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Gilead to Pursue Expanded Breast Cancer Indication for Trodelvy Following Phase III Data

NEW YORK – Gilead Sciences said on Monday that Trodelvy (sacituzumab govitecan-hziy) met its primary endpoint in the Phase III TROPiCS-02 trial, opening the door for the drugmaker to seek regulatory approval for the treatment in hormone receptor (HR)-positive, HER2-negative metastatic breast cancer.

Gilead said in a statement that Trodelvy improved progression-free survival over physician's choice of chemotherapy in HR-positive, HER2-negative metastatic breast cancer patients who were previously treated with endocrine therapy, CDK4/6 inhibitors, and at least two chemo regimens. In the TROPiCS-02 trial, researchers had expected Trodelvy to reduce the risk of disease progression or death by 30 percent versus the control arm.

Additionally, Gilead said that as of the first interim analysis, Trodelvy-treated patients appeared to have better overall survival, which is a secondary study endpoint, compared to those on physician's choice of chemotherapy. The company did not find any new safety signals. The Foster City, California-based firm will present more detailed efficacy and safety data at an upcoming medical meeting.

In a company statement, Merdad Parsey, chief medical officer at Gilead, said the drugmaker is evaluating the data with plans to "explore potential pathways with regulatory authorities to bring Trodelvy to this group of patients." In a call to discuss fourth quarter 2021 financial earnings last month, Parsey said that Gilead expects to file for regulatory approval for this indication during the second half of 2022.

An approval based on the TROPiCS-02 data would allow Gilead to greatly increase its market size for Trodelvy. The Trop-2 directed antibody-drug conjugate initially received accelerated approval from the US Food and Drug Administration as a second-line treatment for triple-negative breast cancer in April 2020 and full approval a year later. The European Commission approved Trodelvy for the same indication this past November.