The European Medicines Agency (EMA) has begun an accelerated review of Gilead’s Trodelvy for the treatment of advanced triple-negative breast cancer.
Gilead is seeking an EU authorisation for Trodelvy (sacituzumab govitecan-hziy) for the treatment of unresectable locally advanced or metastatic TNBC patients who have received at least two prior therapies.
Trodelvy, which Gilead acquired as part of its $21bn buyout of Immunomedics, is an antibody-drug conjugate (ADC) targeting Trop-2, a protein frequently expressed in multiple types of epithelial tumours including TNBC.
TNBC is a particularly aggressive type of cancer, and high expression of Trop-2 in particular is associated with poor survival and relapse.
The ADC was approved by the US Food and Drug Administration (FDA) in April last year for the treatment of metastatic TNBC.
That approval was supported by results from the phase 3 ASCENT study of Trodelvy in metastatic TNBC patients in the later stages of the treatment pathway.
Patients who received Trodelvy in this study had a median progression-free survival of 5.6 months, compared to 1.7 months for those who received chemotherapy alone.
For overall survival, the median rate for those treated with Trodelvy was 12.1 months versus 6.7 months in the chemotherapy group, with the results also showing that more cancers responded to Trodelvy compared to chemotherapy.
“Metastatic triple-negative breast cancer is an aggressive and life-threatening cancer. Unfortunately, for many people with this cancer, there are not enough effective treatment options and their prognosis is extremely poor,” said Merdad Parsey, chief medical officer, Gilead Sciences.
“The validation of our EU marketing application is an important step towards addressing the significant unmet medical need for people with metastatic triple-negative breast cancer,” he added.
The ADC is also being studied in an ongoing phase 3 trial in third line HR+/HER2-positive breast cancer, and a registrational phase 2 study in bladder cancer.
Gilead is also testing Trodelvy’s potential in non-small cell lung cancer and metastatic urothelial (bladder) cancer, either as a monotherapy or in combination with checkpoint inhibitors.