DESTINY-Ovarian01 Phase 3 Trial of ENHERTU initiated as first-line maintenance therapy in patients with HER2 expressing advanced ovarian cancer

CAR-T Digest - August 2020

Weekly Digest - December 2025

09 December 2025: DESTINY-Ovarian01 Phase 3 Trial of ENHERTU initiated as first-line maintenance therapy in patients with HER2 expressing advanced ovarian cancer

The DESTINY-Ovarian01 Phase 3 trial has reached a key milestone, with the first patient now dosed in the randomization phase evaluating ENHERTU plus bevacizumab versus bevacizumab alone as first-line maintenance therapy for HER2-expressing advanced high-grade epithelial ovarian cancer
This milestone follows encouraging early signals, as the study builds directly on the clinically meaningful and durable responses seen in the ovarian cancer cohort of DESTINY-PanTumor02, prompting investigators to explore ENHERTU’s potential in earlier treatment settings
The medical need is significant, as advanced ovarian cancer carries a poor five-year survival rate and up to 80% of patients relapse after standard surgery and platinum-based chemotherapy, yet no HER2-directed maintenance therapies are currently approved despite HER2 expression in more than half of cases
Early data from DESTINY-PanTumor02 showed meaningful responses with ENHERTU, providing the rationale for moving into first-line maintenance, where investigators hope the ENHERTU–bevacizumab combination could establish a new standard for patients with HER2-expressing advanced ovarian cancer