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Gilead (GILD) Announces OS Data on Yescarta From ZUMA-7 Study

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Gilead Sciences, Inc.’s (GILD - Free Report) Kite announces positive primary overall survival (OS) analysis results of the late-stage ZUMA-7 study on Yescarta.

ZUMA-7 is a randomized, open-label, global, multicenter, phase III study evaluating the safety and efficacy of Yescarta versus standard of care for the initial treatment of adult patients with relapsed/refractory large B-cell lymphoma (R/R LBCL) within 12 months of first-line therapy.

The results showed a statistically significant improvement for Yescarta in OS versus historical treatment, which was SOC in a curative setting for nearly 30 years, for the initial treatment of these patients.

This trial was conducted under a Special Protocol Assessment (SPA) with the FDA, whereby the trial design, clinical endpoints and statistical analysis were agreed upon in advance with the agency.

The study’s OS data reach maturity, per protocol, 5 years after the first person was randomized.

Yescarta demonstrated a 2.5-fold increase in patients who were alive at two years and did not experience cancer progression or require the need for additional cancer treatment and a four-fold greater median event-free survival (EFS) compared to SOC.

Yescarta is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. It is also indicated for 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, high-grade B-cell lymphoma and DLBCL arising from follicular lymphoma.

Positive data from the ZUMA-7 study led to its approval for the initial treatment of R/R LBCL in April 2022 in the United States and in the European Union in October 2022.

Gilead is looking to strengthen its position in the lucrative oncology space. Gilead’s another CAR T-cell therapy, Tecartus (brexucabtagene autoleucel), is approved for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (“MCL”) and relapsed or refractory B-cell precursor acute lymphoblastic leukemia (“ALL”).

The oncology business put up a stellar performance in 2022 and fueled the top line. The Cell Therapy franchise, comprising Yescarta and Tecartus, saw its sales increase by 68% from a year ago to $1.5 billion in 2022, primarily due to higher demand for Yescarta in R/R LBCL as well as Tecartus in R/R ALL and MCL.

Shares of Gilead gained 33.1% in the past year against the industry’s decline of 14.2%.


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The uptake of the breast cancer drug Trodelvy was also strong in 2022.


Gilead is making efforts to strengthen its pipeline in this space through strategic collaborations.

Gilead recently exercised its option to exclusively license Nurix Therapeutics’ (NRIX - Free Report) investigational targeted protein degrader molecule NX 0479.

Both companies announced a global strategic collaboration in 2019 to discover, develop and commercialize a pipeline of innovative targeted protein degradation drugs for cancer patients and other challenging diseases.

Bivalent degrader NX 0479, designated as GS-6791, is the first development candidate resulting from this collaboration.

The GS-6791 is a potent, selective, oral IRAK4 degrader that targets both the scaffold and kinase functions of the IRAK4 protein kinase to block inflammatory responses downstream of toll-like receptors (TLR) and the pro-inflammatory IL1 cytokine family of receptors (IL1Rs). The IRAK4 degradation has potential applications in the treatment of rheumatoid arthritis and other inflammatory diseases.

Zacks Rank and Stocks to Consider

Gilead currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Some better-ranked stocks in the overall healthcare sector are Novo Nordisk (NVO - Free Report) and Ligand Therapeutics (LGND - Free Report) , both sporting a Zacks Rank #1 at present.

In the past 30 days, estimates for Novo Nordisk’s 2023 earnings per share have risen from $4.20 to $4.43. Estimates for 2024 have increased 29 cents to $5.19.

Ligand’s earnings per share estimates for 2023 increased to $4.32 from $3.30 in the past 30 days. LGND beat earnings estimates in one of the last four reported quarters.


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