Gilead Sciences and MSD – known as Merck in the US and Canada – have announced a clinical trial collaboration to test a combination of Gilead’s Trodelvy and MSD’s Keytruda for the first-line treatment of certain triple-negative breast cancer (TNBC) patients.
As part of the agreement, Gilead will sponsor a global Phase III clinical trial evaluating Trop-2 targeting antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan-hziy) in combination with MSD’s anti-PD-1 therapy Keytruda (pembrolizumab).
The trial will compare the combination treatment to standard of care Keytruda plus chemotherapy in first-line patients with locally advanced or metastatic TNBC.
"Trodelvy has already been established as a preferred treatment option in second-line metastatic TNBC," said Merdad Parsey, chief medical officer, Gilead Sciences.
"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,” he added.
Gilead’s Trodelvy is designed to specifically target Trop-2 expressing cells to enable local delivery of a cytotoxic payload, which selectively kill the targeted cells.
In the US, Trodelvy’s prescribing information includes a boxed warning for sever or life-threatening neutropenia and severe diarrhoea.