Gilead Sciences Inc filed an additional Biologics License Application with the FDA for sacituzumab govitecan-hziy (Trodelvy) following promising trial results.
Treatment with sacituzumab govitecan-hziy (Trodelvy, Gilead Sciences Inc) produced clinically significant and meaningful results in improved overall survival (OS) in patients with hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2) metastatic breast cancer who had previously treated with endocrine therapy, CDK4/6 inhibitors and 2 to 4 lines of chemotherapy.
These results were from a second interim analysis of the phase 3 TROPiCS-02 study of sacituzumab govitecan-hziy in 543 patients (HER2-low or IHC 0 status).
“These survival results from the TROPiCS-02 trial are important to the breast cancer community and we are encouraged by the potential this may have to help patients who otherwise have limited alternatives,” said Merdad Parsey, MD, PhD, chief medical officer, Gilead Sciences, in a press release.
The primary endpoint of the study is progression-free survival for patients taking sacituzumab govitecan-hziy, as assessed by a blinded independent central review (BICR). Secondary endpoints are OS, overall response rate (ORR), clinical benefit rate, duration of response and assessment of safety, tolerability and quality of life.
TROPiCS-02 is a global, multicenter, open-label, randomized 1:1 Phase 3 study evaluating sacituzumab govitecan-hziy versus physician-prescribed chemotherapy for patients with HR+/HER2 metastatic breast cancer.
HR+/HER2 breast cancer is responsible for 70% of all breast cancers. About 400,000 people are diagnosed worldwide every year and about 33% of all early stages of breast cancer will spread to other parts of the body. The 5-year relative survival rate for these patients fluctuates around 30%.
Endocrine therapy is the first line of defense for HR+/HER2-metastatic breast cancer. If the cancer persists, individuals will receive single-agent chemotherapy. Patients will typically receive several rounds of chemotherapy, although this has a low success rate.
Sacituzumab govitecan-hziy is a conjugated Trop-2 targeting antibody and topoisomerase inhibitor previously approved for the treatment of patients with triple negative breast cancer who have received at least 2 prior therapies for metastatic disease. The FDA also granted accelerated approval for sacituzumab govitecan-hziy in April 2021 based on duration and level of tumor response for the treatment of patients with locally advanced or metastatic urothelial cancer who previously received platinum-containing chemotherapy and either a programmed cell death protein 1 . or programmed death ligand 1 inhibitor.
This drug is approved in more than 35 countries for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer who were previously treated for metastatic disease. In the United States, studies such as TROPiCS-02 are investigating sacituzumab govitecan-hziy for the treatment of HR+/HER2-metastatic breast cancer.
Other studies are investigating sacituzumab govitecan-hziy for metastatic non-small cell lung cancer, metastatic small cell lung cancer, head and neck cancer, and endometrial cancer.
The most common side effects of sacituzumab govitecan-hziy treatment include severe and life-threatening neutropenia and severe diarrhea.
“We look forward to discussing these results with global health authorities, as patients with pre-treated HR+/HER2-metastatic disease currently have limited treatment options and poor quality of life,” Parsey concluded in the press release.
Gilead Sciences, Inc. Trodelvy significantly improves overall survival in patients with pre-treated HR+/HER2 metastatic breast cancer in the TROPiCS-02 trial. Gilead website. August 15, 2022. Accessed August 16, 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