Gilead Sciences reported that its antibody‑drug conjugate Trodelvy did not achieve the primary endpoint of progression‑free survival in the ASCENT‑07 phase 3 study of HR+/HER2‑negative metastatic breast cancer, a first‑line setting that represents a large and lucrative market for the company.
The trial enrolled 654 patients and compared Trodelvy to physician’s choice chemotherapy. Progression‑free survival, assessed by blinded independent central review, was the primary endpoint, and Trodelvy failed to reach statistical significance versus chemotherapy, ending the study’s main objective.
The setback is a significant blow to Gilead’s oncology strategy. Trodelvy is a cornerstone of the company’s TROP2 antibody‑drug conjugate platform, and the failure could delay a regulatory submission for this indication and reduce the drug’s overall revenue potential. The company still maintains strong approvals for Trodelvy in metastatic triple‑negative breast cancer and pre‑treated HR+/HER2‑negative metastatic breast cancer, and an early trend favoring overall survival in the ASCENT‑07 cohort remains under investigation.
Gilead’s Q3 2025 earnings, released the same week, beat expectations with total product sales of $7.3 billion and a non‑GAAP diluted EPS of $2.47, up from $2.02 in Q3 2024. The company raised its full‑year 2025 product sales guidance to $27.4‑$27.7 billion and reiterated a strong outlook for its pipeline. CEO Daniel O’Day emphasized that “with multiple potential product launches in 2026, the strongest clinical pipeline in Gilead’s history, and no major loss of exclusivity expected until 2036, we are well‑positioned to drive positive impact for patients and continued growth of our business.”
Investors reacted to the trial failure with caution, but the strong earnings beat and the company’s optimistic pipeline outlook tempered the negative sentiment. Analysts noted that while the first‑line breast cancer indication is a sizable market, Trodelvy’s continued success in other indications and the potential for an overall‑survival benefit could mitigate the impact. Competition in the HR+/HER2‑negative metastatic breast cancer space remains intense, and the ASCENT‑07 result may open opportunities for rival therapies.
Gilead’s strategy moving forward will focus on leveraging its robust pipeline, maintaining momentum in its HIV and liver‑disease segments, and pursuing additional indications for Trodelvy. The company will continue to monitor overall‑survival data from ASCENT‑07, and management remains confident that the drug’s broader oncology portfolio will sustain growth despite the setback in this particular trial.
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