GILD Announces Positive Data on Trodelvy in First-Line Breast Cancer

Gilead Sciences, Inc. GILD announced positive top-line results from yet another late-stage study on breast cancer drug, Trodelvy (sacituzumab govitecan-hziy).Data from the phase III ASCENT-03 study on Trodelvy showed highly statistically significant and clinically meaningful improvement in progression-free survival (PFS) in patients with first-line metastatic triple-negative breast cancer (mTNBC) who are not candidates for checkpoint inhibitors.This is the second positive phase III study in first-line mTNBC where Trodelvy has demonstrated a clinically meaningful benefit versus standard of care chemotherapy.Gilead’s shares have surged 17.1% year to date against the industry's decline of 5%.Image Source: Zacks Investment ResearchMore on GILD’s TrodelvyTrodelvy is a first-in-class Trop-2-directed antibody-drug conjugate.The ASCENT-03 study is a global, open-label, randomized phase III trial evaluating the efficacy and safety of Trodelvy compared with treatment of physician’s choice in patients with previously untreated, locally advanced, inoperable mTNBC whose tumors do not express PD-L1, or who are PD-L1 positive and previously treated with a PD-(L)1 inhibitor in the curative setting.Approximately 540 patients were enrolled across multiple study sites worldwide.These patients were randomized equally to receive either Trodelvy (10 mg/kg intravenously on Days 1 and 8 of a 21-day cycle) or treatment of the physician’s choice, which included gemcitabine plus carboplatin, paclitaxel, or nab-paclitaxel.The study met its primary endpoint, demonstrating a highly statistically significant and clinically meaningful improvement in PFS compared to chemotherapy in first-line mTNBC patients.The safety profile of Trodelvy in the ASCENT-03 study was consistent with the prior studies.Overall survival (OS) is a key secondary endpoint. The OS data was not mature at the time of PFS primary analysis. Hence, Gilead will continue to monitor OS outcomes, with ongoing patient follow-up and further analysis planned.Please note that Trodelvy is currently approved in more than 50 countries for second-line or later mTNBC patients and in several countries for certain patients with pre-treated HR+/HER2- metastatic breast cancer.Last month, Gilead announced positive top-line results from the phase III ASCENT-04/KEYNOTE-D19 study. Data showed Trodelvy plus Merck’s MRK blockbuster drug Keytruda (pembrolizumab) significantly improved PFS compared to Keytruda and chemotherapy in patients with inoperable (unresectable) locally advanced or mTNBC whose tumors express PD-L1. This study met its primary endpoint, showing a statistically significant and clinically meaningful improvement in PFS.    Per GILD, positive data from the ASCENT-03 and ASCENT-04 study demonstrate Trodelvy’s potential as the backbone treatment for all patients across first-line mTNBC.Gilead has additional ongoing phase III studies evaluating Trodelvy across HER2 breast cancer, including the ASCENT-07 pivotal trial in patients with HR+/HER2- mBC who have received endocrine therapy, and the ASCENT-05 pivotal trial in patients with early-stage TNBC (eTNBC). The drug is also being evaluated in additional late-stage studies across a range of tumor types, including lung and gynecologic cancers.Gilead Sciences, Inc. Price, Consensus and EPS Surprise Gilead Sciences, Inc. price-consensus-eps-surprise-chart | Gilead Sciences, Inc. QuoteGILD Looking to Diversify PortfolioGilead’s oncology portfolio, comprising the Cell Therapy franchise and breast cancer drug Trodelvy, has diversified its overall business. However, the Cell Therapy franchise, comprising Yescarta and Tecartus, is currently under pressure due to competitive headwinds in the United States and Europe that are expected to continue in 2025.The potential launch of anito-cel in multiple myeloma and Trodelvy in first-line metastatic triple-negative breast cancer in 2026 will strengthen the company’s oncology business.GILD is one of the dominant players in the HIV market.  Gilead’s efforts to constantly innovate its HIV portfolio should enable it to maintain growth amid competition from GSK plc.The company’s pipeline candidate, lenacapavir, demonstrated 100% efficacy for the investigational use of HIV prevention in cisgender women. The FDA accepted new drug application submissions for twice-yearly lenacapavir for HIV prevention under priority review, with a target action date of June 19, 2025.GILD has also collaborated with Merck to evaluate the investigational combination of islatravir and lenacapavir for the treatment of HIV. The potential launch of lenacapavir for PrEP in 2025 will be a significant boost for the company.GILD’s Zacks Rank and Stocks to ConsiderGilead currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the pharma/biotech sector are Novartis NVS and Pfizer PFE, both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.The Zacks Consensus Estimate Novartis’ 2025 earnings per share (EPS) has risen from $8.47 to $8.74 over the past 60 days. EPS estimates for 2026 have jumped 20 cents to $9.02 during this timeframe. The stock has risen 18.6% so far this year.Pfizer’s 2025 EPS estimate has risen from $2.97 to $3.06 in the past 60 days, while that for 2026 has gone up from $2.99 to $3.09 over the same timeframe. 7 Best Stocks for the Next 30 DaysJust released: Experts distill 7 elite stocks from the current list of 220 Zacks Rank #1 Strong Buys. They deem these tickers "Most Likely for Early Price Pops."Since 1988, the full list has beaten the market more than 2X over with an average gain of +23.0% per year. So be sure to give these hand picked 7 your immediate attention. See them now >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Novartis AG (NVS): Free Stock Analysis Report Pfizer Inc. (PFE): Free Stock Analysis Report Merck & Co., Inc. (MRK): Free Stock Analysis Report Gilead Sciences, Inc. (GILD): Free Stock Analysis ReportThis article originally published on Zacks Investment Research (zacks.com).Zacks Investment ResearchWeiter zum vollständigen Artikel bei Zacks Weiter zum vollständigen Artikel bei Zacks