Trodelvy shows promise in metastatic breast cancer trial

FOSTER CITY, Calif. - Gilead Sciences, Inc. (NASDAQ:GILD), a prominent biotechnology company with a market capitalization of $132.78 billion and an impressive 78.29% gross profit margin, has announced successful results from a Phase 3 trial, ASCENT-03, for its drug Trodelvy (sacituzumab govitecan-hziy), signaling a potential new treatment option for certain patients with metastatic triple-negative breast cancer (mTNBC). According to InvestingPro analysis, Gilead maintains a "GREAT" financial health score, positioning it well to advance its innovative drug pipeline. The trial met its primary endpoint, showing a significant improvement in progression-free survival (PFS) compared to standard chemotherapy in patients with first-line mTNBC who are not eligible for PD-1/PD-L1 inhibitors.

The study’s findings are particularly relevant for nearly half of mTNBC patients who do not currently receive treatment beyond first-line therapy. Dr. Javier Cortes, the principal investigator of the ASCENT-03 study, underscored the urgent need for innovative treatments in this early setting, where traditional chemotherapy has been the standard. The ASCENT-03 outcome marks the first significant advance for this patient group in over two decades. With annual revenue of $28.73 billion and strong cash flows, Gilead demonstrates the financial capability to bring breakthrough treatments to market. For detailed financial analysis and 10+ additional ProTips, visit InvestingPro.

Trodelvy’s safety profile in the trial was consistent with previous studies, with no new safety concerns identified. While overall survival (OS) data is not yet mature, no detriment to OS was observed. Gilead plans to continue monitoring OS outcomes and conduct further analysis.

The drug, already utilized in over 60,000 patients across more than 50 countries, is the only approved Trop-2-directed antibody-drug conjugate (ADC) that has shown survival advantages in two different types of metastatic breast cancers. With four positive Phase 3 trials for HER2- metastatic breast cancer, Trodelvy is also a preferred treatment per the National Comprehensive Cancer Network® (NCCN®) guidelines and holds high ratings on the ESMO Magnitude of Clinical Benefit Scale (MCBS) for both mTNBC and HR+/HER2- metastatic breast cancer.

Gilead is conducting additional Phase 3 studies investigating Trodelvy across various HER2- breast cancers and in other tumor types. The company expressed gratitude to the patients, families, investigators, and advocates involved in the research and remains committed to addressing unmet needs in breast cancer care. With expectations of net income growth this year and trading near its Fair Value, Gilead continues to demonstrate strong market positioning. Access comprehensive analysis and the full Pro Research Report on Gilead, along with 1,400+ other top stocks, exclusively on InvestingPro.

The detailed results from the ASCENT-03 study will be presented at a future medical meeting and are set to be discussed with regulatory authorities. It is important to note that the use of Trodelvy in first-line mTNBC remains investigational, and its safety and efficacy for this use have not been established. This report is based on a press release statement from Gilead Sciences, Inc.

In other recent news, Gilead Sciences reported its first-quarter 2025 earnings, surpassing Wall Street expectations with an earnings per share (EPS) of $1.81, while revenue reached $6.67 billion, slightly below the anticipated $6.78 billion. Gilead’s HIV product sales, particularly Biktarvy, showed strong growth, contributing to the company’s overall performance despite competitive pressures in the cell therapy market. In a significant legal development, Gilead agreed to a $202 million settlement to resolve a civil fraud lawsuit related to kickbacks to doctors for prescribing its HIV drugs. Additionally, Gilead is preparing to present new liver disease treatment data at the European Association for the Study of the Liver Congress, highlighting its ongoing research efforts. The company recently held its annual stockholders meeting, where nine directors were re-elected, and Ernst & Young LLP was ratified as the independent registered public accounting firm for the fiscal year ending December 31, 2025. During the meeting, stockholders approved the compensation of Named Executive Officers but rejected proposals related to CEO pay ratio and a comprehensive human rights policy. Lastly, S&P upgraded Gilead’s long-term debt rating to A- with a stable outlook, reflecting confidence in the company’s steady revenue growth and strong cash flow generation.

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