Everest and Gilead Announce Positive Phase 3 Results of Breast Cancer Drug

Shanghai’s Everest Medicines announced that its licensing partner, Gilead Sciences reported positive results from the primary analysis of the Phase 3 TROPiCS-02 study of Trodelvy in metastatic breast cancer patients. The study compared Trodelvy with chemotherapy in HR+/HER2- metastatic breast cancer patients who received prior endocrine therapy, CDK4/6 inhibitors, and two to four lines of chemotherapy.

The data presented at the annual meeting of the American Society of Clinical Oncology (ASCO) showed progression-free survival for the Trodelvy group of 5.5 months compared with 4 months for chemotherapy patients. Most HR+/HER2- metastatic breast cancers will ultimately become resistant to endocrine therapy, treatment is then limited to chemotherapy, with declining response, and decreased quality of life. The study demonstrated that at the one-year mark, three times as many patients were progression-free when treated with Trodelvy.

Related article: Shanghai’s Everest Medicines Licenses COVID-19 Oral Antivirals from Singapore’s National Drug Discovery Platform 

Tumor-Targeting Antibody-Drug Conjugate

Trodelvy (sacituzumab govitecan-hziy) is a drug connected with a Trop-2 directed antibody. Trop-2 is a cell surface antigen highly expressed in various tumor types, including in over 90% of breast and bladder cancers. Trodelvy’s proprietary design delivers potent activity to both Trop-2 expressing cells and the microenvironment.

“In TROPiCS-02, we enrolled heavily pre-treated patients with metastatic breast cancer who had disease progression following multiple lines of chemotherapy. To observe a clinically meaningful reduction in the risk of disease progression or death in these patients with limited treatment options is remarkable. Sacituzumab govitecan-hziy will be an important potential future treatment option for these patients” said Dr. Hope Rugo, Professor of Medicine and Director of Breast Oncology and Clinical Trials Education at the University of California San Francisco Comprehensive Cancer Center

Under a 2019 licensing agreement with Gilead Sciences’ Immunomedics, Everest Medicines has exclusive rights to develop, register, and commercialize Trodelvy for all cancer indications in Greater China, South Korea, and certain Southeast Asian countries.

Trodelvy is currently approved for locally advanced or metastatic urothelial cancer and unresectable locally advanced or metastatic triple-negative breast cancer in the US. The drug’s sales for Q4 2021 were $118 million, and is expected to reach $2 billion in 2026.

Author

Fujie Tham