FOSTER CITY, Calif. - Gilead Sciences, Inc. (NASDAQ:GILD) is set to present new data from its lung cancer clinical development program at the upcoming IASLC World Conference on Lung Cancer, scheduled for September 7-10 in San Diego. The data include findings from studies on Trodelvy® (sacituzumab govitecan-hziy) in treating various forms of lung cancer.
The Phase 2 EVOKE-02 study results, to be shared at the conference, show encouraging efficacy of Trodelvy in combination with pembrolizumab and carboplatin for previously untreated advanced or metastatic non-small cell lung cancer (mNSCLC) patients, particularly those with non-AGA-driven mNSCLC across PD-L1 status.
In addition to the EVOKE-02 data, Gilead will present a subgroup analysis from the EVOKE-01 study, which indicates a numerical improvement in overall survival (OS) for second-line mNSCLC patients who did not respond to their last anti-PD-(L)1-therapy, compared to those treated with docetaxel. However, it is important to note that this analysis was not alpha-controlled for formal statistical testing.
Furthermore, updated results from the Phase 2 TROPiCS-03 study in extensive stage small cell lung cancer (ES-SCLC) show promising activity with Trodelvy treatment in both platinum-resistant and platinum-sensitive disease, suggesting the need for further investigation in this area.
Trodelvy is a first-in-class Trop-2-directed antibody-drug conjugate, currently approved in almost 50 countries for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received at least two prior systemic therapies. It is also approved for certain pre-treated HR+/HER2- metastatic breast cancer patients in various countries, including the U.S., where it has accelerated approval for treatment of certain patients with second-line metastatic urothelial cancer.
Despite these promising findings, it is crucial to mention that Trodelvy has not received approval for the treatment of mNSCLC or ES-SCLC, and its safety and efficacy for these uses have not been established. The drug carries a Boxed Warning for severe or life-threatening neutropenia and severe diarrhea.
The information in this article is based on a press release statement from Gilead Sciences, Inc.
In other recent news, Gilead Sciences has seen a series of significant developments. The company's HIV prevention drug, lenacapavir, has shown impressive efficacy in the PURPOSE-1 PrEP study, leading RBC Capital to increase its probability of success estimate for the drug to 95%. The FDA also granted accelerated approval for Livdelzi, a treatment for Primary Biliary Cholangitis (PBC), seen by TD Cowen and BMO Capital Markets as a significant broadening of the PBC market.
Gilead reported a 6% year-over-year rise in total product sales during its second quarter of 2024, reaching $6.7 billion. This increase was driven by an 8% rise in sales for its HIV treatment, Biktarvy, and a 23% increase for the oncology drug, Trodelvy. Following these results, Gilead revised its full-year non-GAAP operating income and EPS guidance upwards.
Analysts from TD Cowen, BMO Capital Markets, and Truist Securities maintained positive outlooks on Gilead's stock, with price targets ranging from $83 to $85. These assessments reflect the potential market expansion for PBC treatments and the anticipated success of Livdelzi. The recent FDA approval and promising clinical data provide a strong foundation for Gilead's next steps in addressing the needs of PBC patients.
InvestingPro Insights
As Gilead Sciences, Inc. (NASDAQ:GILD) prepares to unveil new clinical data that could potentially expand the use of Trodelvy in lung cancer treatment, investors are closely monitoring the company's financial health and market position. According to InvestingPro, Gilead stands out with a high shareholder yield, indicating a commitment to returning value to investors. This is further supported by the company's track record of raising its dividend for 9 consecutive years, showcasing a reliable income stream for shareholders.
InvestingPro Data reveals that Gilead has a market capitalization of $98.52 billion and is trading at a forward P/E ratio of 12.57, suggesting that the stock is priced more reasonably relative to its earnings over the last twelve months as of Q2 2024. The company has also demonstrated a strong return over the last three months, with a price total return of 25.39%, signaling robust investor confidence. Additionally, Gilead's dividend yield stands at 3.89%, which is competitive within the biotechnology industry and attractive for income-focused investors.
Gilead's performance is not just about stock stability and dividends. As an influential player in the Biotechnology sector, the company's profitability is underscored by the InvestingPro Tip that analysts predict Gilead will be profitable this year, having been profitable over the last twelve months. Such financial resilience could be vital as the company invests in expanding the indications for its oncology portfolio.
For those interested in deeper financial analysis and more InvestingPro Tips, Gilead Sciences has an array of additional insights available on InvestingPro, which currently lists 10 tips in total for the company, including the potential impact of earnings revisions and the company's valuation multiples. Visit the detailed page at https://www.investing.com/pro/GILD for a comprehensive understanding of Gilead's investment profile.
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