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Gilead announces positive new data for Trodelvy in metastatic breast cancer

The treatment demonstrated consistent efficacy across Trop-2 expression levels


Gilead Sciences (Gilead) has announced new data for Trodelvy (sacituzumab govitecan-hziy) demonstrating clinical efficacy across Trop-2 expression levels in patients with HR+/HER2- metastatic breast cancer who have progressed on endocrine-based therapies and at least two chemotherapies.

Trop-2, a protein found on the surface of cancer cells, is involved in several cellular processes regulating cancer growth and invasion. It is highly expressed in most human solid tumours, including more than 90% of breast cancers.

In the post-hoc analysis from the phase 3 TROPiCS-02 study, the antibody-drug conjugate improved progression-free survival, overall survival and objective response rate compared with physicians’ choice of chemotherapy across Trop-2 expression levels.

The safety profile for Trodelvy in TROPiCS-02 was consistent with prior studies, the company reported, with no new safety signals observed.

“This post-hoc analysis demonstrates that the level of Trop-2 expression on an individual’s tumour did not impact [Trodelvy] efficacy,” said Dr Hope Rugo, professor of medicine and director, breast oncology and clinical trials education at the University of California San Francisco Comprehensive Cancer Center.

HR+/HER2- breast cancer is the most common type of breast cancer, accounting for around 70% of all new cases, or nearly 400,000 diagnoses worldwide each year. Almost one in three cases of early-stage breast cancer eventually become metastatic, and as patients become resistant to endocrine-based therapy, their primary treatment option is limited to single-agent chemotherapy.

“The prognosis for patients with pre-treated HR+/HER2- metastatic breast cancer who have developed resistance to endocrine-based therapies has been poor, and these TROPiCS-02 study results demonstrate clinical efficacy with Trodelvy, across Trop-2 expression levels,” said Bill Grossman, senior vice president, therapeutic area head, Gilead Oncology.

Trodelvy is currently approved in more than 40 countries for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.

The US Food and Drug Administration (FDA) has also accepted for priority review the supplemental Biologics License Application for Trodelvy in adult patients with unresectable locally advanced or metastatic HR+/HER2- breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.

“Our ambition is to continue our impact beyond our current approval in second-line metastatic TNBC, and we look forward to advancing discussions with the FDA and global health authorities to help bring Trodelvy to more people living with metastatic breast cancer,” Grossman said.

Article by
Emily Kimber

7th December 2022

From: Research



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