Trodelvy-Keytruda Combo Cuts PFS Risk by 35%, Valuation Upside at 13.4%

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NEJM published Gilead’s Phase 3 ASCENT-04/KEYNOTE-D19 trial showing Trodelvy plus Keytruda improved PFS by 35% (HR 0.65) in first-line PD-L1+ (CPS≥10) metastatic TNBC. A DCF-based analysis sets fair value at $141, implying 13.4% upside, backed by Q3 revenue growth of 4% and 22% non-GAAP EPS growth.

1. Gilead Backs Biomarker Collaboration in Phase II Bladder Cancer Study

Gilead Sciences has provided financial and drug supply support for the Phase II DAD-IO clinical trial (NCT04724018) led by Dana-Farber Cancer Institute, evaluating the combination of two antibody–drug conjugates (Sacituzumab Govitecan and Enfortumab Vedotin) with or without Pembrolizumab in patients with locally advanced or metastatic urothelial carcinoma. As the study progresses, 4D Path will apply its QPOR platform to baseline H&E biopsy slides, using physics-driven algorithms to generate predictive biomarkers of immune response and cell proliferation. Gilead’s support underscores its commitment to precision oncology and may pave the way for more tailored treatment strategies in bladder cancer.

2. NEJM Reports Positive Phase III Results for Sacituzumab Govitecan Plus Pembrolizumab

The New England Journal of Medicine published full results from the Phase III ASCENT-04/KEYNOTE-D19 trial assessing first-line therapy for PD-L1–high metastatic triple-negative breast cancer. Patients receiving the combination of Sacituzumab Govitecan and Pembrolizumab achieved a 35% reduction in risk of progression or death (hazard ratio 0.65) compared to control, meeting the study’s primary endpoint of progression-free survival. The publication in NEJM validates Gilead’s strategic focus on combining its antibody–drug conjugate with immunotherapy and sets the stage for potential label expansions and broader commercialization opportunities.

3. Valuation Upside Driven by Margin Expansion and Cash Flow Strength

Analysts project that Gilead is undervalued, with a discounted cash flow-based fair value estimate of $141 per share, implying approximately 13.4% upside. In the third quarter of 2025, the company delivered 4% year-over-year revenue growth and non-GAAP EPS growth of 22%, reflecting robust operational efficiency and margin expansion. Core antiviral franchises remain stable, while product launches and the recent Livdelzi acquisition support diversification. Strong free cash flow generation and disciplined capital allocation underpin the bullish investment thesis for Gilead.

Sources

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