A supplemental Biologics License Application (sBLA) has been submitted to the Food and Drug Administration (FDA) for sacituzumab govitecan-hziy for the treatment of patients with HR+/HER2- metastatic breast cancer who received prior endocrine therapy, CDK4/6 inhibitors and 2 to 4 lines of chemotherapy.

Sacituzumab govitecan, a Trop-2-directed antibody and topoisomerase inhibitor conjugate, binds to Trop-2-expressing cancer cells and is internalized with the subsequent release of SN-38, the active metabolite of irinotecan. The resulting DNA damage leads to apoptosis and cell death.

The sBLA submission includes data from the global, multicenter, open-label phase 3 TROPiCS-02 study (ClinicalTrials.gov Identifier: NCT03901339) that evaluated the efficacy and safety of sacituzumab govitecan in 543 previously treated adults with HR+/HER2- metastatic breast cancer. Patients were randomly assigned 1:1 to receive sacituzumab govitecan or physician’s choice of chemotherapy (eribulin, capecitabine, gemcitabine, or vinorelbine).

According to a second interim analysis, results demonstrated that treatment with sacituzumab govitecan met the key secondary endpoint achieving a statistically significant and clinically meaningful benefit for overall survival compared with chemotherapy. The safety profile of sacituzumab govitecan was consistent with that seen in previous studies, and no new safety signals identified.

Detailed overall survival results will be presented at an upcoming medical conference. 

“These survival results from the TROPiCS-02 study are important for the breast cancer community and we are encouraged by the potential this may have in helping patients who otherwise have limited alternatives,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “We look forward to discussing these results with global health authorities, as pre-treated HR+/HER2- metastatic disease patients currently have limited treatment options and poor quality of life.”

Sacituzumab govitecan-hziy is currently marketed under the trade name Trodelvy and is approved for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received 2 or more prior systemic therapies, at least 1 of them for metastatic disease.

Trodelvy is also indicated for the treatment of adults with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor.

Reference

Trodelvy® significantly improves overall survival in pre-treated HR+/HER2- metastatic breast cancer patients in the TROPiCS-02 study. News release. Gilead Sciences, Inc. Accessed August 15, 2022. https://www.gilead.com/news-and-press/press-room/press-releases/2022/8/trodelvy-significantly-improves-overall-survival-in-pretreated-hrher2-metastatic-breast-cancer-patients-in-the-tropics02-study