Gilead says Trodelvy ASCENT-03 study meets primary endpoint

US antivirals major Gilead Sciences (Nasdaq: GILD) yesterday released positive top-line results from the Phase III ASCENT-03 study of Trodelvy (sacituzumab govitecan-hziy).

Gilead noted that the study met its primary endpoint, demonstrating a highly statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) compared to chemotherapy in patients with first-line metastatic triple-negative breast cancer (mTNBC) who are not candidates for PD-1/PD-L1 inhibitors, meaning they are PD-L1 negative or are ineligible to receive immunotherapy.

“Almost half of the patients diagnosed with metastatic triple-negative breast cancer do not receive treatment beyond first-line, demonstrating an urgent need for innovative treatment options in this early setting,” said Dr Javier Cortes, head of the International Breast Cancer Center in Spain and principal investigator of the ASCENT-03 study. “Traditional chemotherapy has been the standard of care for early treatment of metastatic triple-negative breast cancer, and we know that therapeutic advances in this disease area serve a critical unmet need for patients and the broader oncology community,” he noted.