Trodelvy-Keytruda combo improves cancer trial outcomes

FOSTER CITY, Calif. - Gilead Sciences, Inc. (NASDAQ:GILD), a prominent player in the biotechnology industry with a market capitalization of $130.32 billion, announced today that its Phase 3 ASCENT-04/KEYNOTE-D19 study has met its primary endpoint, showing significant improvement in progression-free survival (PFS) for patients with PD-L1+ metastatic triple-negative breast cancer (mTNBC) treated with Trodelvy and Keytruda compared to the standard Keytruda and chemotherapy treatment. According to InvestingPro analysis, Gilead maintains a strong financial health rating, positioning it well to advance its drug development pipeline.

The study, which enrolled 443 patients with inoperable locally advanced or mTNBC, demonstrated that the combination of Trodelvy (sacituzumab govitecan-hziy) and Keytruda (pembrolizumab) led to a clinically meaningful advance in PFS. The safety profile of the combination was consistent with the known profiles of each drug, and no new safety signals were identified. With annual revenue of $28.75 billion and an impressive gross profit margin of 78.26%, Gilead has demonstrated strong commercial execution in its therapeutic programs.

Dietmar Berger, MD, PhD, Chief Medical Officer at Gilead Sciences, stated that these findings could potentially redefine treatment options for patients with this challenging type of breast cancer. Dr. Sara Tolaney, MD, MPH, from the Dana-Farber Cancer Institute and primary investigator of the study, suggested that combining a potent antibody-drug conjugate with immunotherapy could improve outcomes for patients.

Although overall survival (OS) is a key secondary endpoint, it was not mature at the time of the PFS analysis. However, there was an early indication of improved OS with the Trodelvy plus Keytruda regimen. Gilead will continue to monitor OS outcomes with ongoing patient follow-up and further analyses.

Trodelvy is the only Trop-2-directed antibody-drug conjugate approved for mTNBC and pre-treated HR+/HER2- mBC, recognized as a preferred treatment by the National Comprehensive Cancer Network. The drug has been used in over 50,000 patients across approximately 50 countries for about five years, showing consistent outcomes across clinical trials and real-world studies.

Gilead is conducting several ongoing Phase 3 studies to investigate Trodelvy’s effectiveness in various stages and types of breast cancer, as well as in lung and gynecological cancers. The company expressed gratitude to the patients, families, investigators, and advocates involved in the research and reaffirmed its commitment to addressing unmet needs within the breast cancer community.

The use of Trodelvy plus Keytruda in patients with previously untreated PD-L1+ mTNBC remains investigational, and its safety and efficacy have not been established. Detailed results from the ASCENT-04 study will be presented at a future medical meeting and discussed with regulatory authorities. With Gilead’s next earnings announcement scheduled for April 24, 2025, investors seeking deeper insights into the company’s pipeline and financial performance can access comprehensive analysis through InvestingPro, which offers exclusive access to over 30 key financial metrics and expert ProTips. Get access to Gilead’s detailed Pro Research Report, part of InvestingPro’s coverage of 1,400+ top US stocks, for expert analysis and actionable investment intelligence.

This article is based on a press release statement from Gilead Sciences, Inc.

In other recent news, Gilead Sciences has been in the spotlight due to multiple developments concerning its HIV prevention treatments. Analysts from Citi have maintained a Buy rating on Gilead stock with a $125 target, expressing confidence in the company’s commercial PrEP market despite potential federal funding cuts for HIV prevention. Similarly, BMO Capital Markets reiterated an Outperform rating with a $115 target, suggesting that Gilead’s PrEP business will remain stable even if government support diminishes. Bernstein analysts also maintained an Outperform rating, setting a $120 price target, and highlighted the high efficacy of Gilead’s upcoming PrEP treatment, lenacapavir, which is expected to significantly increase market penetration.

Meanwhile, Gilead Sciences announced a change in its executive team, with Sandra Patterson stepping down and Diane E. Wilfong named as the interim Corporate Controller and Chief Accounting Officer. Wilfong, who previously held the same position, brings extensive experience from her roles at other major corporations. This executive change is part of Gilead’s ongoing adjustments to its leadership team.

The Wall Street Journal reported that the U.S. Department of Health and Human Services is considering substantial funding cuts for domestic HIV prevention, which could impact Gilead’s business. However, Gilead continues to focus on advancing its HIV treatment offerings, with the anticipated launch of lenacapavir in mid-2025. Investors are closely watching these developments, as they could have significant implications for Gilead’s role in the HIV prevention market.

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