Gilead and Kite to present new oncology data, including late-breaking Trodelvy results, at ESMO 2025

Gilead Sciences, Inc. and Kite, a Gilead Company, will demonstrate progress in our commitment to transform how cancer is treated with new data at the European Society for Medical Oncology (ESMO) 2025 Congress October 17 – 21.

Potentially Practice-Changing Results for First-Line Metastatic TNBC Treatment

A late-breaking presentation (#LBA20) will feature full results from the Phase 3 ASCENT-03 study of Trodelvy^® (sacituzumab govitecan-hziy) as a first-line treatment in people with metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitors. Gilead previously announced that ASCENT-03 met its primary endpoint, demonstrating a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS) with Trodelvy compared to chemotherapy in this patient population, potentially offering the first major treatment advance for this patient population since TNBC was classified as a disease 20 years ago.

Late-breaking results will also be presented (#LBA22) from an analysis evaluating quality of life among patients receiving Trodelvy plus Keytruda^® (pembrolizumab) versus Keytruda and chemotherapy in the positive ASCENT-04/KEYNOTE-D19 study in first-line PD-L1+ metastatic TNBC. Primary results from the ASCENT-04 study were recently presented during a late-breaking oral session at the 2025 ASCO Annual Congress.

The use of Trodelvy plus Keytruda in patients with first-line PD-L1+ metastatic TNBC and Trodelvy as monotherapy in patients with first-line metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitors are investigational, and the safety and efficacy of these uses have not been established.

“With ASCENT-04 and now ASCENT-03, our data underscore the potential of Trodelvy to be a standard of care option for all first-line metastatic triple-negative breast cancer patients regardless of PD-L1 status,” said Dietmar Berger, MD, PhD, Chief Medical Officer, Gilead Sciences. “This progress reflects our broader oncology strategy – advancing innovative therapies into earlier lines of treatment, expanding the types of cancer we can treat and applying the very latest innovation to the most challenging forms of cancer, including gastroesophageal, lung and gynecological cancers.”

Expanding Impact in Gastric and Esophageal Cancers

Together with Arcus Biosciences, Gilead will also share the first overall survival (OS) results from Arm A1 of the Phase 2 EDGE-Gastric study (#2112MO) evaluating first-line, combination treatment of the Fc-silent anti-TIGIT antibody domvanalimab, plus the anti-PD-1 monoclonal antibody zimberelimab and chemotherapy in people with advanced gastric or esophageal cancer that has spread or cannot be removed with surgery. In Arm A1 of the study, 50 percent of patients went on to live for more than two years, with a median OS of 26.7 months.

No unexpected safety signals were observed at the time of data cut off. The safety profile of domvanalimab plus zimberelimab and chemotherapy was generally well tolerated and is consistent with that of anti-PD-1 plus chemotherapy. Immune-mediated TEAEs related to domvanalimab and/or zimberelimab occurred in 9 patients (22%), and infusion-related reactions occurred in 3 patients (7%).

Domvanalimab and zimberelimab are investigational molecules, and neither Gilead nor Arcus has received approval from any regulatory authority for any use globally, and their safety and efficacy have not been established.

Summary of Presentations

View accepted abstracts at ESMO 2025 HERE (all times CEST)