Trodelvy–Keytruda Combo Yields 35% PFS Gain; Gilead Q3 EPS Jumps 22%

GILDGILD

NEJM published Phase 3 ASCENT-04/KEYNOTE-D19 results showing Trodelvy plus Keytruda achieved 35% PFS improvement (HR 0.65) in first-line PD-L1+ metastatic TNBC. Gilead’s Q3 2025 revenue rose 4% YoY and non-GAAP EPS jumped 22%, driven by margin expansion from Livteldi launch and acquisitions, supporting a DCF-based target implying 13.4% upside.

1. NEJM Publishes Pivotal Phase 3 ASCENT-04/KEYNOTE-D19 Data

Gilead Sciences announced that The New England Journal of Medicine has published full results from the Phase 3 ASCENT-04/KEYNOTE-D19 trial evaluating Trodelvy® combined with Keytruda® in first-line PD-L1-positive (CPS ≥10) metastatic triple-negative breast cancer. The study met its primary endpoint of progression-free survival with a hazard ratio of 0.65, representing a 35% reduction in risk of disease progression or death versus chemotherapy plus checkpoint inhibitor. Median PFS for the combination was 8.2 months compared with 5.7 months for the control arm. An interim overall survival analysis showed a trend toward benefit, with median OS not yet reached in the investigational arm versus 17.4 months in the comparator cohort. Safety data were consistent with known profiles of both agents, with manageable rates of neutropenia and immune-related events. These findings support the potential for Trodelvy plus Keytruda to become a new standard of care in this hard-to-treat population.

2. Margin Expansion and Cash Flow Strength Underlie Undervalued Thesis

Analysts maintain a Buy recommendation on Gilead Sciences based on robust operational performance and strong free cash flow generation. In Q3 2025, the company delivered 4% year-over-year revenue growth driven by sustained HIV franchise performance and early contributions from Livteldi. Non-GAAP EPS rose 22% as gross margins expanded by 250 basis points and operating leverage improved. Free cash flow margin reached 30%, enabling accelerated debt reduction and funding for targeted business development. A discounted cash flow model, incorporating conservative assumptions for new oncology assets and HIV renewals, suggests the stock trades at a double-digit discount to intrinsic value. Investors point to a diversified portfolio, pipeline catalysts in oncology and inflammation, and a capital allocation framework focused on shareholder returns and strategic reinvestment.

Sources

SB