Gilead Sciences and Merck have signed an agreement to assess the efficacy of Trodelvy (sacituzumab govitecan-hziy) in combination with Keytruda (pembrolizumab) to treat patients with metastatic triple-negative breast cancer (TNBC).
As part of the clinical trial partnership and supply agreement, the combination of Gilead’s Trodelvy and Merck’s Keytruda will be evaluated as a first-line treatment for patients with locally advanced or metastatic TNBC.
An antibody and topoisomerase inhibitor conjugate, Trodelvy targets Trop-2 receptor, which is a protein often expressed in different types of epithelial tumours, including metastatic TNBC and metastatic urothelial cancer (UC).
It targets Trop-2 expressing cells to allow the local delivery of a cytotoxic payload that destroys the targeted cells.
Under the deal, Gilead will provide funding for a global Phase III clinical study to assess the combination treatment against the standard treatment with Keytruda and chemotherapy combination.
According to the company, metastatic TNBC has the lowest survival rate among other types of breast cancers and has an urgent requirement for new treatments that can improve outcomes in patients.
Gilead Sciences chief medical officer Merdad Parsey said: “Trodelvy has already been established as a preferred treatment option in second-line metastatic TNBC.
“Looking ahead, we are excited about the opportunity to advance Trodelvy as a potential treatment for first-line metastatic TNBC. This helps further our ambition of displacing chemotherapy with Trodelvy to improve outcomes for people living with cancer.”
The company expects that the combination of Trodelvy with Keytruda might offer a novel therapy for first-line metastatic TNBC.
Furthermore, the combination therapy is not approved by any regulatory authorities in any therapy setting while its safety and efficacy are still being investigated.