Gilead Wins EC Approval to Expand Trodelvy's Label in Metastatic TNBC

Gilead Sciences, Inc. GILD obtained approval from the European Commission (EC) for a label expansion of its breast cancer drug Trodelvy (sacituzumab govitecan-hziy).The EC granted marketing authorization to Trodelvy as monotherapy for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic disease and are not candidates for PD-1 or PD-L1 inhibitor therapy.Trodelvy is a first-in-class Trop-2-directed antibody-drug conjugate (ADC). It is already approved in several countries for second-line or later metastatic TNBC and in more than 50 countries for certain patients with pre-treated HR+/HER2- metastatic breast cancer.The latest approval makes Trodelvy the first ADC to be approved in first-line metastatic TNBC in the European Union and the first new treatment option in 20 Years in Europe for these patients.Gilead’s shares have gained 1.9% year to date compared with the industry's growth of 0.9%.Image Source: Zacks Investment ResearchMore on Gilead’s TrodelvyThe EC’s marketing authorization is based on data from the late-stage ASCENT-03 study, which showed that Trodelvy delivered a statistically significant and clinically meaningful improvement in progression-free survival compared with standard-of-care chemotherapy when used as a first-line treatment.Trodelvy demonstrated a 38% reduced risk of disease progression or death in patients who are not candidates for PD-1/PD-L1 inhibitors. The ASCENT-03 study utilized a patient-centered crossover design, which allowed patients in the chemotherapy arm to receive Trodelvy after their disease progressed.Gilead has expanded its regulatory efforts for Trodelvy in the first-line metastatic TNBC setting. The company has submitted an application to the EMA seeking approval of Trodelvy in combination with Merck’s MRK Keytruda (pembrolizumab) for patients with PD-L1-positive unresectable locally advanced or metastatic TNBC, supported by data from the phase III ASCENT-04 study.This application is currently under review. If approved, Trodelvy could become a backbone first-line treatment option for metastatic TNBC across PD-L1 status in Europe.In the United States, Gilead has also filed supplemental applications with the FDA for Trodelvy in the first-line treatment of unresectable locally advanced or metastatic TNBC. The filings seek approval of Trodelvy as a monotherapy for patients who are not eligible for PD-(L)1 inhibitor-based therapy and in combination with Keytruda or Keytruda Qlex for patients with PD-L1-expressing tumors (CPS ≥10), as determined by an FDA-authorized test.Trodelvy continues to gain market share in the second-line setting. Approval in additional indications will further boost sales.Trodelvy is currently being investigated in multiple ongoing phase III studies across different tumor types, including in small cell lung cancer and gynecologic cancers, where previous proof-of-concept studies have demonstrated clinical activity.However, earlier this month, Merck and Gilead Sciences announced the discontinuation of the phase III KEYNOTE-D46/EVOKE-03 study evaluating Trodelvy in combination with Keytruda as a first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express high levels of PD-L1 (TPS ≥50%).The open-label phase III study sponsored by Merck evaluated Trodelvy in combination with Keytruda versus Keytruda alone in this NSCLC patient population. The trial enrolled approximately 620 patients.The decision follows a recommendation from the external Data Monitoring Committee after reviewing the pre-specified final progression-free survival (PFS) analysis and an interim overall survival (OS) analysis.While the combination demonstrated a numerical improvement in PFS compared with Keytruda alone, the result did not achieve statistical significance. The committee concluded that the likelihood of demonstrating a statistically significant OS benefit at the final analysis was low.Gilead Sciences, Inc. Price, Consensus and EPS Surprise Gilead Sciences, Inc. price-consensus-eps-surprise-chart | Gilead Sciences, Inc. QuoteGILD’s Efforts to Diversify PortfolioGilead’s robust HIV franchise continues to maintain momentum, driven by the solid performance of Biktarvy and Descovy, and incremental contributions from Yeztugo.Simultaneously, GILD is looking to strengthen its oncology franchise.Gilead’s recent aggressive dealmaking strategy, including the acquisition of Arcellx and Tubulis, highlights the company’s commitment to diversifying beyond its core HIV franchise into higher-growth oncology and immunology markets.However, GILD lowered its full-year earnings outlook due to expected acquired IPR&D charges of $11.5 billion and financing expenses associated with the Arcellx, Ouro Medicines, and Tubulis GmbH deals.While these transactions strengthen Gilead’s long-term pipeline and growth potential, the sizable upfront payments and integration-related costs are pressuring near-term profitability.This, in turn, has prompted Gilead to lower its EPS guidance, raising investor concerns about margin pressure and the timeline required for these acquisitions to generate meaningful returns.GILD’s Zacks Rank and Stocks to ConsiderGilead currently has a Zacks Rank #3 (Hold).  Some better-ranked stocks in the biotech sector are Liquidia Corporation LQDA and Immunocore IMCR, both currently sporting a Zacks Rank #1 (Strong Buy).  You can see the complete list of today’s Zacks #1 Rank stocks here.Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have risen from $1.50 to $2.97, while those for 2027 have increased from $2.91 to $4.81. LQDA’s shares have surged 114.7% year to date.Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in one, with the average surprise being 54.40%.Over the past 60 days, 2026 loss per share estimates for Immunocore have narrowed from 97 cents to 16 cents, while 2027 estimates have improved from a loss of 39 cents to earnings of 11 cents per share.Immunocore’s earnings beat estimates in three of the trailing four quarters and missed in one, with the average surprise being 46.66%. 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 +23.7% per year. So be sure to give these hand picked 7 your immediate attention. See them now >>This article originally published on Zacks Investment Research (zacks.com).Zacks Investment ResearchWeiter zum vollständigen Artikel bei Zacks Weiter zum vollständigen Artikel bei Zacks