overall survival (OS) was 25.8 months.
Yescarta is approved in the United States for the treatment of 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), primary mediastinal large B-cell lymphoma, and high-grade B-cell lymphoma and DLBCL arising from follicular lymphoma.
Moreover, updated results from a separate ZUMA-1 safety management study (Cohort 4) were presented at the meeting. In this analysis, patients with relapsed or refractory large B-cell lymphoma treated with Yescarta received earlier steroid intervention, beginning when patients experienced Grade 1 neurologic events or Grade 1 CRS with no improvement after three days of supportive care. Patients could receive optional bridging chemotherapy prior to Yescarta infusion.
The results from ZUMA-1 Cohort 4 demonstrated that early steroid intervention has the potential to reduce the rate of severe CRS and neurologic events.
The news bodes well for Yescarta, the uptake of which has been quite slow due to its exorbitant cost. Moreover, Novartis’ (NVS - Free Report) Kymriah is posing stiff competition in this space.
Gilead’s stock has gained 7.2% in the year so far compared with the industry's growth of 6.6%.
The massive decline in sales of the HCV franchise has 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 (GSK - Free Report) . Gilead’s intent to foray into the inflammation market to diversify the revenue base is encouraging as well.
Zacks Rank & A Stock to Consider
Gilead currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech space is Vertex Pharmaceuticals Incorporated (VRTX - Free Report) , which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Earnings estimates for 2019 have increased 23 cents for Vertex in the past 60 days.
The Hottest Tech Mega-Trend of All
Last year, it generated $24 billion in global revenues. By 2020, it's predicted to blast through the roof to $77.6 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.
See Zacks' 3 Best Stocks to Play This Trend >>