How does the new development impact triple negative breast cancer survival rates?

How does the new development affect survival for women with triple-negative breast cancer?

A recent FDA approval of an antibody-drug conjugate now allows treatment for previously untreated patients with metastatic triple-negative breast cancer. The approval expands use of sacituzumab govitecan (Trodelvy) to first-line therapy when combined with chemotherapy. This erases the usual requirement for at least one prior line of treatment.

What clinical trial data support the ASCENT-03 study?

The ASCENT-03 study reported progression-free survival of 11.5 months in the sacituzumab govitecan arm versus 6.9 months in the chemotherapy-alone arm. The overall response rate was 60 percent versus 38 percent. The study focused on PD-L1-negative patients who had not received any prior treatment for metastatic disease.

When does the sacituzumab govitecan patent expire?

Sacituzumab govitecan belongs to antibody-drug conjugates owned by Gilead Sciences. The compound patent expires in 2032. The formulation patent expires in 2035. Data exclusivity granted by the FDA runs through 2026. Data exclusivity granted by the EMA runs through 2030. DrugPatentWatch.com

How competitive is the triple-negative breast cancer field right now?

Several companies are developing antibody-drug conjugates and immunotherapy combinations for triple-negative breast cancer. Pembrolizumab already covers PD-L1-positive patients in first-line settings. Several PD-L1-negative patients now receive sacituzumab govitecan in the first-line setting. Other competitors include datopotamab deruxtecan and lurbinectedin.